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

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Procaine hydrochloride; Epinephrine bitartrate

Pieejams no:

VetViva Richter GmbH

ATĶ kods:

QN01BA52

SNN (starptautisko nepatentēto nosaukumu):

Procaine hydrochloride; Epinephrine bitartrate

Zāļu forma:

Solution for haemofiltration

Receptes veids:

POM: Prescription Only Medicine as defined in relevant national legislation

Ārstniecības joma:

procaine, combinations

Autorizācija datums:

2019-08-30

Produkta apraksts

_[Version 8.1,01/2017]_
ANNEX
I
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).
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 placement of
the needle should be verified by
aspiration.
Due to local tissue damage wounds or abscesses may be difficult to
anaesthetise using local
anaesthetics.
Perform local anaesthesia at ambient