Virolex powder for solution for infusion

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

aciclovir

Tilgængelig fra:

KRKA d.d.

ATC-kode:

J05AB01

INN (International Name):

aciclovir

Dosering:

250mg

Lægemiddelform:

powder for solution for infusion

Enheder i pakken:

(5) glass vial

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2022-05-31

Produktets egenskaber

1.
NAME OF THE MEDICINAL PRODUCT
Virolex
®
250 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg aciclovir as sodium salt.
Excipients with known effect:
-
sodium: 1.01 mmol (23.3 mg)/vial
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White or almost white lyophilized powder practically free from foreign
matter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Virolex
®
250 mg powder for solution for infusion is indicated for the treatment
of_ Herpes simplex_ and
_Varicella zoster_ infections in immunocompromised patients.
Virolex
®
250 mg powder for solution for infusion is indicated for the
prophylaxis of_ Herpes _
_simplex_ infections in immunocompromised patients.
Virolex
®
250 mg powder for solution for infusion is indicated for the treatment
of recurrent _Varicella _
_zoster_ infections and severe initial _genital herpes_ in
non-immunocompromised patients.
Virolex
®
250 mg powder for solution or infusion is indicated for the treatment
of herpes encephalitis.
Virolex
®
250 mg powder for solution for infusion is indicated for the treatment
of_ Herpes _
_simplex_ infections in the neonate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Patients with_ Herpes simplex_ (except herpes encephalitis) or
recurrent _Varicella zoster_ infections
should be given Virolex
®
250 mg powder for solution for infusion in doses of 5 mg/kg body
weight
every eight hours provided renal function is not impaired (see Dosage
in renal impairment).
Immunocompromised patients with_ Varicella zoster_ infections or
patients with herpes encephalitis
should be given Virolex
®
250 mg powder for solution for infusion in doses of 10 mg/kg body
weight
every 8 hours provided renal function is not impaired (see Dosage in
renal impairment).
In obese patients dosed with intravenous aciclovir based on their
actual body weight, higher plasma
concentrations may be obtained (see 5.2 Pharmacokinetic properties).
CON