SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZIAPAM, 5 mg/ml, solution for injection for cats and dogs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of solution contains:

Active substance:

Diazepam 5.0 mg

Other components:

Benzyl Alcohol (E1519) 15.7 mg

Benzoic Acid (E210) 2.5 mg

Sodium Benzoate (E211) 47.5 mg

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Greenish-yellow clear liquid.

4. CLINICAL PARTICULARS

4.1 Target species

Cats, Dogs.

4.2 Indications for use, specifying the target species

In cats and dogs:

For the short term management of convulsive disorders and skeletal muscle spasms of central and peripheral origin.

As part of a pre-anaesthetic or sedation protocol.

4.3 Contraindications

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

Do not use in cases of severe hepatic disease.

4.4 Special warnings for each target species

For strict IV use.

Diazepam alone is less likely to be effective as a sedative when used in animals that are already excited.

Diazepam can cause sedation and disorientation and should be used with caution in working animals, such as military, police or service dogs.

4.5 Special precautions for use

Special precautions for use in animals:

The product should be used with caution in animals with hepatic or renal disease and in debilitated, dehydrated, anaemic, obese, or geriatric animals.

The product should be used with caution in animals in shock, coma, or with significant respiratory depression.

The product should be used with caution in animals affected by glaucoma.

It is not recommended to use diazepam for convulsive disorder control in cats in case of chronic chlorpyrifos toxicosis as organophosphate’s toxicity may be potentiated.

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

People with known sensitivity to diazepam or the excipients should avoid contact with the veterinary medicinal product.

The product can cause skin irritation. Avoid contact with skin.

In the case of contact with skin, wash with soap and water. If irritation persists, seek medical advice.

Wash hands after use.

The product can cause eye irritation. Avoid contact with eyes. If the product comes into contact with the eyes, rinse the eyes immediately with plenty of water and seek medical attention if irritation persists.

This product is a CNS depressant. Avoid accidental self-injection. If accidental self-injection occurs, seek medical advice immediately and show the package leaflet or the label to the physician. Do not drive, as sedation may occur.

Diazepam may be harmful for the foetus and unborn child.Diazepam and its metabolites are secreted into milk, thereby exerting a pharmacological effect on the nursing neonate. As such, women of child-bearing potential and nursing mothers should not handle this product.

4.6 Adverse reactions (frequency and seriousness)

Rapid intravenous administration may cause hypotension, cardiac disorders and thrombophlebitis.

In rare cases, mainly in small breeds of dogs, paradoxical reactions may be observed (as excitation, aggression, disinhibiting effect …), therefore, avoid use of diazepam as a sole agent in potentially aggressive animals. In very rare cases the use of diazepam in cats can cause acute hepatic necrosis and liver failure.

Other reported effects include increased appetite (mainly in cats), ataxia, disorientation, changes in mentation and behaviour.

4.7 Use during pregnancy, lactation or lay

Use of the product for the target species during pregnancy and lactation has not been investigated therefore use must be according to the benefit/risk assessment by the responsible veterinarian.

If used in lactating females, puppies/kittens should be monitored carefully for undesired somnolence/sedative effects that could interfere with suckling.

4.8 Interaction with other medicinal products and other forms of interaction

Diazepam is a central nervous system depressant which may potentiate the action of other central nervous system depressants as barbiturates, tranquilizers, narcotics, antidepressants…

Diazepam may increase the action of digoxin.

Cimetidine, erythromycin, azole substances (such as itraconazole or ketoconazole) valproic acid and propanol may slow the metabolism of diazepam. The dose of diazepam may need to be decreased to avoid excessive sedation.

Dexamethasone may decrease the action of diazepam.

The concomitant use with hepatotoxic dosages of other substances should be avoided.

4.9 Amounts to be administered and administration route

For administration by slow, intravenous injection only.

In dogs and cats:

Short term management of convulsive disorders: 0.5 mg diazepam/kg bodyweight (equivalent to 0.5 ml/5kg).

Administered as a bolus and repeated up to three times, after no less than 10 minutes each time.

Short term management of skeletal muscle spasm: 0.5-2.0 mg/kg bodyweight (equivalent to 0.5-2.0 ml/5kg).

As part of sedation protocol: 0.2-0.6 mg/kg bodyweight (equivalent to 0.2-0.6 ml/5kg).

As part of pre-anaesthesia protocol: 0.1-0.2 mg/kg bodyweight (equivalent to 0.1-0.2 ml/5kg).

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

When administered alone, diazepam overdose may cause significant central nervous system depression (confusion, decreased reflexes, coma, etc). Supportive treatment should be given (cardio-respiratory stimulation, oxygen). Hypotension and respiratory and cardiac depression are rare events.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: PSYCHOLEPTICS\ Benzodiazepine derivatives.

ATCvet code: QN05BA01.

5.1 Pharmacodynamic properties

Diazepam is a benzodiazepine derivative thought to depress the sub-cortical levels of the central nervous system (primarily limbic, thalamic and hypothalamic) to produce anxiolytic, sedative, musculoskeletal relaxant and anticonvulsant effects. The exact mechanism of action has not been defined.

5.2 Pharmacokinetic particulars

Diazepam is highly lipid soluble and is widely distributed throughout the body. It readily crosses the blood-brain barrier and is highly bound to plasma proteins. It is metabolised in the liver to produce several pharmacologically active metabolites (major metabolite in dogs is N-desmethyl-diazepam), which are conjugated with glucuronide and eliminated primarily in the urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol

Benzoic acid

Sodium benzoate

Propylene Glycol

Ethanol (96 per cent)

Sodium hydroxide (for pH adjustment)

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: Use immediately after opening.

6.4. Special precautions for storage

Store in the original package, protected from light.

Any solution remaining in the ampoule following withdrawal of the required dose should be discarded.

The sentence “Keep out of the reach and sight of the children” will only be added on the outer packaging and package leaflet.

6.5 Nature and composition of immediate packaging

Cardboard box of 6 colourless glass ampoules type I of 2 ml.

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 products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Laboratoire TVM

57 rue des Bardines

63370 LEMPDES

FRANCE

8. MARKETING AUTHORISATION NUMBER(S)

Vm 35079/4002

9. DATE OF FIRST AUTHORISATION

05 March 2014

10. DATE OF REVISION OF THE TEXT

March 2014

APPROVED 5/03/14