SPIRIVA RESPIMAT

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TIOTROPIUM BROMIDE AS MONOHYDRATE

متاح من:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC رمز:

R03BB04

الشكل الصيدلاني:

SOLUTION FOR INHALATION

تركيب:

TIOTROPIUM BROMIDE AS MONOHYDRATE 2.5 MCG

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

المجال العلاجي:

TIOTROPIUM BROMIDE

الخصائص العلاجية:

Maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).COPD:Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).Asthma:Spiriva Respimat is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year.

تاريخ الترخيص:

2020-06-30

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied upon physician’s prescription only
SPIRIVA
® RESPIMAT
®
SOLUTION FOR INHALATION
Each actuation releases: 2.5 microgram tiotropium (as bromide
monohydrate)
2 puffs, which comprise one therapeutic dose, contain: 5 microgram
tiotropium (as bromide
monohydrate)
Inactive ingredients and allergens in this medicine: See section 2
‘Important information
about some of this medicine’s ingredients’ and section 6
‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your physician or pharmacist. This medicine has been prescribed to
treat your illness. Do not
pass it on to others. It may harm them, even if it seems to you that
their illness is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
COPD
Spiriva Respimat is intended for maintenance bronchodilator treatment
to relieve symptoms in
patients with chronic obstructive pulmonary disease (COPD).
Asthma
Spiriva Respimat is indicated for maintenance treatment in children
over 6 years old and in adults
with severe asthma who experienced at least one severe exacerbation
during the past year.
THERAPEUTIC GROUP: anticholinergic agents.
More information about this medicine
Spiriva Respimat helps patients with COPD or asthma to breathe more
easily. COPD is a
chronic lung disease causing shortness of breath and cough. COPD is a
condition associated
with chronic inflammatory states of the airways (bronchitis) and
emphysema. Asthma is a
chronic disease associated with airway inflammation and narrowing of
the airways. Since
COPD and asthma are chronic diseases, you must take Spiriva Respimat
every day, and not
only when you experience breathing problems or other symptoms. When
used to treat
asthma, you should use Spiriva Respimat in addition to medications
called inhaled
corticosteroids and long-acting

خصائص المنتج

Spiriva Respimat
Prescribing information
Solution for inhalation
July 2019
Boehringer Ingelheim Israel
Page 1 of 21
1
SPIRIVA RESPIMAT
TIOTROPIUM BROMIDE
SOLUTION FOR INHALATION
FULL PRESCRIBING INFORMATION
1
.
NAME OF THE MEDICINAL PRODUCT
Spiriva Respimat
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose is 2.5 microgram tiotropium per puff (2 puffs
comprise one medicinal dose) and is
equivalent to 3.124 microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
Excipient with known effect: This medicine contains 0.0011 mg
benzalkonium chloride in each
actuation.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation solution
Clear, colourless, inhalation solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COPD
Tiotropium is indicated as a maintenance bronchodilator treatment to
relieve symptoms of patients
with chronic obstructive pulmonary disease (COPD).
Asthma
Spiriva Respimat is indicated as add-on maintenance bronchodilator
treatment in patients aged 6 years
and older with severe asthma who experienced one or more severe asthma
exacerbations in the
preceding year (see sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The medicinal product is intended for inhalation use only. The
cartridge can only be inserted and used
in the Respimat inhaler (see 4.2).
Two puffs from the Respimat inhaler comprise one medicinal dose.
Spiriva Respimat
Prescribing information
Solution for inhalation
July 2019
2
The recommended dose for adults is 5 microgram tiotropium given as two
puffs from the Respimat
inhaler once daily, at the same time of the day.
The recommended dose should not be exceeded.
In the treatment of asthma the full benefit will be apparent after
several doses of the medicinal
product. In adult patients with severe asthma, tiotropium should be
used in addition to inhaled
corticosteroids (≥ 800 μg budesonide/day or equivalent) and at
least one controller.