PLANATE 0.0875 MG/ML SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOPROSTENOL (AS CLOPROSTENOL SODIUM BP (VET))

Available from:

Intervet Ireland Limited

ATC code:

QG02AD90

INN (International Name):

CLOPROSTENOL (AS CLOPROSTENOL SODIUM BP (VET))

Dosage:

0.0875 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Porcine

Therapeutic area:

Cloprostenol

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2012-02-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Planate 0.0875 mg/ml Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Cloprostenol
0.0875 mg
(as cloprostenol sodium
0.092 mg)
EXCIPIENTS:
Benzyl alcohol (E1519)
20 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A synthetic prostaglandin analogue for use in pigs as a luteolytic agent to induce farrowing in sows and gilts, thus
providing opportunity for more efficient and convenient management under a variety of systems.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 14/12/2016_
_CRN 7024639_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Induction of farrowing too early in pregnancy can lead to non-viable piglets being born.
An increase in the number of non-viable piglets may result if used more than two days prior to the average gestation
length calculated from farm records.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Planate can be absorbed through the skin and therefore care should be taken when handling the product, especially by
women of childbearing age and by asthmatics.
Accidental spillage on the skin should be washed immediately with plenty of water.
Wear disposal plastic gloves when administering the product. Wash hands after use.
Prostaglandins of the F
2
alpha type may caus