Intetrix 50mg+50mg+200mg capsules

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

tiliquinol, tiliquinol-N-dodecyl sulfate, tilbroquinol

Dostopno od:

Beaufour Ipsen Industrie

Koda artikla:

P01A

INN (mednarodno ime):

tiliquinol, tiliquinol-N-dodecyl sulfate, tilbroquinol

Odmerek:

50mg+50mg+200mg

Farmacevtska oblika:

capsules

Enote v paketu:

(20/2x10/) blisters

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2015-02-20

Lastnosti izdelka

SUMMARY OF PRODUCT CARACTERISTICS
1. TRADENAME OF THE MEDICINAL PRODUCT
INTETRIX, capsule.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active agents : _
TILIQUINOL
................................................................................
50 mg
TILIQUINOL laurylsulphate*
........................................................
50 mg
TILBROQUINOL
..........................................................................
200 mg
_Excipients: _
Monohydrated lactose
..............................................................
90 mg
Corn starch
.................................................................................
30 mg
For one capsule** n° 1 of 420 mg
* N‐dodecylsulphate=laurylsulphate
**Composition of the capsule cap : gelatine, titanium dioxide (E171),
azorubine (E122), indigotine (E132).
3. PHARMACEUTICAL FORM
Capsule
4. CLINICAL DATA
4.1. THERAPEUTIC INDICATIONS
Intestinal amoebiasis in adults:
− Adjunctive therapy to a tissular amoebicide
− Single therapy in the treatment of asymptomatic carriers.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Oral route.
For adult : 2 capsules in the morning, 2 capsules in the evening; that
is to say 4 capsules per day during
10 days. Capsules should be taken preferably at the beginning of
meals.
Fortrans® is contraindicated in patients under 18 years old.
4.3 CONTRA‐INDICATIONS
Hypersensitivity to any component of the drug.
Age under 18. Pregnancy, breastfeeding,
Lactase insufficiency, lactose intolerance, glucose or galactose
malabsorption.
Associated use with drugs containing Hydroxyquinoline or its
derivatives as an active agent.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Recent studies have confirmed that in healthy volunteers INTETRIX
frequently causes an increase in the
transaminases levels, which is moderate, asymptomatic and regressive.
Consequently, in case of
increased transminases levels, and especially in case of icterus, the
treatment must be stopped.
Prolonged use of INTETRIX is highly inadvisable due to the risk of
peripheral n