Fluimucil solution for i/v injection and inhalation

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

acetylcysteine

Доступно од:

Zambon S.P.A.

АТЦ код:

R05CB01, V03AB23

INN (Међународно име):

acetylcysteine

Дозирање:

100mg/ml

Фармацеутски облик:

solution for i/v injection and inhalation

Јединице у пакету:

(5) ampoules 3ml

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2022-05-12

Карактеристике производа

DIREZIONE E AMMINISTRAZIONE / SEDE LEGALE
HEAD OFFICE
/
REGISTERED OFFICE
Via Lillo del Duca, 10
20091 Bresso (MI) - Italy
Tel. [phone] Fax. [phone]
C.P. / PO Box 78 20091 Bresso (MI) - Italy
ZAMBON SPA
Cap.Soc.Euro 5/649/880.00 i.v.
REA Milano n. 1814364 C.F. – P.IVA IT 053471830965
Societa unipersonale – Direzione e coordinamento:
Zambon Company S.p.A.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FLUIMUCIL 300 mg/3 ml
Solution for injection, nebulization and endotracheobronchial
instillation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains:
Active ingredient
N-Acetylcysteine
Excipients: Sodium edetate
For a full list of excipients, see section 6.1
mg 300
3.
PHARMACEUTICAL FORM
Solution for i/v and inhalation
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of respiratory tract diseases characterized by thick and
viscous hypersecretions: acute bronchitis,
chronic bronchitis and its exacerbations, pulmonary emphysema,
mucoviscidosis and bronchiectasis.
ANTIDOTAL TREATMENT
Accidental or voluntary acetaminophen poisoning.
Iso- and cyclophosphamide uropathy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
INTRAVENOUS ADMINISTRATION
ACCIDENTAL OR VOLUNTARY ACETAMINOPHEN POISONING
Initial dose of 150 mg/kg body weight diluted with an equal volume of
a 5% glucose solution and intravenously
injected over 15 minutes.
Subsequent doses: 50 mg/kg by intravenous drip infusion over 4 hours
followed by a further dose of 100 mg/kg
by intravenous perfusion over 16 hours, both in 5% glucose solution.
AEROSOL INHALATION
Nebulize one ampoule for each inhalation session, 1-2 times daily for
5-10 days.
Due to the high drug tolerability, frequency of administrations and
relevant doses can be modified by the
physician within rather wide-ranging limits, in response to the
clinical condition and the therapeutic effect,
without the need to markedly differentiate between doses for adults
and for children.
ENDOBRONCHIAL INSTILLATION
Administer, according to the selected mod