Stomatidin solution for topical use

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

hexetidine

Διαθέσιμο από:

Bosnalijek d.d.

Φαρμακολογική κατηγορία (ATC):

A01AB12

INN (Διεθνής Όνομα):

hexetidine

Δοσολογία:

1mg/ml

Φαρμακοτεχνική μορφή:

solution for topical use

Μονάδες σε πακέτο:

200ml glass vial

Τρόπος διάθεσης:

OTC

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2018-11-07

Αρχείο Π.Χ.Π.

1. NAME OF PROPRIETARY MEDICINAL PRODUCT
STOMATIDIN
®
0.1% oromucosal solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oromucosal solution contains: Hexetidine 1.00 mg
See point 6.1. for excipients.
3. PHARMACEUTICAL FORM
Oromucosal solution.
Clear, red solution.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
STOMATIDIN is indicated for use in minor mouth infections including
thrush, as an aid in the
prevention and treatment of gingivitis, and in the management of sore
throat and recurrent
aphthous ulcers.
STOMATIDIN
is also of value in the alleviation of halitosis and pre- and
post-dental surgery.
4.2. DOSAGE AND METHOD OF ADMINISTRATION
Usual dosage in adults and children 6 years and over:
Rinse the mouth, or gargle with at least 15 ml of undiluted solution,
two or three times a day.
Do not swallow the solution but spit out after use.
4.3. CONTRAINDICATIONS

Hypersensitivity to hexetidine or to any of the excipients in
STOMATIDIN (listed in
section 6.1.).

Children ages to 6 years.
4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTION MEASURES
STOMATIDIN is for external use only, the solution must therefore not
be swallowed.
Not suitable for persistent symptoms.
STOMATIDIN contains propilenglicol, which may irritate the skin when
used locally.
STOMATIDIN contains ethanol 96%. 1 ml oromucosal solution contains
80.9 mg ethanol 96%;
15 ml oromucosal solution (single dose) contains 1213.5 mg ethanol
96%. In case of accidental
ingestion, it can be harmful for those suffering from alcoholism. It
should also be taken into
account in pregnant or breast-feeding women, children and high risk
groups such as patients with
liver disease or epilepsy.
STOMATIDIN contains azorubine (E122). It may cause allergic reaction
(it is important in case
of accidental ingestion).
4.5. DRUG INTERACTION OR OTHER INTERACTION FORMS
Interactions with other drugs have not been registered.
4.6. PREGNANCY AND LACTATION
_Pregnancy _
No formal studies have been conducted in man. However, on the basis of
animal studies and, in
theo