TheraFlu LAR

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

benzoxonium chloride, lidocaine (lidocaine hydrochloride)

Dostupno od:

Kemwell Biopharma Pvt. Ltd.

INN (International ime):

benzoxonium chloride, lidocaine (lidocaine hydrochloride)

Doziranje:

1mg+1mg

Farmaceutski oblik:

lozenges

Tip recepta:

OTC

Svojstava lijeka

Novartis Consumer Health SA
CH-1260 Nyon, Switzerland
Global Regulatory Affairs
Global Labelling & Compliance
OROFAR
Lozenges
Benzoxonium chloride with lidocaine hydrochloride
CORE DATA SHEET (CDS)
Author(s):
Jean-Michel Casado
Document status:
Final
GLC approval date:
16 Jul 2009
GLC tracking ID:
N/A
Amendment date(s):
14 May 2009, 16 Jul 2009
Effective date:
06 Aug 2009
Next update date:
Feb 2010
Number of pages:
6
Property of Novartis
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis
Novartis Consumer Health SA
Page 2
Core Data Sheet (CDS)
Orofar
1. NAME OF THE MEDICINAL PRODUCT
OROFAR
Lozenges
LOCAL NAME : THERAFLU LAR
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoxonium chloride (INN):
N-benzyl N-dodecyl N,N-di(2-hydroxyethyl) ammonium chloride.
Lidocaine hydrochloride (INN), Lignocaine hydrochloride (BAN):
2-Diethylaminoaceto-2’,6’-xylidide hydrochloride.
One lozenge contains: Benzoxonium chloride 1 mg, lidocaine
hydrochloride 1 mg.
1
PHARMACEUTICAL FORM
Lozenges
White to slightly yellowish, round biconvex lozenges with the Zyma
inscription on one side
and the code “OR” on the other side.
_ _
2
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
Treatment of infections in the mouth and throat: sore throat
associated with colds, pharyngitis
or laryngitis; stomatitis, aphthous ulcers, gingivitis. Adjuvant in
tonsillitis.
2.2
POSOLOGY AND METHOD OF ADMINISTRATION
2.2.1
LOZENGES
Per os. Let one lozenge or gelsolet melt in the mouth every two to
three hours. In case of
severe infection, the dose can be increased to one lozenge every one
to two hours. Do not take
more than ten lozenges a day.
Aphthous ulcers: allow the lozenge to dissolve slowly in contact with
the lesion.
Children over 4 years : One lozenge to be dissolved slowly in the
mouth every 2 to 3 hours,
up to a maximum of 6 lozenges in 24 hours.
Novartis Consumer Health SA
Page 3
Core Data Sheet (CDS)
Orofar
2.3
CONTRAINDICATIONS
Hypersensitivity to