PROTIUM I.V 40 Milligram Pdr for Soln for Injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

PANTOPRAZOLE SODIUM HYDRATE

זמין מ:

Takeda UK Limited

קוד ATC:

A02BC02

INN (שם בינלאומי):

PANTOPRAZOLE SODIUM HYDRATE

כמות:

40 Milligram

טופס פרצבטיות:

Pdr for Soln for Injection

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Proton pump inhibitors

מצב אישור:

Transfer Pending

תאריך אישור:

2016-09-02

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTIUM
® I.V. 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 Protium is and what it is used for
2.
What you need to know before you use Protium
3.
How to use Protium
4.
Possible side effects
5.
How to store Protium
6.
Contents of the pack and other information
1.
WHAT PROTIUM IS AND WHAT IT IS USED FOR
Protium contains the active substance pantoprazole. Protium 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 preparation 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 sees fit.
PROTIUM IS USED FOR TREATING:

Reflux oesophagitis. 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 producing too much
acid in the stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROTIUM
DO NOT USE PROTIUM
-
If you are allergic to pantoprazole or to 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, pharmacist or nurse before taking Protium
-
If you have severe liver problems. Please tell your doctor if you ever
had problems

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Protium i.v. 40 mg Powder for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg pantoprazole (as sodium sesquihydrate)
Excipients with known effect:
Each vial contains 1 mg disodium edetate and 0.24 mg sodium hydroxide.
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. is essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection
White to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
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 Protium 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, treatment with Protium i.v. should be
discontinued and 40 mg pantoprazole p.o. should be administered
instead.
Posology
Gastric and duodenal ulcer, reflux oesophagitis
The recommended intravenous dose is one vial of Protium (40 mg
pantoprazole) per day.
Zollinger-Ellison-Syndrome and other pathological hypersecretory
conditions
For the long-term management of Zollinger-Ellison-Syndrome and other
pathological hypersecretory conditions
patients should start their treatment with a daily dose of 80 mg
Protium. Thereafter, the dose can be titrated up or down
as needed using measurements of gastric acid secretion to guide. With
doses above 80 mg daily, 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, a starting dose of 2 x 80 mg
Protium is suffici