Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FORMOTEROL FUMARATE; MOMETASONE FUROATE
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
FORMOTEROL FUMARATE; MOMETASONE FUROATE
1units Units
3M Health Care Limited.
_Consumer Medication Information Leaflet (RiMUP)_ ZENHALE ® Mometasone Furoate/Formoterol Fumarate Dihydrate (50/5mcg, 100/5mcg, 200/5mcg) 1 WHAT IS IN THIS LEAFLET 1. What ZENHALE is used for 2. How ZENHALE works 3. Before you use ZENHALE 4. How to use ZENHALE 5. While you are using ZENHALE 6. Side effects 7. Storage and Disposal of ZENHALE 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ZENHALE IS USED FOR Your doctor has prescribed ZENHALE to help control asthma. ZENHALE is used twice a day to help people 12 years of age or older who need treatment for asthma and the doctor recommends a combination product. ZENHALE is not a rescue medication. Your doctor should prescribe a rescue medication for you. Use the rescue medication if you have sudden asthma symptoms. ZENHALE is for patients with asthma that: was not well controlled with other asthma controlling medications or is severe enough that the doctor recommends starting asthma treatment with two asthma medications This medicine is for YOU. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them, even if their symptoms are the same as yours. HOW ZENHALE WORKS ZENHALE contains two medicines, mometasone furoate and formoterol fumarate dihydrate: Mometasone furoate is a corticosteroid. Corticosteroids are used to prevent asthma attacks because they have an anti-inflammatory effect (reduce swelling and irritation in the walls of the small air passages of the lungs), easing breathing problems. Formoterol fumarate dihydrate is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. It makes breathing easier by relaxing muscle spasms in the air passages of the lungs. The effects last for 12 hours. BEFORE YOU USE ZENHALE SERIOUS WARNINGS FOR ASTHMA PATIENTS Formoterol, one of the medicines in ZENHALE, may increase the risk of asthma-related death. It may increase the risk of asthma-related hospitalization in paediatrics and adolescent pat Прочитајте комплетан документ
ZENHALE ® LPC -MK0887A -AO -062014 a PRESSURIZED INHALATI ON SUSPENSION 50/5 mcg , 100/5 mcg , 200/5mcg mometasone furoate / formoterol fumarate dihydrat e HEALTH PROFESSIONAL INFORMATION Route of Administration Dosage Form / Strength Nonmedicinal Ingredients oral Pressurized Inhalation Suspension / 50, 100 or 200 mcg mometasone furoate & 5 mcg formoterol fumarate dihydrate per actuation Ethanol, HFA ( propellant), oleic acid INDICATIONS AND CLINICAL USE ZENHALE (mometasone furoate / formoterol fumarate dihydrate pressurized inhalation suspension ), is indicated for the treatment of asthma, in patients 12 years of age and older with reversible obstruc tive airway disease. ZENHALE is not indicated for patients whose asthma can be managed by occasional use of a rapid onset, short duration, inhaled beta 2-agonist, or for patients whose asthma can be successfully managed by inhaled corticosteroids along wit h occasional use of a rapid onset, short duration, inhaled beta 2-agonist. Long -acting beta 2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in ZENHALE may increase the risk of asthma -related death. Available data from contro lled clinical trials suggest that LABA increase the risk of asthma -related hospitalization in pediatric and adolescent patients (see WARNINGS AND PRECAUTIONS). Therefore, when treating patients with asthma, physicians should only prescribe ZENHALE for pati ents not adequately Прочитајте комплетан документ