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

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Cloprostenol

Saatavilla:

Fatro S.p.A

ATC-koodi:

QG02AD90

INN (Kansainvälinen yleisnimi):

Cloprostenol

Lääkemuoto:

Solution for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cattle, Pigs

Terapeuttinen alue:

Prostaglandin

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2000-07-27

Valmisteyhteenveto

Revised: June 2023
AN: 01569/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dalmazin, 75 Micrograms/ml, Solution for Injection for Cows and Sows
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.
Revised: June 2023
AN: 01569/2022
Page 2 of 6
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 must be thoroughly cleaned and disinfected in order
to reduce the risk of
infection with anaerobic bacteri