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Date: Friday, May 7, 2021 16:47

Release 2.84
Tralieve® Chewable Tablets for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Neurological preparations: Analgesics
Active ingredient: Tramadol hydrochloride
Product:Tralieve® Chewable Tablets for Dogs
Product index: Tralieve Chewable Tablets for Dogs
Qualitative and quantitative composition
Tralieve 20 mg chewable tablets for dogs
1 tablet contains: Active substance:
Tramadol hydrochloride 20 mg
(equivalent to 17.6 mg tramadol)
Tralieve 80 mg chewable tablets for dogs
1 tablet contains: Active substance:
Tramadol hydrochloride 80 mg
(equivalent to 70.3 mg tramadol)
Pharmaceutical form
Chewable tablet.
20 mg tablet: Light brown with brown spots, round and convex flavoured 7 mm tablet with a cross-shaped break line on one side.
80 mg tablet: Light brown with brown spots, round and convex flavoured 11 mm tablet with a cross-shaped break line on one side.
Tablets can be divided into 2 or 4 equal parts.
Clinical particulars
Target species
Dogs.
Indications for use
For the reduction of acute and chronic mild soft tissue and musculoskeletal pain.
Contraindications
Do not administer in conjunction with tricyclic antidepressants, monoamine oxidase inhibitors and serotonin reuptake inhibitors.
Do not use in cases of hypersensitivity to tramadol or to any of the excipients.
Do not use in animals with epilepsy.
Special warnings for each target species
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 product failing to provide analgesia. For chronic pain, multimodal analgesia should be considered. Dogs should be monitored regularly by a veterinarian to ensure adequate pain relief. In case of recurrence of pain or insufficient analgesia the analgesic protocol may need to be reconsidered.
Special precautions for use in animals
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 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 product. Cessation of long-term analgesic therapy should be done gradually whenever possible.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Tramadol may cause sedation, nausea and dizziness after accidental ingestion, especially by children. To avoid accidental ingestion, particularly by a child, unused tablet parts should be returned to the open blister space and inserted back into the carton and kept in a safe place out of the sight and reach of children as they pose a health risk to small children due to accidental ingestion. In case of accidental ingestion, particularly by children, seek medical advice and show the package leaflet or the label to the physician. In case of accidental ingestion by adults: DO NOT DRIVE as sedation may occur.
People with known hypersensitivity to tramadol or any of the excipients should avoid contact with the veterinary medicinal product.
Wash hands after use.
Adverse reactions
Mild sedation and drowsiness may commonly occur, especially when higher doses are given.
Nausea and vomiting have uncommonly been observed in dogs after administration of tramadol.
In rare cases hypersensitivity can occur. In cases of hypersensitivity reactions the treatment should be discontinued.
In very rare cases tramadol may induce convulsions in dogs with a low seizure threshold.
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)
Use during pregnancy and lactation
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.
Interactions
Concomitant administration of the product with central nervous system depressants, may potentiate the CNS and respiratory depressant effects.
Tramadol can 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.
The combination with mixed agonist/antagonists (e.g. buprenorphine, butorphanol) and tramadol is not advisable, because the analgesic effect of a pure agonist may be theoretically reduced in such circumstances.
See also Contraindications.
Amounts to be administered and administration route
For oral administration.
The recommended dose is 2-4 mg tramadol hydrochloride per kg body weight every 8 hours or as needed based on the intensity of pain.
Minimum dosing interval is 6 hours. The recommended maximum daily dose is 16 mg/kg. 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. The dog should be examined regularly by a veterinarian to assess if additional analgesia is subsequently required. Additional analgesia can be administered by increasing the tramadol dose until the maximum daily dose is reached, and/or by following a multimodal analgesic approach with the addition of other suitable analgesics.
The most appropriate tablet strengths should be used in order to minimise divided tablets to be kept until the next dosing.
Please note that this dosing table is intended as a guide for dispensing the product at the high end of the dose range: 4 mg/kg body weight. It states the number of tablets required to administer 4 mg tramadol hydrochloride per kg body weight.
Tramadol 20 mg chewable tablets for dogs dosage table:
Body weight
Tramadol 20 mg
1.25 kg
¼
2.5 kg
½
3.75 kg
¾
5 kg
1
6.25 kg
7.5 kg
10 kg
2
15 kg
3
Tramadol 80 mg chewable tablets for dogs dosage table:
Body weight
Tramadol 80 mg
20 kg
1
30 kg
40 kg
2
50 kg
60 kg
3
Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.
2 equal parts: press down with your thumbs on both sides of the tablet.
4 equal parts: press down with your thumb in the middle of the tablet.
Overdose
In cases of intoxication with tramadol symptoms similar to those observed with other centrally acting analgesics (opioids) are likely to occur. These 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. Inducing vomiting in order to empty the stomach is suitable unless the affected animal is showing reduced consciousness, in which case gastric lavage may be considered. The antidote for respiratory depression is naloxone. However, naloxone may not be useful in all cases of tramadol overdose as it may only partially reverse some of the other effects of tramadol. In case of seizures, administer diazepam.
Pharmacological particulars
Pharmacotherapeutic group: Opioid analgesics, other opioids
ATCvet Code: QN02AX02
Pharmacodynamic properties
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 has a low affinity for the µ-opioid receptors, inhibits serotonin uptake and enhances its release. The (‑) enantiomer preferentially inhibits norepinephrine reuptake. The metabolite O-desmethyltramadol (M1) 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 1/10-1/6 of that of morphine.
Pharmacokinetic properties
Tramadol is readily absorbed: After a single oral administration of 4.4 mg tramadol HCL per kg body weight, peak plasma concentrations of 65 ng tramadol per mL are achieved within 45 minutes. Food does not significantly affect the absorption of the drug.
Tramadol is metabolized in the liver by cytochrome P450 mediated demethylation followed by conjugation with glucuronic acid. In dogs, lower levels of the active metabolite O-desmethyltramadol are formed compared to humans. Elimination occurs mainly via the kidneys with an elimination half-life of about 0.5-2 hours.
Pharmaceutical particulars
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life of divided tablets after first opening the immediate packaging: 3 days.
Special precautions for storage
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Immediate packaging
Aluminium - PVC/PE/PVDC blister
Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 25 blisters of 10 tablets.
Cardboard box containing 10 separate cardboard boxes, each containing 3 blisters of 10 tablets.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Le Vet Beheer BV, Wilgenweg 7, 3421 TV Oudewater, The Netherlands.
Marketing Authorisation Number
Vm 41821/4058: 20 mg
Vm 41821/4059: 80 mg
Significant changes
Date of the first authorisation or date of renewal
9 July 2018
Date of revision of the text
July 2018
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Tralieve 20 mg chewable tablets for dogs 30 tablets
GTIN:08718469444946
GTIN description:Tralieve 20 mg chewable tablets for dogs 100 tablets
GTIN:08718469444960
GTIN description:Tralieve 80 mg chewable tablets for dogs 30 tablets
GTIN:08718469444953
GTIN description:Tralieve 80 mg chewable tablets for dogs 100 tablets
GTIN:08718469444977