PABRINEX INTRAVENOUS HIGH POTENCY SOLUTION FOR INJECTION

Active substance: THIAMINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pabrinex® Intravenous High Potency, Solution for injection
(Vitamins B & C Injection BP)
Read all of this leaflet carefully before you start
taking this medicine.
– Please keep this leaflet. You may need to read

it again.
– If you have any further questions, ask your

doctor.
– If you suffer from any side effects that get

serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
In this leaflet:
1. 
What Pabrinex Intravenous injection is and
what it is used for
2. Before Pabrinex Intravenous injection is given
3. How Pabrinex Intravenous injection is given
4. Possible side effects
5. How to store Pabrinex Intravenous injection
6. Further information
1. WHAT PABRINEX INTRAVENOUS
INJECTION IS AND WHAT IT IS USED FOR
Vitamins B and C are important for a number of
bodily functions including releasing energy from
food and in the formation of healthy skin, bones
and teeth.
Pabrinex Intravenous High Potency, Solution
for injection (‘Pabrinex’) provides additional
vitamins B and C to correct deficiencies that may
have occurred, for example:
• in alcoholism
• after infections
• after operations
• in certain psychiatric states.
The product is also used to maintain levels of
vitamins B and C in patients who are on longterm intermittent haemodialysis.
2. BEFORE PABRINEX INTRAVENOUS
INJECTION IS GIVEN
You MUST NOT be given Pabrinex Intravenous
injection if you have:
• an allergy (hypersensitivity) to any of the

ingredients in the product (see Section 6 ‘What
Pabrinex contains’)
• a history of sensitivity to vitamins B and/or C.
Take special care with Pabrinex Intravenous
injection
Pabrinex Intravenous injection should be given
with extreme caution if you have:
• ever had a mild allergic reaction (sneezing or
mild asthma) to any previous injections of
vitamin B1 (thiamine). This could mean that
you may have become hypersensitive, and
could have a more severe allergic reaction if
given Pabrinex Intravenous injection.

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including those obtained without a
prescription. These include:
• Levodopa (used in the treatment of
Parkinson’s disease) - Pabrinex interferes with
the effects of this medicine.
• Vitamin B1 (thiamine) injections - if you are
on repeated injections of such preparations,
Pabrinex Intravenous injection may cause
sneezing or mild asthma (chest tightness and
wheezing) anaphylactic shock if you have
become hypersensitive.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, planning
to become pregnant or breast-feeding. Ask your
doctor or pharmacist before taking any medicine.
Driving and using machines
Pabrinex is not expected to affect your ability to
drive or operate machinery.
3. HOW PABRINEX INTRAVENOUS
INJECTION IS GIVEN
Pabrinex Intravenous injection will be given to
you by a healthcare professional by drip infusion
into a vein. The product comes in two vials, the
contents of which are first diluted with either
saline or 5% glucose solution and then given over
a period of 30 minutes. Alternatively, Pabrinex
Intravenous injection can be given undiluted by
mixing the contents of each vial in a syringe just
before use and injecting slowly into a vein over a
period of 10 minutes.
This medicine is for injection into a vein only
and should not be given by any other route.
Dosage for adults including the elderly:
• For rapid therapy of severe depletion or
malabsorption of water soluble vitamins B and
C, particularly in alcoholism: 2 to 3 pairs of
5ml ampoules (1 pair = ampoule 1 + ampoule
2) diluted with 50ml to 100ml of infusion
solution and injected over 30 minutes at
intervals decided by your doctor (typically
every 8 hours).
• For psychosis following unconsciousness from a
narcotic drug (narcosis) or electroconvulsive therapy,
or poisoning from infection: 10ml of the mixed
vials (1 pair) injected twice daily for up to 7
days.
• For haemodialysis patients: 10ml of the mixed
vials (1 pair) injected at the end of dialysis,
once every 2 weeks.

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Children: Pabrinex Intravenous injection is not
usually given to children; however, suitable doses
according to the child’s age are:
Age

Dose

under 6 years

1/4 of the adult dose

6-10 years

1/3 of the adult dose

10-14 years

1/2 to 2/3 of the adult dose

14 years and older

one adult dose

Scheme. Website: 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 PABRINEX
INTRAVENOUS INJECTION
Keep out of the sight and reach of children.

The exact dose you will be given will be decided
by your doctor who will monitor your condition
and determine what treatment you need. If you
feel that you have been given an inappropriate
dose or if you would like more information about
Pabrinex Intravenous injection, speak to your
doctor.
If you are given more Pabrinex Intravenous
injection than you should
This product will be given to you under medical
supervision. It is therefore unlikely that you will be
given too much. However, if you feel unwell, you
should tell your doctor immediately.
If you have any further questions on the use of
this product, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pabrinex Intravenous injection
can cause side effects, although not everybody
gets them.
• Allergic reaction - if following your injection
you experience symptoms such as sneezing
or mild asthma (chest tightness and wheezing)
tell your doctor immediately. This may be an
indication that you are sensitive to Pabrinex
Intravenous and should not be given a repeat
dose.
• Severe allergic reaction (anaphylactic shock) may result from repeated injections of this
product. Symptoms may include: swelling of
the face and or throat, rash, severe itching,
difficulty in breathing and loss of
consciousness due to very low blood pressure.
• Low blood pressure and feeling of ‘pins and
needles’ (mild paraesthesia) - can occur in
some patients given Pabrinex Intravenous.
• Mild ache - some swelling may develop at the
site where Pabrinex is injected.
If any of these side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.
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

Pabrinex should be stored below 25ºC but not
frozen, and protected from light.
The product must not be used after the expiry
date printed on the outer carton and vial labels.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Pabrinex Intravenous injection contains
The active ingredients are:
VIAL 1

5ml

10ml

thiamine hydrochloride
(vitamin B1)

250mg

500mg

riboflavin (vitamin B2)

4mg

8mg

pyridoxine hydrochloride
(vitamin B6)

50mg

100mg

ascorbic acid (vitamin C)

500mg

1000mg

nicotinamide

160mg

320mg

anhydrous glucose

1000mg

2000mg

VIAL 2

The other ingredients are: edetic acid, sodium
hydroxide and water for injections.
What Pabrinex Intravenous injection looks like
and contents of the pack
The product is supplied in pairs of yellow coloured
glass vials containing 5ml or 10ml of sterile solution.
Pack sizes contain 10 pairs of 5ml or 5 pairs of
10ml vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Archimedes Pharma UK Limited
250 South Oak Way
Green Park
Reading
RG2 6UG, UK.
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landstraße 18
D-31028 Gronau/Leine
Germany.
® Pabrinex is a registered trade mark
This leaflet was last revised: 04/2014

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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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