Open menu Close menu Open Search Close search

AMERICAN DRUGS | ANATOMY | HEALTH TOPICS | HIV/AIDS GLOSSARY | DISEASES | HEALTH ARTICLES | GENOME | OCCUPATIONS

Zactran

Spanish Simplified Chinese French German Russian Hindi Arabic Portuguese















Summary for the public


What is Zactran?

Zactran is a solution for injection for cattle that contains the active substance gamithromycin (150 mg/ml).


What is Zactran used for?

Zactran is an anibiotic. It is used in cattle to treat or to prevent Bovine Respiratory Disease (BRD) caused by the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. When using Zactran to prevent BRD the presence of the disease in the herd should be established first. Zactran is given as a single subcutaneous (under the skin) injection. The dose to use is calculated based on the weight of the animal being treated. Animals weighing more than 250 kg will need to be injected at more than one site.


How does Zactran work?

The active substance of Zactran, gamithromycin, is an antibiotic of the macrolide group. It works by blocking the bacteria’s ribosomes, which are the parts of the cells where proteins are produced, and consequently inhibiting the growth of bacteria.


How has Zactran been studied?

Appropriate studies have been made to show the effectiveness of Zactran in cattle. The main clinical studies were carried out on farms in a number of countries in Europe, as well as outside the EU.

For the treatment of BRD, the effect of Zactran was studied in comparison to another macrolide antibiotic (tulathromycin) already authorised in the EU, in cattle already affected by the disease.

For the prevention of BRD the effect of Zactran was studied in comparison to placebo (dummy treatment) in cattle which had been in contact with diseased animals on the same farm and, therefore, likely to also develop the disease.


What benefit has Zactran shown during the studies?

Zactran has been shown to be efficacious in the treatment and prevention of BRD, associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. In the treatment of BRD Zactran has been shown to be as effective as tulathromycin.


What is the risk associated with Zactran?

After injection of Zactran, up to 45% of animals will show some swelling at the site of injection. The animals may also show some signs of slight pain for one day. The swelling generally resolves in 3 to 14 days but may persist in some animals for up to 35 days after treatment.


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

People with known hypersensitivity (allergy) to similar antibiotics (macrolide class) should avoid contact with Zactran. Zactran may cause irritation to the eyes or the skin. Therefore, contact with skin or eyes should be avoided. If Zactran comes in direct contact with the eyes, they should be flushed immediately with clean water. 

Similarly, if Zactran comes into direct contact with skin the affected area should be washed immediately with clean water. In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label should be presented to the physician.


What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

After the last administration of Zactran, cattle should not be slaughtered for 64 days.


What is the time to allow before milk can be taken from the animal for human consumption?

As the safety of Zactran in breeding animals has not been studied, the medicine should not be used in lactating cows or heifers producing milk for human consumption. It should also not be used in pregnant cows or heifers which are intended to produce milk for human consumption within 2 months of calving.


Why has Zactran been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zactran exceeded the risks for the therapeutic and preventive treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, (the presence of the disease in the herd should be established before preventive treatment) and recommended that Zactran should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Zactran

The European Commission granted a marketing authorisation valid throughout the European Union, for Zactran to Merial on 24/07/2008. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Zactran
EMEA Product number: EMEA/V/C/000129
Active substance: gamithromycin
INN or common name: gamithromycin
Species: Cattle
ATCvet Code: QJ01FA95
Marketing Authorisation Holder: Merial
Revision: 5
Date of issue of Market Authorisation valid throughout the European Union: 24/07/2008
Contact address:
Merial
29 avenue Tony Garnier
69007 Lyon
France



  • Drugs Alphabetically





    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZACTRAN 150mg/ml solution for injection for cattle
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    One ml contains:
    Active substance:
    Gamithromycin
    150 mg
    For a full list of excipients, see section 6.1.
    1 g
    3.
    PHARMACEUTICAL FORM
    Solution for injection. Colourless to pale yellow solution.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Cattle
    4.2 Indications for use, specifying the target species
    Therapeutic and preventive treatment of bovine respiratory disease (BRD) associated with
    Mannheimia haemolytica , Pasteurella multocida and Histophilus somni .
    The presence of the disease in the herd should be established before preventive treatment.
    4.3 Contraindications
    Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients.
    Do not use the product simultaneously with other macrolides or lincosamides (see section 4.8).
    Do not use in lactating cattle producing milk for human consumption.
    Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption,
    within 2 months of expected parturition.
    4.4 Special warnings
    None
    4.5 Special precautions for use
    Special precautions for use in animals
    Use of the veterinary medicinal product should be based on susceptibility testing and take into account
    official and local policies on the use of antimicrobials in farm animals.
    2/20
    Excipient:
    onothioglycerol
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    People with known hypersensitivity to the macrolide class should avoid contact with the veterinary
    medicinal product. Gamithromycin may cause irritation to eyes or/and skin.
    Avoid contact with skin or eyes If eye exposure occurs, flush eyes immediately with clean water. If
    skin exposure occurs, wash the affected area immediately with clean water.
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    Wash hands after use.
    4.6 Adverse reactions (frequency and seriousness)
    During clinical trials no treatment related abnormalities were observed except some transient injection
    site swellings. Visible injection site swellings may develop in up to 45% of treated animals associated
    with occasional, slight pain evident for one day. The swellings typically resolve within 3 to 14 days
    but may persist in some animals for up to 35 days after treatment.
    4.7 Use during pregnancy, lactation or lay
    Based on laboratory animal data, gamithromycin has not produced any evidence of selective
    developmental or reproductive effects. The safety of gamithromycin during pregnancy and lactation
    has not been evaluated in cattle. Use only according to the risk/benefit assessment by the responsible
    veterinarian.
    4.8 Interaction with other medicinal products and other forms of interaction
    Cross resistance may occur with other macrolides.
    Avoid simultaneous administration of antimicrobials with a similar mode of action such as other
    macrolides or lincosamides.
    4.9 Amounts to be administered and administration route
    A single subcutaneous injection of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg
    body weight) in the neck.
    For treatment of cattle over 250 kg body weight, divide the dose so that no more than 10 ml are
    injected at one site.
    To ensure correct dosage body weight should be determined as accurately as possible to avoid
    underdosing.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    Clinical studies have demonstrated the wide margin of safety for gamithromycin injection in cattle. In
    a young adult cattle study, gamithromycin was administered by subcutaneous injection at 6, 18, and 30
    mg/kg (1, 3, and 5 times the recommended dose) and repeated three times at 0, 5 and 10 days (three
    times the recommended duration of use). Injection site reactions were noted in a dose related manner.
    4.11 Withdrawalperiod
    Meat and offal: 64 days
    Not permitted for use in lactating animals producing milk for human consumption.
    Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption,
    within 2 months of expected parturition.
    3/20
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Macrolides, ATCvet code: QJ01FA95
    5.1 Pharmacodynamic properties
    Gamithromycin is an azalide, 15-membered semisynthetic macrolide class antibiotic with uniquely
    positioned alkylated nitrogen at 7a-position of the lactone ring. This special chemistry facilitates rapid
    absorption at physiological pH and a long duration of action at the target tissue, lung.
    Macrolides in general have both bacteriostatic and bactericidal action mediated through disruption of
    bacterial protein synthesis. Macrolides inhibit bacterial protein biosynthesis by binding to the 50S
    ribosomal subunit and by preventing peptide chain elongation. The in vitro data show that
    gamithromycin acts in a bactericidal manner. The broad spectrum antimicrobial activity of
    gamithromycin includes Mannheimia haemolytica, Pasteurella multocida and Histophilus somni , the
    bacterial pathogens most commonly associated with BRD. The MIC and MBC data are reported from
    a representative sample of isolates from field materials within different geographic EU areas.
    Species
    MIC 90s
    MBC 90s
    µg/ml
    Mannheimia haemolytica
    0.5
    1
    Pasteurella multocida
    1
    2
    Histophilus somni
    1
    2
    Three mechanisms are generally considered responsible for resistance to the macrolide class of
    compounds. This is often referred to as MLS B resistance as it affects macrolides, lincosamides and
    streptogramins. The mechanisms involve the alteration of the ribosomal target site, the utilization of
    active efflux mechanism and the production of inactivating enzymes.
    5.2 Pharmacokinetic particulars
    Gamithromycin administered subcutaneously into the neck of cattle at single dosage of 6 mg/kg body
    weight, resulted in rapid absorption with peak plasma concentrations observed after 30 to 60 min with
    a long plasma half-life (>2 days). The bioavailability of the drug was >98% with no gender
    differences. The volume of distribution at steady-state was 25 l/kg. Gamithromycin levels in lung
    reached a maximum in less than 24 hr, with lung-to-plasma ratio of >264 indicating that the drug was
    absorbed rapidly into the target tissue for BRD.
    In vitro plasma protein binding studies determined that the mean concentration of the free drug was
    74%. Biliary excretion of the unchanged drug was the major route of elimination.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Monothioglycerol
    Succinic Acid
    Glycerol Formal
    6.2 Incompatibilities
    In the absence of compatibility studies, this veterinary medicinal product should not be mixed with
    other veterinary medicinal products.
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sale: 3 years
    4/20
     
    Shelf life after first opening the immediate packaging: 28 days
    6.4. Specialprecautionsforstorage
    This veterinary medicinal product does not require any special storage conditions.
    6.5 Nature and composition of immediate packaging
    Type 1 glass vial with a chlorobutyl rubber stopper and an aluminum cap.
    Polypropylene vial with a chlorobutyl rubber stopper and an aluminum cap.
    Box containing 1 vial of 100, 250 or 500 ml
    Not all pack sizes may be marketed.
    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
    product should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    MERIAL
    29 avenue Tony Garnier
    F - 69007 Lyon
    France
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/082/001
    EU/2/08/082/002
    EU/2/08/082/003
    EU/2/08/082/004
    EU/2/08/082/005
    EU/2/08/082/006
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    24/07/2008
    10. DATE OF REVISION OF THE TEXT
    20/07/2009
    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.
    5/20
    ANNEX II
    A.
    MANUFACTURING AUTHORISATION HOLDER 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
    6/20
    A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer responsible for batch release
    MERIAL
    4, Chemin du Calquet
    31057 Toulouse Cedex
    France
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    Gamithromycin is included in Annex III of Council Regulation (EEC) No 2377/90 in accordance with
    the following table:
    Pharmacologically
    active substance
    Marker residue Animal
    species
    MRLs
    Target
    tissues
    Other provisions
    Gamithromycin
    Gamithromycin Bovine 20
    µ
    g/kg
    Fat
    Liver
    Kidney
    Provisional MRLs
    expire on 1.7.2009
    200
    µ
    g/kg
    100
    µ
    g/kg
    Not for use in animals
    producing milk for
    human consumption
    Annex II of Council Regulation (EEC) No 2377/90:
    Pharmacologically active substance(s) Animal species
    Other provisions
    Monothioglycerol 1
    All food animal species
    Succinic Acid (E 363) 2
    All food animal species
    Glycerol Formal 3
    All food animal species
    1 OJ No. L290 of 05.12.1995
    2 OJ No. L61 of 18.03.1995
    3 OJ No. L5 of 09.01.1997
    7/20
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    8/20
    A. LABELLING
    9/20
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    {BOX 100 ml, 250ml, 500ml}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZACTRAN 150 mg/ml solution for injection for cattle
    Gamithromycin
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    1 ml contains 150 mg of gamithromycin
    1 mg of monothioglycerol
    3.
    PHARMACEUTICAL FORM
    Solution for injection
    4.
    PACKAGE SIZE
    100 ml
    250 ml
    500 ml
    5.
    TARGET SPECIES
    Cattle
    6.
    INDICATION(S)
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Single subcutaneous injection of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body
    weight).
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Withdrawal period
    Meat and offal: 64 days
    Not permitted for use in lactating animals producing milk for human consumption.
    Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption,
    within 2 months of expected parturition.
    10/20
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    People with known hypersensitivity to the macrolide class should avoid contact with the product.
    Gamithromycin may cause irritation to eyes or/and skin.
    Avoid contact with skin or eyes. If eye exposure occurs, flush eyes immediately with clean water. If
    skin exposure occurs, wash the affected area immediately with clean water.
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    Wash hands after use.
    10. EXPIRY DATE
    EXP
    Once opened, use within 28 days.
    11. SPECIAL STORAGE CONDITIONS
    Not applicable.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Dispose of waste material 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
    MERIAL
    29 avenue Tony Garnier
    F - 69007 Lyon
    France
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/082/001
    EU/2/08/082/002
    EU/2/08/082/003
    EU/2/08/082/004
    11/20
     
    EU/2/08/082/005
    EU/2/08/082/006
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    12/20
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    {VIAL , except 100ml trilingual }
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZACTRAN 150 mg/ml solution for injection for cattle
    Gamithromycin
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    1 ml contains 150 mg of gamithromycin
    1 mg of monothioglycerol
    3.
    PHARMACEUTICAL FORM
    Solution for injection
    4.
    PACKAGE SIZE
    100 ml
    250 ml
    500 ml
    5.
    TARGET SPECIES
    Cattle
    6.
    INDICATION(S)
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Single subcutaneous injection of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body
    weight).
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Withdrawal period
    Meat and offal: 64 days
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Gamithromycin may cause irritation to eyes or/and skin.
    13/20
     
    Avoid contact with skin or eyes. If eye exposure occurs, flush eyes immediately with clean water. If
    skin exposure occurs, wash the affected area immediately with clean water.
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    Wash hands after use.
    10. EXPIRY DATE
    EXP
    Once opened, use within 28 days.
    11. SPECIAL STORAGE CONDITIONS
    Not applicable.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Read the package leaflet before use
    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
    MERIAL
    29 avenue Tony Garnier
    F - 69007 Lyon
    France
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/082/001
    EU/2/08/082/002
    EU/2/08/082/003
    EU/2/08/082/004
    EU/2/08/082/005
    EU/2/08/082/006
    14/20
     
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    15/20
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    {VIAL, 100ml trilingual}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZACTRAN 150mg/ml solution for injection for cattle
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE
    Gamithromycin
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    100 ml
    4.
    ROUTE OF ADMINISTRATION
    Subcutaneous use
    5.
    WITHDRAWAL PERIOD
    Withdrawal period. Meat and offal: 64 days
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP
    Once opened, use within 28 days.
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    16/20
     
    B. PACKAGE LEAFLET
    17/20
    PACKAGE LEAFLET FOR:
    ZACTRAN 150mg/ml solution for injection for cattle
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder :
    MERIAL
    29 avenue Tony Garnier
    F - 69007 Lyon
    France
    Manufacturer for the batch release :
    MERIAL
    4, Chemin du Calquet
    F - 31057 Toulouse Cedex
    France
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZACTRAN 150mg/ml solution for injection for cattle
    Gamithromycin
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
    1 ml contains 150 mg of gamithromycin
    1 mg of monothioglycerol
    4.
    INDICATIONS
    Therapeutic and preventive treatment of bovine respiratory disease (BRD) associated with
    Mannheimia haemolytica , Pasteurella multocida and Histophilus somni .
    The presence of the disease in the herd should be established before preventive treatment.
    5.
    CONTRAINDICATIONS
    Do not use in case of hypersensitivity to a certain type of antibiotics called macrolides or to any of the
    excipients.
    Do not use this product simultaneously with other macrolides or antibiotics known as lincosamides.
    Do not use in lactating cattle producing milk for human consumption.
    Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption,
    within 2 months of expected parturition.
    6.
    ADVERSE REACTIONS
    Transient injection site swellings with occasional slight pain.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinarian.
    18/20
    7.
    TARGET SPECIES
    Cattle
    8.
    DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
    A single subcutaneous injection of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg
    body weight) in the neck.
    For treatment of cattle over 250 kg body weight, divide the dose so that no more than 10 ml are
    injected at one site.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    To ensure correct dosage body weight should be determined as accurately as possible to avoid
    underdosing.
    10. WITHDRAWAL PERIOD
    Withdrawal period. Meat and offal: 64 days
    Not permitted for use in lactating animals producing milk for human consumption.
    Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption,
    within 2 months of expected parturition
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    This veterinary medicinal product does not require any special storage conditions.
    Do not use after the expiry date which is stated on the vial.
    Shelf-life after first opening the container: 28 days.
    12. SPECIAL WARNINGS
    For the animal:
    The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle. Use
    according to the benefit/risk assessment by the responsible veterinarian.
    For the user:
    People with known hypersensitivity to the macrolide class should avoid contact with the product.
    Gamithromycin may cause irritation to eyes or/and skin.
    Avoid contact with skin or eyes. If eye exposure occurs, flush eyes immediately with clean water. If
    skin exposure occurs, wash the affected area immediately with clean water.
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    Wash hands after use.
    Cross resistance may occur with other macrolides.
    ZACTRAN should not be mixed with other medicinal products.
    19/20
    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
    20/07/2009
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMEA) http://www.emea.europa.eu/ .
    15. OTHER INFORMATION
    Box containing 1 vial of 100, 250 or 500 ml.
    Not all pack sizes may be marketed.
    20/20


    Source: European Medicines Agency


    - Please bookmark this page (add it to your favorites).
    - If you wish to link to this page, you can do so by referring to the URL address below this line.

    https://theodora.com/drugs/eu/zactran_veterinary.html

    Copyright © 1995-2021 ITA all rights reserved.