Dechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS Tel: 01939 211200 BOVOCYCLINE PESSARY 2000 MG
damage to the liver. Photodermatitis often occurs in
INTRAUTERINE PESSARY FOR CATTLE
areas of sparsely pigmented skin if these are exposedto sunlight. Allergic reactions are rare. In case of
Qualitative and quantitative composition Each in-
allergic or anaphylactic reactions, discontinue treat-
trauterine tablet contains: Active substance:
ment immediately. Allergic reactions can be treated
Tetracycline hydrochloride 2000.0 mg (equivalent
parenterally with steroids and antihistamines.
Excipients: For a full list of excipients, see Excipi-Use during pregnancy and lactation:
not indicated for use during pregnancy but can beused during lactation. Pharmaceutical form
long-shaped tablet, scored on one side. The tablet is
tween tetracyclines and antibiotics with bactericidalaction. Clinical particulars Target species: Cattle. Amounts to be administered and administrationroute: Tablet for intrauterine use. Cows: A dose of 2 g tetracycline hydrochloride per
post-parturient disorders in cattle: for administration
treatment, equivalent to 1 tablet per cow, is to be
following dystocia, retained foetal membranes and
administered every 24 to 48 hours. The number of
endometritis caused by pathogens susceptible to
treatments required ranges from 1 to 3.
It is recommended to remove part of the lochia by
by pathogens resistant to tetracycline.
rectal massage before treatment. Before administra-
Do not use in severe kidney and liver disorders.
tion, the vulva and perineal area should be carefully
Do not use in case of hypersensitivity to tetracy-
washed and disinfected with a non-irritating solution
and dried with disposable paper. Treatment shouldbe accompanied by an improvement in conditions of
Special precautions for use in animals: The product
should be used based on susceptibility testing and
Overdose: Please refer to Adverse reactions.
take into account official, national and regional anti-microbial policies. Special precautions to be taken by the person admin-istering the veterinary medicinal product to ani-Pharmacological particulars
Direct contact with the skin or the mucous
group: Anti-infectives and antiseptics for intrauterine
membranes of the user should be avoided. The use
of gloves is recommended when administering the
product to avoid sensitisation. Wash your hands afterhandling the product.
broad-spectrum antibiotic with bacteriostatic action
in vivo. The spectrum includes gram-positive and
ful monitoring to avoid super-infection (for example
gram-negative, aerobic and anaerobic micro-organ-
with yeasts). Occurrence of renal disorders is en-
isms. The primary pathogens involved in puerperal
hanced in dehydrated animals. Tetracycline can cause
intrauterine infections, Arcanobacterium (Actinomy-ces) pyogenes and Escherichia coli, are susceptible to
tetracycline. For systemic action against most suscep-
the outer carton in order to protect from light. Keep
tible micro-organisms, in vivo serum concentrations
out of the reach and sight of children.
of 0.5-2 μg/ml are considered efficacious, which need
to be sustained over a sufficiently long period of time.
PVDC top foil and aluminium bottom foil.
Concentrations of more than 2 μg/ml of tetracycline
Carton with 1 blister of 5 intrauterine tablets.
are easily obtained in lochia following intrauterine
Carton with 2 blisters of 5 intrauterine tablets each
administration of the recommended dose.
Carton with 4 blisters of 5 intrauterine tablets each
Carton with 10 blisters of 5 intrauterine tablets each
membranes is limited due to the amphotheric prop-
Carton with 20 blisters of 5 intrauterine tablets each
erties of the molecule. Absorption of tetracycline
hydrochloride from the uterus to the peripheral blood
Carton with 40 blisters of 5 intrauterine tablets each
is limited in post-parturient cows. The rate of absorp-
tion of tetracycline depends on various individual
factors such as the relative blood flow to the myome-trium, contractions of the uterus, lochial volume,
discharge from the vulva and the severity of inflam-
or waste materials derived from such veterinary
mation and infection. Tetracycline undergoes entero-
medicinal products should be disposed of in accor-
hepatic circulation and its antimicrobially active form
is eliminated primarily via urine, faeces and milk. The
Marketing authorisation holder (if different from
biological half-life following systemic administration
is 8 hours in ruminants. It varies depending on the
25, 5531 AE Bladel, The Netherlands.
route of administration; it is prolonged in animalswith renal insufficiency. Marketing authorisation number Vm 16849/4021 Date of the first authorisation or date of renewal- Pharmaceutical particulars
fate, sodium starch glycolate type A, microcrystalline
Date of revision of the text June 2011
cellulose, silica colloidal anhydrous, magnesium ste-
Any other information
To be supplied only on veterinary prescription. Legal category POM-V
product as packaged for sale: 3 years. GTIN (Global Trade Item No)
Do not use after the expiry date stated on the blister
Bovocycline Pessary 2000 mg Intrauterine Pessary for
Requested by: [email protected] Approved datasheets found: 1 Creation date: 10/10/2012 14:20:26 (UK) Approved for book but not on website: 0 Datasheets marked as draft (ignored): 0 Directory of participants Dechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS Tel: 01939 211200Fax: 01939 211201email: [email protected]
LIST OF PRODUCTS BY THERAPEUTIC INDICATION
List of Products by Therapeutic Indication PHARMACEUTICALS Antimicrobials Uterine products List of Products by Species
Please note that a species in brackets after a product name may not necessarily be a part of that product namebut is intended to make the index easier to use. Cattle Bovocycline Pessary 2000 mg Intrauterine Pessary List of Products by Active Ingredients
This index of non-proprietary names (active ingredients) is provided to enable users of the Compendium toidentify the brand names of relevant products when only the non-proprietary names are known.
It should be noted that although different products may contain the same active ingredient this does not implythat they are equivalent in regard to bioavailability or therapeutic activity.
Some products contain a number of ingredients and it has not been possible in every instance to identify suchproducts by a reference in this index to each ingredient.
Non-proprietary name in bold type. Proprietary name in ordinary type. Tetracycline Hydrochloride
Bovocycline Pessary 2000 mg Intrauterine Pessary
GRED IN E IV Alphabetical Index of Products
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FARM. RESP.: Marcio Machado CRF-RJ Nº 3045 BREXIN® Forma farmacêutica e apresentações Comprimidos: cartuchos com 5 e 10 comprimidos. LABORATÓRIO GROSS S.A. Rua Padre Ildefonso Peñalba, Nº 389 Composição Excipientes: lactose monoidratada, crospovidona, amidoglicolato de sódio, dióxido de silício coloidal, amido, estearato Nº do lote, Data de Fabricação e Prazo de Valid