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

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Cloprostenol

Dostopno od:

Fatro S.p.A

Koda artikla:

QG02AD90

INN (mednarodno ime):

Cloprostenol

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cattle, Pigs

Terapevtsko območje:

Prostaglandin

Status dovoljenje:

Authorized

Datum dovoljenje:

2000-07-27

Lastnosti izdelka

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