Methadyne 10 mg/ml Solution for Injection for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Methadone Hydrochloride

Available from:

Zoetis UK Limited

ATC code:

QN02AC90

INN (International Name):

Methadone Hydrochloride

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Neurological Agent analgesic

Authorization status:

Authorized

Authorization date:

2018-09-20

Summary of Product characteristics

Unlimited Renewal: September 2023
AN: 01815/2023
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Methadyne 10 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Methadone hydrochloride
10.0 mg
Equivalent to Methadone
8.9 mg
Excipient(s):
Methyl parahydroxybenazoate (E218)
1.0 mg
Propyl parahydroxybenzoate
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
A clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
•
Analgesia.
•
Premedication for general anaesthesia or neuroleptanalgesia in
combination with
a neuroleptic drug.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance
or to any of the
excipients.
Do not use in animals with advanced respiratory failure.
Do not use in animals with severe liver and renal dysfunction.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Due to the variable individual response to methadone, animals should
be monitored
regularly to ensure sufficient efficacy for the desired duration of
effect.
Unlimited Renewal: September 2023
AN: 01815/2023
Page 2 of 7
Use of the product must be preceded by a thorough clinical
examination.
In cats, pupil dilation is seen long after the analgesic effect has
disappeared. It is
therefore not an adequate parameter to assess clinical efficacy of the
administered
dose.
Greyhounds may require higher doses than other breeds to achieve
efficacious
plasma levels.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Methadone may occasionally cause respiratory depression and, as with
other opioid
drugs, care should be taken when treating animals with impaired
respiratory function,
or animals that are receiving drugs that can cause respiratory
depression. To ensure
safe use of the product, treated animals should be monitored
regularly, including
examinati