Tralieve 50 mg/ml Solution for Injection for Dogs

Composition

Each ml contains:

Active substance:

Tramadol 43.9 mg

(equivalent to 50 mg tramadol hydrochloride)

Excipients:

Clear and colourless solution.

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Pharmacological properties

4.1 ATCvet code:

QN02AX02.

4.2 Pharmacodynamics

Tramadol is a centrally acting analgesic agent with a complex mode of action exerted by its 2 enantiomers and primary metabolite, involving opioid, norepinephrine, and serotonin receptors. The (+) enantiomer of tramadol inhibits serotonin uptake. The (-) enantiomer inhibits norepinephrine reuptake. The metabolite O- desmethyltramadol has greater affinity for the µ-opioid receptors.

Unlike morphine, tramadol does not have depressing effects on respiration for an extensive analgesic dose range. Likewise, it does not affect gastrointestinal motility. The effects on the cardiovascular system tend to be mild. The analgesic potency of tramadol is about 1/10 to 1/6 of that of morphine.

In humans genotypic differences result in up to 10% of individuals being non- responders to tramadol hydrochloride. In these individuals the analgesic effect of tramadol is decreased or absent. A similar phenomenon is known to exist in dogs, however the percentage of dogs affected is not known.

4.3 Pharmacokinetics

After intramuscular administration, the absorption is almost total, with a bioavailability of 92%. Protein binding is moderate (15%). Tramadol is metabolized in the liver by cytochrome P450 mediated demethylation followed by conjugation with glucuronic acid. Elimination occurs mainly via the kidneys, with an elimination half-life of about 0.5-2 hours.

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Target species

Dogs.

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Indications

For the reduction of mild postoperative pain.

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Dosage

Intramuscular or intravenous use.

2−4 mg tramadol hydrochloride per kg bodyweight, corresponding to 0.04−0.08 ml veterinary medicinal product per kg bodyweight. Repeat doses can be administered every 6 to 8 hours (3-4 times daily). The recommended maximum daily dose is 16 mg/kg.

Intravenous administration must be carried out very slowly.

As the individual response to tramadol is variable, and depends partly on the dosage, the age of the patient, individual differences in pain sensitivity and general condition, the optimal dosing regimen should be individually tailored using the above dose and re-treatment interval ranges. In the event of the veterinary medicinal product failing to provide adequate analgesia by 30 minutes following administration or for the duration of any planned re-treatment interval, a suitable alternative analgesic should be used.

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

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Contraindications

Do not use in animals with epilepsy.

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

Do not administer in conjunction with tricyclic antidepressants, monoamine oxidase inhibitors and serotonin reuptake inhibitors.

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Adverse reactions

Dogs:

*Treatment should be discontinued.

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 the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Use with caution in dogs with renal or hepatic impairment. In dogs with hepatic impairment the metabolism of tramadol to the active metabolites may be decreased which may reduce the efficacy of the veterinary medicinal product. One of the active metabolites of tramadol is renally excreted and therefore in dogs with renal impairment the dosing regimen used may need to be adjusted. Renal and hepatic function should be monitored when using this veterinary medicinal product. See also section 3.8.

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

People with known hypersensitivity to tramadol or any of the excipients should avoid contact with the veterinary medicinal product.

The veterinary medicinal product may cause skin and eye-irritation. Avoid contact with the skin and eyes. Wash hands after use. In case of accidental eye exposure, rinse with clean water.

There is inadequate evidence available on the safety of tramadol in human pregnancy. Pregnant women and women of childbearing age should therefore take great care when handling this veterinary medicinal product and, in the event of exposure, seek medical advice immediately.

Tramadol may cause nausea and dizziness following accidental self-injection. If you develop symptoms following accidental exposure, seek medical advice and show the package leaflet or the label to the physician. However, DO NOT DRIVE as sedation may occur.

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

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

Laboratory studies in mice and/or rats and rabbits have not produced any evidence of teratogenic, foetotoxic, maternotoxic effects.

Use only according to the benefit-risk assessment by the responsible veterinarian.

Lactation:

Laboratory studies in mice and/or rats and rabbits have not produced any evidence of adverse effects in the peri- and postnatal development of offspring.

Use only according to the benefit-risk assessment by the responsible veterinarian.

Fertility:

In laboratory studies in mice and/or rats and rabbits, the use of tramadol at therapeutic doses did not adversely affect reproductive performance and fertility in males and females.

Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

Concomitant administration of the veterinary medicinal product with central nervous system depressants may potentiate the CNS and respiratory depressant effects. When the veterinary medicinal product is administered together with veterinary medicinal products with a sedative effect, the duration of sedation may be increased. Tramadol can induce convulsions and increase the effect of drugs that lower the seizure threshold.

Drugs that inhibit (e.g. cimetidine and erythromycin) or induce (e.g. carbamazepine) CYP450 mediated metabolism may have an effect on the analgesic effect of tramadol. The clinical relevance of these interactions has not been studied in dogs. See also section 3.3.

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Overdose

In cases of intoxication with tramadol symptoms similar to those observed with other centrally acting analgesics (opioids) are likely to occur. This include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest.

General emergency measures: Maintain a patent airway; support cardiac and respiratory function depending on the symptoms. The antidote for respiratory depression is naloxone. However, the decision to use naloxone in the event of an overdose should be made following an assessment of the benefit-risk ratio for the individual as it may only partially reverse some of the other effects of tramadol and may increase the risk of seizures, although data on the latter are conflicting. In case of seizures, administer diazepam.

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Special warnings

The analgesic effects of tramadol hydrochloride may be variable. This is thought to be due to individual differences in the metabolism of the drug to the primary active metabolite O-desmethyltramadol. In some dogs (non-responders) this may result in the veterinary medicinal product failing to provide analgesia. Dogs should therefore be monitored regularly to ensure sufficient efficacy.

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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

Clear type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.

Pack sizes:

Box with 1 vial of 10 ml

Box with 1 vial of 20 ml

Box with 1 vial of 50 ml

Multi-pack with 6 boxes each containing 1 vial of 10 ml

Multi-pack with 6 boxes each containing 1 vial of 20 ml

Multi-pack with 6 boxes each containing 1 vial of 50 ml

Multi-pack with 10 boxes each containing 1 vial of 10 ml

Multi-pack with 10 boxes each containing 1 vial of 20 ml

Multi-pack with 10 boxes each containing 1 vial of 50 ml

Not all pack sizes may be marketed.

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Storage

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

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months.

Shelf life after first opening the immediate packaging: 8 weeks.

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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 41821/5024

8 DATE OF FIRST AUTHORISATION

26 March 2018

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

September 2024

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: 18 December 2024

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Registration holder

Le Vet Beheer B.V.

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