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Date: Tuesday, December 1, 2020 9:11

Description: MSD-AH
Release 2.38
Engemycin® LA 200 mg/ml, Solution for injection
 
Species: Cattle, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Oxytetracycline Dihydrate
Product:Engemycin® LA 200 mg/ml, Solution for injection
Product index: Engemycin® LA 200 mg/ml
Cattle - milk: 8 days
Cattle - meat: 41 days
Sheep - meat: 24 days
Pig - meat: 20 days
Qualitative and quantitative composition
Each ml contains:
Active substance
Oxytetracycline 200 mg
(Equivalent to Oxytetracycline Dihydrate 216 mg)
Excipient
Sodium Formaldehyde Sulfoxylate 2 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Clear amber solution for injection
Clinical particulars
Target Species
Cattle, sheep and pigs
Indications for use
The product is indicated for use in cattle, sheep and pigs in the treatment of:
- Atrophic rhinitis caused by Bordetella bronchiseptica, Mannheimia haemolytica and Pasteurella multocida.
- Navel/joint ill caused by Trueperella pyogenes, Escherichia coli or Staphylococcus aureus.
- Mastits caused by Corynebacterium pyogenes, E. coli, Staphylococcus aureus, Streptococcus agalactiae or Streptococcus uberis.
- Metritis caused by E. coli or Streptococcus pyogenes.
- Pasteurellosis and infections of the respiratory tract caused by Mannheimia haemolytica and Pasteurella multocida.
- Septicaemia caused by Salmonella dublin and Streptococcus pyogenes.
- Erysipelas caused by Erysipelothrix rhusiopathiae.
The product can also be used in the control of enzootic abortion in sheep.
Contraindications
Do not use in horses, cats and dogs.
Do not use in animals suffering from renal or hepatic damage.
Special warnings for each target species
None
Special precautions for use
Do not dilute the product.
If concurrent treatment is administered, use a separate injection site.
Operator warnings
Wash hands after use.
In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.
Take care to avoid accidental injection.
Adverse Reactions
Although the product is well tolerated, occasionally a slight local reaction of a transient nature has been observed.
Use during pregnancy or lactation
The use of oxytetracycline during the period of tooth and bone development, including late pregnancy, may lead to tooth discolouration. The product can be safely administered to lactating animals.
Interactions
None known
Amounts to be administered and administration route
The recommended dosage rate is 20 mg/kg bodyweight (i.e.1 ml per 10 kg bodyweight) by deep intramuscular injection. This product is recommended for a single administration only.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Maximum recommended dose at any one site:
Cattle 20 ml
Pigs 10 ml
Sheep 5 ml
Piglets 1 day 0.2 ml
7 days 0.3 ml
14 days 0.4 ml
21 days 0.5 ml
over 21 days 1 ml/10 kg
Overdose
There is no known specific antidote, if signs of possible overdose occur, treat the animal symptomatically.
Withdrawal periods
Cattle: Meat and offal – 41 days
Milk – 8 days
Sheep: Meat and offal – 24 days
Milk – 7 days
Pigs: Meat and offal – 20 days
Pharmacological particulars
ATC Vet Code: QJ01AA06
Pharmacotherapeutic group: Antibiotic
Pharmacodynamic properties
Oxytetracycline is a bacteriostatic antibiotic that inhibits protein synthesis in susceptible bacteria. Inside the cell it binds irreversibly to receptors on the 30S subunit of the bacterial ribosome where it interferes with the binding of the aminoacyl-transfer RNA to the acceptor site on the messenger RNA ribosome complex. This effectively prevents the addition of amino acids to the elongating peptide chain, inhibiting protein synthesis. The product is specifically formulated to provide a prolonged action resulting in sustained antibacterial activity.
Oxytetracycline has a broad spectrum of activity, i.e. active against Gram-positive and Gram-negative organisms. Oxytetracycline has been shown to be effective in vitro against the following bacterial species: Bordetella bronchiseptica, Corynebacterium pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Histophilus somni, Pasteurella haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes and Streptococcus uberis.
Pharmacokinetic particulars
Blood levels persist for at least 4 days after administration by the intramuscular route. Maximum blood levels are achieved between 4 and 8 hours following intramuscular administration.
Pharmaceutical particulars
Excipients
Sodium formaldehyde sulfoxylate
Magnesium Oxide Light
2-Pyrrolidone
Povidone K12
Monoethanolamine
Hydrochloric Acid
Water for Injections
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for storage
Do not store above 25oC. Protect from light.
Following withdrawal of the first dose, use the product within 28 days.
Discard unused material.
When the vial has been broached and the contents exposed to air the solution may darken but the potency will be unchanged.
Immediate packaging
Amber type II glass vials of 50 ml and 100 ml sealed with Chlorobutyl Rubber Bungs and aluminium seal.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
Vm 01708/4338
Significant changes
Date of the first authorisation or date of renewal
20 February 1996
Date of revision of the text
06 July 2020
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Engemycin LA 1x100ml:
GTIN:8713184073846