NOXAFIL Oral suspension (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Noxafil 40 mg/mL oral suspension.
Qualitative and quantitative composition
Each mL of oral suspension contains 40 mg of posaconazole. Excipient with known effect: This medicinal product contains approximately 1.75 g of glucose per 5 mL of suspension. For the full list of excipients, ...
Pharmaceutical form
Oral suspension. White suspension.
Therapeutic indications
Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): Invasive aspergillosis in patients with disease that is refractory to amphotericin ...
Posology and method of administration
Non-Interchangeability between Noxafil Tablets and Noxafil Oral Suspension The tablet and oral suspension are not to be used interchangeably due to the differences between these achieved. Therefore, follow ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with ergot alkaloids (see section 4.5). Co-administration with the CYP3A4 substrates terfenadine, ...
Special warnings and precautions for use
Hypersensitivity There is no information regarding cross-sensitivity between posaconazole and other azole antifungal agents. Caution should be used when prescribing Noxafil to patients with hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on posaconazole Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for p-glycoprotein (P-gp) efflux in vitro. Therefore, inhibitors ...
Fertility, pregnancy and lactation
Pregnancy There is insufficient information on the use of posaconazole in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. ...
Effects on ability to drive and use machines
Since certain adverse reactions (e.g. dizziness, somnolence, etc.) have been reported with posaconazole use, which potentially may affect driving/operating machinery, caution needs to be used.
Undesirable effects
Summary of the safety profile The safety of posaconazole oral suspension has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience. The ...
Overdose
During clinical trials, patients who received posaconazole oral suspension doses up to 1,600 mg/day experienced no different adverse reactions from those reported with patients at the lower doses. Accidental ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives ATC code: J02AC04 Mechanism of action Posaconazole inhibits the enzyme lanosterol 14α-demethylase (CYP51), which catalyses ...
Pharmacokinetic properties
Absorption Posaconazole is absorbed with a median t<sub>max</sub> of 3 hours (fed patients). The pharmacokinetics of posaconazole are linear following single and multiple dose administration of up to 800 ...
Preclinical safety data
As observed with other azole antifungal agents, effects related to inhibition of steroid hormone synthesis were seen in repeated-dose toxicity studies with posaconazole. Adrenal suppressive effects were ...
List of excipients
Polysorbate 80 Simeticone Sodium benzoate (E211) Sodium citrate dihydrate Citric acid monohydrate Glycerol Xanthan gum Liquid glucose Titanium dioxide (E171) Artificial cherry flavour containing benzyl ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Unopened container: 3 years. After first opening the container: 4 weeks.
Special precautions for storage
Do not freeze.
Nature and contents of container
105 mL of oral suspension in a bottle (glass amber type IV) closed with a plastic child-resistant cap (polypropylene) and a measuring spoon (polystyrene) with 2 graduations: 2.5 mL and 5 mL.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/05/320/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 October 2005 Date of latest renewal: 25 October 2010
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