البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Allen and Hanburys Limited
SALBUTAMOL SULFATE
200 mcg Microgram
Inhalation Powder, Capsule
Withdrawn
2007-03-02
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ventolin Rotacap 200 micrograms 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule (Rotacap) contains 200 micrograms salbutamol as salbutamol sulphate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Inhalation powder, hard capsule. Size 3 hard gelatin capsule with pale blue opaque cap and a clear body containing a small amount of white powder. Each capsule is marked ‘Ventolin 200’, printed in red ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventolin Rotacaps are indicated in the prophylaxis and treatment of bronchial asthma and other conditions associated with reversible airways obstruction. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Ventolin Rotacaps capsules are for inhalation use only, using a Ventolin Rotahaler inhaler. Salbutamol has a duration of action of 4 to 6 hours in most patients. Increasing use of beta agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice. _For acute therapy:-_ _For chronic or prophylactic therapy:-_ 4.3 CONTRAINDICATIONS Ventolin Rotacaps are contraindicated in patients with a history of hypersensitivity to sympathomimetics or any component of the preparation. Adults: 200 or 400 micrograms as a single dose. Children: 200 micrograms as a single dose. Adults: 400 micrograms three or four times daily. Children: 200 micrograms three or four times daily. 2 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 29/08/2005_ _CRN 201420 اقرأ الوثيقة كاملة