RELENZA Inhalation powder, pre-dispensed (2019)
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Περιεχόμενα
Name of the medicinal product
Relenza 5mg/dose, inhalation powder, pre-dispensed.
Qualitative and quantitative composition
Each pre-dispensed quantity of inhalation powder (one blister) contains 5 mg zanamivir. Each delivered inhalation (the amount that leaves the mouthpiece of the Diskhaler) contains 4.0 mg zanamivir. Excipients ...
Pharmaceutical form
Inhalation powder, pre-dispensed. White to off-white powder.
Therapeutic indications
Treatment of influenza Relenza is indicated for treatment of both influenza A and B in adults and children (≥5 years) who present with symptoms typical of influenza when influenza is circulating in the ...
Posology and method of administration
Inhaled drugs, e.g. asthma medication, should be administered prior to administration of Relenza (see section 4.4). Treatment of influenza Treatment should begin as soon as possible, within 48 hours after ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Contraindicated in patients with milk protein allergy.
Special warnings and precautions for use
Due to the limited number of patients with severe asthma or with other chronic respiratory disease, patients with unstable chronic illnesses or immunocompromised patients (see Section 5.1) who have been ...
Interaction with other medicinal products and other forms of interaction
Potential for other drugs to affect zanamivir Zanamivir is eliminated through renal filtration. Clinically significant drug interactions are unlikely. Potential for zanamivir to affect other drugs Zanamivir ...
Fertility, pregnancy and lactation
Pregnancy Systemic exposure to zanamivir is low following administration by inhalation; however, there is no information on placental transfer of zanamivir in humans. There is a limited amount of data ...
Effects on ability to drive and use machines
Zanamivir has no or negligible influence on ability to drive and use machines.
Undesirable effects
There have been rare reports of patients with previous history of respiratory disease (asthma, COPD) and very rare reports of patients without previous history of respiratory disease, who have experienced ...
Overdose
Symptoms The clinical signs and symptoms reported with overdoses of inhaled zanamivir are similar to those reported with therapeutic doses of inhaled zanamivir and/or the underlying disease. Management ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiviral, neuraminidase inhibitor ATC code: J05AH01 Mechanism of action Zanamivir is a selective inhibitor of neuraminidase, the influenza virus surface enzyme. Neuraminidase ...
Pharmacokinetic properties
Absorption Pharmacokinetic studies in humans have shown that the absolute oral bioavailability of the drug is low (mean (min, max) is 2%(1%, 5%)). Similar studies of orally inhaled zanamivir indicate that ...
Preclinical safety data
General toxicity studies did not indicate any significant toxicity of zanamivir. Zanamivir was not genotoxic and no clinically relevant findings were observed in long term carcinogenicity studies in rats ...
List of excipients
Lactose monohydrate (which contains milk protein)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 10 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Relenza inhalation powder is packed in a circular aluminium foil disk (a Rotadisk) with four regularly distributed blisters. An inspiration driven inhaler made of plastic (a Diskhaler) is used for administration ...
Special precautions for disposal and other handling
The inhaler (Diskhaler) is loaded with a disk containing inhalation powder packed in individual blisters. These blisters are pierced when the inhaler is used, and with a deep inhalation the powder can ...
Marketing authorization holder
Glaxo Wellcome UK Ltd trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Marketing authorization number(s)
PL 10949/0327
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 June 1999 Date of last renewal: 02 October 2008
Date of revision of the text
18<sup>th</sup> November 2019
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