Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Salbutamol sulfate 0.48 mg/mL equivalent to 0.4 mg/ml salbutamol (or 2 mg salbutamol per 5 mL);
GlaxoSmithKline NZ Limited
Salbutamol sulfate 0.48 mg/mL (equiv to 0.4 mg/ml salbutamol (or 2 mg salbutamol per 5 mL))
2 mg/5mL
Syrup
Active: Salbutamol sulfate 0.48 mg/mL equivalent to 0.4 mg/ml salbutamol (or 2 mg salbutamol per 5 mL) Excipient: Citric acid monohydrate Hypromellose Orange flavour 17-42-8187 Purified water Saccharin sodium Sodium benzoate Sodium chloride Sodium citrate dihydrate
Bottle, glass, 150 mL
Prescription
Prescription
Cambrex Profarmaco Milano Srl
Ventolin Syrup is indicated for the treatment or prevention of bronchospasm. It provides short acting bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment. Ventolin Syrup is suitable oral therapy for children or those adults who prefer liquid medicines.
Package - Contents - Shelf Life: Bottle, glass, Type III amber glass bottle with child resistant cap - 150 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, glass, - 300 mL -
1983-07-29
VENTOLIN SYRUP 1 VENTOLIN SYRUP _Salbutamol sulphate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you take Ventolin Syrup. This leaflet answers some common questions about Ventolin Syrup. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of you taking Ventolin Syrup against the risks this medicine could have for you. IF THERE IS ANYTHING YOU DO NOT UNDERSTAND OR IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. IF YOU WANT MORE INFORMATION, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS VENTOLIN SYRUP USED FOR? Ventolin Syrup helps you breathe more easily. Ventolin Syrup works by opening up the airways tubes in your lungs when your chest is tight or when you are wheezing. Ventolin Syrup belongs to a group of medicines called bronchodilators. Because the medicine in your syrup gives relief from your chest symptoms, it is often called a 'reliever'. There are other types of medicines that prevent wheezing or chest tightness. These medicines are called 'preventers' and must be used every day. Your doctor may tell you to use a 'preventer' in addition to your Ventolin Syrup. Ventolin Syrup is not the only form of Ventolin available. Your doctor will decide which form of Ventolin is right for you. Your doctor may have prescribed Ventolin Syrup for another reason. Ventolin Syrup is not addictive. BEFORE YOU TAKE VENTOLIN SYRUP _DO NOT TAKE IF: _ You must not take Ventolin Syrup: • if you have ever had an allergic reaction to salbutamol sulphate or any of the ingredients listed toward the end of this leaflet. (See "Ingredients) • to stop a miscarriage or premature labour. • THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED. • THE PA Leggi il documento completo
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ VENTOLIN 2 mg/5 mL Syrup. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Salbutamol 2 mg as sulphate in each 5 mL of a fruit-flavoured, sugar free syrup, which is devoid of artificial colouring agents. For full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM_ _ Syrup. 4. CLINICAL PARTICULARS _ _ 4.1 THERAPEUTIC INDICATIONS Salbutamol is a selective beta-2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short acting bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment. VENTOLIN Syrup is suitable oral therapy for children or those adults who prefer liquid medicines. 4.2 DOSE AND METHOD OF ADMINISTRATION Route of administration: oral Salbutamol has a duration of action of 4 to 6 hours in most patients. Increasing use of beta-2 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. 2 DOSE _ADULTS: _ The usual effective dose is 10 mL salbutamol (4 milligrams of salbutamol) 3 or 4 times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 20 mL of syrup (8 milligrams salbutamol). Some patients obtain adequate relief with 5 mL of syrup (2 milligrams salbutamol) three or four times daily. _PAEDIATRIC POPULATION: _ 2-6 years: 2.5-5 mL of syrup (1-2 mg salbutamol) 3 or 4 time Leggi il documento completo