البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
oseltamivir phosphate, Quantity: 39.4 mg
Strides Pharma Science Pty Ltd
Capsule, hard
Excipient Ingredients: Gelatin; purified water; povidone; titanium dioxide; croscarmellose sodium; pregelatinised maize starch; purified talc; sodium stearylfumarate; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
10
(S4) Prescription Only Medicine
OSMIVIR is indicated for the treatment of infections due to influenza A and B viruses in adults and children including full-term neonates. Treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,OSMIVIR is indicated for the prevention of influenza in adults and children aged 1 year and older. Vaccination is the preferred method of routine prophylaxis against infection with influenza virus.
Visual Identification: White to off white powder filled in size "4" hard gelatin capsule with light yellow opaque cap/body printed 30 on cap and OP on body in black.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-03-04
Osmivir® 1 OSMIVIR ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING OSMIVIR? Osmivir is an antiviral medicine containing the active ingredient oseltamivir. Osmivir is used for the treatment and prevention of influenza (an infection caused by the influenza virus). It has no effect on the common cold or other respiratory virus infections. For more information, see Section 1. Why am I using Osmivir? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE OSMIVIR? Do not use if you have ever had an allergic reaction to oseltamivir or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Osmivir? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Osmivir and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE OSMIVIR? • Take Osmivir exactly as your doctor has prescribed. • Start taking Osmivir as soon as possible within the first two days of the onset of the first symptoms of influenza or exposure to someone with influenza. More instructions can be found in Section 4. How do I use Osmivir? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING OSMIVIR? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Osmivir. • Tell your doctor if you have kidney failure or impairment or any other problems with your kidneys. • Tell your doctor if you become pregnant while taking Osmivir. THINGS YOU SHOULD NOT DO • Do not give Osmivir to children under 1 year of age for the prevention of influenza. • Do not stop taking Osmivir capsules or change the dose without first checking with your doctor. • Do not اقرأ الوثيقة كاملة
Osmivir 1 AUSTRALIAN PRODUCT INFORMATION OSMIVIR (OSELTAMIVIR PHOSPHATE) CAPSULES 1. NAME OF THE MEDICINE Oseltamivir (as phosphate) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Osmivir75 mg capsule contains of 98.5 mg of oseltamivir phosphate equivalent to 75 mg oseltamivir. Osmivir 45 mg capsule contains 59.1 mg oseltamivir phosphate, equivalent to 45 mg of oseltamivir. Osmivir 30 mg capsule contains 39.4 mg of oseltamivir phosphate, equivalent to 30 mg of oseltamivir. Excipients with known effect Contains gelatin, which may contain sulfites as residue. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Hard capsules Osmivir 75 mg capsules has a white to off white powder filled in size “2” hard gelatin capsule with cream cap and brown body printed “OP” on cap and “75” on body in black. Osmivir 45 mg capsules has a white to off white powder filled in size “3” hard gelatin capsule with grey opaque cap/body printed “45” on cap and “OP” on body in black. Osmivir 30 mg capsules has a white to off white powder filled in size “4” hard gelatin capsule with light yellow opaque cap/body printed “30” on cap and “OP” on body in black 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Osmivir is indicated for the treatment of infections due to influenza A and B viruses in adults and children including full-term neonates. Treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection. Osmivir is indicated for the prevention of influenza in adults and children aged 1 year and older. Vaccination is the preferred method of routine prophylaxis against infection with influenza virus. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE _Oseltamivir oral suspension is unavailable in this brand but it is available in other brands. _ _Where correct dosing requires oseltamivir oral suspension, or if a patient is unable to _ Osmivir 2 _swallow capsules, refer to the specific product information for this fo اقرأ الوثيقة كاملة