Engemycin 10%

FOR ANIMAL USE ONLY

ENGEMYCIN^® 10%

INJECTABLE SOLUTION

Reg. No. G2470 (Act 36/1947)

Namibia Reg. No. V98/17.1.2/668 NS0

INDICATIONS

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.

STORAGE

• Store in the dark, at or below 25 °C.
• Do not freeze.

• Protect from exposure to direct sunlight.
• Do not use this veterinary medicinal product after the expiry date which is stated on the container label.

COMPOSITION

Engemycin^® 10% is an aqueous solution containing oxytetracycline in a complex with magnesium oxide and polyvinylpyrrolidone.

Each 1 mℓ of Engemycin^® 10% contains 100 mg oxytetracycline in a complex with magnesium oxide and polyvinylpyrrolidone in water for injection. It contains sodium formaldehyde-desulfoxylate as a preservative.

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.
•  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.

PRECAUTIONS

•  Observe aseptic precautions.
•  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.
•  Dispose of all the empty containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
•  Do not contaminate rivers, dams or any water sources with containers or waste.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED.

•   Three to five dosages are required to control bacterial infections.
•   Repeat intramuscular (IM) or subcutaneous (SC) injections should be given at different injection sites.
•   Not more than 20 mℓ should be given at the same injection site.
•   Intravenous injections should be given slowly over a period of at least 1 minute.
•   For the indication of anaplasmosis/heartwater, the recommended dose is 20 mg/kg    intravenously (IV) or intramuscularly (IM).
•   Observe aseptic conditions when administering the injection.

DOSAGE

Cattle and Horses

• 1 mℓ per 10 kg body mass (10 mg/kg) IV/IM. Intramuscular injections should be made deep into the fleshy part of the muscle. Administer in a minimum of 2 locations to limit the volume per site.

Pigs

• 1 mℓ per 10 kg body mass (10 mg/kg) SC or IM.
• In very young pigs below 10 kg body mass, the subcutaneous route is preferred.
• In pigs weighing more than 10 kg body mass, administer by intramuscular injection at 1 site in the neck.
• In pigs weighing more than 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 per 10 kg body mass (10 mg/kg) IV/IM.
• In sheep and goats more than 50 kg body mass, the dose should be divided and administered at 2 injection sites.

PRESENTATION

100 mℓ and 500 mℓ amber bottles or PET flasks each packed in a cardboard box.