Dalmazin 75 micrograms/ml solution for injection for cows and sows

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

R-cloprostenol

Dostopno od:

FATRO S.p.A.

Koda artikla:

QG02AD90

INN (mednarodno ime):

R-cloprostenol

Odmerek:

75 microgram(s)/millilitre

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cattle, Pigs

Terapevtsko območje:

cloprostenol

Terapevtske indikacije:

Hormone

Status dovoljenje:

Authorised

Datum dovoljenje:

2000-10-13

Lastnosti izdelka

_[Version 9,03/2022] corr. 11/2022 _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dalmazin, 75 micrograms/ml, solution for injection for cattle and pigs
(AT, BE, DE, IE, IT, LU, NI).
Reprosténol, 75 micrograms/ml, solution for injection for cattle and
pigs (FR).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
d-cloprostenol …………………………….75 μg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT_ _
Ethanol
Chlorocresol
1 mg
Sodium hydroxide
Citric acid
Water for injections
Clear, colourless solution for injection with no visible particles.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (cows) and pigs (sows and young females).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Cows
Indications for reproduction:
synchronisation 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 and young females
Indications for reproduction: induction of parturition.
3.3
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.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
As with parenteral administration of any substance, basic antiseptic
rules should be observed.
The injection site mu