NASONEX NASAL SPRAY

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Organon South Africa (Pty) Ltd

Annus:

See ingredients

Ravimvorm:

NASAL SPRAY

Koostis:

EACH METERED-DOSE CONTAINS MOMETASONE FUROATE 50,0 ug

Volitamisolek:

Registered

Loa andmise kuupäev:

2000-06-10

Infovoldik

PRODUCT NAME:
NASONEX AQUEOUS NASAL SPRAY
COMPONENT: PATIENT INFORMATION INFORMATION
LEAFLET
SR-PIN: APPROVED 19 JANUARY 2018
AJ20180119
INITIAL:
PAGE 1 OF 13
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
PROPRETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
NASONEX
® Aqueous Nasal Spray
PHARMACEUTICAL FORM: Metered dose bottle with manual spray pump for
administration into
the nostrils.
ACTIVE SUBSTANCE: Mometasone furoate monohydrate.
50 mcg Mometasone furoate/spray.
Read all of this leaflet carefully, because it contains important
information for you.
NASONEX Aqueous Nasal Spray is available without a doctor’s
prescription, for you to treat
a mild illness. Nevertheless you still need to use NASONEX Aqueous
Nasal Spray carefully
to get the best results from it.

Keep this leaflet. You may need to read it again.

Do not share NASONEX Aqueous Nasal Spray with any other person.

Ask your pharmacist if you need more information or advice.

You must see a doctor if your symptoms worsen or do not improve.
1.
WHAT NASONEX AQUEOUS NASAL SPRAY CONTAINS
The active substance is mometasone furoate monohydrate.
S2
PRODUCT NAME:
NASONEX AQUEOUS NASAL SPRAY
COMPONENT: PATIENT INFORMATION INFORMATION
LEAFLET
SR-PIN: APPROVED 19 JANUARY 2018
AJ20180119
INITIAL:
PAGE 2 OF 13
Each metered dose pump actuation delivers approximately 100 mg of
mometasone furoate
suspension, containing mometasone furoate monohydrate equivalent to 50
mcg
mometasone furoate.
The other ingredients are: Citric acid monohydrate, dispersible
cellulose, glycerol,
polysorbate 80, sodium citrate dihydrate and purified water.
PRESERVATIVE: Benzalkonium chloride 0,02 % _m/m_
2.
WHAT NASONEX AQUEOUS NASAL SPRAY IS USED FOR
PHARMACOTHERAPEUTIC GROUP: Mometasone furoate is a cortisone-like
medicine.
THERAPEUTIC INDICATIONS: NASONEX Aqueous Nasal Spray is for use in
adults, adolescents
and children between the ages of 2 and 11 years to relieve symptoms
that may occur with
seasonal allergic hay fever or year-round nasal allergies, including
stuffiness (co

Toote omadused

PRODUCT NAME:
NASONEX AQUEOUS NASAL SPRAY
COMPONENT: ENGLISH PROFESSIONAL INFORMATION
SR-PIN: 19 JANUARY 2018
AJ20180119
INITIAL:
PAGE 1 OF 8
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
NASONEX
®
Aqueous Nasal Spray
COMPOSITION
NASONEX Aqueous Nasal Spray is a metered dose, manual pump spray unit
containing a
suspension of mometasone furoate. Each metered dose pump actuation of
NASONEX
Aqueous Nasal Spray delivers approximately 100 mg of mometasone
furoate suspension,
containing mometasone furoate monohydrate equivalent to 50 mcg
mometasone furoate.
INACTIVE INGREDIENTS: Citric acid monohydrate, dispersible cellulose,
glycerol, polysorbate
80, sodium citrate dihydrate and purified water.
PRESERVATIVE: Benzalkonium chloride 0,02 % _m/m _
PHARMACOLOGICAL CLASSIFICATION
A.21.5.1 Corticosteroids and analogues
PHARMACOLOGICAL ACTION
Mometasone furoate is a topical glucocorticosteroid with local
anti-inflammatory properties.
S2
PRODUCT NAME:
NASONEX AQUEOUS NASAL SPRAY
COMPONENT: ENGLISH PROFESSIONAL INFORMATION
SR-PIN: 19 JANUARY 2018
AJ20180119
INITIAL:
PAGE 2 OF 8
INDICATIONS
NASONEX Aqueous Nasal Spray is indicated for use in adults,
adolescents and children
between the ages of 2 and 11 years to treat the symptoms of seasonal
allergic or perennial
allergic rhinitis.
In patients who have a history of moderate to severe symptoms of
seasonal allergic rhinitis,
prophylactic treatment with NASONEX Aqueous Nasal Spray is recommended
prior to the
anticipated start of the pollen season.
CONTRAINDICATIONS
Hypersensitivity to any ingredients of NASONEX Aqueous Nasal Spray.
Pregnancy and lactation (see PREGNANCY AND LACTATION ).
Children under 2 years, as safety and efficacy have not been
demonstrated.
WARNINGS AND SPECIAL PRECAUTIONS
NASONEX Aqueous Nasal Spray should not be used in the presence of
untreated localised
infection involving the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing,
patients who have
experienced recent nasal surgery or trauma should not use a nasal
corticoste