ISOPRINOSINE 500 Milligram Tablets
País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Características técnicas
(SPC)
15-05-2024
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Ingredientes ativos:
INOSINE ACEDOBEN DIMEPRANOL
Disponível em:
Newport Pharmaceuticals Limited
DCI (Denominação Comum Internacional):
INOSINE ACEDOBEN DIMEPRANOL
Dosagem:
500 Milligram
Forma farmacêutica:
Tablets
Tipo de prescrição:
Product subject to prescription which may not be renewed (A)
Status de autorização:
Withdrawn
Data de autorização:
2012-04-05
Características técnicas
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoprinosine 500 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg Inosine Acedoben Dimepranol
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A round white to off-white uncoated tablet with a bisecting scoreline on one side and ‘NPT’ on the obverse.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Isoprinosine tablets are 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, 2 tablets x 3-4 times a day).
Children over the age of 1 year:
50mg/kg of body weight daily. (1 tablet per 10 kg up to 20 kgs; 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/11/2011_
_CRN 2084704_
_page number: 1_
Genital Warts Do
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