ENGEMYCIN SPRAY, 25 MG/ML, CUTANEOUS SPRAY, SUSPENSION FOR CATTLE, SHEEP AND PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYTETRACYCLINE HYDROCHLORIDE (EQUIVALENT TO OXYTETRACYCLINE PH.EUR.)

Available from:

Intervet Ireland Limited

ATC code:

QD06AA03

INN (International Name):

OXYTETRACYCLINE HYDROCHLORIDE (EQUIVALENT TO OXYTETRACYCLINE PH.EUR.)

Dosage:

25 Mg/Ml

Pharmaceutical form:

Cutaneous Spray, suspension

Prescription type:

POM

Therapeutic group:

Bovine, Ovine, Porcine

Therapeutic area:

Oxytetracycline

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2009-10-02

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Engemycin Spray, 25 mg/mL, cutaneous spray, suspension for cattle,
sheep and pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains:
3 PHARMACEUTICAL FORM
Cutaneous spray, suspension.
Green to green-blue suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of the following infections caused by,
or associated with,
organisms sensitive to oxytetracycline in
cattle, sheep and pigs:
Treatment of foot infections caused in particular by:_ Dichelobacter
nodosus_,_ Fusobacterium necrophorum_ and other
_Fusobacterium_ spp., and_ Bacteroides_ spp.
Supporting treatment of superficial wound infections following surgery
or physical injuries, e.g., tail biting in pigs,
scratches and abrasions.
4.3 CONTRAINDICATIONS
Do not use for treatment of teats in order to prevent the product from
getting into milk.
Do not use in animals in cases of hypersensitivity to oxytetracycline
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE SUBSTANCE:
Oxytetracycline Hydrochloride
25.00 mg
(equivalent to Oxytetracycline
23.15 mg)
EXCIPIENTS:
Patent Blue V (E131)
1.25
mg
For the full list of excipients, see section 6.1.
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