Procamidor Duo 40 mg/ml + 0.036 mg/ml solution for injection

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Procaine hydrochloride; Epinephrine bitartrate

Доступна з:

Richter Pharma AG

Код атс:

QN01BA52

ІПН (Міжнародна Ім'я):

Procaine hydrochloride; Epinephrine bitartrate

Дозування:

40, 0.036 milligram(s)/millilitre

Фармацевтична форма:

Solution for injection

Тип рецепту:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Терапевтична области:

procaine, combinations

Статус Авторизація:

Authorised

Дата Авторизація:

2019-08-30

Характеристики продукта

Health Products Regulatory Authority
06 September 2019
CRN000Y60
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Procamidor Duo 40 mg/ml + 0.036 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCES:
​
​
Procaine hydrochloride
​40 mg
​
(equivalent to 34.65 mg procaine)
​
​
Adrenaline tartrate
​0.036 mg
​
(equivalent to 0.02 mg adrenaline)
​
​
​
​
EXCIPIENTS:
​
​
Sodium methyl parahydroxybenzoate (E219)
​1.14 mg
​
Sodium metabisulfite (E223)
​1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to almost colourless solution, free of visible
particles
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle, pigs and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Local anaesthesia with an anaesthetic effect of 1 – 2 hours.

Infiltration anaesthesia

Perineural anaesthesia
4.3 CONTRAINDICATIONS
Do not use in:

conditions of shock

in animals with cardiovascular diseases

in animals under treatment with sulphonamides

in animals treated with phenothiazines (see also section 4.8)
Do not use in cases of hypersensitivity to local anaesthetics
belonging to the esters subgroup or in case of possible allergic
cross reactions to p-aminobenzoic acid and sulphonamides.
Do not administer by the intravenous or the intra-articular route.
Do not use to anaesthetise regions with terminal circulation (e.g.
ears, tail, penis, etc.), owing to the risk of tissue necrosis
following complete circulatory arrest, due to the presence of
adrenaline (a vasoconstrictor).
Do not use with cyclopropane- or halothane-based anaesthetics (see
also section 4.8).
Health Products Regulatory Authority
06 September 2019
CRN000Y60
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
To avoid inadvertent intravenous administration, correct placem