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

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Methadone hydrochloride

Доступно од:

Richter Pharma AG

АТЦ код:

QN02AC90

INN (Међународно име):

Methadone hydrochloride

Дозирање:

10 milligram(s)/millilitre

Фармацеутски облик:

Solution for injection

Тип рецептора:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Терапеутска област:

methadone

Статус ауторизације:

Authorised

Датум одобрења:

2018-07-20

Карактеристике производа

Health Products Regulatory Authority
27 July 2020
CRN009RFG
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Insistor 10 mg/ml solution for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
​
ACTIVE SUBSTANCES:
​
​
Methadone hydrochloride
​
10 mg
​
(equivalent to 8.9 mg Methadone)
​
​
EXCIPIENTS:
​
​
Methyl parahydroxybenzoate (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.
Clear colourless to slightly yellow 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 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.
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 examin