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Gonazon

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Summary for the public


What is Gonazon?

Gonazon contains the active substance azagly-nafarelin. Gonazon is authorised as a concentrate that is made into a solution for injection for salmonid fish and also as an implant for dogs. Gonazon implant is rectangular in shape, off white, with dimensions of 14x3x1 mm.


What is Gonazon used for?

In fish, Gonazon is used to induce and synchronise ovulation (egg production) in female salmonids such as Atlantic salmon, rainbow trout, brown trout and Arctic charr for the production of eyed-eggs and fry. Following anaesthesia, the fish are injected intraperitoneally (into the area that contains the abdominal organs) along the central line, 1/2 to 1 fin length in front of the pelvic fin base. The recommended dose is 32 μg/kg bodyweight.

In bitches, Gonazon is also indicated for the prevention of gonadal function via long term blockade of gonadotrophin synthesis. Gonazon is injected subcutaneously, in the region of the umbilicus. The implant may be administered to bitches from the age of four months (blocking reproductive function for an average of 12 months) to 6 years (blocking reproductive function for an average of 11 months).


How does Gonazon work?

Gonazon contains azagly-nafarelin, which is an analogue of a natural hormone called gonadotrophinreleasing hormone (GnRH). GnRH controls reproduction in fish by increasing the secretion of the gonadotrophins controlling egg production.

In dogs, administration of higher doses of GnRH agonists over a period of time desensitises the pituitary gland with the result that release of gonadotrophins is suppressed, leading to a suppression of reproductive function.


How has Gonazon been studied?

In fish, Gonazon has been studied in three studies of rainbow trout, two studies of Altlantic salmon, and one study of Arctic charr. The main measure of effectiveness was the speed of response to treatment and the advance in time and synchronisation of the spawning period.

In bitches, the results of two field studies with Gonazon implants were provided, one investigating a single administration, another one the repeated application over a second year. Bitches treated with Gonazon generally failed to display heat during the study compared to bitches who did not receive the treatment. Good efficacy has been demonstrated for the prevention of heat and ovulation in adult bitches aged up to 7 years during the one or two years of treatment. Data on the return to oestrus, ovulatory oestrus and subsequent fertility once treatment has ended (i.e. once the implant had been removed) were limited, especially for repeated treatment.


What benefit has Gonazon shown during the studies?

In fish, the results of the trials showed that Gonazon was effective to induce and synchronise ovulation.

In most cases, an effect was induced within 6-11 days of treatment, and ovulation was generally advanced by 2-3 weeks. The use of Gonazon while not necessarily improving reproductive performance over the course of the spawning season, by synchronising spawning will shorten the time span dedicated to eyed egg production. This optimises organisation of the fish farm.

In bitches, it has been demonstrated that the insertion of a Gonazon implant will prevent heat and ovulation in adult bitches aged up to 7 years during the one or two years of treatment.


What is the risk associated with Gonazon?

In fish, the injection of Gonazon may be associated with a reduction in fecundity (ability to breed), egg quality and survival to the eyed-egg stage. In some cases this can be caused by use of Gonazon too early in the spawning season.

In bitches, Gonazon works by inhibition of the production of sex steroids and may be associated with rare cases of vaginitis in prepubertal females.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Operators should wear gloves when mixing the concentrate solution or handling the implant and avoid self injection.

In case of accidental contact with either the skin or the eyes, rinse thoroughly with water. If the concentrated solution or the diluted solution is spilled onto the skin or into the eyes, or the implant is accidentally self-injected, medical advice should be sought immediately. The package leaflet or the label should be shown to the doctor. Operators should wash their hands after use of the product.


Why has Gonazon been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Gonazon are greater than any risks for the induction and synchronisation of ovulation for the production of eyed-eggs and fry. Gonazon implants are effective in prevention of gonadal function via long term blockade of gonadotrophin synthesis. The CVMP recommended that Gonazon should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Gonazon:

The European Commission granted a marketing authorisation valid throughout the European Union, for Gonazon to Intervet International BV on 22 July 2003. Gonazon implants were authorised by an extension application, granted by the European Commission in January 2007. Information on the prescription status of this product may be found on the labelling.

Authorisation details
Name: Gonazon
EMEA Product number: EMEA/V/C/000075
Active substance: azagly-nafarelin
INN or common name: Azagly-nafarelin
Species: Salmonidae (Salmonid fish)Dogs
ATCvet Code: QH01CA
Marketing Authorisation Holder: Intervet International BV
Revision: 7
Date of issue of Market Authorisation valid throughout the European Union: 20/07/2003
Contact address:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon concentrate for solution for injection of female salmonid fish
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    V IAL CONTAINING C ONCENTRATE :
    Active substance(s)
    Azagly-nafarelin 1600
    µ
    g/ml as azagly-nafarelin acetate.
    Excipients
    Benzyl alcohol (1%)
    V IAL CONTAINING S OLVENT :
    Excipients
    Benzyl alcohol (1%)
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Concentrate for solution for injection
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Female salmonid fish such as Atlantic salmon ( Salmo salar ), rainbow trout ( Oncorhynchus mykiss ),
    brown trout ( Salmo trutta ) and Arctic charr ( Salvelinus alpinus ).
    4.2 Indications for use, specifying the target species
    Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
    4.3 Contraindications
    Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated
    naturally.
    The product should not be used in fish maintained in water temperatures that would normally inhibit
    ovulation as this can result in a decrease in egg quality.
    4.4 Special warnings for each target species
    Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish
    treated with azagly-nafarelin. In some cases this can be related to the use of the compound too early in
    the spawning season.
    2/37
    It is recommended to strip fish after injection at intervals of approximately 50-100 degree days.
    For Arctic charr, injections should be given only if the water temperature is < 8°C.
    The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
    4.5 Special precautions for use
    Special precautions for use in animals
    High standards of biosecurity must be observed at the time of injection in order to prevent introduction
    and spread of infectious diseases between broodstock fish.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    Operators should wear gloves when mixing the concentrate solution with the solvent.
    Avoid self injection.
    In case of accidental contact with either the skin or the eyes, rinse thoroughly with water. Medical
    advice should be sought immediately in cases in which the concentrated solution or several ml of the
    diluted solution are spilled onto the skin or into the eyes or in the case of accidental self-injection. The
    package insert or the label should be shown to the physician
    Operators should wash their hands after use of the product.
    4.6 Adverse reactions (frequency and seriousness)
    None known.
    4.7 Use during pregnancy, lactation or lay
    Not applicable.
    4.8 Interaction with other medicinal products and other forms of interaction
    No information on interactions with other veterinary medicinal products is available.
    4.9 Amounts to be administered and administration route
    Fish should be anaesthetised.
    Inject intraperitoneally along the central line, 1/2 to 1 fin length in front of the pelvic fin base.
    The recommended dose is 32 µg/kg body weight.
    This dose should be administered in the preferred volume for the particular body weight of fish. The
    supplied solvent is used to dilute the concentrate to the correct dilution to allow for optimisation of
    injection volumes for fish of widely varying body weights.
    The empty, sterile vial is intended to be used for mixing the concentrate and solvent. Additional
    sterile vials will be supplied on request.
    3/37
    The table below provides the required volume of concentrate and the required volume of solvent to obtain
    the preferred injection volume of 0.1 ml/ kg fish, 0.2 ml/kg fish, 0.5 ml/kg fish or 1 ml/kg fish.
    Preferred injection volume per kg fish (depending on fish
    size)*
    0.1 ml
    0.2 ml
    0.5 ml
    1.0 ml
    Total kg of fish
    to be injected
    Concentrate
    volume
    Solvent volume
    50 kg
    1 ml
    4 ml
    9 ml
    24 ml
    49 ml
    100 kg
    2 ml
    8 ml
    18 ml
    48 ml
    98 ml
    * this volume will be minimized for the species with the largest body weights.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    An overdose will not accelerate the onset or increase the degree of ovulation. A reduction in the egg
    quality is seen after administration of doses above the recommended therapeutic dose. No antidotes
    are available.
    4.11 Withdrawalperiod(s)
    Zero days.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmaceutical group: gonadotrophin-releasing hormone.
    ATC vet code: QH01CA
    5.1 Pharmacodynamic properties
    Azagly-nafarelin is a synthetic analogue of gonadotrophin-releasing hormone (GnRH). GnRH is
    synthesised by neurones in the hypothalamus in all vertebrate species. It controls reproduction in fish
    by modulating the secretion of the pituitary gonadotrophins, luteinizing hormone (LH) and follicle
    stimulating hormone (FSH), also known in fish endocrinology as GtH-II and GtH-I, respectively.
    GnRH analogues are peptides.
    Azagly-nafarelin, like other GnRH analogues, mimics the action of GnRH, through modulation of the
    secretion of LH and FSH in mammals and fish.
    5.2 Pharmacokinetic particulars
    Azagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout. The distribution
    and metabolism of azagly-nafarelin have not been studied in the target species. Azagly-nafarelin is
    rapidly eliminated from plasma after IP treatment in rainbow trout. The elimination half-life (T 1/2 ) and
    Mean Residence Time of azagly-nafarelin in trout after IP treatment of 32 µg/kg BW are 4.9 h and 6.8
    h, respectively.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Benzyl alcohol
    Sodium acetate (tri-hydrate)
    Acetic acid, glacial
    Sodium chloride / Hydrochloric acid 4N (for pH adjustment)
    4/37
     
    Water for injection
    6.2 Incompatibilities
    In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
    veterinary medicinal products.
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sage: 3 years.
    Shelf life after first opening the immediate packaging: 28 days.
    Shelf life after dilution according to directions: the product should be used immediately.
    6.4 Special precautions for storage
    Store and transport at 2
    °
    C - 8
    °
    C (in a refrigerator).
    Do not freeze.
    6.5 Nature and composition of immediate packaging
    Carton : 1 concentrate vial and 1 solvent vial.
    Concentrate vial: 3 ml brown glass vial containing 2 ml of solution; rubber stopper and crimp cap.
    Solvent vial: 100 ml clear glass vial containing 100 ml of solution; rubber stopper and crimp cap.
    Sterile container: 50-ml empty
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/040/001
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    22.07.2003 / 13.06.2008
    5/37
    10. DATE OF REVISION OF THE TEXT
    13.06.2008
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.europa.eu
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    6/37
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon 18.5 mg implant for dogs
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance:
    Azagly-nafarelin 18.5 mg per implant
    For a full list of excipients see section 6.1
    3.
    PHARMACEUTICAL FORM
    Implant
    Gonazon implant is a solid, off white, 14x3x1 mm implant.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Dogs (bitches)
    4.2 Indications for use, specifying the target species
    Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.
    4.3 Contraindications
    Do not use in bitches (prepubertal and adult) intended for breeding (see section 4.7).
    4.4 Special warnings
    Based on field trial data, it is evident that the implant may not be retained in a proportion (1.2%) of
    treated bitches. If the implant cannot be palpated in the month following administration, the owner is
    encouraged to seek veterinary advice as efficacy cannot be ensured in these cases.
    At the end of a one year treatment, it may not be possible to locate and remove the implant in
    approximately 10% of cases. To minimise this problem, caution needs to be exercised to ensure that
    the implant is administered by subcutaneous injection, particularly in dogs with pronounced depots of
    subcutaneous fat. Inability to locate and remove Gonazon will not have serious effects on the general
    health of the dog. However, the timing of return to heat cannot be predicted.
    Following a single administration, return to ovarian activity after implant removal may take longer in
    bitches treated before puberty (average 255 days, range 36-429 days) than in adult bitches (average 68
    days, range 12 to 264 days). A large proportion (68%) of the first heat after a single treatment in adult
    bitches were non-ovulatory. In addition following a repeat treatment, the timing of a return to heat
    cannot be accurately predicted. No data are available on repeat treatments in prepubertal bitches.
    Accidental ingestion of the implant by the dog will not affect its health, since the oral bio-availability
    of GnRH agonists is very low.
    7/37
    4.5 Special precautions for use
    Special precautions for use in animals
    Treatment in proestrus will not suppress that particular heat (proestrus and oestrus).
    In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches of
    giant breeds over 45 kg bodyweight.
    In adult bitches, heat is commonly induced in the first month following the first administration of the
    implant. The frequency of induced heat is lower when the first treatment is administered in metoestrus
    (32%) than in anoestrus (84%). Therefore, the first treatment should preferably be administered in
    metoestrus. The incidence of induced heat following administration of a repeat treatment to bitches
    that have not shown signs of oestrus following a previous administration of the product is low
    (estimated to be 8%).
    The risk of inducing a fertile heat is low in metoestrus (5%). Administration of Gonazon at other
    stages of the cycle may induce heat that may be fertile. If a bitch becomes pregnant following induced
    heat, embryonic resorption or abortion may occur. Therefore, if heat is observed, contact with male
    dogs should be prevented until all signs of heat (vulvar swelling, bleeding and attractiveness to male
    dogs) cease.
    Induced heat is not observed if treatment is started before puberty. In addition, the frequency of
    induced heat is lower in younger bitches than in older bitches.
    A proportion of bitches that show induced heat may subsequently develop pseudopregnancy.
    However, based on field trial data, the incidence of pseudopregnancy in treated bitches is not greater
    than in control (untreated) bitches.
    The product when administered at the recommended treatment dose is ineffective in bitches aged 7
    years or older.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    Personal protective equipment, consisting of gloves, should be worn when handling the veterinary
    medicinal product.
    Avoid accidental self-injection. In case of accidental self-administration of the implant, seek medical
    advice immediately and show the package leaflet or the label to the physician.
    4.6 Adverse reactions (frequency and seriousness)
    Owing to their pharmacological activity (inhibition of the production of sex steroids), administration
    of GnRH agonists to bitches might be associated with vaginitis.
    4.7 Use during pregnancy, lactation or lay
    The use is not recommended during pregnancy and lactation. Laboratory studies have shown that
    administration of the product during early pregnancy in the bitch is unlikely to affect that pregnancy
    (that is, pregnancy will be carried to full term with the birth of viable pups).
    The product is contraindicated in bitches intended for breeding (adult and prepubertal) as laboratory
    studies in which dogs received 3 simultaneous implants for a period of 12 months revealed a reduction
    in the numbers of live pups at whelping and weaning compared to an untreated control group.
    8/37
    4.8 Interaction with other medicinal products and other forms of interaction
    Azagly-nafarelin is a peptide that is primarily degraded by peptidases and not by cytochrome P-450
    enzymes. Therefore, drug interactions would not be expected to occur. In a limited laboratory study,
    co-administration of Gonazon and short-acting progestagens has been shown to be well tolerated.
    However, interactions with other medicinal products have not been investigated.
    4.9 Amounts to be administered and administration route
    The recommended dose is one implant per bitch.
    The implant may be administered to bitches from the age of four months.
    In adult bitches, the first treatment should be administered preferably in metoestrus.
    The duration of prevention of gonadal function is obtained as detailed in the table below:
    Age at which treatment is started
    4 months – 3 years old
    3 - 6 years old
    Average duration
    of blockade
    12 months
    11 months
    (
    ±
    24 days)
    ±
    93 days)
    (standard
    deviation)
    90 % of treated prepubertal bitches. However, it should be
    noted that within the first month after treatment a proportion of treated bitches also experienced an
    induced heat (see section 4.5). The product, when administered at the recommended treatment dose, is
    ineffective in bitches aged seven years or older.
    ≥
    In bitches where gonadal function has been successsfully prevented for a period of 12 months, then a
    second treatment may be administered at that time for continued prevention of oestrus. There are no
    data available for animals treated on more than two occasions.
    ADMINISTRATION:
    Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the
    umbilicus, using aseptic technique. The method of administration is as follows:
    1. Position the bitch on her back. Prepare a small area ( e.g. 4 cm²) of the ventral anterior
    abdominal/ umbilical region for an aseptic procedure.
    2. Open the foil pouch using the pre-cut incision to remove the sterile injection device.
    3. Remove the needle cap. Unlike liquid injections, there is no need to remove air bubbles as
    attempts to do so may displace the implant from the needle.
    4. Using aseptic technique, raise a small piece of skin in the region of the dogs umbilicus. With
    the bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin
    in a single motion, subcutaneously.
    5. Take care to avoid penetrating the abdominal wall musculature or fat tissue.
    6. With your free hand, use the thumb grip to hold the injection device in position, and depress
    the plunger as far as it can go. This retracts the needle and withdraws it, leaving the implant
    beneath the skin. Withdraw the needle from the skin.
    7. Ensure that the administration site is clean and dry. Instruct the owner to keep the
    administration site clean and dry for 24 hours.
    8. Record the date of treatment in the clinical records of the animals.
    9/37
    (
    Based on field data, the occurrence of oestrus after a single treatment was prevented for 12 months or
    more in 75% of treated adult bitches and
     
    REMOVAL:
    Chemical restraint (sedation and/or general anaesthesia) may be required for implant removal.
    Position the dog as described for administration of the implant.
    1. Locate the implant by gentle digital palpation of the administration site. Prepare the site for an
    aseptic technique.
    2. After adequate (local) anaesthesia is present, apply gentle digital pressure to the far end of the
    implant. Make a stab incision, approximately 5 mm long, along the elevated near end of the
    implant. Push the implant gently towards the stab incision. If necessary, dissect away any
    fibrous tissue to free the implant. Grasp it with forceps and remove.
    3. Instruct the owner to keep the administration site clean and dry for 24 hours.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    Risk of overdose is negligible owing to the type of formulation and administration (single dose
    implant for subcutaneous administration). Simultaneous administration of five implants during a one-
    year period was well tolerated.
    4.11 Withdrawalperiod
    Not applicable.
    5.
    PHARMACOLOGICAL PROPERTIES
    5.1 Pharmacodynamic properties
    Pharmacotherapeutic group: Gonadotrophin-Releasing Hormone (GnRH)
    ATCvet code: QH01CA
    Azagly-nafarelin, a GnRH agonist, has biphasic effects on the pituitary gland when administered
    continuously. Initially, it stimulates pituitary function and secretion of the gonadotrophins LH
    (luteinising hormone) and FSH (follicle stimulating hormone). This brief phase may result in induced
    heat within one to four weeks following the first administration of the implant (see section 4.5). Long-
    term administration results in pituitary desensitisation to the effects of GnRH resulting in a
    suppression of LH and FSH secretion by the pituitary. As a consequence, there is no follicular follicle
    growth (hence no oestrus is observed) and no ovulation. The transition between the stimulatory and
    inhibitory effects is completed within approximately one month.
    5.2 Pharmacokinetic particulars
    Absorption: Following subcutaneous administration of a single implant to dogs (approximate weight
    of 10 kg), maximum serum concentrations (0.13 µg/ml) of azagly-nafarelin are reached around
    3.5 hours. These maximal azagly-nafarelin concentrations are followed by a slow decline in circulating
    azagly-nafarelin concentrations lasting up to 12 months.
    Distribution: The apparent volume of distribution of azagly-nafarelin following intravenous bolus
    administration, at a dose equivalent to the content of one implant, is 0.12 l/kg.
    Metabolism and excretion: The clearance of azagly-nafarelin following intravenous administration of
    the same dose is 0.46 l/h and the elimination half-life is 1.8 hours.
    10/37
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Cured elastomer, resulting from the polymerisation of polydimethylsiloxane and
    tetrapropylorthosilicate in the presence of stannous octoate.
    6.2 Incompatibilities
    Not applicable.
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
    6.4 Special precautions for storage
    Do not store above 25
    °
    C.
    6.5 Nature and composition of immediate packaging
    Single disposable injection device, preloaded inside a hypodermic needle covered with a protective
    cap. The unit is sterile and comes in a sealed, light-proof, aluminium foil laminate pouch, packed in an
    individual carton box.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/040/002
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    22.07.2003 / 13.06.2008
    11/37
    10. DATE OF REVISION OF THE TEXT
    13.06.2008
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.europa.eu/ .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    12/37
    ANNEX II
    A.
    MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    13/37
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer(s) responsible for batch release
    Gonazon for fish:
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Gonazon for dogs:
    Intervet GesmbH
    Siemensstrasse 107
    A-1210 Wien
    Austria
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    Veterinary medicinal product subject to prescription.
    The holder of this marketing authorisation must inform the European Commission about the marketing
    plans for the medicinal product authorised by this decision.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    14/37
    D. STATEMENT OF THE MRLs
    Substance
    MRL status
    Comments
    Azagly-nafarelin Annex II for Salmonidae 1
    Not for use in fish from which eggs
    are produced for human
    consumption
    Sodium acetate
    (tri-hydrate)
    Annex II for all food
    producing species
    Approved food additive (E 262),
    CR No 2034/96
    Acetic acid
    (glacial)
    Annex II for all food
    producing species
    Approved food additive (E 260),
    CR No 2034/96
    Benzyl alcohol
    Annex II for all food
    producing species. For use as
    excipient
    CR No 1442/95
    Sodium chloride Annex II for all food
    producing species
    CR No 2796/95
    Sodium hydroxide Included in Annex II for all
    food producing species
    Approved food additive (E 524),
    CR No 2034/96
    Hydrochloric acid Annex II for all food
    producing species, for use as
    excipient.
    CR No 1442/95
    Water for
    injections
    Not within the scope of
    Council Regulation 2377/90
    1 Regulation 1530/02 / OJL230 of 28 August 2002
    15/37
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    16/37
    A. LABELLING
    17/37
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon concentrate for solution for injection of female salmonid fish
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    V IAL CONTAINING C ONCENTRATE :
    Active substance(s)
    Azagly-nafarelin 1600
    µ
    g/ml as azagly-nafarelin acetate.
    Excipients
    Benzyl alcohol
    V IAL CONTAINING S OLVENT :
    Excipients
    Benzyl alcohol
    3.
    PHARMACEUTICAL FORM
    Concentrate for solution for injection.
    4.
    PACKAGE SIZE
    Carton containing one vial with 2 ml of concentrate solution and 1 bottle with 100 ml of solvent. An
    empty sterile mixing vial is supplied separately. Additional sterile vials will be supplied on request.
    5.
    TARGET SPECIES
    Female salmonid fish such as Atlantic salmon ( Salmo salar ), rainbow trout ( Oncorhynchus mykiss ),
    brown trout ( Salmo trutta ) and Arctic charr ( Salvelinus alpinus ).
    6.
    INDICATION(S)
    Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    18/37
     
    8.
    WITHDRAWAL PERIOD
    Zero days.
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish
    treated with azagly-nafarelin too early in the spawning season. It is recommended to strip fish after
    injection at intervals of approximately 50-100 degree days. For Arctic charr, injections should be
    given only if the water temperature is < 8°C.
    High standards of biosecurity must be observed at the time of injection in order to prevent introduction
    and spread of infectious diseases between broodstock fish.
    The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
    Operators should wear gloves when mixing the concentrate solution with the solvent. Read the
    package insert before use.
    10. EXPIRY DATE
    "Month/Year"
    After dilution, the product should be used immediately.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport at 2
    °
    C - 8
    °
    C (in a refrigerator).
    Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    19/37
     
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/040/001
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot> <BN> {number}
    20/37
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Carton Box
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon 18.5 mg implant for dogs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Azagly-nafarelin (18.5 mg)
    3.
    PHARMACEUTICAL FORM
    Implant
    4.
    PACKAGE SIZE
    One implant.
    5.
    TARGET SPECIES
    Dog (bitches)
    6.
    INDICATION(S)
    Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Subcutaneous administration.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    9.
    SPECIAL WARNING(S), IF NECESSARY
    10. EXPIRY DATE
    EXP {month/year}
    21/37
     
    11. SPECIAL STORAGE CONDITIONS
    Do not store above 25
    °
    C.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/040/002
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot> <BN> {number}
    22/37
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    2 ml concentrate vials
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon concentrate for solution for injection of female salmonid fish
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Azagly-nafarelin 1600
    µ
    g/ml as azagly-nafarelin acetate.
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    2 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    Intraperitoneal (IP) use
    5.
    WITHDRAWAL PERIOD
    Zero days
    6.
    BATCH NUMBER
    <Batch> <Lot> {number}
    7.
    EXPIRY DATE
    EXP {month/year}
    After dilution, the product should be used immediately.
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only- to be supplied only on veterinary prescription.
    23/37
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Sachet
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon 18.5 mg implant for dogs
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Azagly-nafarelin
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    One implant.
    4.
    ROUTE(S) OF ADMINISTRATION
    Subcutaneous administration.
    5.
    WITHDRAWAL PERIOD
    6.
    BATCH NUMBER
    Batch < number >
    7.
    EXPIRY DATE
    EXP {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    24/37
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Vial containing solvent
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon concentrate for solution for injection of female salmonid fish
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Excipients
    Benzyl alcohol
    3.
    PHARMACEUTICAL FORM
    Solvent for solution for injection.
    4.
    PACKAGE SIZE
    Carton containing one vial with 2 ml of concentrate solution and 1 bottle with 100 ml of solvent. An
    empty sterile mixing vial is supplied separately. Additional sterile vials will be supplied on request.
    5.
    TARGET SPECIES
    Female salmonid fish such as Atlantic salmon ( Salmo salar ), rainbow trout ( Oncorhynchus mykiss ),
    brown trout ( Salmo trutta ) and Arctic charr ( Salvelinus alpinus ).
    6.
    INDICATION(S)
    Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Zero days.
    25/37
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish
    treated with azagly-nafarelin too early in the spawning season. It is recommended to strip fish after
    injection at intervals of approximately 50-100 degree days. For Arctic charr, injections should be
    given only if the water temperature is < 8°C.
    High standards of biosecurity must be observed at the time of injection in order to prevent introduction
    and spread of infectious diseases between broodstock fish.
    The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
    Operators should wear gloves when mixing the concentrate solution with the solvent. Read the
    package insert before use.
    10. EXPIRY DATE
    "Month/Year"
    After dilution, the product should be used immediately.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport at 2
    °
    C - 8
    °
    C (in a refrigerator).
    Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    26/37
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/040/001
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot> <BN> {number}
    27/37
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Separate empty sterile containers
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Azagly-nafarelin 1600
    µ
    g/ml as azagly-nafarelin acetate.
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    50 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    5.
    WITHDRAWAL PERIOD
    Zero days.
    6.
    BATCH NUMBER
    <Batch> <Lot> {number}
    7.
    EXPIRY DATE
    EXP {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    28/37
     
    B. PACKAGE LEAFLET
    29/37
    PACKAGE LEAFLET
    Gonazon concentrate for solution for injection of female salmonid fish
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder and manufacturer
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon concentrate for solution for injection of female salmonid fish
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Azagly-nafarelin 1600
    µ
    g/ml as azagly-nafarelin acetate.
    Excipient: Benzyl alcohol
    4.
    INDICATION(S)
    Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
    5.
    CONTRAINDICATIONS
    Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated
    naturally.
    The product should not be used in fish maintained in water temperatures that would normally inhibit
    ovulation as this can result in a decrease in egg quality.
    6.
    ADVERSE REACTIONS
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Female salmonid fish such as Atlantic salmon ( Salmo salar ), rainbow trout ( Oncorhynchus mykiss ),
    brown trout ( Salmo trutta ) and Arctic charr ( Salvelinus alpinus ).
    30/37
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Inject intraperitoneally along the central line, 1/2 to 1 fin length in front of the pelvic fin base. Fish
    should be anaesthetised.
    The dose should be administered in the preferred volume for the particular body weight of fish. The
    supplied solvent is used to dilute the concentrate to the correct dilution to allow for optimisation of the
    preferred injection volumes for fish of widely varying body weights.
    The empty, sterile vial is intended to be used for mixing the concentrate and solvent. Additional
    sterile vials will be supplied on request.
    The table below provides the required volume of concentrate and the required volume of solvent to obtain
    thepreferred injection volumes of 0.1 ml/kg fish, 0.2 ml/kg fish, 0.5 ml/kg fish or 1 ml/kg fish.
    Preferred injection volume per kg fish (depending on fish
    size) *
    0.1 ml
    0.2 ml
    0.5 ml
    1.0 ml
    Total kg of fish
    to be injected
    Concentrate
    volume
    Solvent volume
    50 kg
    1 ml
    4 ml
    9 ml
    24 ml
    49 ml
    100 kg
    2 ml
    8 ml
    18 ml
    48 ml
    98 ml
    * this volume will be minimized for the species with the largest body weights.
    The diluted solution for injection should be used immediately.
    10. WITHDRAWAL PERIOD
    Zero days
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store at 2 – 8
    °
    C (in a refrigerator).
    Do not freeze.
    Do not use after the expiry date stated on the label.
    After first opening the container, the solvent may be stored for 28 days.
    After dilution, the product should be used immediately.
    12. SPECIAL WARNING(S)
    Do not mix with other medicinal products.
    Operators should wear gloves when mixing the concentrate solution with the solvent.
    Avoid self injection.
    In case of accidental contact with either the skin or the eyes, rinse thoroughly with water. Medical
    advice should be sought immediately in cases in which the concentrated solution or several ml of the
    31/37
     
    diluted solution are spilled onto the skin or into the eyes or in the case of accidental self-injection. The
    package insert or the label should be shown to the physician
    Operators should wash their hands after use of the product.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    13.06.2008
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.europa.eu
    15. OTHER INFORMATION
    None.
    32/37
    PACKAGE LEAFLET
    Gonazon 18.5 mg implant for dogs
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder :
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Manufacturer responsible for the batch release :
    Intervet GesmbH
    Siemensstraβe 107
    A-1210 Wien
    Austria
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Gonazon 18.5 mg implant for dogs
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Azagly-nafarelin 18.5 mg
    4.
    INDICATION(S)
    Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.
    5.
    CONTRAINDICATIONS
    Do not use in bitches (prepubertal and adult) intended for breeding.
    6.
    ADVERSE REACTIONS
    Owing to their pharmacological activity (inhibition of the production of sex steroids), administration
    of GnRH agonists to bitches might be associated with vaginitis.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Dog (bitches).
    33/37
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    For subcutaneous administration.
    In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches of
    giant breeds over 45 kg bodyweight.
    The recommended dose is one implant per bitch.
    The implant may be administered to bitches from the age of four months.
    In adult bitches, the first treatment should be administered preferably in metoestrus.
    The duration of prevention of gonadal function is obtained as detailed in the table below:
    Age at which treatment is started
    4 months – 3 years old
    3 - 6 years old
    Average duration of
    blockade
    12 months
    11 months
    (
    ±
    24 days)
    ±
    93 days)
    (standard deviation)
    In bitches where gonadal function has been successsfully prevented for a period of 12 months, then a
    second treatment may be administered at that time for continued prevention of oestrus. There are no
    data available for animals treated on more than two occasions.
    Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the
    umbilicus, using aseptic technique.
    ADVICE ON CORRECT ADMINISTRATION
    ADMINISTRATION:
    1. Position the bitch on her back. Prepare a small area ( e.g. 4 cm²) of the ventral anterior
    abdominal/umbilical region for an aseptic procedure (Fig. 1).
    2. Open the foil pouch using the pre-cut incision to remove the sterile injection device.
    3. Remove the needle cap. Unlike liquid injections, there is no need to remove air bubbles as attempts
    to do so may displace the implant from the needle.
    4. Using aseptic technique, raise a small piece of skin in the region of the dog’s umbilicus. With the
    bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin in a single
    motion (Fig. 2).
    5. Take care to avoid penetrating the abdominal wall musculature or fat tissue.
    6. With your free hand, use the thumb grip to hold the injection device in position, and depress the
    plunger as far as it can go. This retracts the needle and withdraws it, leaving the implant beneath the
    skin (Fig. 3). Withdraw the needle from the skin.
    7. Ensure that the administration site is clean and dry. Instruct the owner to keep the administration
    site clean and dry for 24 hours. Record the date of treatment in the clinical records of the animal.
    34/37
    (
    9.
     
    Fig.1
    Fig.2
    Fig.3
    Fig.4
    REMOVAL:
    Chemical restraint (sedation and/or general anaesthesia) may be required for implant removal. Position
    the dog as described for administration of the implant.
    1. Locate the implant by gentle digital palpation of the administration site. Prepare the site for an
    aseptic technique.
    2. After adequate (local) anaesthesia is present, apply gentle digital pressure to the far end of the
    implant. Make a stab incision, approximately 5 mm long, along the elevated near end of the
    implant. Push the implant gently towards the stab incision. If necessary, dissect away any
    fibrous tissue to free the implant. Grasp it with forceps and remove.
    3. Instruct the owner to keep the administration site clean and dry for 24 hours.
    Treatment in proestrus will not suppress that particular heat (proestrus and oestrus).
    In adult bitches, heat is commonly induced in the first month following the first administration of the
    implant. The frequency of induced heat is lower when the first treatment is administered in metoestrus
    (32%) than in anoestrus (84%). Therefore, the first treatment should preferably be administered in
    metoestrus. The incidence of induced heat following administration of a repeat treatment to bitches
    that have not shown signs of oestrus following a previous administration of the product is low
    (estimated to be 8%).
    The risk of inducing a fertile heat is low in metoestrus (5%). Administration of Gonazon at other
    stages of the cycle may induce heat that may be fertile. If a bitch becomes pregnant following induced
    heat, embryonic resorption or abortion may occur. Therefore, if heat is observed, contact with male
    dogs should be prevented until all signs of heat (vulvar swelling, bleeding and attractiveness to male
    dogs) cease.
    Induced heat is not observed if treatment is started before puberty. In addition, the frequency of
    induced heat is lower in younger bitches than in older bitches.
    A proportion of bitches that show induced heat may subsequently develop pseudopregnancy.
    However, based on field trial data, the incidence of pseudopregnancy in treated bitches is not greater
    than in control (untreated) bitches.
    The product when administered at the recommended treatment dose is ineffective in bitches aged 7
    years or older.
    10. WITHDRAWAL PERIOD
    Not applicable.
    35/37
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Do not use after the expiry date which is stated on the label ‘EXP’
    Do not store above 25
    °
    C.
    12. SPECIAL WARNING(S)
    The implant may not be retained in a proportion (1.2%) of treated bitches. If the implant cannot be
    palpated in the month following administration, the owner is encouraged to seek veterinary advice as
    efficacy cannot be ensured in these cases.
    At the end of a one year treatment, it may not be possible to locate and remove the implant in
    approximately 10% of cases. To minimise this problem, caution needs to be exercised to ensure that
    the implant is administered by subcutaneous injection, particularly in dogs with pronounced depots of
    subcutaneous fat. Inability to locate and remove Gonazon will not have serious effects on the general
    health of the dog. However, the timing of return to heat cannot be predicted.
    Following a single administration, return to ovarian activity after implant removal may take longer in
    bitches treated before puberty (average 255 days, range 36-429 days) than in adult bitches (average 68
    days, range 12 to 264 days). A large proportion (68%) of the first heat after a single treatment in adult
    bitches were non-ovulatory. In addition following a repeat treatment, the timing of a return to heat
    cannot be accurately predicted. No data are available on repeat treatments in prepubertal bitches.
    Accidental ingestion of the implant by the dog will not affect its health, since the oral bio-availability
    of GnRH agonists is very low.
    The use is not recommended during pregnancy and lactation. Laboratory studies have shown that
    administration of the product during early pregnancy in the bitch is unlikely to affect that pregnancy
    (that is, pregnancy will be carried to full term with the birth of viable pups).
    Personal protective equipment, consisting of gloves, should be worn when handling the veterinary
    medicinal product.
    Avoid accidental self-injection. In the event of accidental self-administration of the implant, seek
    medical advice immediately and show the package leaflet or the label to the physician.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
    help to protect the environment.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    13.06.2008
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.europa.eu/ .
    36/37
    15. OTHER INFORMATION
    An individual carton box contains a single disposable injection device, preloaded inside a hypodermic
    needle covered with a protective cap.
    37/37


    Source: European Medicines Agency


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