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PROTIUM I.V. 40 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): PANTOPRAZOLE SODIUM LYOPHILE / PANTOPRAZOLE SODIUM SESQUIHYDRATE

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The following information is intended
for medical or healthcare professionals only:

Protium® i.v. 40 mg powder for solution for injection
A ready-to-use solution is prepared by
injecting 10 ml of sodium chloride 9 mg/ml
(0.9 %) solution for injection into the vial
containing the dry powder. This solution may
either be administered directly or after mixing
it with 100 ml sodium chloride 9 mg/ml (0.9
%) solution for injection or glucose 55 mg/ml
(5 %) solution for injection. Glass or plastic
containers should be used for dilution.
Protium should not be prepared or mixed with
solvents other than those stated.
After preparation, the solution must be used
within 12 hours. From a microbiological
point of view, the product should be used

immediately. If not used immediately, in-use
storage times and conditions prior to use
are the responsibility of the user and would
normally not be longer than 12 hours, at no
more than 25 °C.
The medicine should be administered
intravenously over 2 - 15 minutes.
The content of the vial is for single intravenous
use only. Any product that has remained in
the container or whose visual appearance has
changed (e.g. if cloudiness or precipitation is
observed) must be discarded.
Tear off the lower section and give to patient.

Package leaflet: Information for the user

Protium® i.v. 40 mg powder for solution for injection
Pantoprazole

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 with
your liver in the past. He will check your liver
enzymes more frequently. In the case of a
rise of liver enzymes the treatment should
be stopped.
- If you are taking HIV protease inhibitors
such as atazanavir (for the treatment
of HIV-infection) at the same time as
pantoprazole, ask your doctor for specific
advice.
- Taking a proton pump inhibitor like
pantoprazole, especially over a period
of more than one year, may slightly
increase your risk of fracture in the hip,
wrist or spine. Tell your doctor if you
have osteoporosis or if you are taking
corticosteroids (which can increase the risk
of osteoporosis).
- If you are on Protium for more than
three months it is possible that the levels
of magnesium in your blood may fall.
Low levels of magnesium can be seen as
fatigue, involuntary muscle contractions,
disorientation, convulsions, dizziness or
increased heart rate. If you get any of these
symptoms, please tell your doctor promptly.
Low levels of magnesium can also lead to
a reduction in potassium or calcium levels
in the blood. Your doctor may decide to
perform regular blood tests to monitor your
levels of magnesium.
- If you have ever had a skin reaction after
treatment with a medicine similar to Protium
that reduces stomach acid.
- If you get a rash on your skin, especially in
areas exposed to the sun tell your doctor as
soon as you can, as you may need to stop
your treatment with Protium. Remember to
also mention any other ill-effects like pain in
your joints.
Tell your doctor immediately, before or
after taking this medicine, if you notice any
of the following symptoms, which could be a
sign of another, more serious, disease:
- an unintentional loss of weight
- vomiting, particularly if repeated
- vomiting blood; this may appear as dark
coffee grounds in your vomit
- you notice blood in your stools; which
may be black or tarry in appearance
- difficulty in swallowing or pain when
swallowing
- you look pale and feel weak (anaemia)
- chest pain
- stomach pain
- severe and/or persistent diarrhoea,
because this medicine has been

LFT Protium iv UK_V03.indd 1

associated with a small increase in
infectious diarrhoea.
Your doctor may decide that you need some
tests to rule out malignant disease because
pantoprazole also alleviates the symptoms of
cancer and could cause delay in diagnosing
it. If your symptoms continue in spite of
your treatment, further investigations will be
considered.
Children and adolescents
Protium is not recommended for use in
children as it has not been proven to work in
children below 18 years of age.
Other medicines and Protium
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines, including medicines obtained
without a prescription.
This is because Protium may influence the
effectiveness of other medicines, so tell your
doctor if you are taking:
- Medicines such as ketoconazole,
itraconazole and posaconazole (used to
treat fungal infections) or erlotinib (used for
certain types of cancer) because Protium
may stop these and other medicines from
working properly.
- Warfarin and phenprocoumon, which affect
the thickening, or thinning of the blood.
You may need further checks.
- Medicines used to treat HIV-infection, such
as atazanavir.
- Methotrexate (used to treat rheumatoid
arthritis, psoriasis, and cancer) – if you
are taking methotrexate your doctor may
temporarily stop your Protium treatment
because pantoprazole can increase levels of
methotrexate in the blood.
- Fluvoxamine (used to treat depression and
other psychiatric diseases – if you are taking
fluvoxamine your doctor may reduce the
dose.
- Rifampicin (used to treat infections
- St John’s wort (Hypericum perforatum) (used
to treat mild depression)
Pregnancy and breast-feeding
There are no adequate data from the use of
pantoprazole in pregnant women. Excretion
into human milk has been reported.
If you are pregnant or breast feeding, think
you may be pregnant, or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
You should use this medicine, only if your
doctor considers the benefit for you greater
than the potential risk for your unborn child
or baby.
Driving and using machines
Protium has no or negligible influence on the
ability to drive and use machines.
If you experience side effects like dizziness
or disturbed vision, you should not drive or
operate machines.
Important information about some of the
ingredients of Protium
This medicine contains less than 1 mmol
sodium (23 mg) per vial, i.e. is essentially
‘sodium- free’.

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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

3. How to take Protium
Your nurse or your doctor will administer the
daily dose to you as an injection into a vein
over a period of 2 - 15 minutes.
The recommended dose is:
Adults
-For gastric ulcers, duodenal ulcers and reflux
oesophagitis.
One vial (40 mg pantoprazole) a day.
-For the long-term treatment of
Zollinger-Ellison syndrome and other
conditions in which too much stomach acid is
produced.
Two vials (80 mg pantoprazole) a day.
Your doctor may later adjust the dose,
depending on the amount of stomach acid
you produce. If you are prescribed more than
two vials (80 mg) a day, the injections will be
given in two equal doses. Your doctor may
prescribe a temporary dose of more than four
vials (160 mg) a day. If your stomach acid level
needs to be controlled rapidly, a starting dose
of 160 mg (four vials) should be enough to
lower the amount of stomach acid sufficiently.
Patients with liver problems
If you suffer from severe liver problems, the
daily injection should be only 20 mg (half a
vial).
Use in children and adolescents
These injections are not recommended for use
in children and adolescents under 18 years.
If you use more Protium than you should
These doses are carefully checked by your
nurse or your doctor so an overdose is
extremely unlikely. There are no known
symptoms of overdose.
If you have any further questions about
the use of this medicine, ask your doctor,
pharmacist or nurse.

07.12.15 09:26

Other side effects are:
- Common (may affect up to 1 in 10 people)
Inflammation of the wall of the vein and
blood clotting (thrombophlebitis) where the
medicine is injected.
- Uncommon (may affect up to 1 in 100
people)
Headache; dizziness; diarrhoea; feeling sick,
vomiting; bloating and flatulence (wind);
constipation; dry mouth; abdominal pain
and discomfort; skin rash, exanthema,
eruption; itching; feeling weak, exhausted
or generally unwell; sleep disorders; fracture
in the hip, wrist or spine.
- Rare (may affect up to 1 in 1,000 people)
Distortion or complete lack of the sense of
taste; disturbances in vision such as blurred
vision; hives; pain in the joints; muscle pains;
weight changes; raised body temperature;
high fever; swelling of the extremities
(peripheral oedema); allergic reactions;
depression; breast enlargement in males.
- Very rare (may affect up to 1 in 10,000
people)
Disorientation.
- Not known (frequency cannot be estimated
from the available data)
Hallucination, confusion (especially in
patients with a history of these symptoms);
decreased sodium level in blood, decreased
magnesium level in blood (see section
2), feeling of tingling, prickling, pins and
needles, burning sensation or numbness ,
rash, possibly with pain in the joints.
Side effects identified through blood
tests:
- Uncommon (may affect up to 1 in 100
people)
an increase in liver enzymes.
- Rare (may affect up to 1 in 1,000 people)
an increase in bilirubin; increased fat levels
in blood; sharp drop in circulating granular
white blood cells, associated with high fever.
- Very Rare (may affect up to 1 in 10,000
people)
a reduction in the number of blood
platelets, which may cause you to bleed or
bruise more than normal; a reduction in the
number of white blood cells, which may
lead to more frequent infections; coexisting
abnormal reduction in the number of red
and white blood cells, as well as platelets.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You
can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard. By reporting side effects you can
help provide more information on the safety of
this medicine.

appearance has changed (e.g. if cloudiness or
precipitation is observed).
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other
information
What Protium contains
- The active substance is pantoprazole. Each
vial contains 40 mg of pantoprazole.
- The other ingredients are: disodium edetate
and sodium hydroxide (for pH adjustment).
What Protium looks like and contents of
the pack
Protium is a white to off-white powder for
solution for injection. It comes in a 10 ml clear
glass vial closed with an aluminium cap and
grey rubber stopper containing 40 mg powder
for solution for injection.
Protium is available in the following pack sizes:
Pack with 1 vial.
Pack with 5 (5x1) vials.
Hospital pack with 1 vial.
Hospital pack with 5 (5x1) vials.
Hospital pack with 10 (10x1) vials.
Hospital pack with 20 (20x1) vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Takeda GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz, Germany
Manufacturer
Takeda GmbH
Production site Singen
Robert-Bosch-Straße 8
D-78224 Singen
Germany
This medicine is authorised in the Member
States of the EEA under the following
names:
Name of Member
State

Name of the
medicinal product

Austria

Pantoloc 40 mgTrockenstechampulle

Cyprus,
Czech Republic,
Greece, Hungary,
Romania, Slovakia

Controloc i.v.

Denmark, Sweden

Pantoloc

Finland

SOMAC 40 mg
powder for solution
for injection

France

Eupantol 40 mg
poudre pour solution
injectable IV

Germany,
Netherlands

Pantozol i.v.

Ireland, UK

Protium i.v.

Italy

Pantorc

Norway

Somac

Poland

Controloc 40 mg

Portugal

Pantoc IV

Slovenia

Controloc 40 mg
prašek za raztopino za
injiciranje

Spain

Anagastra 40 mg
polvo para solución
inyectable I.V.

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4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you get any of the following side
effects, tell your doctor immediately, or
contact the casualty department at your
nearest hospital:
- Serious allergic reactions (frequency
rare: may affect up to 1 in 1,000 people):
swelling of the tongue and/or throat,
difficulty in swallowing, hives (nettle rash),
difficulties in breathing, allergic facial
swelling (Quincke’s oedema / angioedema),
severe dizziness with very fast heartbeat and
heavy sweating.
- Serious skin conditions (frequency not
known: frequency cannot be estimated
from the available data): blistering of
the skin and rapid deterioration of your
general condition, erosion (including
slight bleeding) of eyes, nose, mouth/lips
or genitals (Stevens-Johnson-Syndrome,
Lyell-Syndrome, Erythema multiforme), and
sensitivity to light.
- Other serious conditions (frequency
not known): yellowing of the skin or
whites of the eyes (severe damage to liver
cells, jaundice) or fever, rash, and enlarged
kidneys sometimes with painful urination,
and lower back pain (serious inflammation
of the kidneys), possibly leading to kidney
failure.

This leaflet was last revised in 11/2015.

5. How to store Protium
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date,
which is stated on the carton and the vial after
EXP. The expiry date refers to the last day of
that month.
Do not store above 25 °C.
Keep the vial in the outer carton in order to
protect it from light.
Use the reconstituted solution within 12 hours.
Use the reconstituted and diluted solution
within 12 hours.
From a microbiological point of view, the
product should be used immediately. If not
used immediately, in-use storage times and
conditions prior to use are the responsibility
of the user and would normally not be longer
than 12 hours at not more than 25 °C.
Do not use Protium if you notice that the visual
GBR R0x/xxxx/6069878

LFT Protium iv UK_V03.indd 2

07.12.15 09:26

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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