Gastro-Kit Tablets/Capsules 267/250/500

Nazione: Tanzania

Lingua: inglese

Fonte: Tanzania Medicinces & Medical Devices Authority

Principio attivo:

Lansoprazole, Clarithromycin , Tinidazole

Commercializzato da:

Zota HealthCare Ltd, INDIA

Codice ATC:

Drugs for peptic ulcer and gastro-oesophageal refl

INN (Nome Internazionale):

Lansoprazole, Clarithromycin and Tinidazole

Dosaggio:

267/250/500

Forma farmaceutica:

Tablets/Capsules

Prodotto da:

ZOTA HEALTHCARE LIMITED , INDIA

Dettagli prodotto:

Physical description: Lansoprazole Capsules: Pink/clear transparent size “2” hard gelatine capsule containing white to off white colour pallets Tinidazole Tablets: Orange color, Capsule shaped, film coated tablet with break line on one side and plain on other side Clarithromycin Tablets: White colour, round shaped coated tablets plain on both side; Local technical representative: Moraf Pharmaceuticals Limited (5668)

Stato dell'autorizzazione:

Registered/Compliant

Data dell'autorizzazione:

2022-12-05

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
GASTRO KIT (Lansoprazole, Clarithromycin and Tinidazole
Combi kit
)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION:
EACH COMBI
KIT CONTAINS:
A. Two Lansoprazole Delayed Release Capsules USP 30 mg:
Each Hard Gelatin Capsule Contains:
Lansoprazole USP…...30 mg
(As enteric coated pellets)
Excipients …………q.s
Approved
Colour
is used in empty capsule shells
B. Two Clarithromycin Tablets USP 250 mg
Each Film Coated Tablets Contains
Clarithromycin USP…250 mg
Excipients ………….q.s
Colour: Titanium Dioxide
C. Two Tinidazole Tablets 500 mg
Each Film-Coated Tablet Contains:
Tinidazole USP….500 mg
Excipients …...q.s
Colour: Sunset Yellow
EXCIPIENTS
SUGAR
As lansoprazole contains sugar, patients with rare hereditary problems
of fructose intolerance,
glucose-galactose
malabsorption
or
sucrase-isomaltase
insufficiency
should
not
take
this
medicine. 7% Sugar concentration is used in the formulation of
pellets.
SODIUM METHYL HYDROXYBENZOATE
Sodium Methyl Hydroxybenzoate has no teratogenic, carcinogenic,
mutagenic or embryotoxic
toxicity in the amounts at which it is used as 0.1%.
SODIUM PROPYL HYDROXYBENZOATE
Sodium Propyl Hydroxybenzoate has no teratogenic, carcinogenic,
mutagenic or embryotoxic
toxicity in the amounts at which it is used as 0.1%.
SUNSET YELLOW:
The acceptable daily intake (ADI) is 0–4 mg/kg under both EU and
WHO/FAO guidelines.
Sunset Yellow FCF has no carcinogenicity, genotoxicity, or
developmental toxicity in the
amounts at which it is used.
3. PHARMACEUTICAL FORM
A. Lansoprazole Delayed Release Capsules USP 30 mg
Hard Gelatin Capsule
Pink / Clear transparent size '2' hard gelatin capsules containing
white to off white colour
pellets.
B. Clarithromycin Tablets USP 250 mg
Film coated tablets
White
Colour
, round shaped coated tablets plain on both side.
C. Tinidazole Tablets 500 mg
Film coated tablets
Orange color, Capsule shaped, film coated tablet with break line on
one side and plain on
other side.
THE SCORE