Dalmazin, 75 Micrograms/ml, Solution for Injection for Cows and Sows

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Cloprostenol

제공처:

Fatro S.p.A

ATC 코드:

QG02AD90

INN (국제 이름):

Cloprostenol

약제 형태:

Solution for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Cattle, Pigs

치료 영역:

Prostaglandin

승인 상태:

Authorized

승인 날짜:

2000-07-27

제품 특성 요약

Revised 28/07/2010 – AN 01440/2009
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DALMAZIN, 75 micrograms/ml, solution for injection for cows and sows.
_(Name in France: Reprosténol)_
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
d-cloprostenol……………………………….75 μg
EXCIPIENT:
Chlorocresol……………………………..1.000 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution with no visible particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (cows) and Pigs (sows and gilts).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
COWS
Indications for reproduction:
synchronization or induction of oestrus. Induction of
parturition after day 270 of gestation.
Therapeutic indications:
ovarian
dysfunction
(persistent
corpus
luteum,
luteal
cyst), endometritis/pyometra, delayed uterine involution,
induction of abortion in the first half of pregnancy and
expulsion of mummified foetuses.
SOWS
Indications for reproduction: induction of parturition.
4.3
CONTRAINDICATIONS
Do not use in pregnant females, unless it is desirable to induce
parturition or induction of
abortion.
Do not use in sows which are expected to have a distocic parturition
due to abnormal
position of the foetus, mechanical obstruction, etc.
Do not use in animals suffering cardiovascular or respiratory
diseases.
Do not use in animals with spastic diseases of the respiratory or
gastrointestinal tract.
Revised 28/07/2010 – AN 01440/2009
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
As with parenteral administration of any substance, basic antiseptic
rules should be observed.
The injection site must be thoroughly cleaned and disinfected in order
to reduce the risk of
infection with anaerobic bacteria.
Induction of labour before the 111th day of gestation may cause
mortality in piglets and an