Adrenacaine Solution for Injection for Cattle

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Osta kohe

Laadi alla Toote omadused (SPC)
13-08-2021
Laadi alla Avaliku hindamisaruande (PAR)
13-08-2021
Laadi alla DSU (DSU)
30-08-2023

Toimeaine:

Procaine hydrochloride; Adrenaline tartrate

Saadav alates:

Norbrook Laboratories (Ireland) Limited

ATC kood:

QN01BA52

INN (Rahvusvaheline Nimetus):

Procaine hydrochloride; Adrenaline tartrate

Annus:

50, 0.02 milligram(s)/millilitre

Ravimvorm:

Solution for injection

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline ala:

procaine, combinations

Volitamisolek:

Authorised

Loa andmise kuupäev:

2009-07-17

Toote omadused

                                Health Products Regulatory Authority
12 August 2021
CRN00CDJL
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Adrenacaine Solution for Injection for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Procaine Hydrochloride
50 mg/ml
Adrenaline (Epinephrine) (as Adrenaline Tartrate)
0.02 mg/ml
EXCIPIENTS:
Chlorocresol (as preservative)
1.0 mg/ml
Sodium Metabisulphite E223 (as antioxidant)
1.0 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for use in minor surgical procedures
particularly dehorning and disbudding in cattle.
4.3 CONTRAINDICATIONS
Do not administer by intravenous, intra-articular or epidural
injection.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5 SPECIAL PRECAUTIONS FOR USE
I SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Care should be taken not to inject the product intravascularly.
II SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or label to the physician.
Immediately wash off any splashes to the eyes or skin with copious
amounts of water.
Health Products Regulatory Authority
12 August 2021
CRN00CDJL
Page 2 of 4
Seek medical attention if irritation occurs.
Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The product can be administered at any stage of pregnancy or
lactation.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Procaine may inhibit the action of sulfonamides and their concurrent
administration should be 
                                
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