Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OSELTAMIVIR PHOSPHATE
GERMAX SDN. BHD.
OSELTAMIVIR PHOSPHATE
10Capsule Capsules
Strides Pharma Science Limited
_Consumer Medication Information Leaflet (RiMUP) _ STARFLU CAPSULE 75MG Oseltamivir (75mg) 1 WHAT IS IN THIS LEAFLET 1. What Oseltamivir Capsule 75mg is used for 2. How Oseltamivir Capsule 75mg works 3. Before you use Oseltamivir Capsule 75mg 4. How to take Oseltamivir Capsule 75mg 5. While you are using Oseltamivir Capsule 75mg 6. Side Effects 7. Storage and Disposal of Oseltamivir Capsule 75mg 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision WHAT OSELTAMIVIR CAPSULE 75MG IS USED FOR Oseltamivir capsules is used for adults, adolescents, and children 1 year old or older. Oseltamivir capsules is prescribed to you for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be circulating in your community. Oseltamivir capsule is prescribed for preventing flu. It can be used if you have been in contact with someone who has flu. This is generally decided on a case-by- case basis. HOW OSELTAMIVIR CAPSULE 75MG WORKS Oseltamivir capsules contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection. Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 0 C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of infection or illness. BEFORE YOU TAKE OSELTAMIVIR CAPSULE 75MG _-When you must not take it _ Do not take Oseltamivir Capsule if: • if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Oseltamivir capsules. _-Before you start to take it _ Before you take Oseltamivir caps Pročitajte cijeli dokument
xxxx STARFLU-75 OSELTAMIVIR CAPSULES 75MG PRODUCT DESCRIPTION : White to off white powder filled in size 2 hard gelatin capsule with cream cap & brown body printed OP on cap and 75 on body in black. COMPOSITION: Each capsule contains Oseltamivir phosphate equivalent to Oseltamivir 75mg. PHARMACOLOGY: Oseltamivir is an ethyl ester prodrug requiring ester hydrolysis for conversion to the active form, oseltamivir carboxylate. The proposed mechanism of action of oseltamivir is inhibition of influenza virus neuraminidase with the possibility of alteration of virus particle aggregation and release. The concentrations of oseltamivir carboxylate required for inhibition of influenza virus were highly variable depending on the assay method used and the virus tested. The 50% and 90% inhibitory concentrations (IC 50 and IC 90 ) were in the range of 0.0008 μ M to >35 μ M and 0.004 μ M to >100 μ M, respectively (1 μ M=0.284 μ g/mL). The relationship between the in vitro antiviral activity in cell culture and the inhibition of influenza virus replication in humans has not been established. PHARMACOKINETICS: _Absorption: _ Oseltamivir is readily absorbed from the GIT after oral administration of oseltamivir phosphate (pro-drug) and is extensively converted by predominantly hepatic esterases to the metabolite (oseltamivir carboxylate). At least 75% of an oral dose reaches the systemic circulation as the metabolite. Exposure to the pro-drug is <5% relative to the active metabolite. Plasma concentrations of both pro-drug and active metabolite are proportional to dose and are unaffected by co-administration with food. _Distribution: _ The mean volume of distribution (Vss) of the active metabolite is approximately 23L in humans, a volume equivalent extracellular body fluid. Since neuraminidase activity is extracellular, oseltamivir carboxylate distributes to all sites of influenza virus spread. The binding of the oseltamivir carboxylate to human plasma protein is negligible (approximately 3%). _Metabolism: _ Oseltamivir is exte Pročitajte cijeli dokument