An aqueous oxytetracycline injectable solution for the treatment and control of disease conditions caused by or associated with oxytetracycline susceptible organisms.
FOR ANIMAL USE ONLY
Reg. No. G2470 (Act 36/1947)
Namibia Reg. No. V98/17.1.2/668 NS0
Engemycin® 10% is an aqueous oxytetracycline injectable solution for the treatment and control of disease conditions caused by or associated with oxytetracycline susceptible organisms.
Cattle: For the treatment of tick-borne gallsickness (anaplasmosis), heartwater, bacterial pneumonia, mastitis, bacterial enteritis, navel/joint-ill and bacterial wound infections.
Horses: For the treatment of strangles, bacterial pneumonia and enteritis.
Pigs: For the treatment of bacterial pneumonia, mastitis, bacterial enteritis, navel/joint-ill and bacterial wound infections.
Sheep and Goats: For the treatment of heartwater, bacterial pneumonia, footrot, mastitis, navel/joint-ill and bacterial wound infections.
Engemycin® 10% is an aqueous solution containing oxytetracycline in a complex with magnesium oxide and polyvinylpyrolidone.
Each 1 mℓ of Engemycin® 10% contains 100 mg oxytetracycline in a complex with magnesium oxide and polyvinylpyrolidone in water for injection. It contains sodium formaldehydedesulfoxylate as a preservative.
- Store in the dark, below 25 °C.
- Do not freeze.
- Protect from exposure to direct sunlight.
WARNINGS • Withdrawal periods
Meat and other organs : 14 days after the last dosage.
Milk : 60 hours after the last dosage.
- The use of tetracyclines during the period of tooth development including late pregnancy may lead to tooth discolouration.
- A darkened solution must be discarded.
- Rapid intravenous injection may result in an acute shock reaction and collapse.
- Discard empty vials and disposable needles and syringes in accordance with local waste disposal regulations.
- KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
- Although this remedy has been tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.
- Do not administer to animals known to be allergic to oxytetracyclines (infrequent allergies may occur).
- Do not inject piglets with iron preparations on the same day.
- Do not dilute with calcium salts as this may lead to precipitation of crystals which would make the solution not suitable for intravenous infusion.
- Oxytetracycline must be used with caution in animals with existing kidney impairment.
- Consult a veterinarian for an accurate diagnosis.
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
- For the control of bacterial infections, 3 to 5 doses are required.
- For the indication of anaplasmosis/heartwater, the recommended dose is 20 mg/kg intravenously (i.v.) or intramuscularly (i.m.).
- Repeat intramuscular or subcutaneous (s.c.) injections should be given at different sites.
- Not more than 20 mℓ should be given at any 1 site.
- Intravenous injections should be given slowly over a period of at least 1 minute.
- Observe aseptic conditions when administering the injection.
Cattle and Horses
- Intramuscular injections of 1 mℓ/10 kg body mass (10 mg/kg) i.v./i.m. should be made deep into the fleshy part of the muscle. Administer in a minimum of 2 locations to limit the volume per site.
- 1 mℓ/10 kg body mass (10 mg/kg) s.c. or i.m.
- In very young pigs below 10 kg body mass, the subcutaneous route is preferred.
- Pigs in excess of 10 kg body mass, administer by intramuscular injection at 1 site in the neck.
- In pigs weighing over 100 kg the dose should be divided and administered at 2 injection sites.
- Do not administer more than 0,5 mℓ oxytetracycline in piglets of less than 2 kg body mass.
Sheep and Goats
- 1 ml/10 kg body mass (10 mg/kg) i.v./i.m.
- In sheep and goats over 50 kg body mass, the dose should be divided and administered at 2 injection sites.
100 mℓ and 500 mℓ amber bottles or PET flasks each packed in a cardboard box.
|Intervet South Africa (Pty) Ltd.||Intervet International GmbH|
|20 Spartan Road||Feldstrasse 1a|
|Spartan, 1619, RSA||85716 Unterschleissheim|
|Tel: +27 (0) 11 923 9300 Fax: +27 (0) 11 392 3158 www.msd-animal-health.co.za||Germany|
DATE OF PUBLICATION OF THIS PACKAGE INSERT
Zimbabwe Reg. No.: E94/80.22.11/9381
Pharmacological classification: 80.22.11 Distribution category: VMGD