ACYCLOVENIR

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ACICLOVIR

Available from:

BIOAVENIR LTD, ISRAEL

ATC code:

J05AB01

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

ACICLOVIR 250 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABORATORY REIG JOFRE S.A., SPAIN

Therapeutic group:

ACICLOVIR

Therapeutic area:

ACICLOVIR

Therapeutic indications:

• indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised. • indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients. • indicated for the treatment of Varicella zoster infections. • indicated for the treatment of herpes encephalitis. • indicated for the treatment of Herpes simplex infections in the neonate and infant up to 3 months of age.

Authorization date:

2015-02-28

Summary of Product characteristics

ACYCLOVENIR
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Acyclovenir
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
250 mg Aciclovir in each vial
Excipients with known effect:
Sodium hydroxide
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for Solution for Infusion
PRESENTATION
A sterile, white to off-white, freeze dried powder in vials containing
250mg acyclovir as the
sodium salt. 4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acyclovenir is indicated for:
•
For the treatment of Herpes Simplex infections and severe initial
genital herpes in the
non immunocompromised.
•
For the prophylaxis of Herpes Simplex infections in immunocompromised
patients.
•
For the treatment of Varicella Zoster infections.
•
For Herpes Simplex Encephalitis.
•
For the treatment of Herpes Simplex infection in the neonate and
infant up to 3 months
of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE AND ADMINISTRATION
Route of administration
Slow intravenous infusion:-
A course of treatment with Acyclovenir 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 and Neonatal Herpes Simplex infections usually lasts 10
days.
The duration of prophylactic administration of Acyclovenir for
Infusion is determined by the
duration of the period at risk.
DOSAGE IN ADULTS:
Patients with Herpes Simplex (except Herpes Encephalitis) or Varicella
Zoster infections
should be given Acyclovenir for Infusion in doses of 5 mg/kg
bodyweight every 8 hours.
Immunocompromised patients with Varicella Zoster infections or
patients with Herpes
Encephalitis should be given Acyclovenir for Infusion in doses of 10
mg/kg bodyweight every
8 hours provided renal function is not impaired (see _"Dosage in Renal
Impairment"_).
DOSAGE IN CHILDREN:
The dose of Acyclovenir for Infusion for children aged between 3
months and 12 years is
calculated on the basis of body surface area.
Children with Herpes Simpl