Procamidor Duo 40 mg/ml + 0.036 mg/ml Solution for Injection

País: Reino Unido

Idioma: inglés

Fuente: VMD (Veterinary Medicines Directorate)

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23-01-2023

Ingredientes activos:

Epinephrine Acid Tartrate, Procaine Hydrochloride

Disponible desde:

Richter Pharma AG

Código ATC:

QN01BA52

Designación común internacional (DCI):

Epinephrine Acid Tartrate, Procaine Hydrochloride

formulario farmacéutico:

Solution for injection

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Cattle, Horses, Pigs, Sheep

Área terapéutica:

Neurological Agent local anaesthetic

Estado de Autorización:

Authorized

Fecha de autorización:

2019-08-08

Ficha técnica

                                Revised: January 2023
AN: 02966/2022
Page 1 of 7
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.
Revised: January 2023
AN: 02966/2022
Page 2 of 7
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
anaesthet
                                
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