PROCAÏNE HCl 4% + ADRÉNALINE PRODIVET

PROCAÏNE HCl 4% + ADRÉNALINE PRODIVET

  • Procaine HCl 4 % + Adrenaline
  • Injectable solution
  • Vials of 250 ml
Cattle
Horses

PACKAGE LEAFLET

PROCAÏNE HCl 4%+ADRENALINE PRODIVET

injectable solution

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorization holder and manufacturer responsible for batch release:
Prodivet pharmaceuticals sa
Hagbenden 39c
B-4731 EYNATTEN

NAME OF THE VETERINARY MEDICINAL PRODUCT

PROCAÏNE HCl 4% + Adrenaline Prodivet, injectable solution

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

per ml:
Active substance: Procaine Hydrochloride 40 mg - Adrenaline tartrate 0,036 mg
Excipients: Sodium Chloride – Chlorocresol 1 mg – Sodium Metabisulfite 1 mg – Water for injection

INDICATIONS

Horses and bovines:

  • Local anaesthesia by infiltration
  • Nerve conduction anaesthesia by infiltration

CONTRAINDICATIONS

  • Shock
  • Animals with cardiovascular damage.
  • Animals treated with sulfonamides drugs (risk of inhibition of the action of sulfonamides).
  • Anaesthesia of areas with terminal circulation (ears, tail, penis, ...) because the presence of adrenaline may induce tissue necrosis due to total blockage of blood flow.
  • Narcosis with cyclopropane or halothane as cardiac sensitivity to the action of adrenaline (sympaticomimetic) is increased (arrhythmia).
  • Congenital deficiency in specific pseudocholinesterase.
  • Simultaneous use of curare-like agents.
  • Known hypersensitivity to any of the components

ADVERSE REACTIONS

  • Possible allergic reaction to Procaïne.
  • Toxic effects may be shown in case of overdosage and are described in this heading

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

TARGET SPECIES

Horses and bovines

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Local anaesthesia by infiltration :
Bovines: According to the surface to be anesthetized: 10 - 20 ml of Procaïne HCl 4% + adrenaline (that means 400 to 800 mg) per animal
Horses: 10 ml of Procaïne HCl 4% + adrenaline (that means 400 mg) per animal

Anaesthesia of the nerve conduction by infiltration
Bovines and horses: 5 – 10 ml of procaine HCl 4% + adrenaline (that means 200 to 400 mg), per animal

ADVICE ON CORRECT ADMINISTRATION

Do not inject by intravascular way.

WITHDRAWAL PERIOD

Meat and offals: 0 hours
Milk: 0 hours

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.
Store below 25°C protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the bottle after {EXP}.
Shelf-life after first opening the container: 28 days

SPECIAL WARNING(S)

Special precautions for use in animals

 

  • Do not inject by intravascular way
  • The local anaesthesia must be avoided in infected or inflamed areas.
  • Horses are particularly sensitive to CNS effects of Procaine. The occurrence of CNS effects is particularly observed during administration and the administration must be stopped immediately if these occur.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

  • Avoid any direct skin contact
  • In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician
  • People with known hypersensitivity to Procaine Hydrochloride should avoid contact with the veterinary medicinal product

Use during pregnancy, lactation or lay

The product can be administered during gestation

Interaction with other medicinal products and other forms of interaction

Incompatible with a Sulfonamide treatment. The sulfonamides inhibit the conversion of the primary metabolite of procaine acid, the para-aminobenzoic acid in dihydrofolic acid. The para-aminobenzoic acid can inhibit the action of sulfonamides

Overdose (symptoms, emergency procedures, antidotes), if necessary

Symptoms

An important overdose by fast intravenous injection can cause a stimulation of the CNS evolving to clonic convulsions. Then, a phase of depression is observed which can lead in serious cases to a respiratory blockage

Treatments

Apply current measures of reanimation with intravenous injection of a barbiturate of short duration to control the muscular tremors, and envisage a source of oxygen to facilitate the respiration.

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY

Medicines should not be disposed of via wastewater or household waste.
Any unused product or waste materials should be disposed of in accordance with local requirements

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

October 2016

OTHER INFORMATION

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
Prodivet pharmaceuticals sa/nv
Hagbenden 39c
B - 4731 EYNATTEN
Phone : 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20
e-mail : info@prodivet.com

available on prescription only

AMM : BE-V107791

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