MEDOVIR Powder for solution for infusion (2014)
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Περιεχόμενα
1. Name of the medicinal product
Medovir 250mg powder for solution for infusion. Medovir 500mg powder for solution for infusion.
2. Qualitative and quantitative composition
Each vial of Medovir powder for solution for infusion contains the equivalent of either 250mg or 500mg aciclovir as the sterile sodium salt.
3. Pharmaceutical form
Powder for solution for infusion.
4.1. Therapeutic indications
Medovir powder for solution for infusion is indicated for the treatment and prophylaxis of herpes simplex infections in immunocompromised patients, and severe initial genital herpes in non-immunocompromised. ...
4.2. Posology and method of administration
Posology Adults Herpes simplex or Varicella zoster infection: 5mg/kg body weight, every eight hours. Immunocompromised patients with Varicella zoster infection or patients with herpes encephalitis: 10mg/kg ...
4.3. Contraindications
Hypersensitivity to the active substance or valaciclovir.
4.4. Special warnings and precautions for use
The dose of Medovir i.v. must be adjusted in patients with impaired renal function in order to avoid accumulation of aciclovir in the body (see dosage in Renal impairment). In patients receiving Medovir ...
4.5. Interaction with other medicinal products and other forms of interaction
No clinically significant interactions have been identified. Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete ...
4.6. Pregnancy and lactation
Pregnancy A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Medovir. The birth defects described amongst Medovir exposed subjects have ...
4.7. Effects on ability to drive and use machines
Medovir has no influence on the ability to drive and use machines (see also 4.8).
4.8. Undesirable effects
The following convention has been used for the classification of undesirable effects in terms of frequency: very common 1/10, common 1/100 to <1/10, uncommon 1/1000 to <1/100, rare 1/10,000 to <1/1000, ...
4.9. Overdose
Symptoms Aciclovir is only partly absorbed in the gastrointestinal tract. Patients have been ingested overdoes of up to 20g of aciclovir on a single occasion, usually without toxic effects. Accidental, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Nucleosides and nucleotides excl. reverse transcriptase inhibitors, Antivirals for Systemic Use <b>ATC code:</b> J05AB01 Aciclovir is a synthetic purine nucleoside analogue ...
5.2. Pharmacokinetic properties
Aciclovir is only partially absorbed from the gut. Mean steady state peak plasma concentration (C<sup>ss</sup>max) following doses of 200 mg administered four-hourly were 3.1 micromol (0.7 micrograms/ml) ...
5.3. Preclinical safety data
The results of a wide range of mutagenicity test in vitro and in vivo indicate that aciclovir is unlikely to pose a genetic risk to man. Aciclovir was not found to be carcinogenic in long-term-studies ...
6.1. List of excipients
Medovir powder for solution for infusion contains no excipients.
6.2. Incompatibilities
Sterile aciclovir sodium is incompatible with biological or colloidal solutions. It is incompatible with hydroxybenzoate esters (parabens) and precipitation may occur.
6.3. Shelf life
36 months. Following dilution, the solution is stable for up to 12 hours at room temperature. Solutions should not be refrigerated.
6.4. Special precautions for storage
Store below 25°C, in the original package. Do not refrigerate or freeze. Use immediately after reconstitution. For storage conditions after dilution of the medicinal product, see section 6.3.
6.5. Nature and contents of container
Medovir powder for solution for infusion is supplied in type I clear glass vials, sealed with a rubber stopper and aluminium overcap. Cartons of 1, 10, 50 or 100 vials are available. Not all pack sizes ...
6.6. Special precautions for disposal and other handling
Carry out reconstitution and dilution under aseptic conditions immediately prior to use. Any unused solution must be discarded. For reconstitution either sterile Water for Injection B.P or sterile Sodium ...
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Medovir 250 mg: 16554 Medovir 500 mg: 16555
9. Date of first authorization / renewal of the authorization
Medovir 250 mg: 15-3-1996 Medovir 500 mg: 15-3-1996
10. Date of revision of the text
07/2014
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