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, footrot, 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 formaldehydedesulfoxylate 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 500 mℓ amber bottles or PET flasks each packed in a cardboard box.

 

REGISTRATION HOLDER

MANUFACTURER          

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

July 2003

 

Zimbabwe Reg. No.: E94/80.22.11/9381

 

Pharmacological classification: 80.22.11  Distribution category: VMGD