Atrovent N aerosol for inhalation, dosed

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

ipratropium bromide (ipratropium bromide monohydrate)

Доступна с:

Boehringer Ingelheim Pharma GmbH & Co. KG

код АТС:

R03BB01

ИНН (Международная Имя):

ipratropium bromide (ipratropium bromide monohydrate)

дозировка:

20mcg/dose

Фармацевтическая форма:

aerosol for inhalation, dosed

Штук в упаковке:

10ml (200doses) aluminium container with measuring pump

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2017-02-10

Характеристики продукта

Status:
FUT_v17_02.10.2015
Atrovent N metered-dose inhaler20 µg/actuation
Record no.:
-
Product information
Page 1 of 9
PRODUCT INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Atrovent
®
N metered-dose inhaler
20 µg/actuation, pressurised inhalation, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Ipratropium bromide
Each metered dose (ex-valve) contains:
21 µg ipratropium bromide monohydrate (equivalent to 20 µg
ipratropium bromide)
Excipient with known effect: Anhydrous ethanol (alcohol)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, solution
(10 ml = 200 metered doses)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prevention and treatment of dyspnoea in:

chronic obstructive pulmonary disease (COPD)

mild to moderate adult and childhood asthma, if

2
-agonists are not indicated or as an adjunct to

2
-agonists during acute asthma attacks.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be adapted to the individual requirements of the
patient.
The following dosages are recommended for adults and children over 6
years of age:
Preventive treatment and maintenance treatment:
1 - 2 puffs several times daily
Average daily dose: 1- 2 puffs 3 - 4 times daily
The dose recommendations are the same for children < 6 years of age.
As there is insufficient ex-
perience in this age group, inhalation of the product should be
medically supervised.
An increasing dose requirement suggests that additional therapeutic
modalities may be needed and a
total daily dose of 12 puffs should therefore not be exceeded.
IMPORTANT NOTE
Status:
FUT_v17_02.10.2015
Atrovent N metered-dose inhaler20 µg/actuation
Record no.:
-
Product information
Page 2 of 9
The patient should be medically monitored during treatment.
If the patient's condition fails to show a satisfactory improvement or
deteriorates despite treatment,
medical advice must be sought so that modifications to the treatment
plan, including the addition of
corticos