País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OSELTAMIVIR PHOSPHATE
RANBAXY (MALAYSIA) SDN. BHD.
OSELTAMIVIR PHOSPHATE
10Capsule Capsules; 100Capsule Capsules
RANBAXY (MALAYSIA) SDN. BHD.
FLUHALT Capsule Page 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FLUHALT CAPSULES _OSELTAMIVIR PHOSPHATE CAPSULES 75MG _ WHAT IS IN THIS LEAFLET 1. What FLUHALT is used for 2. How FLUHALT works 3. Before you use FLUHALT 4. How to use FLUHALT 5. While you are using FLUHALT 6. Side effects 7. Storage and disposal of FLUHALT 8. Product description 9. Manufacturer and Product registration holder 10. Date of revision IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FLUHALT CAPSULES ARE USED FOR Your doctor has prescribed FLUHALT CAPSULES to you for the treatment or prevention of influenza. HOW FLUHALT CAPSULES WORKS FLUHALT CAPSULES belongs to a group of medicines named “neuraminidase inhibitors”. These medicines prevent the influenza virus from spreading inside the body and so help to ease or prevent the symptoms arising from the influenza virus infection. Influenza is an infection caused by the influenza virus. The signs (symptoms) of influenza include the sudden onset of fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and often extreme fatigue. These symptoms may also be caused by infections other than influenza. True influenza infection only occurs during annual outbreaks (epidemics) at times when influenza viruses are spreading in the local community. Outside of the epidemic period, these symptoms will mainly be caused by a different type of infection or illness. Ask your doctor if you have any questions about why this medicine has been prescribed for you. FLUHALT CAPSULES are available in strength of 75mg. This medicine is available only with a doctor’s prescription. BEFORE YOU USE FLUHALT CAPSULES _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE FLUHALT CAPSULES If you have previously had sever allergic reaction (hypersensitive) associated with the use of oseltamivir or to any of the capsule ingredients listed (symptoms of an allergic reaction may include skin r Llegiu el document complet
1 _For the Use Only of a Registered Medical _ _Pr_ _actitione_ _r_ PRESCRIBING INFORMATION FLUHALT CAPSULES (OSELTAMIVIR PHOSPHATE CAPSULES 75 M G) COMPOSITION Each hard gelatin capsule contains: Oseltamivir Phosphate equivalent Oseltamivir…………….75 mg EXCIPIENTS: Croscarmellose Sodium, Povidone, Pregelatinized Starch, Talc Purified, Sodium Stearyl Fumarate, Purified Water. PRODUCT DESCRIPTION Size ‘2’ capsule with yellow cap and light grey body printed in blue ink with OS 75 on both cap and body, containing white to off white powder. DESCRIPTION FLUHALT CAPSULES contain oseltamivir phosphate which has the chemical name - (3R,4R,5S)-4- acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C 16 H 28 N 2 O 4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as given below: OSELTAMIVIR PHOSPHATE 2 INDICATIONS _TREATMENT OF INFLUENZA_ Oseltamivir is indicated for the treatment of influenza in children 6 to 12 months of age during a pandemic influenza outbreak. Oseltamivir is indicated for the treatment of influenza in adults and children > 1 year of age. Treatment should commence as soon as possible but no later than forty-eight hours after the onset of the initial symptoms of infection. _PROPHYLAXIS OF INFLUENZA_ Oseltamivir is indicated for post exposure prophylaxis in adults and children >1 year of age following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. DOSE AND METHOD OF ADMINISTRATION FLUHALT CAPSULES 75 MG (Oseltamivir Capsules 75 mg) may not be suitable for all dosages and therefore, other suitable available strengths and/or dosage forms (e.g. suspension) of oseltamivir should be used in such cases. Oseltamivir may be taken with or without food. However, oseltamivir taken with food may enhance tolerability in some patients. During situations when commercially manufactured oseltami Llegiu el document complet