Hexaspray aerosol for local use

দেশ: আর্মেনিয়া

ভাষা: ইংরেজি

সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

সক্রিয় উপাদান:

biclotymol

থেকে পাওয়া:

Laboratoires Bouchara-Recordati

এটিসি কোড:

R02AA20 օրիգինալ դեղի առաջին դեղաձև, դեղաչափ

INN (আন্তর্জাতিক নাম):

biclotymol

ডোজ:

750mg/30g 30g glass bottle with pump dispenser

ফার্মাসিউটিকাল ফর্ম:

aerosol for local use

প্যাকেজ ইউনিট:

750mg/30g 30g glass bottle with pump dispenser

প্রেসক্রিপশন টাইপ:

OTC

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2020-09-25

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE MEDICINAL PRODUCT
HEXASPRAY, AEROSOL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Biclotymol…………………………………750 mg
For a bottle of 30 g.
Excipient: methylparahydroxybenzoate (E218).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Aerosol.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Infectious - inflammatory treatment oropharyngeal disorders
(
including stomatitis,
gingivitis), pharynx, larynx, caused by pathogens susceptible to
biclotimol.
Topical treatment of inflammatory and infectious diseases of the
nasopharynx and
respiratory tract (acute and chronic pharyngitis, pharyngolaryngitis,
tonsillitis,
conditions after tonsillectomy, glossitis).
4.2 POSOLOGY AND MODE OF ADMINISTRATION
FOR ADULT AND CHILD OVER 30 MONTHS ONLY.
Adults and children over 30 months: 2 sprays 3 times per day.
The treatment is limited to 5 days.
4.3 CONTRA-INDICATIONS
- Hypersensitivity to active ingredient or to one of the excipients.
- Throat sprays are contraindicated in infants below 30 months of age
(risk of laryngospasm).
-Due to the presence of soy lecithin, this medicine is contraindicated
in case of allergy to peanuts
or soya.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
- The indication does not justify prolonged treatment for more than 5
days, in particular as this may
disturb the homeostasis of the normal microbial flora of the oral
cavity with a risk of spreading
bacterial or fungal infection.
- Treatment should be reviewed if the symptoms persist for 5 days
and/or if there is associated fever.
- The simultaneous or successive use of other antiseptics should be
avoided because of possible
interference (antagonism, inactivation).
-The presence of methyl parahydroxybenzoate (E218) and soybean
lecithin may give rise to allergic
reactions
4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
Non applicable.
4.6 PREGNANCY AND LACTATION
No reliable data are available to evaluate the teratogenicity in
e