NULOC Tablets 40 mg

Ülke: Tanzanya

Dil: İngilizce

Kaynak: Tanzania Medicinces & Medical Devices Authority

Aktif bileşen:

Esomeprazole Magnesium

Mevcut itibaren:

Alkem Laboratories Limited, INDIA

ATC kodu:

Drugs for peptic ulcer and gastro-oesophageal refl

INN (International Adı):

Esomeprazole Magnesium

Doz:

40 mg

Farmasötik formu:

Tablets

Tarafından üretildi:

East African (India) Overseas, INDIA

Ürün özeti:

Physical description: Coloured, square shaped, biconvex, film coated tablets plain on both side; Local technical representative: Planet Pharmaceutical Limited (6099)

Yetkilendirme durumu:

Registered/Compliant

Yetkilendirme tarihi:

2022-05-04

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
A) NAME OF PRODUCT
: NULOC TABLETS 40 MG
B) GENERIC NAME
: ESOMEPRAZOLE GASTRO-RESISTANT TABLETS
C) PHARMACEUTICAL FORM
: Tablets
D) COMPOSITION
: EACH ENTERIC COATED TABLETS CONTAINS:
Esomeprazole Magnesium USP
Eq. to Esomeprazole 40 mg
Excipients
q.s.
Colour: Brilliant Blue Lake & Titanium Dioxide USP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A. QUALITATIVE COMPOSITION
EACH ENTERIC COATED TABLETS CONTAINS: Esomeprazole Magnesium USP
Eq. to Esomeprazole
40 mg
Excipients
q.s.
Colour: Brilliant Blue Lake & Titanium Dioxide USP
B. QUANTITATIVE COMPOSITION
SR
.
N
O.
ITEM
CODE
MATERIAL NAME
SPEC
QUANTITY
(MG) /
TABLET
%
FORMULA
W/W
THEORETICAL
QUANTITY/
BATCH (KG)
OVG.
IN
(%)
STANDARD
QUANTITY
/ BATCH
(KG)
DRY MIXING
01
R/1464
Esomeprazole
Magnesium
Trihydrate *
USP
44.550
22.275
8.910
…..
8.910
02
R/299
Corn Starch
USP
35.000
17.500
7.000
….
7.000
03
R/42
Microcrystalline
Cellulose (101)**
USP
31.250
15.625
6.250
…..
6.250
04
R/360
Mannitol
USP
25.000
12.500
5.000
…..
5.000
BINDER (BINDER PREPARATION)
05
R/7
Polyvinyl
Pyrrolidone K-30
USP
6.000
3.000
1.200
…..
1.200
06
R/57
Isopropyl Alcohol
USP
…..
….
14.200
…..
14.200
3.
PHARMACEUTICAL FORM
Tablets
Blue coloured, round, biconvex, enteric coated tablets having both
side plain.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Esomeprazole Gastro-resistant tablets are indicated in adults for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
- Treatment of erosive reflux esophagitis
- Long-term management of patients with healed esophagitis to prevent
relapse
- Symptomatic treatment of gastroesophageal reflux disease (GERD)
IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR
THE
ERADICATION OF _HELICOBACTER PYLORI _AND
- Healing of _Helicobacter pylori _associated duodenal ulcer and
- Prevention of relapse of peptic ulcers in patients with
_Helicobacter pylori _associated
ulcers
PATIENTS REQUIRING CONTINUED NSAID THERAPY
- Healing of gastric ulcers associated with NSAID t