ACIC LYOPHILISATE 250 Milligram Unknown
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
17-04-2024
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Aktiva substanser:
ACICLOVIR
Tillgänglig från:
Rowex Ltd
INN (International namn):
ACICLOVIR
Dos:
250 Milligram
Läkemedelsform:
Unknown
Bemyndigande status:
Withdrawn
Tillstånd datum:
2007-11-30
Produktens egenskaper
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ACIC 250 mg Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg aciclovir as the freeze-dried sodium salt.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ACIC is indicated for:
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION:
Intravenous.
RECOMMENDED DOSAGE SCHEDULE:
The required dose of ACIC should be administered by slow intravenous infusion over a one-hour period.
A course of treatment with ACIC usually lasts 5 days, but this may be adjusted according to the patient’s condition and
response to therapy. Treatment for herpes simplex encephalitis usually lasts 10 days.
The duration of prophylactic administration of ACIC is determined by the duration of the period at risk.
NON-IMMUNO-COMPROMISED PATIENTS
IMMUNO-COMPROMISED PATIENTS
Severe initial genital herpes
Herpes simplex infection
Recurrent varicella Zoster virus infection
Primary and recurrent varicella zoster
infection
Prophylaxis of herpes simplex infection
Herpes simplex encephalitis
Herpex simplex encephalitis
INDICATION
IMMUNE STATUS
DOSAGE
Herpes simplex infections
Normal or Immuno-compromised
5 mg/kg every 8 hours
Recurrent varicella zoster
infections
Normal
5 mg/kg every 8 hours
Primary and recurrent varicella
zoster infections
Immuno-compromised
10 mg/kg every 8 hours
Herpes simplex encephalitis
Normal or Immuno-compromised
10 mg/kg every 8 hours
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/03/2007_
_CRN 2034608_
_page number: 1_
Patients with renal impairment should be administered ACIC with caution. The following modifications in
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