Tamiflu特敏福

Tamiflu Special Precautions

oseltamivir

Manufacturer:

Roche

Distributor:

Firma Chun Cheong
/
DKSH
Full Prescribing Info
Special Precautions
Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses (see Pharmacology: Pharmacodynamics under Actions).
Tamiflu is not a substitute for influenza vaccination. Use of Tamiflu must not affect the evaluation of individuals for annual influenza vaccination. The protection against influenza lasts only as long as Tamiflu is administered. Tamiflu should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community. Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable (see Pharmacology: Pharmacodynamics under Actions). Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use Tamiflu.
Severe concomitant condition: No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation.
Immunocompromised patients: The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised patients has not been firmly established (see Pharmacology: Pharmacodynamics under Actions).
Cardiac/respiratory disease: Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population (see Pharmacology: Pharmacodynamics under Actions).
Severe renal impairment: Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment. There is insufficient clinical data available in infants and children (1 year of age or older) with renal impairment to be able to make any dosing recommendation (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Neuropsychiatric events: Neuropsychiatric events have been reported during administration of Tamiflu in patients with influenza, especially in children and adolescents. These events are also experienced by patients with influenza without oseltamivir administration. Patients should be closely monitored for behavioural changes, and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see Adverse Reactions).
Excipients: This medicinal product contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
This medicinal product contains sodium benzoate. Sodium benzoate (E211) may increase jaundice in newborn babies (up to 4 weeks old).
Effects on ability to drive and use machines: Tamiflu has no influence on the ability to drive and use machines.
Use in Children: No data allowing a dose recommendation for premature children (<36 weeks post-conceptual age) are currently available.
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