ZARIDEX 150

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

RANITIDINE AS HYDROCHLORIDE

זמין מ:

DEXCEL LTD, ISRAEL

קוד ATC:

A02BA02

טופס פרצבטיות:

TABLETS

הרכב:

RANITIDINE AS HYDROCHLORIDE 150 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

DEXCEL LTD, ISRAEL

קבוצה תרפויטית:

RANITIDINE

איזור תרפויטי:

RANITIDINE

סממני תרפויטית:

Adults:ZARIDEX is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. Zaridex is also indicated for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and oesophageal reflux disease including long term management of healed oesophagitis. ZARIDEX 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 (6 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.

תאריך אישור:

2013-01-31

עלון מידע

_ _
ילוי
1029
ZARIDEX 150, TABLETS
ZARIDEX 300, CAPLETS
,דבכנ יאופר תווצ
לסקד תרבח
מ"עב
תשקבמ
םכעידוהל
ןוכדע לע
ב
ולע
ן
אפורל
לש
רישכתה
םי
:
סקדירז
250 ,
000
.
העדוהב
וז
םינוכדעה םיטרופמ
יתוחיטבה עדימב הרמחה םיווהמה
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.
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ן
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אפ
תואירבה דרשמ רתאבש תופורתה רגאמב
םוסרפל חלשנ
לבקל ןתינו
ספדומ ו
היינפ י"ע
לסקד :םושירה לעבל
לסקד 'חר ,מ"עב
1
רוא ,
אביקע
0363333
:'לט ,לארשי ,
30-6060333
.
בכרה
רישכתה
:
ZARIDEX 150: Each tablet contains ranitidine 150 mg (as
hydrochloride).
ZARIDEX 300: Each caplet contains ranitidine 300 mg (as
hydrochloride).
יוותה
תו
רשואמ
ו
:ת
Adults:
Zaridex is indicated for the treatment of duodenal ulcer and benign
gastric ulcer, including that associated
with non-steroidal anti-inflammatory agents. Zaridex is also indicated
for the treatment of post-operative
ulcer, Zollinger-Ellison Syndrome and oesophageal reflux disease
including long term management of
healed oesophagitis.
Zaridex 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 (6 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.
ןולעה
ל
אפור
כדוע ן
ב ךיראת
ינוי
1029
. ןלהל םינוכדעה
יתוחיטבה עדימב הרמחה םיווהמה
(
םינמוסמ
ב
םודא
)
:
4. CLINICAL PARTICULARS
]...[
4.8 UNDESIRABLE EFFECTS
]...[
IMMUNE SYSTEM DISORDE

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ZARIDEX 150, tablets
ZARIDEX 300, caplets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ZARIDEX 150 mg: Each tablet contains ranitidine 150 mg (as
hydrochloride).
Excipients with known effect:
Each tablet contains approximately 4 mg lactose.
Each tablet contains approximately 1.1 mg sodium.
ZARIDEX 300 mg: Each caplet contains ranitidine 300 mg (as
hydrochloride).
Excipients with known effect:
Each caplet contains approximately 7 mg lactose.
Each tablet contains approximately 2.2 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
150 mg tablet, 300 mg caplet.
ZARIDEX 150: Yellow, round, film-coated tablets.
ZARIDEX 300: Yellow, film-coated caplets scored on one side. The score
line
is not intended for breaking the caplet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults:
Zaridex is indicated for the treatment of duodenal ulcer and benign
gastric
ulcer, including that associated with non-steroidal anti-inflammatory
agents.
Zaridex is also indicated for the treatment of post-operative ulcer,
Zollinger-
Ellison Syndrome and oesophageal reflux disease including long term
management of healed oesophagitis. Zaridex 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 (6 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.
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 ulceration, gastric ulceration
or
oesophageal refl