Protium i.v. 40 mg Powder for Solution for Injection

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Pantoprazole sodium sesquihydrate

Dostupné z:

Takeda Products Ireland Ltd

ATC kód:

A02BC; A02BC02

INN (Medzinárodný Name):

Pantoprazole sodium sesquihydrate

Dávkovanie:

40 milligram(s)

Forma lieku:

Powder for solution for injection

Typ predpisu:

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

Terapeutické oblasti:

Proton pump inhibitors; pantoprazole

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1998-03-20

Príbalový leták

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 ADULTS FOR
•
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 USE 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 using Protium
2
-
If you have
severe liver problems. Please tell your doctor if you have eve

Súhrn charakteristických

Health Products Regulatory Authority
06 June 2023
CRN00D38Q
Page 1 of 9
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
Protium 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 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 hyper secretory
conditions_
For the long-term management of Zollinger Ellison Syndrome and other
pathological hyper secretory 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
re