SteroClear

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Budesonide 2 mg/mL ((100 micrograms/spray));  

Disponible des:

AFT Pharmaceuticals Ltd

Designació comuna internacional (DCI):

Budesonide 2 mg/mL ((100 micrograms/spray))

Dosis:

100 mcg/dose

formulario farmacéutico:

Nasal spray suspension

Composición:

Active: Budesonide 2 mg/mL ((100 micrograms/spray))   Excipient: Disodium edetate Dispersible cellulose Glucose Hydrochloric acid Polysorbate 80 Potassium sorbate Purified water

tipo de receta:

Prescription

Fabricat per:

Farmabios SpA

indicaciones terapéuticas:

For the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis. For the symptomatic relief of nasal polyposis.

Resumen del producto:

Package - Contents - Shelf Life: Bottle, glass, 15 mL borosilicate glass bottle amber glass with metered-dose manual pump - 200 dose units - 24 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate. 3 months opened stored at or below 30°C - Bottle, glass, 15 mL Type II amber glass with metered-dose manual pump - 200 dose units - 24 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate 3 months opened stored at or below 30°C

Data d'autorització:

2015-12-11

Fitxa tècnica

Page 1 of 8
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
STEROCLEAR 50 µg & 100 µg per actuation
Aqueous Nasal Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Budesonide aqueous spray 50µg and 100µg per metered actuation.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
50 µg/actuation: An almost white opaque suspension, almost odourless.
Amber glass bottle fitted
with a metered pump device delivering 50 µg budesonide per actuation.
Delivery of valve: 50 µl
(each 50 µl contains 50 µg of budesonide).
100 µg/actuation: An almost white opaque suspension, almost
odourless. Amber glass bottle fitted
with a metered pump device delivering 100 µg budesonide per
actuation. Delivery of valve: 50 µl
(each 50 µl contains 100 µg of budesonide).
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
STEROCLEAR 50 Aqueous Nasal Spray is indicated for the short-term
prevention and treatment of
seasonal allergic rhinitis (hayfever).
STEROCLEAR 100 Aqueous Nasal Spray is indicated for the prevention and
treatment of seasonal and
perennial allergic rhinitis and vasomotor rhinitis.
STEROCLEAR 100 Aqueous Nasal Spray is also indicated for the
symptomatic relief of nasal polyposis.
4.2
Dose and method of administration
Dose
STEROCLEAR 50
_FOR ADULTS AND CHILDREN OVER 12 YEARS:_
Initially one or two sprays into each nostril twice a day (morning and
night), then after 2 to 3 days,
one spray into each nostril twice a day.
STEROCLEAR 100
_FOR ADULTS AND CHILDREN OVER 6 YEARS:_
Initially one or two sprays into each nostril in the morning, then
after 2 to 3 days, one spray into
each nostril in the morning.
For patients with only mild initial symptoms, a total daily dose of
200 micrograms may be sufficient.
For long term treatment, the lowest dose which keeps the patient
symptom-free should be used.
Continuous long term use in children is not recommended.
Method of administration
Patients should be instructed in the correct use of STEROCLEAR.
Patients should be informed that
full response may not occur until af