Macrosyn 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Tulathromycin

제공처:

Triveritas Limited

ATC 코드:

QJ01FA94

INN (국제 이름):

Tulathromycin

약제 형태:

Solution for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Cattle, Pigs, Sheep

치료 영역:

Antimicrobial

승인 상태:

Authorized

승인 날짜:

2020-08-24

제품 특성 요약

Issued: August 2020
AN: 01168/2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Macrosyn 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS
ACTIVE SUBSTANCE:
Tulathromycin 100 mg
EXCIPIENT:
Monothioglycerol 5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, pigs and sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
Treatment and metaphylaxis of bovine respiratory disease (BRD)
associated with
_Mannheimia haemolytica_, _Pasteurella multocida, Histophilus somni
_and _Mycoplasma _
_bovis _susceptible to tulathromycin. The presence of the disease in
the herd should be
established before metaphylactic treatment.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated
with _Moraxella _
_bovis _susceptible to tulathromycin.
Pigs
Treatment and metaphylaxis of swine respiratory disease (SRD)
associated with
_Actinobacillus pleuropneumoniae_, _Pasteurella multocida, Mycoplasma
_
_hyopneumoniae, Haemophilus parasuis _and _Bordetella bronchiseptica
_susceptible to
tulathromycin. The presence of the disease in the herd should be
established before
Page 1 of 8
Issued: August 2020
AN: 01168/2019
metaphylactic treatment. The product should only be used if pigs are
expected to
develop the disease within 2–3 days.
Sheep
Treatment of the early stages of infectious pododermatitis (foot rot)
associated with
virulent _Dichelobacter nodosus _requiring systemic treatment.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to macrolide antibiotics or to
any of the
excipients.
Do not use simultaneously with other macrolides or lincosamides (see
section 4.8).
Do not use in lactating animals producing milk for human consumption.
Do not use in pregnant animals, which are intended to produce milk for
human
consumption, within 2 months of expected partu