ZOVIRAX IV FOR INFUSION 250MG

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

ACYCLOVIR

Dostopno od:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (mednarodno ime):

ACYCLOVIR

Enote v paketu:

5Units Units

Izdeluje:

GlaxoSmithKline Manufacturing S.p.A

Navodilo za uporabo

CONFIDENTIAL

ZOVIRAX POWDER FOR I.V. INFUSION
ACICLOVIR
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ZOVIRAX_
250 mg: The sodium ion content is approximately 26 mg per vial.
PHARMACEUTICAL FORM
Freeze dried powder for Injection.
CLINICAL PARTICULARS
INDICATIONS
_ZOVIRAX_
i.v. for infusion is indicated for the treatment of herpes simplex
infections.
_ZOVIRAX_
i.v. for infusion is indicated for the prophylaxis of herpes simplex
infections in
immune-compromised patients.
_ZOVIRAX_
i.v. for infusion is indicated in the treatment of varicella zoster
infections.
_ZOVIRAX_
i.v. for infusion is indicated for the treatment of herpes simplex
infections in
the neonate.
DOSAGE AND ADMINISTRATION
To be given as intravenous infusion over 1 hour.
A course of treatment with
_ZOVIRAX_
_IV_
for infusion usually lasts 5 days, but this may be
adjusted according to the patient's condition and response to therapy.
Treatment for
herpes encephalitis usually lasts 10 days. Treatment for neonatal
herpes infections
usually lasts 14 days for mucocutaneous (skin-eye-mouth) infections
and 21 days for
disseminated or central nervous system disease. The duration of
prophylactic
administration of
_ZOVIRAX IV_
for infusion is determined by the duration of the period at
risk.
CONFIDENTIAL


ADULTS
TREATMENT OF HERPES SIMPLEX
Obese patients should be dosed at the recommended adult dose using
ideal body weight,
rather than actual body weight.
Patients with herpes simplex (except herpes encephalitis) should be
given aciclovir
_IV_
for
infusion in doses of 5 mg/kg bodyweight every eight hours if renal
function is not
impaired.
Patients with herpes encephalitis should be given aciclovir
_IV_
for infusion in doses of
10 mg/kg bodyweight every eight hours provided renal function is not
impaired.
PROPHYLAXIS OF HERPES SIMPLEX IN IMMUNE-COMPROMISED PATIENTS
Obese patients should be dosed at the recommended adult dose using
ideal body weight,
rather than actual body weight.
Refer to adult dosing recommendations for the treatment of

Lastnosti izdelka

CONFIDENTIAL
ZOVIRAX POWDER FOR I.V. INFUSION
ACICLOVIR
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ZOVIRAX_
250 mg: The sodium ion content is approximately 26 mg per vial.
PHARMACEUTICAL FORM
Freeze dried powder for Injection.
CLINICAL PARTICULARS
INDICATIONS
_ZOVIRAX_
i.v. for infusion is indicated for the treatment of herpes simplex
infections.
_ZOVIRAX_
i.v. for infusion is indicated for the prophylaxis of herpes simplex
infections in
immune-compromised patients.
_ZOVIRAX_
i.v. for infusion is indicated in the treatment of varicella zoster
infections.
_ZOVIRAX_
i.v. for infusion is indicated for the treatment of herpes simplex
infections in
the neonate.
DOSAGE AND ADMINISTRATION
Route of administration: Slow intravenous infusion over 1 hour.
A course of treatment with
_ZOVIRAX_
_IV_
for infusion usually lasts 5 days, but this may be
adjusted according to the patient's condition and response to therapy.
Treatment for
herpes encephalitis usually lasts 10 days. Treatment for neonatal
herpes infections
usually lasts 14 days for mucocutaneous (skin-eye-mouth) infections
and 21 days for
disseminated or central nervous system disease. The duration of
prophylactic
administration of
_ZOVIRAX IV_
for infusion is determined by the duration of the period at
risk.
CONFIDENTIAL
DOSAGE IN ADULTS:
Patients with Herpes simplex (except herpes encephalitis) or Varicella
zoster infections
should be given Zovirax I.V. in doses of 5 mg/kg body weight every 8
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 Zovirax I.V. 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).
Consideration should therefore be given to dosage reduction in obese
patients and
especia