DARAPRIM Tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Daraprim 25 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 25 mg of pyrimethamine. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Each tablet is white and round with the marking GS A3A.
Therapeutic indications
For the treatment of: Toxoplasmosis, including ocular infections, proven foetal infection following maternal infection during pregnancy, and toxoplasmosis in immune-deficient patients (for the treatment ...
Posology and method of administration
Posology Toxoplasmosis (including ocular infections) Daraprim should be given concurrently with sulphadiazine or another appropriate antibiotic. In the treatment of toxoplasmosis, all patients receiving ...
Contraindications
Daraprim is contraindicated in: Hypersensitivity to pyrimethamine or to any of the excipients of this medicinal product. Daraprim should not generally be used during the first trimester of pregnancy (see ...
Special warnings and precautions for use
Depression of haematopoesis Daily therapeutic doses of Daraprim have been shown to depress haematopoesis in 25% to 50% of patients. The likelihood of inducing leucopenia, anaemia or thrombocytopenia is ...
Interaction with other medicinal products and other forms of interaction
Folate inhibitors, agents associated with myelosuppression Daraprim, by its mode of action, may further depress folate metabolism in patients receiving treatment with other folate inhibitors, or agents ...
Fertility, pregnancy and lactation
Pregnancy Daraprim should not be used during the first trimester of pregnancy unless the benefits outweigh the risk. Daraprim has been shown to be teratogenic in animal studies. The risks associated with ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Some patients may experience dizziness or convulsions, therefore, caution is recommended (see section 4.8).
Undesirable effects
Since a concurrent sulphonamide is to be taken with pyrimethamine for the indications listed, the relevant prescribing information for the sulphonamide should be consulted for sulphonamide-associated adverse ...
Overdose
Symptoms Vomiting and convulsions occur in cases of severe, acute overdoses. Ataxia, tremor and respiratory depression can also occur. There have been isolated cases with fatal outcomes following acute ...
Pharmacodynamic properties
Pharmacotherapeutic group: diaminopyrimidines ATC code: P01BD01 Pyrimethamine is an antiparasitic agent. Mechanism of Action The antiparasitic action of pyrimethamine is due to its specific activity on ...
Pharmacokinetic properties
Absorption Pyrimethamine is almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations generally occur 2 to 4 hours after a dose and can vary widely between individuals; concentrations ...
Preclinical safety data
Mutagenicity In microbial tests, pyrimethamine was found to be non-mutagenic in the Ames Salmonella assay whereas DNA damage was seen in the Escherichia coli repair assay. Further in vitro data indicate ...
List of excipients
Lactose monohydrate Maize starch Hydrolysed starch Docusate sodium Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Store below 30°C. Store in the original container.
Nature and contents of container
PVC/PVdC/aluminium foil blister pack or PVC/PVdC/child-resistant aluminium foil blister pack. Pack size: 30 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
The Wellcome Foundation Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom Trading as: GlaxoSmithKline UK
Marketing authorization number(s)
PL 00003/5026R
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 September 1986 Date of latest renewal: 19 February 2011
Date of revision of the text
17 February 2020
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