Tantum Verde spray for local use

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

benzydamine (benzydamine hydrochloride)

متاح من:

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Via Vecchia Del Pinocchio

ATC رمز:

A01AD02

INN (الاسم الدولي):

benzydamine (benzydamine hydrochloride)

جرعة:

0,255mg/dose (150mg/100ml)

الشكل الصيدلاني:

spray for local use

الوحدات في الحزمة:

30ml (176 doses) plastic container with pump dispenser

نوع الوصفة الطبية :

OTC

الوضع إذن:

Registered

تاريخ الترخيص:

2020-12-26

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tantum Verde spray for local use 1,5 mg/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution contain:_ _
_active substance:_ benzydamine hydrochloride 0.15 g, equivalent to
benzydamine 0.134 g;
For the complete list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Spray for local use
Colourless transparent liquid with the specific mint odour.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Symptomatic treatment
of pain and irritation, including those accompanied by pain in
oropharyngeal zone (for example, gingivitis, stomatitis, and
pharyngitis), as well as the results
of conservative stomatological procedures or after teeth extraction.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Administer 2-6 times a day (with each spray 0.17 ml of the solution is
sprayed out).
_Adults and adolescents over 12 years of age: _by 4-8 sprays 2-6 times
a day.
_Children _ (6 – 12 years): the medicinal product should be
administered only after doctor
recommendation and in prescribed doses.
Do not exceed the recommended dose.
4.3. CONTRAINDICATIONS
-
hypersensitivity to active ingredient or to any of excipients listed
in section 6.1.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Administration of this medicinal product, especially for the extended
period may lead to
hypersensitivity development. In such case the drug administration
should be stopped and it is
necessary to consult a doctor, who has prescribed an appropriate
treatment.
Oro-pharyngeal ulcerations can be a sign of more serious pathologies
in a limited number of
patients. Therefore, in the event that the symptoms persist for more
than three days, the
patient should contact their doctor or dentist as needed.
The
use
of
benzidamine
is
not
recommended
in
patients
with
hypersensitivity
to
acetylsalicylic acid or other NSAIDs.
This medicine should be administered with caution in subjects who in
the past have had
episodes of bronchial asthma, as bronchospasm could occur in this type
of pa