Diazedor 5 mg/ml Solution for Injection for Dogs and Cats

Composition

Each ml contains:

Active substances:

Diazepam 5.0 mg

Excipients:

Qualitative composition of excipients and other constituents

Ethanol 96%

Propylene glycol

Sodium hydroxide (for pH adjustment)

Water for injections

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Pharmaceutical form

Clear, colourless to greenish-yellow solution.

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Pharmacological properties

4.1 ATCvet code: QN05BA01

4.2 Pharmacodynamics

Diazepam is a sedative and muscle relaxant of the benzodiazepine family that binds to the benzodiazepine binding domain of GABAA receptors and thus enhances the inhibitory effect of GABA. This mechanism produces sedative, anxiolytic, myorelaxant and anticonvulsive effects.

4.3 Pharmacokinetics

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.

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Target species

Dogs and cats

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Indications

Dogs, cats:

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.

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Dosage

For slow intravenous use only.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Dogs, cats:

• Short term management of convulsive disorders: 0.5 - 1.0 mg diazepam/kg bodyweight (equivalent to 0.5 - 1.0 ml/5 kg). 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/5 kg).

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

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

The rubber stopper may be safely punctured up to 100 times. (Broaching study was performed with a 23G injection needle.)

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Contraindications

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

Do not use in cases of severe hepatic disease.

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Adverse reactions

Dogs, cats:

1Paradoxical reactions may be observed mainly in small breeds of dogs.

Therefore, avoid use of diazepam as a sole agent in potentially aggressive animals.

2Only in cats.

3Associated with rapid intravenous administration.

4Mainly in cats.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

The veterinary medicinal product should be used with caution in animals with hepatic or renal disease and in debilitated, dehydrated, anaemic, obese, or geriatric animals. The veterinary medicinal product should be used with caution in animals in shock, coma, or with significant respiratory depression.

The veterinary medicinal 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:

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

People with known hypersensitivity to diazepam, other benzodiazepines or any of the excipients should avoid contact with the veterinary medicinal product.

The veterinary medicinal product can cause skin irritation. Avoid contact with skin. In case of accidental spillage onto skin, wash with soap and water. If irritation persists, seek medical advice.

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

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 veterinary medicinal product.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only 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.

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Interactions

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

Diazepam may enhance the action of digoxin.

Cimetidine, erythromycin, azole substances (such as itraconazole or ketoconazole), valproic acid and propranolol 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.

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Overdose

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.

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Special warnings

• For strict intravenous 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.

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Withdrawal period

Not applicable.

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Incompatibilities

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

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Immediate packaging

Colourless glass ampoules, type I, with 2 ml solution for injection or colourless glass vials, type I, with 10 ml solution for injection, closed with a chlorobutyl rubber stopper and either an aluminium pull off cap or an aluminium/plastic flip off cap.

Pack sizes: 5 x 2 ml, 10 x 2 ml ampoules and 1 x 10 ml vial in a cardboard box.

Not all pack sizes may be marketed.

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Storage

Keep the ampoules/vial in the outer carton in order to protect from light.

This veterinary medicinal product does not require any special temperature storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale in 2 ml ampoule: 3 years.

Shelf-life of the veterinary medicinal product as packaged for sale in 10 ml vial: 30 months.

Shelf life after first opening the immediate packaging (2 ml): Use immediately. Discard any unused material.

Shelf life after first opening the immediate packaging (10 ml): 56 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 57446/4010

8 DATE OF FIRST AUTHORISATION

02 May 2018

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

February 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 02 April 2025

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Registration holder

VetViva Richter GmbH

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