WELLVONE Oral suspension (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Wellvone 750 mg/5 ml oral suspension.
Qualitative and quantitative composition
Each 5 ml of oral suspension contains 750 mg atovaquone. <u>Excipient with known effect:</u> Each 5 ml of oral suspension contains 50.66 mg benzyl alcohol. For the full list of excipients, see section ...
Pharmaceutical form
Oral suspension. Wellvone oral suspension is a bright yellow liquid.
Therapeutic indications
Wellvone Suspension is indicated for: Acute treatment of mild to moderate Pneumocystis pneumonia (PCP, caused by <em>Pneumocystis jiroveci</em>, formerly classified as <em>P. carinii</em>) (alveolar arterial ...
Posology and method of administration
The importance of taking the full prescribed dose of Wellvone with food should be stressed to patients. The presence of food, particularly high fat food, increases bioavailability two to three fold. The ...
Contraindications
Wellvone Suspension is contra-indicated in individuals with known hypersensitivity to atovaquone or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Diarrhoea at the start of treatment has been shown to be associated with significantly lower atovaquone plasma levels. These in turn correlated with a higher incidence of therapy failures and a lower survival ...
Interaction with other medicinal products and other forms of interaction
As experience is limited, care should be taken when combining other drugs with Wellvone. Concomitant administration of rifampicin or rifabutin is not recommended as it is known to reduce plasma concentrations ...
Pregnancy and lactation
Pregnancy There is no information on the effects of atovaquone administration during human pregnancy. Atovaquone should not be used during pregnancy unless the benefit of treatment to the mother outweighs ...
Effects on ability to drive and use machines
There have been no studies to investigate the effect of Wellvone on driving performance or the ability to operate machinery but a detrimental effect on such activities is not predicted from the pharmacology ...
Undesirable effects
Patients participating in clinical trials with atovaquone have often experienced undesirable effects consistent with the course of advanced Human Immunodeficiency Virus (HIV) disease or of concomitant ...
Overdose
There is insufficient experience to predict the consequences or suggest specific management of atovaquone overdose. However, in the reported cases of overdosage, the observed effects were consistent with ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiprotozoals <b>ATC Code:</b> P01AX06 Mechanism of Action Atovaquone is a selective and potent inhibitor of the eukaryotic mitochondrial electron transport chain in ...
Pharmacokinetic properties
Absorption Atovaquone is a highly lipophilic compound with a low aqueous solubility. It is 99.9% bound to plasma proteins. The bioavailability of the drug demonstrates a relative decrease with single doses ...
Preclinical safety data
Carcinogenicity Oncogenicity studies in mice showed an increased incidence of hepatocellular adenomas and carcinomas without determination of the no observed adverse effect level. No such findings were ...
List of excipients
Benzyl alcohol Xanthan Gum Poloxamer 188 Saccharin Sodium Purified water Tutti Frutti Flavour (Firmenich 51.880/A) containing sweet orange oil, concentrated orange oil, propylene glycol, benzyl alcohol, ...
Incompatibilities
Not applicable.
Shelf life
12 months. After first opening, the suspension may be stored for up to 21 days.
Special precautions for storage
Do not store above 25°C. Do not freeze.
Nature and contents of container
A 240 ml high density polyethylene bottle with child resistant polypropylene closure, containing 226 ml of atovaquone suspension. A double ended measuring spoon (polypropylene) is included, however, only ...
Special precautions for disposal and other handling
Do not dilute. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK
Marketing authorization number(s)
PL 10949/0271
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 March 1997 Date of latest renewal: 21 May 2006
Date of revision of the text
31 August 2023
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