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

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

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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
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 illeffects like pain in your joints.
- if you are due to have a specific blood test
(Chromogranin A).
Tell your doctor immediately, before or
after taking this medicine, if you notice any

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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
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’.
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

23.01.17 15:21

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): frequency cannot be
estimated from the available data):
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.
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; benign polyps in
the stomach.
- 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.
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 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 UK Limited
Building 3,
Glory Park,
Glory Park Avenue,
Wooburn Green,
Bucks,
HP10 0DF
UK
Manufacturer
Takeda GmbH
Production site Singen
Robert-Bosch-Straße 8
D-78224 Singen
Germany

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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.

This leaflet was last revised in 03/2017.

GBR R0x/xxxx/6069878

LFT Protium iv GBR_V01.indd 2

23.01.17 15:21

Expand Transcript

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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