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

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: VMD (Veterinary Medicines Directorate)

Ingredjent attiv:

Methadone Hydrochloride

Disponibbli minn:

Zoetis UK Limited

Kodiċi ATC:

QN02AC90

INN (Isem Internazzjonali):

Methadone Hydrochloride

Għamla farmaċewtika:

Solution for injection

Tip ta 'preskrizzjoni:

POM-V - Prescription Only Medicine – Veterinarian

Grupp terapewtiku:

Cats, Dogs

Żona terapewtika:

Neurological Agent analgesic

L-istatus ta 'awtorizzazzjoni:

Authorized

Data ta 'l-awtorizzazzjoni:

2018-09-20

Karatteristiċi tal-prodott

Unlimited Renewal: September 2023
AN: 01815/2023
Page 1 of 7
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