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Date: Saturday, April 20, 2024 10:37

Description: Animalcare_UK_2SpotCol_RGB_vertical_Logo
Release 2.135
Oxycare Tablets 250mg
Species: Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Oxytetracycline Dihydrate
Product:Oxycare Tablets 250mg
Product index: Oxycare Tablets 250mg
Incorporating:
Qualitative and quantitative composition
Each tablet contains:
Active substance(s) :
Oxytetracyline dihydrate 250mg
Excipient(s) :
Quinoline Yellow (E104) 0.572mg
Riboflavin (E101) 0.135mg
Sunset Yellow (E110) 0.008mg
Ferric Oxide yellow (E172) 0.006mg
Pharmaceutical form
Film coated tablet
Yellow, round, convex tablets with a cross-snap-tab on one side
Clinical particulars
Target species
Dogs
Indications for use, specifying the target species
For the treatment of dogs with bacterial infections sensitive to tetracycline
therapy only. Soft tissue infections caused by Staphylococcus aureus or
Streptococcus spp. have been shown to be highly sensitive. Respiratory
infections caused by Bordetella bronchiseptica are also commonly sensitive.
Contraindications
Contraindicated for use in animals with hypersensitivity to any tetracycline.
Special warnings for each target species
Not applicable
Special precautions for use
Special precautions for use in animals
Oxytetracycline is deposited in growing teeth and bones and may cause yellow discolouration. It also crosses the placenta. For this reason it is not recommended in late pregnancy or in young animals. Caution must be taken in treating animals with renal or hepatic dysfunction; in such cases it may be necessary to reduce dosage levels.
Special precautions for the person administering the veterinary medicinal product to animals
If you know you are hypersensitive (allergic) to oxytetracycline, do not handle the product.
In the event of accidental ingestion, flush mouth with plenty of water and seek medical advice.
In the event of eye contact, flush thoroughly with clean, running water. If irritation persists seek medical attention.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Prolonged use of antibiotics of all types may promote the overgrowth of
non-susceptible organisms to that antibiotic. Where it occurs therapy should be discontinued and appropriate control of the organisms substituted
Use during pregnancy, lactation or lay
Oxytetracycline crosses the placenta. The product should not be used in late pregnancy.
Interaction with other medicinal products and other forms of interaction
The product must not be given concurrently with milk or antacids.
Amounts to be administered and administration route
For oral administration
An initial dose of 50mg/kg bodyweight should be given, followed by subsequent doses of 25mg/kg every 12 hours for 5 days. To be taken by mouth at least one hour before or two hours after feeding.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Gastric lavage may be beneficial in the first hours after ingestion and milk will reduce absorption. Most common signs of overdose would be vomiting, anorexia and/or diarrhoea, in which case fluid and electrolytes should be administered.
Pharmacological particulars
Pharmacotherapeutic group: Oxytetracycline
ATC Vet Code: QJ01AA06
Pharmacodynamic properties
Antibiotic of the tetracycline group, with a broad spectrum of activity against Mycoplasma, Chlamydia and Rickettsia and a range of Gram-positive and Gram-negative bacteria. (Little activity against E. coli, Salmonella, Proteus and Pseudomonads.) Tetracyclines are bacteriostatic; bacterial sensitivity testing is advisable to preclude resistance in the target infecting bacteria.
Pharmaceutical particulars
List of excipients
Cellulose microcrystalline, Lactose monohydrate, Sodium Starch glycollate Type A, Magnesium stearate, Silica,colloidal hydrated, Coating, Purified Water, Hypromellose (HPMC) 6, Talc, Titanium dioxide, Hydroxypropylcellulose, Polyethylene glycol (PEG) 3350, Quinoline Yellow (E104), Riboflavin (E101), Sunset Yellow (E110), Ferric oxide yellow (E172)
Incompatibilities
Aluminium, magnesium and calcium interfere with absorption of oxytetracycline; it must not be given concurrently with milk or antacids.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
Do not store above 25°C. Protect from light. Return any ¼ tablet to the pot and use within 48 hours
Nature and composition of immediate packaging
A white, polypropylene tub with a low density polyethylene packing with a white, low density polyethylene cap (push fit), containing 1000 tablets.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Ecuphar NV
Legeweg 157-i
8020 Oostkamp
Belgium
Marketing Authorisation Number
Vm 32742/4032
Significant changes
Date of the first authorisation or date of renewal
22 June 1992
Date of revision of the text
May 2019
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:OXYCARE 250MG TABLETS
GTIN:5055037400359