Medine.co.uk

Oxycare Tablets 100 Mg

Revised: June 2013

AN: 00242/2013



SUMMARY OF PRODUCT CHARACTERISTICS


1.

NAME OF THE VETERINARY MEDICINAL PRODUCT



Oxycare Tablets 100mg


2.

QUALITATIVE AND QUANTITATIVE COMPOSITION



Each tablet contains:


Active substance(s) :

Oxytetracyline dihydrate


Excipient(s) :

Titanium dioxide (E171)

Tartrazine Lake 15002 (E102)


For a full list of excipients, see section 6.1




100mg


1.4mg

0.8mg


3.

PHARMACEUTICAL FORM



Tablet

A yellow, sugar-coated, biconvex tablet.


4.

CLINICAL PARTICULARS



4.1

Target species



Dogs


4.2

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.


4.3

Contraindications



Contraindicated for use in animals with hypersensitivity to any tetracycline.


4.4

Special warnings for each target species



Not applicable.


4.5

Special precautions for use



i.

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.


ii.

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.


iii.


Other precautions



None


4.6

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.


4.7

Use during pregnancy, lactation or lay



Oxytetracycline crosses the placenta. The product should not be used in late pregnancy.


4.8

Interaction with other medicinal products and other forms of interaction



The product must not be given concurrently with milk or antacids.


4.9

Amount(s) 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.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary



Gastric lavage may be beneficial in the first hours after ingestion and milk will reduce absorption. Thereafter conservative treatment.


4.11

Withdrawal period(s)



Not applicable.


5.

PHARMACOLOGICAL PROPERTIES



Pharmacotherapeutic group: Oxytetracycline




ATC Vet Code: QJ01AA06



5.1

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.



6.

PHARMACEUTICAL PARTICULARS



6.1

List of excipients


Coating

Tartrazine Lake 15002 (E102)

Titanium Dioxide (E171)

Sucrose

Talc

White Beeswax

Carnauba Wax

Glucose Monohydrate

Povidone

Liquid Paraffin

Sodium Starch Glycollate Type A

Maize Starch

Stearic Acid

Magnesium Stearate

IMS 74 OP


6.2

Incompatibilities



Aluminium, magnesium and calcium interfere with absorption of oxytetracycline; it must not be given concurrently with milk or antacids.


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 25C.

Protect from light.


6.5

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.


6.6

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.


7

MARKETING AUTHORISATION HOLDER



Animalcare Ltd

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB


8.

MARKETING AUTHORISATION NUMBER



Vm 10347 / 4002


9.

DATE OF FIRST AUTHORISATION



Date: 22 June 1992


10.

DATE OF REVISION OF THE TEXT


Date: June 2013

APPROVED 3/07/13

Page 4 of 4