Ventipulmin Solution for Injection 30 micrograms/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Clenbuterol hydrochloride
Available from:
Boehringer Ingelheim Ltd
ATC code:
QR03CC13
INN (International Name):
Clenbuterol hydrochloride
Dosage:
30 microgram(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Horses
Therapeutic area:
clenbuterol
Therapeutic indications:
Respiratory Tract preparations
Authorization status:
Authorised
Authorization number:
VPA10007/011/002
Authorization date:
1988-10-01

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Ventipulmin Solution for Injection 30 micrograms/ml

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Clenbuterol hydrochloride 30 micrograms

Preservative:

Benzyl alcohol (E1519) 10 mg

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

Horses.

4.2 Indications for use, specifying the target species

Treatment of respiratory disease in horses where it is considered that airway obstruction due to bronchospasm and/or

accumulation of mucus is a contributing factor, and improved muco-ciliary clearance is desirable.

To be used alone or as

adjuvant therapy.

In particular:

Acute, sub-acute and chronic respiratory allergies.

Acute, sub-acute and chronic infections where the presence of mucus and/or micro-organisms may stimulate

bronchospasm or cause airway obstruction and thus an increase in airway resistance.

For example, bronchitis, bronchiolitis

and bronchopneumonia alone, or associated with equine influenza and other viral diseases.

iii)

Chronic Obstructive Pulmonary Disease (COPD).

In cases accompanied by bacterial infection the administration of antimicrobial agents is recommended.

4.3 Contraindications

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

Do not use in horses with known cardiac disease.

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4.4 Special warnings for each target species

None known.

4.5 Special precautions for use

Special precautions for use in animals

None known.

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 produce 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.

4.6 Adverse reactions (frequency and seriousness)

Clenbuterol may cause side efects such as sweating (mainly neck region), muscle tremor, tachycardia, slight hypotension or

restlessness.

These are typical for beta-agonists amd occcur rarely. These effects may be minimised by administering

Vetipulmin Injection slowly.

4.7 Use during pregnancy, lactation or lay

If used during pregnancy, treatment must be discontinued at the expected time of delivery, since uterine contractions may

be abolished under its influence.

4.8 Interaction with other medicinal products and other forms of interaction

Ventipulmin antagonises the effects of prostglandin F

-alpha and oxytocin.

Ventipulmin is antagonised by beta-adrenergic blocking agents.

4.9 Amounts to be administered and administration route

Administer by slow intravenous injection at a dose of 2.7 ml per 100 kg bodyweight twice daily.

This is equivalent to twice daily administration of 0.8 micrograms of clenbuterol hydrochloride per kg bodyweight.

Treatment should continue for as long as necessary.

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

Dosages up to 4 times the therapeutic dose (administered orally) for a period of 90 days caused transient adverse

reactions typical for beta2-adrenoceptor agonists (sweating, tachycardia, muscle tremor), which required no treatment.

In case of accidental overdose, a

-blocker (such as propranolol) may be used as antidote.

4.11 Withdrawal Period(s)

Meat and offal: 28 days

Do not use in animals producing milk for human consumption.

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5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATC Vetcode:

QR03CC13:

Drugs for obstructive airway disease

5.1 Pharmacodynamic properties

Ventipulmin contains clenbuterol hydrochloride, which is a sympathomimetic amine which preferentially binds to beta

adrenoreceptors on cell membranes of the bronchi.

This subsequently activates the enzyme adenylate cyclase in smooth

muscle cells, thus providing intense bronchodilating properties and decreasing airway resistance with minimum effect on

the cardiovascular system.

Ventipulmin has been shown to inhibit histamine release from mast cells in the lungs, and

enhance mucociliary clearance in horses.

5.2 Pharmacokinetic properties

Following intravenous injection, the substance is rapidly distributed into the tissues and metabolised primarily by the liver.

Clenbuterol is the main excretory product and approximately 45% of the dose is eliminated unchanged in the urine.

kidneys excrete 70 - 91% of the total dose, and the remainder is eliminated in the faeces (6-15%).

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol (E1519)

Sodium chloride

Hydrochloric acid

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary

medicinal products.

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°C.

Protect from light.

Keep the container in the outer carton.

6.5 Nature and composition of immediate packaging

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

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

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Ltd.

Bracknell

Berkshire

RG12 8YS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10007/011/002

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

October 1988

Date of last renewal: 30

September 2008

10 DATE OF REVISION OF THE TEXT

November 2014

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