DBL™ Aciclovir Intravenous
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
01-01-2024
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Active ingredient:
Aciclovir 25 mg/mL
Available from:
Pfizer New Zealand Limited
INN (International Name):
Aciclovir 25 mg/mL
Dosage:
25 mg/mL
Pharmaceutical form:
Solution for infusion
Composition:
Active: Aciclovir 25 mg/mL Excipient: Sodium hydroxide Water for injection
Units in package:
Vial, glass, 5x10ml, 50 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Excella GmbH & Co KG
Therapeutic indications:
DBL Aciclovir intravenous infusion is indicated for: - treatment of Herpes simplex infections. - prophylaxis of Herpes simplex infections in immune-compromised patients. - treatment of Varicella zoster infections. - the treatment of Herpes simplex infections in the neonate. - prophylaxis of CMV infection in bone marrow transplant recipients. It has been shown that high dose intravenous aciclovir reduces the incidence and delays the onset of CMV infection. When high dose intravenous aciclovir is followed by 6 months treatment with high dose oral aciclovir (see prescribing information for oral aciclovir) mortality and the incidence of viraemia are also reduced.
Product summary:
Package - Contents - Shelf Life: Vial, glass, 5x10ml - 50 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, 5x20ml - 100 mL - 24 months from date of manufacture stored at or below 25°C
Authorization date:
1995-10-04
Summary of Product characteristics
Version
pfdacii11223
Supersedes Version 6.0
Page 1 of 15
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL
™
Aciclovir Intravenous Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Aciclovir Intravenous Infusion contains the equivalent of 25 mg/mL
of aciclovir; the
aciclovir is present as aciclovir sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Infusion
DBL Aciclovir Intravenous Infusion is a clear colourless or almost
colourless sterile solution.
DBL Aciclovir Intravenous Infusion has a pH of approximately 11.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBLAciclovir Intravenous Infusion is indicated for the treatment of
_Herpes simplex_ infections,
including in the neonate.
DBL Aciclovir Intravenous Infusion is indicated for the prophylaxis of
_ Herpes simplex_
infections in immune-compromised patients.
DBL Aciclovir Intravenous Infusion is indicated in the treatment of
_Varicella zoster_ infections.
DBL Aciclovir
Intravenous Infusion formulations are indicated for prophylaxis of CMV
infection in bone marrow transplant recipients. It has been shown that
high dose intravenous
aciclovir reduces the incidence and delays the onset of CMV infection.
When high dose
intravenous aciclovir is followed by 6 months treatment with high dose
oral aciclovir (see
prescribing information for oral aciclovir) mortality and the
incidence of viraemia are also
reduced.
4.2 DOSE AND METHOD OF ADMINISTRATION
_DOSAGE IN ADULTS_
Patients with _Herpes simplex_ (except herpes encephalitis) or
_Varicella zoster_ infections should
be given DBL Aciclovir Intravenous Infusion in doses of 5 mg/kg
bodyweight every 8 hours
provided renal function is not impaired.
Version
pfdacii11223
Supersedes Version 6.0
Page 2 of 15
Immune-compromised
patients
with
_Varicella zoster_
infections
or
patients
with
herpes
encephalitis should be given DBL Aciclovir Intravenous Infusion in
doses of 10 mg/kg
bodyweight every 8 hours provided renal function is not impaired.
For prophylaxis of CMV infection in
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