SEREVENT DISKUS

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

SALMETEROL AS XINAFOATE

Disponible des:

GLAXO SMITH KLINE (ISRAEL) LTD

Codi ATC:

R03AC12

formulario farmacéutico:

POWDER FOR INHALATION

Composición:

SALMETEROL AS XINAFOATE 50 MCG

Vía de administración:

INHALATION

tipo de receta:

Required

Fabricat per:

GLAXO WELLCOME PRODUCTION, FRANCE

Grupo terapéutico:

SALMETEROL

Área terapéutica:

SALMETEROL

indicaciones terapéuticas:

Salmeterol is a selective beta-2-agonist indicated for reversible airways obstruction in patients with asthma and chronic obstructive pulmonary disease (COPD).In asthma (including nocturnal asthma and exercise induced symptoms) it is indicated for those treated with inhaled corticosteroids who require a long-acting beta agonist in accordance with current treatment guidelines.

Data d'autorització:

2020-03-31

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Fitxa tècnica

_Page 1 of 11 _
SEREVENT DISKUS
1.
NAME OF THE MEDICINAL PRODUCT
Serevent Diskus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Serevent Diskus is a moulded plastic device containing a foil strip
with regularly spaced
blisters each containing 50 micrograms of salmeterol (as xinafoate).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Inhalation powder.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Salmeterol is a selective
β
2
-agonist indicated for reversible airways obstruction in patients
with asthma and chronic obstructive pulmonary disease (COPD).
In asthma (including nocturnal asthma and exercise induced symptoms)
it is indicated for
those treated with inhaled corticosteroids who require a long-acting
beta agonist in
accordance with current treatment guidelines.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Serevent Diskus is not a replacement for inhaled or oral
corticosteroids which should be
continued at the same dose, and not stopped or reduced, when treatment
with Serevent
Diskus is initiated.
Serevent Diskus is for inhalation use only.
Serevent Diskus should be used regularly. The full benefits of
treatment will be apparent
after several doses of the drug.
In asthma
_Adults (including the elderly):_
One inhalation (50 micrograms) twice daily, increasing to
two inhalations (2 x 50 micrograms) twice daily if required.
_Children 4 years and over:_
One inhalation (50 micrograms) twice daily.
The dosage or frequency of administration should only be increased on
medical advice.
_Page 2 of 11 _
There are insufficient clinical data to recommend the use of Serevent
Diskus in children
under the age of four.
In chronic obstructive pulmonary disease
_Adults (including the elderly):_
One inhalation (50 micrograms) twice daily.
_Children:_
Not appropriate.
_Special patient groups:_
There is no need to adjust the dose in patients with impaired renal
function.
Using the Diskus:
The Diskus should be used in a standing or sitting position. The
device is opened and
primed by sliding the lever. The