Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie

País: Holanda

Língua: holandês

Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes ativos:

MOMETASONFUROAAT 1-WATER 51,7 µg/dosis SAMENSTELLING overeenkomend met ; MOMETASONFUROAAT 50 µg/dosis

Disponível em:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Código ATC:

R01AD09

DCI (Denominação Comum Internacional):

MOMETASONFUROAAT 1-WATER 51,7 µg/dosis SAMENSTELLING overeenkomend met ; MOMETASONFUROAAT 50 µg/dosis

Forma farmacêutica:

Neusspray, suspensie

Composição:

BENZALKONIUMCHLORIDE ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CITROENZUUR 1-WATER (E 330) ; GLYCEROL (E 422) ; POLYSORBAAT 80 (E 433) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE, BENZALKONIUMCHLORIDE ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 1-WATER (E 330) ; GLYCEROL (E 422) ; POLYSORBAAT 80 (E 433) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,

Via de administração:

Nasaal gebruik

Área terapêutica:

Mometasone

Resumo do produto:

Hulpstoffen: BENZALKONIUMCHLORIDE; CARMELLOSE NATRIUM (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); CITROENZUUR 1-WATER (E 330); GLYCEROL (E 422); POLYSORBAAT 80 (E 433); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;

Data de autorização:

1900-01-01

Folheto informativo - Bula

Sandoz B.V.
Page 1/7
Mometasonfuroaat Sandoz 50
microgram/dosis, neusspray, suspensie
RVG 120041
1313-v3
1.3.1.3 Bijsluiter
Oktober 2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOMETASONFUROAAT SANDOZ 50 MICROGRAM/DOSIS, NEUSSPRAY, SUSPENSIE_ _
MOMETASONFUROAAT
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What {[nationally completed name]} is and what it is used for
2.
What you need to know before you use {[nationally completed name]}
3.
How to use {[nationally completed name]}
4.
Possible side effects
5.
How to store {[nationally completed name]}
6.
Contents of the pack and other information
1. WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR
WHAT IS {[NATIONALLY COMPLETED NAME]}?
{[Nationally completed name]} Nasal Spray contains mometasone furoate,
one of a group of
medicines called corticosteroids. When mometasone furoate is sprayed
into the nose, it can
help to relieve inflammation (swelling and irritation of the nose),
sneezing, itching and a
blocked up or runny nose.
WHAT IS {[NATIONALLY COMPLETED NAME]} USED FOR?
Hay fever and perennial rhinitis
{[Nationally completed name]} is used to treat the symptoms of hay
fever (also called
seasonal allergic rhinitis) and perennial rhinitis in adults and
children aged 3 and older.
Hay fever, which occurs at certain times of the year, is an allergic
reaction caused by breathing
in pollen from trees, grasses, weeds and also moulds and fungal
spores. Perennial rhinitis
occurs throughout the year and symptoms can be caused by a sensiti

Características técnicas

Sandoz B.V.
Page 1/10
Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie
RVG 120041
1311-v3
1.3.1.1 Samenvatting van de Productkenmerken
September 2022
1
NAME OF THE MEDICINAL PRODUCT
Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation of the pump delivers a metered dose of 50 micrograms of
mometasone
furoate (as mometasone furoate monohydrate).
Excipient with known effect
This medicinal product contains 0.02 mg of benzalkonium chloride per
actuation.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Nasal spray, suspension.
White, homogenous suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
{[Nationally completed name]} nasal spray is indicated for use in
adults and children 3
years of age and older to treat the symptoms of seasonal allergic or
perennial rhinitis.
{[Nationally completed name]} nasal spray is indicated for the
treatment of nasal polyps in
adults 18 years of age and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
After initial priming of the {[Nationally completed name]} nasal spray
pump, each
actuation delivers approximately 100 mg of mometasone furoate
suspension, containing
mometasone furoate monohydrate equivalent to 50 micrograms mometasone
furoate.
POSOLOGY
Seasonal allergic or perennial rhinitis
_Adults (including older patients) and children 12 years of age and
older: _
The usual recommended dose is two actuations (50 micrograms/actuation)
in each nostril
once daily (total dose 200 micrograms). Once symptoms are controlled,
dose reduction to
one actuation in each nostril (total dose 100 micrograms) may be
effective for
maintenance.
If symptoms are inadequately controlled, the dose may be increased to
a maximum daily
dose of four actuations in each nostril once daily (total dose 400
micrograms). Dose
reduction is recommended following control of symptoms.
Sandoz B.V.
Page 2/10
Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie
RVG 120041
1311-v3
1.3.1.1