Pantoprazole 40 mg powder for solution for injection

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Pantoprazole sodium sesquihydrate

थमां उपलब्ध:

AS Kalceks

ए.टी.सी कोड:

A02BC02

INN (इंटरनेशनल नाम):

Pantoprazole sodium sesquihydrate

फार्मास्यूटिकल फॉर्म:

Powder for solution for injection

चिकित्सीय क्षेत्र:

pantoprazole

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2023-06-09

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION
pantoprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, pharmacist or
nurse.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Pantoprazole is and what it is used for
2.
What you need to know before you are given Pantoprazole
3.
How Pantoprazole will be given
4.
Possible side effects
5.
How to store Pantoprazole
6.
Contents of the pack and other information
1.
WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR
This medicine contains the active substance pantoprazole. It is a
selective ‘proton pump inhibitor’, a
medicine which reduces the amount of acid produced in your stomach. It
is used for treating acid
related diseases of the stomach and intestine.
This medicine is injected into a vein and will only be given to you if
your doctor thinks pantoprazole
injections are more suitable for you at the moment than pantoprazole
tablets. Tablets will replace your
injections as soon as your doctor thinks it is possible.
PANTOPRAZOLE IS USED IN ADULTS FOR TREATING:
–
reflux oesophagitis. This is an inflammation of your oesophagus (the
tube which connects your
throat to your stomach) accompanied by the regurgitation of stomach
acid.
–
stomach and duodenal ulcers.
–
Zollinger-Ellison syndrome and other conditions that cause too much
acid to be produced in the
stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PANTOPRAZOLE
YOU SHOULD NOT BE GIVEN PANTOPRAZOLE
–
if you are allergic to pantoprazole or any of the other ingredients of
this medicine (listed in
section 6).
–
if you are allergic to medicines containing other proton pump
inhibitors.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse b

उत्पाद विशेषताएं

Health Products Regulatory Authority
13 June 2023
CRN00CPP5
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole 40 mg powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg pantoprazole (as sodium sesquihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White or almost white uniform porous cake.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pantoprazole is indicated for use in adults for:

reflux oesophagitis.

gastric and duodenal ulcer.

Zollinger-Ellison syndrome and other pathological hypersecretory
conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This medicine should be administered by a healthcare professional and
under appropriate medical supervision.
Intravenous administration of pantoprazole is recommended only if oral
administration is not appropriate. Data are available
on intravenous use for up to 7 days. Therefore, as soon as oral
therapy is possible, intravenous treatment with pantoprazole
should be discontinued and 40 mg of pantoprazole should be
administered orally instead.
Posology
_Gastric and duodenal ulcer, reflux oesophagitis_
The recommended dose is 40 mg pantoprazole daily.
_Zollinger-Ellison syndrome and other pathological hypersecretory
conditions_
For the long-term management of Zollinger-Ellison syndrome and other
pathological hypersecretory conditions the
recommended initial dose is 80 mg pantoprazole daily. Thereafter, the
dose can be adjusted according to measurements of
gastric acid secretion. With daily doses above 80 mg, the dose should
be divided and given twice daily. A temporary increase
of the dose above 160 mg pantoprazole is possible but should not be
applied longer than required for adequate acid control.
In case a rapid acid control is required, an initial dose of 2 x 80 mg
pantoprazole is sufficient to manage a decrease of acid
output into the target range (< 10 mEq/h) within one hour in the
majority of