Comfortan 10 mg/ml solution for injection for dogs and cats

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Methadone hydrochloride

Saadav alates:

Eurovet Animal Health B.V.

ATC kood:

QN02AC90

INN (Rahvusvaheline Nimetus):

Methadone hydrochloride

Annus:

10 milligram(s)/millilitre

Ravimvorm:

Solution for injection

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Cats, Dogs

Terapeutiline ala:

methadone

Näidustused:

Miscellaneous

Volitamisolek:

Authorised

Loa andmise kuupäev:

2016-10-14

Toote omadused

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Comfortan 10 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Methadone
8.9 mg
Equivalent to methadone hydrochloride
10.0 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Methyl parahydroxybenzoate (E218)
1.0 mg
Propyl parahydroxybenzoate
0.2 mg
Sodium chloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections
A clear colourless to pale yellow solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
-
Analgesia in dogs and cats.
-
Premedication for general anaesthesia or neuroleptanalgesia in dogs
and cats in combination with a
neuroleptic drug.
3.3
CONTRAINDICATIONS
Do not use in 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.
3.4
SPECIAL WARNINGS
Due to the variable individual response to methadone, animals should
be monitored regularly to ensure
sufficient efficacy for the desired duration of effect.
Use of the veterinary medicinal 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.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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