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Date: Friday, March 29, 2024 6:54

Release 3.116
Planipart Solution for Injection 30 micrograms/ml
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Neurological preparations: Others
Active ingredient: Clenbuterol
Product:Planipart® Solution for Injection 30 micrograms/ml
Product index: Planipart
Cattle - milk: 60 hours
Cattle - meat: 14 days
Incorporating:
Presentation
Pale yellow, clear solution for injection. Each ml contains 30 micrograms clenbuterol hydrochloride as active substance and 10 mg benzyl alcohol as preservative.
Uses
To relax the uterus in cattle, usually at the time of parturition. In particular:
1In heifers to delay delivery to allow full preparation of the soft birth canal.
2As an aid to obstetrical manoeuvres in dystocia e.g. malpresentation and malposture.
3To relax the uterus for caesarean section.
4To delay and therefore programme delivery to permit observation of parturition e.g. avoidance of night time delivery.
5To facilitate the replacement of prolapsed uterus.
6In embryo transfer to ensure less traumatic manipulation of the uterus.
Dosage and administration
10 ml by slow intravenous route as a single injection.
Contra-indications, warnings, etc
Do not use in animals with known hypersensitivity to the active substance.
Special precautions to be taken by the person administering the veterinary medicinal product to the animal
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. If 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.
This product is indicated for use during the early (embryo transfer) or the final stages of pregnancy as well as during labour. The 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.
Not to be used in conjunction with atropine.
Not to be used with general anesthesia because of the possible hypotensive effects.
Antagonistic to the effects of prostaglandin F and oxytocin.
The product is a β-adrenergic stimulant and is therefore antagonised by β-blocking agents. In order to prevent additive effects, the product should not be given with other sympathomimetics or vasodilators.
In case of accidental overdosage a β-blocker, such as propranolol, may be used as antidote.
Withdrawal Periods
Meat and Offal : 14 days.
Milk: 60 hours.
Pharmaceutical precautions
Shelf life of the medicinal product as packaged for sale : 3 years.
Shelf life after first broaching the immediate packaging : 28 days.
Protect from light. Do not store above 25°C.
Should any apparent growth or discolouration occur, the product should be discarded.
Keep out of the reach and sight of children. For animal treatment only.
To be supplied only on veterinary prescription.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Legal category description:CD(Sch 4 Pt 2)
Packaging quantities
50 ml amber glass injection vial (Ph Eur. Type II) with pink bromobutyl rubber stopper and aluminium crimp cap.
Further information
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, The product will only delay parturition for a maximum of a few hours.
Pharmacokinetic properties
Clenbuterol and its metabolites are rapidly distributed and excreted. Most of the dose is excreted by 96 hours, largely as clenbuterol.
Marketing Authorisation Number
Vm 08327/4299
Significant changes
GTIN
GTIN description:Planipart Solution for Injection 30 micrograms/ml
GTIN:5012917074871