Product Details - ENGEMYCIN® 10%

CattleGoatsHorsesPigsSheep

Product Class

FOR ANIMAL USE ONLY

ENGEMYCIN® 10%
Injectable Solution

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.

INDICATIONS
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, foot rot, mastitis, navel/joint-ill and bacterial wound infections.

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

CONTENTS
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 formaldehyde-desulfoxylate as a preservative.

STORAGE

  • 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.

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.

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.

DOSAGE

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.

Pigs

  • 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.

PRESENTATION
100 mℓ and 250 mℓ amber bottles or PET flasks each packed in a cardboard box.

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road
Spartan, 1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Intervet International
GmbH
Feldstrasse 1a
85716 Unterschleissheim
Germany

DATE OF PUBLICATION OF THIS PACKAGE INSERT
July 2003

Zimbabwe Reg. No.: E94/80.22.10/9381
Pharmacological classification: 80.22.10
Distribution category: VMGD