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Date: Sunday, June 16, 2024 6:00

Description: MSD-AH
Release 2.62
Engemycin® 10% DD Solution for injection
 
Species: Cats, Cattle, Dogs, Horses and other equidae, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Oxytetracycline Hydrochloride
Product:Engemycin® 10% DD Solution for injection
Product index: Engemycin® 10% DD
Cattle - milk: 144 hours
Cattle - meat: 35 days
Sheep - meat: 14 days
Pig - meat: 14 days
Incorporating:
Qualitative and quantitative composition
Active substance per ml:
Oxytetracycline (as hydrochloride) 100 mg
Antioxidant preservative per ml:
Sodium formaldehyde sulphoxylate 5 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Clear, yellow, aqueous solution for injection
Clinical particulars
Target Species
Cattle, sheep, pigs, horses, dogs and cats
Indications for use
For the treatment of infections caused by organisms sensitive to oxytetracycline in horses, cattle, sheep and pigs
In vitro, oxytetracycline is active against a range of both Gram-positive and Gram-negative micro organisms including:
Streptococcus spp., Staphylococcus spp., L. monocytogenes, P. haemolytica, H. parahaemolyticus and B. bronchiseptica and against Chlamydophila abortus, the causative organism of enzootic abortion in sheep.
Contraindications
Not to be administered to horses during concomitant therapy with corticosteroids.
Special warnings for each target species
As with other tetracyclines, caution should be exercised in treating horses under stress.
Exercise caution in animals with hepatic or renal impairment.
Special precautions for use
Not for intravenous administration in dogs or cats.
Operator warnings
Take care to avoid accidental injection.
In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.
Wash hands after use.
Adverse Reactions
A transient swelling may be observed following intramuscular administration in horses and subcutaneous administration in dogs.
Photodermatitis may occur after treatment if exposure to intense sunlight occurs.
Use during pregnancy or lactation
The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to discolouration.
Interactions
It is not recommended to administer bacteriostatic and bactericidal antibiotics concurrently.
Amounts to be administered and administration route
Can be administered at either a low dose rate for a 24 hour duration of activity or at a high dose rate for prolonged duration of activity.
24 hour dosage regime:
The recommended dosage rate is 3-10 mg/kg bodyweight (depending on age and species - see table) by intramuscular or intravenous injection in large animals and by subcutaneous or intramuscular injection in small animals.
The treatment may be repeated at 24 hour intervals up to 4 times (5 treatments in all).
Intravenous injections must be given slowly over a period of at least one
minute.
Prolonged action dosage regime:
10 or 20 mg/kg bodyweight depending on age and species (see table) by intramuscular injection only, repeated once after 48-60 hours if required.
This dosage regime is not advised for use in horses, dogs or cats.
Animal
Weight kg
24 hour dosage
Prolonged action
Dose mg/kg
Volume ml
Dose mg/kg
Volume ml
Horse
500
5
25
Not recommended
Foal
100
10
10
Not recommended
Cow
500
3
15
10
50
Calf
100
8
8
20
20
Sow/boar
150
5
7.5
10
15
Pig
25
8
2
20
5
Sheep
50
8
4
20
10
Lamb
25
8
2
20
5
Dog
10
10
1
Not recommended
Cat
5
10
0.5
Not recommended
Prophylactic treatment of enzootic abortion in sheep: 20 mg/kg administered about day 95-100 of gestation. A further treatment may be given 2-3 weeks later.
Before administration, clean the area of the injection site and swab with spirit. Repeat doses should be administered at different sites, and the sites massaged well after injection.
Maximum recommended dose at any one site: 20 ml for cattle, 10 ml for sheep and pigs.
Overdose
Oxytetracyline has low toxicity, but is irritant. Overdosage should be avoided, particularly in horses. No recommended treatment.
Withdrawal periods
24 hour dose
Milk Cows
6 days
Cattle
35 days
Sheep
14 days
Pigs
14 days
Prolonged action dose
Milk cows
6 days
Cattle
21 days
Sheep
14 days
Pigs
10 days
Not for use in horses intended for human consumption.
Not for use in sheep producing milk for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
Pharmacological particulars
ATC Vet Code: QJ01AA06
Pharmacotherapeutic group:
Oxytetracycline is a bacteriostatic antibiotic which has broad spectrum antibacterial activity against both gram-positive and gram-negative bacteria. After absorption it enters most tissues and body fluids, with the exception of CSF. It is excreted unchanged, mainly in urine.
Pharmacokinetics properties
From the site of injection the drug is effectively and rapidly absorbed with minimal irritation of the tissue thanks to the low viscosity of the solvent contained in the formulation, polyvinyl pyrrolidone (PVP).
Depending on the dose rate the duration of the action after a single administration is for 24 hours or prolonged to 48 – 60 hours.
After a standard dose of 3-8 mg oxytetracycline/kg BW to target animals, drug peak plasma concentrations were achieved in 1 - 4 hours and lasted to the level of 0.5 - 1.0 µg/mL, regarded as effective, in about 24 hours; by giving IM doses of 10 – 20 mg oxytetracycline/kg BW the action was prolonged and concentrations exceeding 0.5 – 1.0 µg/ml were maintained for about 48 hours.
The drug is widely distributed in the body with highest concentrations in liver, spleen, kidneys and the lungs. Oxytetracycline is moderately protein bound (about 50 %) and is excreted mainly unchanged by the renal route, with some in the faeces and milk.
Pharmaceutical particulars
Excipients
Sodium formaldehyde sulphoxylate
Magnesium Oxide
Povidone K12
Ethonolamine
Water for injection
Major incompatibilities
Dilution with calcium salts is not recommended as this may lead to precipitation of crystals.
Shelf-life
Shelf life: 2 years
Following withdrawal of the first dose, use the product within 28 days.
Special precautions for storage
Do not store above 25oC. Protect from light. Do not freeze.
Keep container in outer carton.
Immediate packaging
Vials of amber Type II (Ph Eur) glass or PET closed with halogenated butyl rubber stopper with aluminium overseal.
Multi-dose vials of 100 ml.
Disposal
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4623
Significant changes
Date of the first authorisation or date of renewal
11 December 2005
Date of revision of the text
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 10% DD 1x100ml:
GTIN:8713184011251