Planipart Solution for Injection 30 microgram/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Clenbuterol hydrochloride
Available from:
Boehringer Ingelheim Ltd
ATC code:
QG02CA91
INN (International Name):
Clenbuterol hydrochloride
Dosage:
30 microgram(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
VPO: Veterinary Practitioner Only as defined in relevant national legislation
Therapeutic group:
Cattle
Therapeutic area:
clenbuterol
Therapeutic indications:
Miscellaneous
Authorization status:
Authorised
Authorization number:
VPA10007/013/002
Authorization date:
1989-10-01

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Planipart Solution for Injection 30 microgram/ml.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Clenbuterol hydrochloride

30 micrograms

Excipients:

Benzyl alcohol

10 mg

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Solution for injection.

Pale yellow, clear solution for injection.

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle.

4.2 Indications for use, specifying the target species

To relax the uterus in cattle, usually at the time of parturition.

In particular:

In heifers to delay delivery to allow full preparation of the soft birth canal.

As an aid to obstetrical manoeuvres in dystocia, e.g. malpresentation and malposture.

To relax the uterus for Caesarean section.

To delay and therefore programme delivery to permit observation of parturition, e.g. avoidance of night time delivery.

To facilitate the replacement of prolapsed uterus.

In embryo transfer technique to ensure less traumatic manipulation of the uterus.

4.3 Contraindications

Do not use in animals with known hypersensitivity to the active ingredient.

4.4 Special warnings for each target species

The earlier in the stage of labour that treatment is given, the longer will be the period of abolition of uterine

contraction.

Once the cervix is fully diilated or the foetal feet are passing into the cervical area, the product will only

delay parturition for a maxiumum of a few hours.

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4.5 Special precautions for use

Special precautions for use in animals

None.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

When using do not eat, drink or smoke.

After use, wash any contaminated skin immediately with soap and clean

water.

This product contains clenbuterol, a beta-agonist.

Accidental self-injection may cause tachycardia and tremor.

These effects may be reversed by the use of a non-selective beta-blocker.

It accidental self-injection occurs seek

medical advice immediately, avoiding driving if possible.

Clenbuterol decreases the tonus of the uterine muscles. Pregnant women should avoid any risk of exposure to Planipart

and should not administer the product.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

This product

is indicated for use during the early (embryo transfer) or the final

stages or pregnancy as well

as during

labour.

Use of the product has not been shown to adversely affect the viability of the new-born animal nor the normal

course of the post partum period including subsequent fertility.

In case of lactation the withdrawal time for milk has to be

considered.

4.8 Interaction with other medicinal products and other forms of interaction

Not to be used in conjunction with atropine.

Not to be used with general anaesthesia because of a possible hypotensive effect.

Antagonistic to the effects of prostaglandin F2-alpha and oxytocin.

The product is a beta-adrenergic stimulant and is therefore antagonised by beta-adrenergic blocking agents.

In order to prevent additive effects, the product should not be given with other sympathomimetics or vasodilators.

4.9 Amounts to be administered and administration route

10 ml by slow intravenous route as a single injection.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of accidental overdosage a

-blocker, such as propranolol, may be used as antidote.

4.11 Withdrawal Period(s)

Meat and offal:

14 days.

Milk:

60 hours.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Sympathomimetics, labour repressants.

ATCvet code:

QG02CA91

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5.1 Pharmacodynamic properties

Clenbuterol is a beta-sympathomimetic agonist which has potent bronchodilator and tocolytic properties.

The earlier in

the stage of labour that treatment is given, the longer will be the period of abolition of uterine contractions.

Once the cervix

is fully dilated or the foetal feet are passing into the cervical area, Planipart will only delay parturition for a maximum of a

few hours.

5.2 Pharmacokinetic properties

No data available

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Chloride

Benzyl Alcohol

Hydrochloric Acid

Water for Injection

6.2 Incompatibilities

None known.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

Do not store above 25

Protect from light.

6.5 Nature and composition of immediate packaging

50 ml amber glass injection vial (Ph. Eur. Type II) with pink brombutyl rubber stopper and aluminium crimp cap.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal

product

or waste materials derived from such veteriary medicinal

products should be

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

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8 MARKETING AUTHORISATION NUMBER(S)

VPA 10007/013/002

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

October 1989

Date of last renewal: 30th September 2009

10 DATE OF REVISION OF THE TEXT

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