Engemycin Spray, 25 mg/ml, Cutaneous Spray, Suspension for Cattle, Sheep and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxytetracycline Hydrochloride

Available from:

MSD Animal Health UK Limited

ATC code:

QD06AA03

INN (International Name):

Oxytetracycline Hydrochloride

Pharmaceutical form:

Cutaneous spray, suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2009-10-13

Summary of Product characteristics

Revised: August 2020
AN. 00299/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Engemycin Spray, 25mg/mL, cutaneous spray, suspension for cattle,
sheep and
pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains
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.
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.
Revised: August 2020
AN. 00299/2020
Page 2 of 5
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.
4.5
SPECIAL PRECAUTIONS FOR USE
I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The animals should be treated in a well ventilated area.
Do not spray in or near the eyes.
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 information about
susceptibility of the
target bacteria.
II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Because of the risk of sensitisation and contact dermatitis, the user
should
avoid skin