ENGEMYCIN 10 % DD SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE PH.EUR

Available from:

Intervet Ireland Limited

ATC code:

QJ01AA06

INN (International Name):

OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE PH.EUR

Dosage:

10 %

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Canine, Equine - Food, Feline, Ovine, Porcine

Therapeutic area:

Oxytetracycline

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Engemycin 10 % DD Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Oxytetracycline
(as oxytetracycline hydrochloride)
100 mg
EXCIPIENTS
Sodium formaldehyde sulphoxylate
5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, pigs, horses, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by organisms sensitive to oxytetracycline in horses, cattle, sheep, pigs, dogs and
cats.
_In vitro_, oxytetracycline is active against a range of both Gram-positive and Gram-negative microorganisms including:
_Streptococcus _spp., _Staphylococcus _spp., _Listeria monocytogenes_, _Mannheimia haemolytica_, _Haemophilus_
_parahaemolyticus _and _Bordetella bronchiseptica_, and against _Chlamydophila abortus_, the causative organism of
enzootic abortion in sheep.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses during concomitant corticosteroid therapy.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Exercise caution when treating stressed horses with tetracyclines.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 23/11/2016_
_CRN 7024614_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible,
therapy should be based on local (regional, farm level) epidemiological i