Noroprost 0.5% w/v Solution for Injection

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Dinoprost

זמין מ:

Norbrook Laboratories Limited

קוד ATC:

QG02AD01

INN (שם בינלאומי):

Dinoprost

טופס פרצבטיות:

Solution for injection

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Cattle

איזור תרפויטי:

Prostaglandin

מצב אישור:

Expired

תאריך אישור:

1996-01-09

מאפייני מוצר

Revised: 16
th
December 2008
AN: 02406/2007
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroprost 0.5 % w/v Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml of product contains 5 mg (0.5% w/v) of Dinoprost
(Prostaglandin F
2

),
EXCIPIENTS:
2.5 mg (0.25% w/v) Phenol as antimicrobial preservative.
For a 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
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Noroprost is indicated for its luteolytic effect on corpora lutea in
cattle. This
luteolytic action of Noroprost may be utilised as follows:
1. To improve control of the time of oestrus in cycling cattle.
2. To control breeding in cattle.
3. To induce parturition in cattle.
4. Synchronisation of recipient cattle for embryo transplantation.
5. To induce abortion in cattle.
6. To treat cattle which have a functional corpus luteum but do not
express
behavioural oestrus (sub-oestrus or silent heat).
7. For treatment of chronic metritis and pyometra in cattle.
8. For treatment of ovarian luteal cysts.
Revised: 16
th
December 2008
AN: 02406/2007
4.3
CONTRAINDICATIONS
Do not administer by the intravenous route.
Animals should not be treated if they suffer from either acute or sub
acute
disorders of the vascular system, gastrointestinal tract or
respiratory system.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Noroprost is ineffective when administered prior to day 5 after
ovulation.
Observe aseptic precautions during use.
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Prostaglandins of the F
2

type can be absorbed through the skin and MAY
CAUSE BRONCHOSPASM OR MISCARRIAGE.
Care should be taken when handling the product to AVOID SELF-INJECTION
OR SKIN CONTACT.
In case of accidental self-injection, seek medical