ZANTAC SYRUP

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

RANITIDINE AS HYDROCHLORIDE

제공처:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC 코드:

A02BA02

약제 형태:

SYRUP

구성:

RANITIDINE AS HYDROCHLORIDE 150 MG / 10 ML

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

ASPEN BAD OLDESLOE GMBH, GERMANY

치료 그룹:

RANITIDINE

치료 영역:

RANITIDINE

치료 징후:

Adults:Zantac syrup is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. Zantac syrup is also indicated for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and oesophageal reflux disease including long term management of healed oesophagitis. Zantac syrup is indicated for the following conditions where reduction of gastric secretion and acid output is desirable; the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's Syndrome), particularly obstetric patients during labour. Children (3 to 18 years):Short term treatment of peptic ulcer. Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

승인 날짜:

2013-03-31

환자 정보 전단

Patient leaflet in accordance with the
Pharmacists' Regulations (Preparations) – 1986
The medicine is dispensed according to a physician’s prescription
only
Zantac Syrup
Each 10 ml of syrup contains 150 mg Ranitidine (as Hydrochloride)
For the list of inactive and allergenic ingredients, see section 2 -
“Important
information about some of the ingredients of the medicine” and
section 6 -
“Additional information”.
Read the entire leaflet carefully before using the medicine. This
leaflet contains
concise information about the medicine. If you have further questions,
refer to
the physician or the pharmacist.
This medicine has been prescribed for you or for your child. Do not
pass it on
to others. It may harm them even if it seems to you that their medical
condition
is similar.
1. What is the medicine intended for?
Adults:
Zantac Syrup is indicated for the treatment of duodenal ulcer and
benign gastric
ulcer,
including
ulcer
that
is
caused
by
treatment
with
non-steroidal
anti-inflammatory agents. Zantac Syrup is also indicated for the
treatment of
post-operative
ulcer,
Zollinger-Ellison
Syndrome
and
oesophageal
reflux
disease including long-term management of healed oesophagitis.
Zantac Syrup is indicated for conditions where reduction of gastric
secretion is
desirable;
the
prophylaxis
of
gastro-intestinal
haemorrhage
from
stress
ulceration in seriously ill patients and before general anaesthesia in
patients
considered to be at risk of acid aspiration (Mendelson’s Syndrome),
particularly
in obstetric patients during labour.
Children (3 to 18 years):
Short term treatment of peptic ulcer. Treatment of gastro-oesophageal
reflux,
including reflux oesophagitis and symptomatic relief of
gastro-oesophageal
reflux disease.
Therapeutic group
Zantac Syrup contains a medicine called ranitidine. This belongs to a
group of
medicines called H
2
-receptor antagonists.
2. Before using the medicine
Do not use the medicine if:
∙ you or your child is sensitive (allergic) to ranitidine or to any
of the other
ingredients

제품 특성 요약

_Page 1 of 11 _
_ _
ZANTAC
SYRUP
1.
NAME OF THE MEDICINAL PRODUCT
Zantac Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of syrup contains Ranitidine Hydrochloride 168.0 mg
(Equivalent
to Ranitidine 150.0 mg)
Each 10 ml of syrup also contains the following excipients:
-
800 mg ethanol
-
1.5 mg propyl Parahydroxybenzoate
-
0.75 mg butyl Parahydroxybenzoate
-
1000 mg Sorbitil Liquid (Non-crystallising)
For the full list of excipients, see section 6.1
The preparation contains: Ethanol (96%)
The amount of ethanol per bottle (300 ml): 24 grams
The amount of ethanol in every 10 ml:800 mg
The concentration of ethanol in the preparation: approximately 7.5%
w/v
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults:
Zantac syrup is indicated for the treatment of duodenal ulcer and
benign
gastric ulcer, including that associated with non-steroidal
anti-inflammatory
agents. Zantac syrup is also indicated for the treatment of
post-operative ulcer,
Zollinger-Ellison Syndrome and oesophageal reflux disease including
long
term management of healed oesophagitis. Zantac syrup is indicated for
the
following conditions where reduction of gastric secretion and acid
output is
desirable; the prophylaxis of gastro-intestinal haemorrhage from
stress
ulceration in seriously ill patients and before general anaesthesia in
patients
considered to be at risk of acid aspiration (Mendelson's Syndrome),
particularly obstetric patients during labour. For appropriate cases
Zantac
injection is also available (see separate Physician Leaflet).
_Page 2 of 11 _
_ _
Children (3 to 18 years):
Short term treatment of peptic ulcer. Treatment of gastro-oesophageal
reflux,
including reflux oesophagitis and symptomatic relief of
gastro-oesophageal
reflux disease.
See section 4.4 Special warnings and precautions for use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (including the elderly)
The usual dosage is 150 mg twice daily, taken in the morning and
evening.
Alternatively, patients with duodenal ulc