TRICLONAM ELIXIR

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

TRICLOFOS SODIUM

Commercializzato da:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Codice ATC:

N05CM07

Forma farmaceutica:

ELIXIR

Composizione:

TRICLOFOS SODIUM 500 MG / 5 ML

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

CTS CHEMICAL INDUSTRIES LTD

Gruppo terapeutico:

TRICLOFOS

Area terapeutica:

TRICLOFOS

Indicazioni terapeutiche:

Insomnia, daytime sedation and pre-medication in EEC.

Data dell'autorizzazione:

2020-04-30

Foglio illustrativo

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.دامتعلاا
:

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
TRICLONAM ELIXIR
TRICLOFOS SODIUM 500 MG / 5 ML
TREATMENT MATTERS
1. THERAPEUTIC INDICATIONS
Insomnia, daytime sedation and pre-medication in EEC.
2. DOSAGE AND ADMINISTRATION
For insomnia:
Adults and children over 12 years: 10 ml daily, in certain cases a
higher dosage
may be required - up to 20 ml daily.
Children 6-12 years: 5-10 ml daily.
Children 1-5 years: 2.5-5 ml daily.
Infants up to 1 year: 1-2.5 ml daily.
As a sedative:
Adults and children over 12 years: 5 ml twice daily.
Children 6-12 years: 5 ml daily.
Children 1-5 years: 2.5 ml daily.
Infants up to 1 year: 1 ml daily.
3. CLINICAL RESULTS
(1) CLINICAL DATA PACKAGE
None
(2) CLINICAL EFFECTS
Clinical results judging by sleeping effects were 84.3% (321/381). (3) CLINICAL PHARMACOLOGICAL TEST
No applicable data
(4) EXPLORATORY TEST
No applicable data
(5) VERIFICATION TEST
1) RANDOMIZED PARALLEL DOSAGE RESPONSE STUDY
No applicable data
2) COMPARATIVE TEST
The following results were obtained comparing chloral hydrate
(22mg/kg) and
triclofos sodium (33mg/kg) in 71 children aged 4 to 14 years old who
require
sedation during EEG. EEG was used for the sleep start monitor.
Triclofos Sodium syrup (37 subjects)
Chloral hydrate (34 subjects)
Dosage*
Average 1 g (480 mg to 1960 mg)
Average: 680 mg (300mg to 1,510mg)
Sleep introduction time
37.3 ± 12.1 minutes
36.6 ± 14.4 minutes
Ineffective cases
6 cases
4 cases
Taste
Aversion
2 cases (5%)
9 cases (27%)
Good
14 cases (33%)
11 cases (32%)
Very good
21 cases (51%)
14 cases (41%)
Adverse reactions
16 types in 9 people (24%)
16 types in 9 people (26%)
*: Dosage is expressed in the amount of the active ingredient.
Triclofos Sodium Syrup active ingredient: Triclofos sodium
Chloral hydrate active ingredient
3) SAFETY TEST
No applicable data
4) TESTING BY PATIENT/CONDITION
No applicable data
(6) THERAPEUTIC USE
1) TREATMENT OUTCOME STUDY AND RESEARCH OF SPECIFIC USES (SPECIAL
SURVEY)/CLINICAL
STUDIES AFTER MANUFACTURING AND SALES (POST-MARKETING CLINICAL
RESULTS)
No applicable uses
2) APP