Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Beclometasone dipropionate 1 mg/g;
Viatris Limited
Beclometasone dipropionate 1 mg/g
100 mcg/dose
Nasal spray solution
Active: Beclometasone dipropionate 1 mg/g Excipient: Benzalkonium chloride Dispersible cellulose Glucose Phenethyl alcohol Polysorbate 80 Purified water
Spray bottle, metered, 1 x 200 metered doses, 200 dose units
Prescription
Prescription
Farmabios SpA
ALANASE 100 Aqueous Nasal Spray (100 µg per actuation) is indicated for the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis. ALANASE 100 can significantly delay the recurrence of nasal polyps in those patients who have undergone nasal polypectomy. In those polyps that do recur, ALANASE 100 can suppress their increase in size.
Package - Contents - Shelf Life: Spray bottle, metered, amber glass bottle, fitted with metered atomising polyethylene pump unit - 200 dose units - 36 months from date of manufacture stored at or below 25°C
1992-02-14
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION ALANASE 100 _BECLOMETASONE DIPROPIONATE NASAL SPRAY _ _100 MICROGRAM (ΜG) PER SPRAY _ _ _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using ALANASE 100. This leaflet answers some common questions about ALANASE 100. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using ALANASE 100 against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ALANASE 100 IS USED FOR ALANASE 100 is used to prevent and treat seasonal and perennial allergic rhinitis (including hay fever) and vasomotor rhinitis. It works by reducing the swelling and irritation in the lining of the nose. It relieves the symptoms of blocked nose, runny nose, itchy nose and sneezing. ALANASE 100 may also be used to delay the recurrence of nasal polyps in patients who have undergone nasal polypectomy. It can suppress the increase in size of the polyps that do recur. ALANASE 100 contains 100 micrograms (µg) of beclometasone dipropionate per spray. It belongs to a group of medicines known as corticosteroids, frequently referred to as ‘steroids’. They are not ‘anabolic steroids’ that are sometimes misused by athletes. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor’s prescription. There is no evidence that ALANASE 100 is addictive. There is not enough information to recommend the use of this medicine for children under the age of 6 years. BEFORE YOU USE ALANASE 100 _WHEN YOU MUST NOT USE _ _IT _ DO NOT USE ALANASE 100 IF YOU HAVE AN ALLERGY TO: • any medicine containing beclometasone • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: sh Read the complete document
Page 1 of 7 NEW ZEALAND DATA SHEET ALANASE 1. PRODUCT NAME ALANASE, 50 micrograms per actuation, nasal spray solution. ALANASE 100, 100 micrograms per actuation, nasal spray solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg spray delivered by the nasal applicator contains 50 micrograms or 100 micrograms of beclometasone dipropionate. Excipient with known effect: Benzalkonium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ALANASE aqueous nasal spray (50 micrograms per actuation) is an almost white opaque suspension of microfine beclometasone dipropionate delivered by a metering, atomising pump. ALANASE 100 aqueous nasal spray (100 micrograms per actuation) is an almost white opaque suspension of microfine beclometasone dipropionate delivered by a metering, atomising pump. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ ALANASE aqueous nasal spray (50 micrograms per actuation) is indicated for the short-term prevention and treatment of seasonal allergic rhinitis (hay fever). ALANASE 100 aqueous nasal spray (100 micrograms per actuation) is indicated for the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis. ALANASE 100 can significantly delay the recurrence of nasal polyps in those patients who have undergone nasal polypectomy. In those polyps that do recur, ALANASE 100 can suppress their increase in size. _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ DOSE ALANASE and ALANASE 100 should be shaken before use. Page 2 of 7 _ALANASE (50 MICROGRAMS PER ACTUATION) _ FOR ADULTS AND CHILDREN OVER 12 YEARS OF AGE: 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. Do not use ALANASE (50 micrograms per actuation) for children under 12 years of age without first consulting with a doctor. If hayfever symptoms do not improve within 7 days of treatment with ALANASE, consult with a doctor. _ALANASE 100 (100 MICROGRAMS PER ACTUATION) _ FOR Read the complete document