Ziapam
Active substance
Species
Dog and cat.
Indications
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.
Dose 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).
Adverse reactions
Dogs and cats:
Rare (1 to 10 animals / 10,000 animals treated): |
Behavioural disorders (e.g. excitation, aggression, desinhibiting effect)1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Hepatic necrosis (acute) 2, liver failure 2 |
Undetermined frequency: |
Hypotension 3, cardiac disorders 3, and thrombophlebitis 3 |
1 Paradoxical reactions. Mainly in small breeds of dogs. Avoid use of diazepam as a sole agent in potentially aggressive animals.
2 In cats only.
3 May be caused by rapid intravenous administration.
4 Mainly 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 its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
Dispensing
POM-V - Prescription Only Medicine – VeterinarianSUMMARY 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
Each ml of solution contains: Active substance: |
|
Diazepam Excipients: |
5.0 mg |
Benzyl Alcohol (E1519) |
15.7 mg |
Benzoic Acid (E210) |
2.5 mg |
Sodium Benzoate (E211) |
47.5 mg |
For the 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
Dog and cat.
4.2 Indications for use, specifying the target species
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 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 intravenous use only.
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
i). 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.
ii). 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. Take care to 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.
Special precautions for the protection of the environment:
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Dogs and cats:
Rare (1 to 10 animals / 10,000 animals treated): |
Behavioural disorders (e.g. excitation, aggression, desinhibiting effect)1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Hepatic necrosis (acute) 2, liver failure 2 |
Undetermined frequency: |
Hypotension 3, cardiac disorders 3, and thrombophlebitis 3 Ataxia, disorientation, change in mentation and behaviour Increased appetite 4 |
1 Paradoxical reactions. Mainly in small breeds of dogs. Avoid use of diazepam as a sole agent in potentially aggressive animals.
2 In cats only.
3 May be caused by rapid intravenous administration.4 Mainly 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 its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in cats and dogs.
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.
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 Amount(s) 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.
ATC Vet 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, musculosketetal 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 metabolized 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 (E1519)
Benzoic acid (E210)
Sodium benzoate (E211)
Propylene Glycol
Ethanol (96 per cent)
Sodium hydroxide (for pH adjustment)
Water for injections
6.2 Major 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: 4 years. Shelf life after first opening the immediate packaging: use immediately.
6.4 Special precautions for storage
Store in the original package. Protect from light.
Any solution remaining in the ampoule following withdrawal of the required dose should be discarded.
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
Domes Pharma
3 Rue Andre Citroën
63430 Pont-Du-Chateau France
8. MARKETING AUTHORISATION NUMBER
Vm 54982/5005
9. DATE OF FIRST AUTHORISATION
05 March 2014
10. DATE OF REVISION OF THE TEXT
November 2023
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
POM-V
Approved 16 November 2023