Beconase Allergy & Hayfever

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Beclometasone dipropionate 50ug (as monohydrate);  

MAH:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN:

Beclometasone dipropionate 50 µg (as monohydrate)

dosage:

50 mcg/dose

pharmaceutical_form:

Nasal spray suspension

composition:

Active: Beclometasone dipropionate 50ug (as monohydrate)  

units_in_package:

Spray bottle, metered, propylene, 100 dose units

class:

Pharmacy only

prescription_type:

Pharmacy only

manufactured_by:

Farmabios SpA

therapeutic_indication:

BECONASE Allergy & Hayfever is indicated for the prophylaxis and treatment of seasonal and perennial allergic rhinitis including hayfever.

leaflet_short:

Package - Contents - Shelf Life: Spray bottle, metered, propylene - 100 dose units - 24 months from date of manufacture stored at or below 30°C - Spray bottle, metered, propylene - 200 dose units - 24 months from date of manufacture stored at or below 30°C - Spray bottle, metered, glass - 200 dose units - 24 months from date of manufacture stored at or below 30°C

authorization_date:

1997-04-01

SPC

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BECONASE Allergy & Hayfever nasal spray suspension 50 mcg/dose.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BECONASE Allergy & Hayfever contains microfine beclometasone
dipropionate.
Each 100 mg spray delivered by the nasal applicator contains 50
micrograms
beclometasone dipropionate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
BECONASE Allergy & Hayfever is a white aqueous suspension delivered by
a
metering, atomising pump.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BECONASE Allergy & Hayfever is indicated for the prophylaxis and
treatment of
seasonal and perennial allergic rhinitis including hayfever.
4.2 DOSE AND METHOD OF ADMINISTRATION
BECONASE Allergy & Hayfever is for administration by the intranasal
route only.
ADULTS AND CHILDREN OVER 12 YEARS OF AGE:
The recommended dose is 100 micrograms into each nostril twice daily.
Total daily
administration should not normally exceed 400 micrograms.
Once symptoms are controlled, protection can be maintained at half the
dose; one
spray into each nostril twice daily. This dose may need to be
increased if symptoms
worsen.
For full therapeutic benefit regular usage is essential. The
co-operation of the patient
should be sought to comply with the regular dosage schedule and it
should be
explained that maximum relief may not be obtained within the first few
applications.
For children under twelve years old, there are insufficient clinical
data to recommend
use.
Do not use for more than six months without obtaining medical advice.
4.3 CONTRAINDICATIONS
Hypersensitivity to any component of BECONASE Allergy & Hayfever.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Infections of the nasal passages and paranasal sinuses should be
appropriately
treated
but
do
not
constitute
a
specific
contra-indication
to
treatment
with
BECONASE Allergy & Hayfever.
Care must be taken while transferring patients from systemic steroid
treatment to
BECONASE Allergy & Hayfever if there is any reason to suppose that
their a