LidoBel 20 mg/ml solution for injection for horses, dogs, and cats.

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Lidocaine hydrochloride

Διαθέσιμο από:

Bela-Pharm GmbH & Co. KG

Φαρμακολογική κατηγορία (ATC):

QN01BB02

INN (Διεθνής Όνομα):

Lidocaine hydrochloride

Δοσολογία:

20 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

lidocaine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-07-06

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
10 July 2018
CRN000VL5
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
LidoBel 20 mg/ml solution for injection for horses, dogs, and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
​
ACTIVE SUBSTANCE:
​
​
Lidocaine hydrochloride:
​
20 mg
​
(equivalent to Lidocaine:
16.23 mg)
EXCIPIENTS:
​
​
Methyl parahydroxybenzoate (E 218):
​
1.8 mg
​
Propyl parahydroxybenzoate:
​
0.2 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For local/nerve block (regional infiltration) including field block
anaesthesia.
Superficial anaesthesia of mucous membranes.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipient.
Do not use in cases of inflammatory tissue disorders at the site of
application.
Do not use in infected tissue.
Do not use in new-born animals.
Health Products Regulatory Authority
10 July 2018
CRN000VL5
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not administer by intravenous injection.
Use with extreme care in animals with cardiac insufficiency, cardiac
arrhythmia,
hyperkalaemia, liver dysfunction, Diabetes mellitus, acidosis and
neurological
diseases.
Exact dosing and appropriate injection technique must therefore be
ensured.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Wash hands after use.
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 lidocaine hydrochloride or any
of the
excipients should avoid contact with the veterinary medicinal product.
4.6 ADVERSE REACTIONS