ZANTAC TABLET 150 mg (Round)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

RANITIDINE HCl EQV RANITIDINE

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

A02BA02

Dosage:

150 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

RANITIDINE HCl EQV RANITIDINE 150 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Glaxo Wellcome S.A.

Authorization status:

ACTIVE

Authorization date:

2002-10-29

Patient Information leaflet

1 

NAME OF THE MEDICINAL PRODUCT 
ZALTRAP 25 mg/ml Concentrate for Solution for Infusion 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
One ml of concentrate for solution for infusion contains 25
mg aflibercept* 
One vial of 4 ml of concentrate contains 100
mg of aflibercept 
One vial of 8 ml of concentrate contains 200
mg of aflibercept 

* Aflibercept is produced in
a Chinese hamster ovary (CHO) K-1 mammalian expression system 
by recombinant DNA technology. 

For the full list of excipients, see section List
of Excipients. 

PHARMACEUTICAL FORM 
Concentrate for solution for infusion (sterile concentrate) 
The concentrate is a clear colourless to pale yellow solution 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
ZALTRAP in combination with
irinotecan/5-fluorouracil/folinic  acid (FOLFIRI) chemotherapy 
is  indicated in adults with metastatic colorectal
cancer (MCRC) that is resistant to or has 
progressed after an oxaliplatin-containing regimen. 

POSOLOGY AND METHOD OF ADMINISTRATION 
ZALTRAP should be administered under the supervision
of a physician experienced in the use of 
antineoplastic medicinal products. 

Posology 
The recommended dose of ZALTRAP, administered as an
intravenous infusion over 1 hour, is 4 
mg/kg of body weight, followed by the FOLFIRI regimen.
This is considered as one treatment 
cycle. 

The FOLFIRI regimen to be used is irinotecan 180 mg/m
2
 intravenous infusion over 90 minutes 
and folinic acid (dl racemic) 400 mg/m² intravenous infusion
over 2 hours at the same time on 
day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400
mg/m² intravenous bolus, followed 
by 5-FU 2400 mg/m² continuous intravenous infusion over 46
hours. 

The treatment cycle is repeated every 2 weeks. 

ZALTRAP treatment should be continued until disease progression
or unacceptable toxicity 

Summary of Product characteristics

ZANTAC™
RANITIDINE HYDROCHLORIDE
QUALITATIVE AND QUANTITATIVE COMPOSITION
For all presentations, ranitidine is present as the hydrochloride
salt.
_SYRUP: _
Ranitidine 150 mg in 10 ml.
_TABLETS: _
Ranitidine 150 mg or 300 mg.
_INJECTION: _
Ranitidine 50 mg in 2 ml aqueous solution (25 mg/ml).
PHARMACEUTICAL FORM
_ORAL FORMULATIONS _
Syrup.
Tablets: film-coated.
_PARENTERAL FORMULATION _
Injection.
CLINICAL PARTICULARS
INDICATIONS
_ORAL FORMULATIONS: _
-
Duodenal ulcer and benign gastric ulcer, including that associated
with non-
steroidal anti-inflammatory agents.
-
Post-operative ulcer.
-
Reflux oesophagitis.
-
Zollinger-Ellison Syndrome.
-
Chronic episodic dyspepsia, characterised by pain (epigastric or
retrosternal)
which is related to meals or disturbs sleep but not associated with
the above
conditions.
-
Prophylaxis of stress ulceration in seriously ill patients.
-
Prophylaxis of recurrent haemorrhage from peptic ulcer.
-
Prophylaxis of Mendelson's syndrome.
_INJECTION: _
-
Duodenal ulcer.
-
Benign gastric ulcer.
-
Post-operative ulcer.
-
Reflux oesophagitis.
-
Zollinger-Ellison Syndrome.
-
Prophylaxis of stress ulceration in seriously ill.
-
Prophylaxis of recurrent haemorrhage from peptic ulcer.
-
Prophylaxis of Mendelson's syndrome.
DOSAGE AND ADMINISTRATION
GENERAL INFORMATION:
Syrup:
_ZANTAC_
syrup contains approximately 7.5%w/v ethanol (alcohol), i.e. up to 405
mg
per 5 ml spoonful (approximately a teaspoonful) which is equivalent to
about 11 ml of
beer or 5 ml of wine.
_ _
POPULATIONS
•
ADULTS/ADOLESCENTS (12 YEARS AND OVER)_ _
_ORAL FORMULATIONS: _
DUODENAL ULCER AND BENIGN GASTRIC ULCER
ACUTE TREATMENT
The standard dosage regimen for duodenal or benign gastric ulcer is
150 mg twice
daily or 300 mg once nightly. In most cases of duodenal ulcer or
benign gastric ulcer
healing occurs within 4 weeks. Healing usually occurs after a further
4 weeks in those
not fully healed after the initial 4 weeks.
In duodenal ulcer 300 mg twice daily for 4 weeks results in healing
rates which are
higher than those a