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Draxxin

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Summary for the public


What is Draxxin?

Draxxin contains tulathromycin, which belongs to a class of medicines having an antibiotic action. Draxxin is a solution for injection (100 mg/ml).


What is Draxxin used for?

Draxxin is used to treat the following diseases if they are caused by bacteria that are sensitive to tulathromycin:

  • bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni or Mycoplasma bovis,
  • infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis,
  • swine respiratory disease (SRD) in pigs caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae or Haemophilus parasuis.

DRAXXIN can also be used to prevent BRD and SRD.The medicine should only be used for prevention in cattle and pigs once the presence of the disease in the herd has been established, and for pigs if they are expected to develop the disease within two to three days.

Draxxin is given as a single injection of 2.5 mg per kilogram body weight. In cattle, it is injected under the skin, and the dose is divided in cattle weighing over 300 kg so that no more than 7.5 ml are injected at one site. In pigs it is injected into a muscle, and the dose is divided in pigs weighing over 80 kg so that no more than 2 ml are injected at one site. It is recommended that animals are treated in the early stages of the disease and that their response is evaluated within 48 hours. If symptoms continue to be present, get worse or come back, treatment should be changed to another antibiotic.


How does Draxxin work?

The active substance in Draxxin, tulathromycin, is an antibiotic that belongs to the class ‘macrolides’. It works by attaching to the RNA (the molecules that instruct the cell how to make proteins) within the bacterial cells. This prevents the bacteria being able to make vital proteins and stops them growing and multiplying. Draxxin is effective against the bacteria that most commonly cause BRD, SRD and IBK. However, some bacteria can develop resistance against tulathromycin, which will reduce its effectiveness.


How has Draxxin been studied?

The effectiveness of Draxxin in treating or preventing BRD has been studied in nine main studies involving calves, carried out during an outbreak of the disease. In the treatment studies, the cattle were infected with BRD-causing bacteria, but the cattle in the prevention studies had no symptoms of the disease. Draxxin was compared with tilmicosin or florfenicol (other antibiotics), and, in the prevention studies also with placebo (a dummy treatment). The main measure of effectiveness was the change in symptoms, including body temperature, breathing and recovery over a period of between two weeks and two months.

For the treatment of IBK, the effectiveness of Draxxin has been studied in three main studies involving calves. In two studies, it was compared with the effectiveness of placebo, but the third also compared it to oxytetracycline (another antibiotic). The main measure of effectiveness was the proportion of cattle whose disease had been cured after three weeks.

The effectiveness of Draxxin in treating SRD has been studied in pigs in two main studies, where it was compared with tiamulin or florfenicol. The main measure of effectiveness was the change in symptoms over 10 days. For the prevention of SRD, the effectiveness of Draxxin was studied in six main studies, in which it was compared with placebo. The main measure of effectiveness was the proportion of pigs that completed the full three or six weeks of each study without needing to be removed from the study because of SRD.


What benefit has Draxxin shown during the studies?

A single 2.5-mg/kg dose of Draxxin was effective in treating and preventing BRD in cattle and SRD in pigs. In all studies, Draxxin was at least as effective as the comparator medicines. Looking at the studies taken together, it was more effective than placebo.

In two of the three studies of IBK, Draxxin was more effective than placebo in curing the disease. However, the third study found no difference between the effectiveness of Draxxin, oxytetracycline and placebo. The reasons for this are not clear.


What is the risk associated with Draxxin?

The subcutaneous injection of Draxxin to cattle often causes temporary pain and swelling at the injection site, which can last up to 30 days. These reactions have not been seen in pigs after intramuscular injection. Other types of reaction to the injection persist for about 30 days after injection in cattle and pigs.

Draxxin should not be used in animals that are hypersensitive (allergic) to macrolideantibiotics. It should also not be used at the same time as other macrolide antibiotics or lincosamides (another type of antibiotic medicine), in cattle that are producing milk for human consumption, or in pregnant cows intended to produce milk for human consumption within two months of their expected date of giving birth.


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

Draxxin can irritate the eyes. If Draxxin accidentally get into the eyes, flush them immediately with clean water. Draxxin may also cause sensitisation (redness, itching and swelling) if it comes into contact with the skin. If accidental skin exposure occurs, wash the skin immediately with soap and water. Wash hands after use. In case of accidental self injection, seek medical advice immediately and show the Package Leaflet or the label to the doctor.


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

For cattle intended for consumption as either meat or offal, 49 days must be allowed before slaughter. For pigs intended for consumption as either meat or offal, 33 days must be allowed.


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

Draxxin must not be used in cattle that are producing milk for human consumption, or in pregnant cows intended to produce milk for human consumption within two months of their expected date of giving birth.


Why has Draxxin been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Draxxin exceed the risks for the treatment and prevention of BRD and the treatment of IBK in cattle, and for the treatment and prevention of SRD in pigs, and recommended that Draxxin be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Draxxin

The European Commission granted a marketing authorisation valid throughout the European Union for Draxxin to Pfizer Limited on 23 July 2003. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Draxxin
EMEA Product number: EMEA/V/C/000077
Active substance: tulathromycin
INN or common name: Tulathromycin
Species: PigsCattle
ATCvet Code: QJ01FA94
Marketing Authorisation Holder: Pfizer Limited
Revision: 8
Date of issue of Market Authorisation valid throughout the European Union: 11/11/2003
Contact address:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance(s):
    Tulathromycin 100 mg/ml
    Excipient(s):
    Monothioglycerol 5 mg/ml
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Solution for injection
    4.
    CLINICAL PARTICULARS
    4.1
    Target species
    Cattle and pigs
    4.2
    Indications for use, specifying the target species
    Cattle
    Treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia
    haemolytica , Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to
    tulathromycin. The presence of the disease in the herd should be established before preventative
    treatment.
    Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to
    tulathromycin .
    Pigs
    Treatment and prevention of swine respiratory disease (SRD) associated with Actinobacillus
    pleuropneumoniae , Pasteurella multocida, Mycoplasma hyopneumoniae and Haemophilus parasuis
    sensitive to tulathromycin. The presence of the disease in the herd should be established before
    preventative treatment. Draxxin should only be used if pigs are expected to develop the disease within
    2-3 days.
    4.3
    Contraindications
    Do not use in case of hypersensitivity of the target animals to macrolide antibiotics.
    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.
    2
    4.4
    Special warnings for each target species
    None
    4.5
    Special precautions for use
    Special precautions for use in animals
    Use of the product should be based on susceptibility testing and take into account offical and local
    antimicrobial policies.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    Tulathromycin is irritating to eyes. If accidental eye exposure occurs, flush the eyes immediately with
    clean water.
    Tulathromycin may cause sensitisation by skin contact. If accidental skin exposure occurs, wash the
    skin immediately with soap and water.
    Wash hands after use.
    In case of accidental self-injection, seek medical advice immediately and show the package insert or
    the label to the physician.
    4.6 Adverse reactions (frequency and seriousness)
    Subcutaneous administration of DRAXXIN to cattle frequently causes transient pain reactions and
    local swellings at the injection site that can persist for up to 30 days . No such reactions have been
    observed in pigs after intramuscular administration. Pathomorphological injection site reactions are
    present for approximately 30 days after injection in both species.
    4.7 Use during pregnancy, lactation or lay
    Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or
    maternotoxic effects . The safety of tulathromycin during pregnancy and lactation has not been
    established in cattle and pigs. Use only according to the benefit/risk assessment by the responsible
    veterinarian.
    4.8 Interaction with other medicinal products and other forms of interaction
    Cross resistance occurs with other macrolides. Do not administer simultaneously with antimicrobials
    with a similar mode of action such as other macrolides or lincosamides.
    4.9
    Amounts to be administered and administration route
    Cattle
    A single subcutaneous injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg
    body weight). For treatment of cattle over 300 kg body weight, divide the dose so that no more than
    7.5 ml are injected at one site.
    Pigs
    A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg
    body weight) in the neck. For treatment of pigs over 80 kg body weight, divide the dose so that no
    more than 2 ml are injected at one site.
    3
    It is recommended to treat animals in the early stages of the disease and to evaluate the response to
    treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or
    if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical
    signs have resolved.
    To ensure correct dosage body weight should be determined as accurately as possible to avoid
    underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to
    avoid excessive broaching of the stopper.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to
    injection site discomfort were observed and included restlessness, head-shaking, pawing the ground,
    and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving
    5-6X the recommended dose.
    In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient
    signs attributed to injection site discomfort were observed and included excessive vocalisation and
    restlessness. Lameness was also observed when the hind leg was used as the injection site.
    4.11 Withdrawalperiod(s)
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    Not permitted for 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.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Macrolide, ATCvet code: QJ01F A 94
    5.1
    Pharmacodynamic properties
    Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a
    fermentation product. It differs from many other macrolides in that it has a long duration of action
    that is, in part, due to its three amine groups; therefore it has been given the chemical subclass
    designation of triamilide.
    Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of
    their selective binding to bacterial ribosomal RNA. They act by stimulating the dissociation of
    peptidyl-tRNA from the ribosome during the translocation process.
    Tulathromycin possesses in vitro activity against Mannheimia haemolytica , Pasteurella multocida,
    Histophilus somni and Mycoplasma bovis , and Actinobacillus pleuropneumoniae , Pasteurella
    multocida, Mycoplasma hyopneumonia, Haemophilus parasuis and Bordetella bronchiseptica the
    bacterial pathogens most commonly associated with bovine and swine respiratory disease,
    respectively. Increased MIC values have been found in some isolates of Histophilus somni and
    Actinobacillus pleuropneumoniae .
    Tulathromycin also possesses in vitro activity against Moraxella bovis , the bacterial pathogen most
    commonly associated with infectious bovine keratoconjunctivitis (IBK).
    4
    Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or
    some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site,
    generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLS B
    resistance); by enzymatic inactivation; or by macrolide efflux. MLS B resistance may be constitutive or
    inducible. Resistance may be chromosomal or plasmid-encoded and may be transferable if associated
    with transposons or plasmids.
    5.2
    Pharmacokinetic particulars
    In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous
    dose of 2.5 mg/kg body weight, was characterised by rapid and extensive absorption followed by high
    distribution and slow elimination. The maximum concentration (C max ) in plasma was approximately
    0.5 µg/ml; this was achieved approximately 30 minutes post-dosing (T max ). Tulathromycin
    concentrations in lung homogenate were considerably higher than those in plasma. There is strong
    evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages.
    However, the in vivo concentration of tulathromycin at the infection site of the lung is not known.
    Peak concentrations were followed by a slow decline in systemic exposure with an apparent
    elimination half-life (t 1/2 ) of 90 hours in plasma. Plasma protein binding was low, approximately
    40%. The volume of distribution at steady-state (V ss ) determined after intravenous administration was
    11 L/kg. The bioavailability of tulathromycin after subcutaneous administration in cattle was
    approximately 90%.
    In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular
    dose of 2.5 mg/kg body weight, was also characterised by rapid and extensive absorption followed by
    high distribution and slow elimination. The maximum concentration (C max ) in plasma was
    approximately 0.6 µg/ml; this was achieved approximately 30 minutes post-dosing (T max ).
    Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma.
    There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar
    macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is
    not known. Peak concentrations were followed by a slow decline in systemic exposure with an
    apparent elimination half-life (t 1/2 ) of approximately 91 hours in plasma. Plasma protein binding was
    low, approximately 40%. The volume of distribution at steady-state (V ss ) determined after
    intravenous administration was 13.2 L/kg. The bioavailability of tulathromycin after intramuscular
    administration in pigs was approximately 88%.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Monothioglycerol
    Propylene glycol
    Citric acid
    Hydrochloric acid
    Sodium hydroxide
    Water for injections
    6.2 Incompatibilities
    In the absence of incompatibility studies, DRAXXIN must not be mixed with other veterinary
    medicinal products.
    6.3 Shelf life
    Shelf life:
    3 years
    In use shelf life:
    28 days
    5
    6.4. Special precautions for storage
    No special precautions for storage.
    6.5 Nature and composition of immediate packaging
    Primary packaging: Type 1 glass vial with a fluoropolymer coated chlorobutyl stopper and an
    aluminium overseal.
    Secondary packaging: Cardboard box containing one vial.
    Vial sizes:
    20 ml, 50 ml, 100 ml, 250 ml, and 500 ml
    Not all vial sizes may be marketed.
    500 ml vials must not be used for pigs .
    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
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK.
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/041/001-005
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    Renewal: 19/09/2008
    11/11/2003
    10.
    DATE OF REVISION OF THE TEXT
    15.03.2010
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency http://www.ema.europa.eu/
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    6
    First authorisation:
    ANNEX II
    A.
    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
    7
    A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer(s) responsible for batch release
    Pfizer PGM
    Z.I. d’Amboise
    F-37530 Pocé-sur-Cisse
    France
    Manufacturing Authorisation issued on 21.06.2001 by Agence Nationale du Médicaments Vétérinaire,
    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
    Tulathromycin is included in Annex I of Council Regulation (EEC) No 2377/90 in accordance with
    the following table:
    Pharmacologically
    active substance(s)
    Marker
    residue
    Animal
    species
    MRLs
    Target
    tissues
    Other
    provisions
    Tulathromycin 1
    (2R, 3S, 4R, 5R, 8R, 10R, 11R,
    12S, 13S, 14R)-2-ethyl-
    3,4,10,13-tetrahydroxy-
    3,5,8,10,12,14-hexamethyl-11-
    [[3,4,6-trideoxy-3-
    (dimethylamino)-ß-D-
    xylohexopyranosyl]oxy]-1-oxa-
    6-azacyclopentadecan-15-on,
    expressed as tulathromycin
    equivalents
    Bovine 100 µg/kg
    3000 µg/kg
    3000 µg/kg
    Fat
    Liver
    Kidney
    Not for use in
    lactating cattle
    producing milk
    for human
    consumption.
    Porcine 100 µg/kg
    3000 µg/kg
    3000 µg/kg
    Skin + fat
    Liver
    Kidney
    Annex II of Council Regulation (EEC) No 2377/90:
    Pharmacologically active substance
    Animal Species
    Other provisions
    Propylene Glycol 2
    All food animal species
    Monothioglycerol 3
    All food animal species
    Citric Acid 4
    All food animal species
    Hydrochloric Acid 5
    All food animal species
    For use as excipient
    1 OJ No. L211 of 12.06.2004
    2 OJ No. L045 of 15.02.1997
    3 OJ No. L290 of 05.12.1995
    4 OJ No. L272 of 25.10.1996
    8
    5 OJ No. L143 of 27.06.1995
     
     
     
     
     
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (20 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Monothioglycerol
    100 mg/ml
    5 mg/ml
    3.
    PHARMACEUTICAL FORM
    Solution for injection
    4.
    PACKAGE SIZE
    20 ml
    5.
    TARGET SPECIES
    Cattle and pigs
    6.
    INDICATION(S)
    Treatment and prevention of bacterial and mycoplasmal infections in cattle and pigs. See package
    leaflet for complete list of indications, sensitive pathogens and directions for use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/kg body
    weight (1 ml/40 kg body weight).
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    Not permitted for 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.
    11
    Tulathromycin
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    Tulathromycin is irritating to eyes and may cause sensitisation by skin contact.
    Wash hands after use.
    In case of accidental self-injection, seek medical advice immediately and show the package insert or
    the label to the physician.
    10. EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    11. SPECIAL STORAGE CONDITIONS
    No special precautions for storage.
    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
    Marketing Authorisation Holder
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK
    12
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/041/001
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot>
    13
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (50 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Monothioglycerol
    100 mg/ml
    5 mg/ml
    3.
    PHARMACEUTICAL FORM
    Solution for injection
    4.
    PACKAGE SIZE
    50 ml
    5.
    TARGET SPECIES
    Cattle and pigs
    6.
    INDICATION(S)
    Treatment and prevention of bacterial and mycoplasmal infections in cattle and pigs. See package
    leaflet for complete list of indications, sensitive pathogens and directions for use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/kg body
    weight (1 ml/40 kg body weight).
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    Not permitted for 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.
    14
    Tulathromycin
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    Tulathromycin is irritating to eyes and may cause sensitisation by skin contact.
    Wash hands after use.
    In case of accidental self-injection, seek medical advice immediately and show the package insert or
    the label to the physician.
    10. EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    11. SPECIAL STORAGE CONDITIONS
    No special precautions for storage.
    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
    Marketing Authorisation Holder
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK
    15
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/041/002
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot>
    16
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (100 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Tulathromycin
    100 mg/ml
    Monothioglycerol
    5 mg/ml
    3.
    PHARMACEUTICAL FORM
    Solution for injection
    4.
    PACKAGE SIZE
    100 ml
    5.
    TARGET SPECIES
    Cattle and pigs
    6.
    INDICATION(S)
    Treatment and prevention of bacterial and mycoplasmal infections in cattle and pigs. See package
    leaflet for complete list of indications, sensitive pathogens and directions for use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/kg body
    weight (1 ml/40 kg body weight).
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    Not permitted for 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.
    17
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    Tulathromycin is irritating to eyes and may cause sensitisation by skin contact.
    Wash hands after use.
    In case of accidental self-injection, seek medical advice immediately and show the package insert or
    the label to the physician.
    10. EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    11. SPECIAL STORAGE CONDITIONS
    No special precautions for storage.
    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
    Marketing Authorisation Holder
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK
    18
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/041/003
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot>
    19
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (250 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Tulathromycin
    100 mg/ml
    Monothioglycerol
    5 mg/ml
    3.
    PHARMACEUTICAL FORM
    Solution for injection
    4.
    PACKAGE SIZE
    250 ml
    5.
    TARGET SPECIES
    Cattle and pigs
    6.
    INDICATION(S)
    Treatment and prevention of bacterial and mycoplasmal infections in cattle and pigs. See package
    leaflet for complete list of indications, sensitive pathogens and directions for use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/kg body
    weight (1 ml/40 kg body weight).
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    Not permitted for 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.
    20
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    Tulathromycin is irritating to eyes and may cause sensitisation by skin contact.
    Wash hands after use.
    In case of accidental self-injection, seek medical advice immediately and show the package insert or
    the label to the physician.
    10. EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    11. SPECIAL STORAGE CONDITIONS
    No special precautions for storage.
    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
    Marketing Authorisation Holder
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK
    21
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/041/004
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot>
    22
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    (500 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Tulathromycin
    100 mg/ml
    Monothioglycerol
    5 mg/ml
    3.
    PHARMACEUTICAL FORM
    Solution for injection
    4.
    PACKAGE SIZE
    500 ml
    5.
    TARGET SPECIES
    Cattle
    6.
    INDICATION(S)
    Treatment and prevention of bacterial and mycoplasmal infections in cattle. See package leaflet for
    complete list of indications, sensitive pathogens and directions for use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) injection of 2.5 mg tulathromycin/kg body weight (1 ml/40 kg body
    weight).
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Not permitted for 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.
    23
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    Tulathromycin is irritating to eyes and may cause sensitisation by skin contact.
    Wash hands after use.
    In case of accidental self-injection, seek medical advice immediately and show the package insert or
    the label to the physician.
    10. EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    11. SPECIAL STORAGE CONDITIONS
    No special precautions for storage.
    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
    Marketing Authorisation Holder
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK
    24
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/03/041/005
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot>
    25
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    (20 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Monothioglycerol
    100 mg/ml
    5 mg/ml
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    20 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/kg body
    weight (1 ml/40 kg body weight).
    5.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    6.
    BATCH NUMBER
    <Batch> <Lot>
    7.
    EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    26
    Tulathromycin
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    (50 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Monothioglycerol
    100 mg/ml
    5 mg/ml
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    50 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/kg body
    weight (1 ml/40 kg body weight).
    5.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    6.
    BATCH NUMBER
    <Batch> <Lot>
    7.
    EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    27
    Tulathromycin
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    (100 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Tulathromycin
    100 mg/ml
    Monothioglycerol
    5 mg/ml
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    100 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/kg body
    weight (1 ml/40 kg body weight).
    5.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    6.
    BATCH NUMBER
    <Batch> <Lot>
    7.
    EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    28
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    (250 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Monothioglycerol
    100 mg/ml
    5 mg/ml
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    250 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/kg body
    weight (1 ml/40 kg body weight).
    5.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    6.
    BATCH NUMBER
    <Batch> <Lot>
    7.
    EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    29
    Tulathromycin
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    (500 ml)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Monothioglycerol
    100 mg/ml
    5 mg/ml
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    500 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    A single subcutaneous (cattle) injection of 2.5 mg tulathromycin/kg body weight (1 ml/40 kg body
    weight).
    5.
    WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    6.
    BATCH NUMBER
    <Batch> <Lot>
    7.
    EXPIRY DATE
    Expires <mm/yyyy>
    In use shelf life: 28 days
    Discard date:
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    30
    Tulathromycin
     
    B. PACKAGE LEAFLET
    31
    PACKAGE LEAFLET
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK.
    Manufacturer for the batch release
    Pfizer PGM
    Z.I. d’Amboise
    F-37530 Pocé-sur-Cisse
    France
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    DRAXXIN 100 mg/ml solution for injection for cattle and pigs
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Monothioglycerol
    100 mg/ml
    5 mg/ml
    4.
    INDICATION(S)
    Cattle
    Treatment and prevention of bovine respiratory disease associated with Mannheimia haemolytica ,
    Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. The
    presence of the disease in the herd should be established before preventative treatment.
    Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to
    tulathromycin .
    Pigs
    Treatment and prevention of swine respiratory disease associated with Actinobacillus
    pleuropneumoniae , Pasteurella multocida, Mycoplasma hyopneumonia and Haemophilus parasuis
    sensitive to tulathromycin. The presence of the disease in the herd should be established before
    preventative treatment. Draxxin should only be used if pigs are expected to develop the disease within
    2-3 days.
    32
    Tulathromycin
    5.
    CONTRAINDICATIONS
    Do not use in case of hypersensitivity of the target animals to macrolide antibiotics
    Do not use the product simultaneously with other macrolides or 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
    Subcutaneous administration of DRAXXIN to cattle frequently causes transient pain reactions and
    local swellings at the injection site that can persist for up to 30 days . No such reactions have been
    observed in pigs after intramuscular administration. Pathomorphological injection site reactions are
    present for approximately 30 days after injection in both species.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Cattle and pigs
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Cattle (treatment and prevention)
    2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight).
    A single subcutaneous injection. For treatment of cattle over 300 kg body weight, divide the dose so
    that no more than 7.5 ml are injected at one site.
    Pigs
    2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight).
    A single intramuscular injection in the neck. For treatment of pigs over 80 kg body weight, divide
    the dose so that no more than 2 ml are injected at one site.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    It is recommended to treat animals in the early stages of the disease and to evaluate the response to
    treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or
    if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical
    signs have resolved.
    To ensure correct dosage body weight should be determined as accurately as possible to avoid
    underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to
    avoid excessive broaching of the stopper.
    33
    10. WITHDRAWAL PERIOD
    Cattle (meat and offal): 49 days
    Pig (meat and offal): 33 days
    Not permitted for 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.
    11. SPECIAL STORAGE PRECAUTIONS
    Use within 28 days of first opening or broaching the vial.
    Do not use after the expiry date stated on the label.
    Keep out of the reach and sight of children.
    12. SPECIAL WARNING(S)
    For the animal:
    Use of the product should be based on susceptibility testing and take into account offical and local
    antimicrobial policies. Do not administer simultaneously with antimicrobials with a similar mode of
    action such as other macrolides or lincosamides.
    Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or
    maternotoxic effects . The safety of tulathromycin during pregnancy and lactation has not been
    established in cattle and pigs. Use only according to the benefit/risk assessment by the responsible
    veterinarian.
    In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to
    injection site discomfort were observed and included restlessness, head-shaking, pawing the ground,
    and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving
    5-6X the recommended dose.
    In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient
    signs attributed to injection site discomfort were observed and included excessive vocalisation and
    restlessness. Lameness was also observed when the hind leg was used as the injection site.
    For the user:
    Tulathromycin is irritating to eyes. If accidental eye exposure occurs, flush the eyes immediately with
    clean water.
    Tulathromycin may cause sensitisation by skin contact. If accidental skin exposure occurs, wash the
    skin immediately with soap and water.
    Wash hands after use.
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    34
    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
    15.03.2010
    Detailed information on this product is available on the website of the European Medicines Agency
    15. OTHER INFORMATION
    Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a
    fermentation product. It differs from many other macrolides in that it has a long duration of action
    that is, in part, due to its three amine groups; therefore it has been given the chemical subclass
    designation of triamilide.
    Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of
    their selective binding to bacterial ribosomal RNA. They act by stimulating the dissociation of
    peptidyl-tRNA from the ribosome during the translocation process.
    Tulathromycin possesses in vitro activity against Mannheimia haemolytica , Pasteurella multocida,
    Histophilus somni and Mycoplasma bovis , and Actinobacillus pleuropneumoniae , Pasteurella
    multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica the
    bacterial pathogens most commonly associated with bovine and swine respiratory disease,
    respectively. Increased MIC values have been found in some isolates of Histophilus somni and
    Actinobacillus pleuropneumoniae .
    Tulathromycin also possesses in vitro activity against Moraxella bovis , the bacterial pathogen most
    commonly associated with infectious bovine keratoconjunctivitis (IBK).
    Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or
    some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site,
    generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLS B
    resistance); by enzymatic inactivation; or by macrolide efflux. MLS B resistance may be constitutive or
    inducible. Resistance may be chromosomal or plasmid-encoded and may be transferable if associated
    with transposons or plasmids.
    In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous
    dose of 2.5 mg/kg body weight, was characterised by rapid and extensive absorption followed by high
    distribution and slow elimination. The maximum concentration (C max ) in plasma was approximately
    0.5 µg/ml; this was achieved approximately 30 minutes post-dosing (T max ). Tulathromycin
    concentrations in lung homogenate were considerably higher than those in plasma. There is strong
    evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages.
    However, the in vivo concentration of tulathromycin at the infection site of the lung is not known.
    Peak concentrations were followed by a slow decline in systemic exposure with an apparent
    elimination half-life (t 1/2 ) of 90 hours in plasma. Plasma protein binding was low, approximately
    40%. The volume of distribution at steady-state (V ss ) determined after intravenous administration was
    11 L/kg. The bioavailability of tulathromycin after subcutaneous administration in cattle was
    approximately 90%.
    35
    In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular
    dose of 2.5 mg/kg body weight, was also characterised by rapid and extensive absorption followed by
    high distribution and slow elimination. The maximum concentration (C max ) in plasma was
    approximately 0.6 µg/ml; this was achieved approximately 30 minutes post-dosing (T max ).
    Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma.
    There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar
    macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is
    not known. Peak concentrations were followed by a slow decline in systemic exposure with an
    apparent elimination half-life (t 1/2 ) of approximately 91 hours in plasma. Plasma protein binding was
    low, approximately 40%. The volume of distribution at steady-state (V ss ) determined after
    intravenous administration was 13.2 L/kg. The bioavailability of tulathromycin after intramuscular
    administration in pigs was approximately 88%.
    Not all pack sizes may be marketed.
    500 ml vials must not be used for pigs.
    For any information about this veterinary medicinal product, please contact the local representative of
    the Marketing Authorisation Holder.
    België/Belgique/Belgien
    Pfizer Animal Health s.a.,
    Tel./Tél.: +32 (0)2 554 62 11
    Luxembourg/Luxemburg
    Pfizer Animal Health s.a.,
    Tél/Tel: + 32 (0)2 554 62 11
    Република България
    Pfizer H.C.P. Corporation
    Tel: + 359 2 970 43 21
    Magyarország
    Pfizer KFT
    Tel: +361 488 3695
    Česká republika
    Pfizer Animal Health
    Tel: +420 283 004 111
    Malta
    Agrimed Limited
    Tel: +356 21 465 797
    Danmark
    Orion Pharma
    Animal Health
    Tlf: +45 49 12 67 65
    Nederland
    Pfizer Animal Health B.V.,
    Tel: +31 (0)10 4064 600
    Deutschland
    Pfizer GmbH
    Tel: +49 (0) 30 5500 5501
    Norge
    Orion Pharma
    Animal Health
    Tlf: +47 40 00 41 90
    Eesti
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    Österreich
    Pfizer Corporation Austria G.m.b.H,
    Tel: +43 (0)1 52 11 57 20
    Ελλάδα
    Pfizer Hellas A.E.
    Τηλ.: +30 210 6785800
    Polska
    Pfizer Trading Polska Sp. z.o.o.
    Tel: +48 22 335 62 00
    España
    Pfizer S.A.
    Tel: +34 91 4909900
    Portugal
    Laboratórios Pfizer, Lda.
    Tel: +351 21 423 55 00
    36
    France
    Pfizer
    Tél: +33 (0)1 58 07 46 00
    România
    Pfizer Romania SRL
    Tel: + 0040 21 207 28 93
    Ireland
    Pfizer Healthcare Ireland, trading as:
    Pfizer Animal Health
    Tel: + 353 (0) 1 467 6500
    Slovenija
    Pfizer Luxemburg SARL
    Tel: +386 (0) 1 52 11 670
    Ísland
    Icepharma Ltd
    Tel: +354 540 80 00
    Slovenská republika
    Pfizer Luxembourg SARL o.z.
    Pfizer AH
    Tel: +421 2 3355 5500
    Italia
    Pfizer Italia s.r.l.,
    Tel: +39 06 3318 2933
    Suomi/Finland
    Pfizer Oy Animal Health,
    Puh/Tel: +358 (0)9 4300 40
    Κύπρος
    Pfizer Hellas A.E.
    Τηλ.: +30 210 6785800
    Sverige
    Orion Pharma
    Animal Health
    Tel: +46 (0)8 623 64 40
    Latvija
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    United Kingdom
    Pfizer Ltd
    Tel: +44 (0) 1304 616161
    Lietuva
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    37


    Source: European Medicines Agency


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