Equipulmin

Main information

  • Trade name:
  • Equipulmin 25 micrograms/ ml Syrup for Horses
  • Pharmaceutical form:
  • Syrup
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Equipulmin 25 micrograms/ml Syrup for Horses
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Horses
  • Therapeutic area:
  • Respiratory expectorant

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 20916/4024
  • Authorization date:
  • 18-12-2012
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Revised: December 2017

AN: 01907/2017

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Equipulmin 25 micrograms/ml syrup for horses. (AT, HU, UK)

Equipulmin vet. 25 micrograms/ml syrup for horses. (FI, SE)

Equipulmin vet. (DK)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance

Clenbuterol hydrochloride

25 micrograms

(corresponding to 22 micrograms clenbuterol)

Preservatives:

Methyl parahydroxybenzoate (E218)

2.02 mg

Propyl parahydroxybenzoate

0.26 mg

For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Syrup

Clear colourless syrup

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 mucociliary clearance is desirable. To be used alone or as adjuvant therapy.

4.3

Contraindications

Do not use in cases of known hypersensitivity to the active substance or any of the

excipients.

Do not use in horses with known cardiac disease.

For use during pregnancy or lactation see section 4.7.

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4.4

Special warnings for each target species

None

4.5

Special precautions for use

Special precautions for use in animals

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

recommended.

In case of glaucoma the product must only be used after a careful risk-benefit

assessment.

Special precautions should be taken in case of halothane anaesthesia, since the heart

function can show increased sensitivity to catecholamines.

Special precautions to be taken by the person administering the

veterinary

medicinal

product to animals

This product contains clenbuterol hydrochloride, a beta-agonist.

Wear gloves to avoid skin contact. In case of accidental skin contact, wash affected area

thoroughly. If irritation occurs/persists seek medical advice. Wash hands thoroughly after

using the product.

Take care to avoid eye contact. In the case of accidental eye contact, flush thoroughly

with clean water and seek medical advice.

Do not eat, drink or smoke when using this product. In case of accidental ingestion, seek

medical advice immediately and show the package leaflet to the healthcare professional.

People with known hypersensitivity to clenbuterol should avoid contact with the

veterinary medicinal product.

4.6

Adverse reactions (frequency and seriousness)

Clenbuterol may cause side effects such as sweating (mainly neck region), muscle

tremor, tachycardia, slight hypotension or restlessness. These are typical for

-agonists

and occur rarely.

If you notice any serious effects or other effects not mentioned in this leaflet, please

inform your veterinary surgeon.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

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4.7

Use during pregnancy or lactation

If used during pregnancy, treatment must be discontinued a minimum of 4 days before

the expected time of delivery, since uterine contractions may be abolished or labour may

be prolonged under its influence.

4.8

Interaction with other medicinal products and other forms of interaction

The product antagonises the effects of prostaglandin F2 -alpha and oxytocin.

The product is antagonised by

-adrenergic blocking agents.

Do not administer concurrently with other beta-adrenergic agents.

During the use of both local and general anaesthetics one cannot exclude a further

vascular dilatation and fall of blood pressure, particularly if used in combination with

atropine.

4.9

Amounts to be administered and administration route

For oral use.

Each depression of the pump delivers 4 ml of product (0.100 mg of clenbuterol

hydrochloride, equivalent to 0.088 mg clenbuterol).

The pump needs to be primed before the first use only. Prime the pump by pressing

twice and discard the retrieved syrup.

It is not possible to extract all the contents using the pump provided.

Administer 4 ml of the product per 125 kg bodyweight twice daily.

This is equivalent to twice daily administration of 0.8 micrograms clenbuterol

hydrochloride per kg bodyweight.

The syrup should be added to the feed.

Treatment should continue for as long as necessary

4.10

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

Dosages of clenbuterol hydrochloride up to 4 times the therapeutic dose (administered

orally) for a period of 90 days caused transient side effects 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

Not authorised for use in lactating animals producing milk for human consumption.

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5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: selective beta-2-adrenoreceptor agonists

ATC vet code: QR03CC13

5.1

Pharmacodynamic properties

The product contains clenbuterol hydrochloride, which is a sympathomimetic amine

which preferentially binds to

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. The product has been shown to inhibit

histamine release from mast cells in the lungs, and enhance mucociliary clearance in

horses

5.2

Pharmacokinetic particulars

After oral administration in horses, clenbuterol is readily absorbed and maximum plasma

concentrations reached within 2 hours of dosing. Steady state concentrations in plasma

are reached after 3-5 days treatment and range from 1.0 – 2.2 ng/ml.

The substance is rapidly distributed in 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. The 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

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate

Sucrose

Carbomer 974P

Macrogol 400

Glycerol (85%)

Ethanol (96%)

Sodium hydroxide

Water, purified

6.2

Major incompatibilities

Not known.

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging: 3 months

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6.4

Special precautions for storage

Do not store above 25°C. Protect from light.

6.5

Nature and composition of immediate packaging

355 ml HDPE bottle sealed with an aluminium/PE heat seal and a transparent HDPE

cap. The product is supplied in a carton box with a multi-component mechanical pump

dispenser capable of delivering 4 ml of the product.

6.6

Special precautions for the disposal of unused veterinary medicinal product

or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal product should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

CP Pharma Handelsgesellschaft mbH

Ostlandring 13

31303 Burhdorf

Germany

8. MARKETING AUTHORISATION NUMBER

Vm 20916/4024

9.

DATE OF FIRST AUTHORISATION

18 December 2012

10.

DATE OF REVISION OF THE TEXT

December 2017

Approved: 21 December 2017

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