ISOPRINOSINE 250 MG/5ml Oral Solution
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
15-05-2024
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Aktiva substanser:
INOSINE ACEDOBEN DIMEPRANOL
Tillgänglig från:
Newport Pharmaceuticals Limited
INN (International namn):
INOSINE ACEDOBEN DIMEPRANOL
Dos:
250 MG/5ml
Läkemedelsform:
Oral Solution
Receptbelagda typ:
Product subject to prescription which may not be renewed (A)
Bemyndigande status:
Withdrawn
Tillstånd datum:
2008-02-14
Produktens egenskaper
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoprinosine Syrup 250mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of syrup contains 250mg Inosine Acedoben Dimepranol.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A clear viscous oral solution with a mirabelle plum aroma.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Isoprinosine syrup is indicated:
a) As an immunomodulator for the management of patients with immunodepression suffering from viral infections
such as subacute sclerosing panencephalitis, varicella, herpes simplex Type 1 & 2.
b) In the management of recurrent herpes simplex Type 1 & 2.
c) As an adjunct in the treatment of genital warts.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
a)
Route of administration: Oral
b)
Dosing:
Dosage is determined on the basis of lean body weight of the patient and the severity of the disease. Daily
administration should be divided evenly during waking hours. The normal duration of acute treatment is 5-14 days.
Adults and the Elderly:
50mg/kg of body weight daily, up to a maximum of 4g, (usually, 20ml x 3-4 times a day).
Children over the age of 1 year:
50mg/kg of body weight daily, (10ml per 10 kg up to 20kgs; thereafter, use adult dose).
SSPE Dosage:
100mg/kg of body weight daily, up to a maximum of 3-4g, continuously, with regular monitoring to evaluate patient
status and requirement for extended treatment.
Genital Warts Dosage:
3g (20ml x 3 times a day) for a total of 14-28 days, as an adjunct to conventional topical or surgical procedures,
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/02/2011_
_CRN 2091681_
_page number: 1_
according to the following schedules:
a.
14-28 days
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