Fertigest 0.004 mg/ml Solution for Injection

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Buserelin Acetate

Inapatikana kutoka:

Vetpharma Animal Health, S.L

ATC kanuni:

QH01CA90

INN (Jina la Kimataifa):

Buserelin Acetate

Dawa fomu:

Solution for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cattle, Horses, Pigs, Rabbits

Eneo la matibabu:

Hormone

Idhini hali ya:

Authorized

Idhini ya tarehe:

2017-08-10

Tabia za bidhaa

Revised: February 2023
AN: 01964/2022 & 01965/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FERTIGEST 0.004 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Buserelin.....................................................0.004 mg
(corresponding to 0.0042 mg buserelin acetate)
EXCIPIENTS:
Benzyl Alcohol (E1519) ..............................20 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (cows), horse (mares), pig (sows and gilts) and rabbit (female
rabbit for
reproduction).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
-
Treatment of follicular cysts.
-
Improvement of conception rate in artificial insemination procedures.
-
Synchronisation of oestrus and ovulation in cyclical cattle, for
artificial
insemination at a fixed time together with prostaglandin F2α
administration.
HORSE:
-
Treatment of follicular cysts.
-
Ovulation induction to synchronise ovulation more closely with mating.
PIG:
-
Ovulation induction after oestrus synchronisation by weaning (sows) or
by
administering a progestagen (gilts) that can be used as part of a
single fixed
time artificial insemination programme.
RABBIT:
-
Improving the conception rate.
-
Ovulation induction postpartum.
Revised: February 2023
AN: 01964/2022 & 01965/2022
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient or to the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
CATTLE:
Cattle with a short interval between calving and insemination (< 60
days), a low Body
Condition Score or high parity may display a lower pregnancy rate
after a standard
synchronisation protocol (see section 4.9). There is no guarantee that
all cows that
were synchronised according to the protocol will be in oestrus at the
time of artificial
insemination. The chances of conception