Berodual solution inhalation

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ipratropium bromide (ipratropium bromide monohydrate), fenoterol (fenoterol hydrobromide)

Available from:

Istituto de Angeli S.R.L. Loc. Prulli

ATC code:

R03AL01

INN (International Name):

ipratropium bromide (ipratropium bromide monohydrate), fenoterol (fenoterol hydrobromide)

Dosage:

261mcg/ml+ 500mcg/ml

Pharmaceutical form:

solution inhalation

Units in package:

20ml glass container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-04-12

Summary of Product characteristics

Berodual inhalation solution – Armenian Local Product Information
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Berodual
®
250 µg/500 µg inhalation solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: ipratropium bromide and fenoterol hydrobromide
1 ml (= 10 actuations with the solution dispenser) contains:
261 µg ipratropium bromide 1 H
2
O (corresponds to 250 µg ipratropium bromide) and
500 µg fenoterol hydrobromide.
1 actuation contains:
26.1 µg ipratropium bromide 1 H
2
O (corresponds to 25 µg ipratropium bromide) and
50 µg fenoterol hydrobromide.
Excipient with known effect: benzalkonium chloride (see Section 4.4).
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prevention and treatment of dyspnoea in chronic obstructive
airway disorders:
Allergic and non-allergic (endogenous) bronchial asthma,
exercise-induced asthma and
chronic obstructive bronchitis with and without emphysema.
Note
If long-term medication is necessary, it should always be accompanied
by anti-inflammatory
treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ONLY FOR INHALATION WITH A NEBULIZER
Treatment should be initiated and administered under medical
supervision, e.g. in the
hospital setting. After consultation with an experienced physician,
home-based treatment can
be recommended in patients when a low dose rapid acting beta-agonist
bronchodilator such
Berodual inhalation solution – Armenian Local Product Information
Page 2 of 13
as Berodual pressurised inhalation solution has been insufficient in
providing relief. It can
also be recommended in patients who are in need for nebuliser
treatment for other reasons
(e.g. handling issues of pressurised inhalation solution) or
requirement of higher doses in
experienced patients.
The treatment with the nebuliser solution should always be started
with the lowest
recommended dose. The dosage should be adapted to the individua