PABRINEX INTRAVENOUS HIGH POTENCY SOLUTION FOR INJECTION

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pabrinex® Intravenous High Potency, Solution for injection
(Vitamins B & C Injection)
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
– Please keep this leaflet. You may
need to read it again.
– If you have any further questions,
ask your doctor.
– If you get any side effects, talk to
your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
In this leaflet:
1. What Pabrinex Intravenous
injection is and what it is used for
2. What you need to know before you
are given Pabrinex Intravenous
injection
3. How Pabrinex Intravenous
injection is given
4. Possible side effects
5. How to store Pabrinex Intravenous
injection
6. Contents of the pack and other
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 long-term intermittent
haemodialysis.
2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN
PABRINEX INTRAVENOUS
INJECTION
You MUST NOT be given Pabrinex
Intravenous injection:
• if you are allergic to any of the
ingredients of this medicine
(listed in section 6)
• if you have a history of sensitivity to
vitamins B and/or C.
Warnings and precautions
Talk to your doctor before taking
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.
Other medicines and Pabrinex
Intravenous injection
Tell your doctor if you are taking, have
recently taken, or might take, any
other medicines.

•

•

 evodopa (used in the treatment
L
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) or even
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.
Pabrinex contains sodium:
This medicinal product contains
approximately 3.4 mmol (or 79 mg)
sodium per dose (1 pair of 5ml
ampoules). To be taken into consideration
by patients on a controlled sodium diet.
This medicinal product contains
approximately 6.8 mmol (or 158mg)
sodium per dose (1 pair of 10ml
ampoules). To be taken into consideration
by patients on a controlled sodium diet.
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
ampoules, the contents of which are
first diluted with either saline or 5%
glucose solution and then given over a
period of 30 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
ampoules (1 pair) diluted with
50ml to 100ml of infusion solution
and injected over 30 minutes.
Injected twice daily for up to 7 days.
• For haemodialysis patients: 10ml
of the mixed ampoules (1 pair)
diluted with 50ml to 100ml of
infusion solution and injected over
30 minutes. Injected at the end of
dialysis, once every 2 weeks.

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

Dose

under 6 years
6-10 years
10-14 years

1/4 of the adult dose
1/3 of the adult dose
1/2 to 2/3 of the adult
dose
14 years and older one adult dose

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 medicine, ask your
doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine
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
injection and should not be given
a repeat dose.
• Severe allergic reaction
(anaphylactic shock) - may result
from repeated injections of
this medicine. 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.
• Mild ache at the site of the
injection - some swelling may
develop at the site of injection.
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.
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 this medicine out of the sight
and reach of children.
Pabrinex should be stored below 25ºC
but not frozen, and protected from
light.

Once diluted in an infusion fluid
Pabrinex should normally be used
immediately.
If necessary the diluted product can be
kept at room temperature:
For 7 hours in the following infusion
fluids:
• Glucose 5%
• Physiological saline (sodium
chloride 0.9%)
• Sodium lactate M/6;
For 4 hours in the following infusion
fluids:
• Glucose 4.3% with sodium
chloride 0.18%
• Glucose 5% with potassium
chloride 0.3%
Do not freeze diluted solution.
Do not use this medicine after the
expiry date which is stated on the
outer carton and ampoule labels after
“EXP”. The expiry date refers to the
last day of that month.
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 protect the
environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Pabrinex Intravenous injection
contains
The active ingredients are:
AMPOULE 1
thiamine
hydrochloride
(vitamin B1)
riboflavin
(vitamin B2)
pyridoxine
hydrochloride
(vitamin B6)
AMPOULE 2

5ml
250mg

10ml
500mg

4mg

8mg

50mg

100mg

ascorbic acid
(vitamin C)
nicotinamide
glucose (as
monohydrate)

500mg

1000mg

160mg
1000mg

320mg
2000mg

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 amber coloured glass ampoules
containing 5ml or 10ml of sterile
solution. Each pack contains 6 or 10
pairs of 5ml ampoules or 5 pairs of
10ml ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Kyowa Kirin Limited
Galabank Business Park
Galashiels
TD1 1QH
United Kingdom.
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landstraße 18
D-31028 Gronau/Leine
Germany.

This leaflet was last revised: 09/2016
LFT-PAB-GB-004

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pabrinex® Intravenous High Potency, Solution for injection
(Vitamins B & C Injection)
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
– Please keep this leaflet. You may need to read it
again.
– If you have any further questions, ask your doctor.
– If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet. See section 4.
In this leaflet:
1. What Pabrinex Intravenous injection is and what it
is used for
2. What you need to know before you are given
Pabrinex Intravenous injection
3. How Pabrinex Intravenous injection is given
4. Possible side effects
5. How to store Pabrinex Intravenous injection
6. Contents of the pack and other 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 long-term intermittent
haemodialysis.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN PABRINEX INTRAVENOUS INJECTION
You MUST NOT be given Pabrinex Intravenous
injection:
• if you are allergic to any of the ingredients of this
medicine (listed in section 6)
• if you have a history of sensitivity to vitamins B
and/or C.
Warnings and precautions
Talk to your doctor before taking 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.
Other medicines and Pabrinex Intravenous injection
Tell your doctor if you are taking, have recently taken,
or might take, any other medicines.
• Levodopa (used in the treatment of Parkinson’s
disease) - Pabrinex interferes with the effects of this
medicine.

•

 itamin B1 (thiamine) injections - if you are on
V
repeated injections of such preparations, Pabrinex
Intravenous injection may cause sneezing or
mild asthma (chest tightness and wheezing) or
even 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.
Pabrinex contains sodium:
This medicinal product contains approximately
3.4 mmol (or 79 mg) sodium per dose (1 pair of
5ml ampoules). To be taken into consideration by
patients on a controlled sodium diet.
This medicinal product contains approximately
6.8 mmol (or 158mg) sodium per dose (1 pair of
10ml ampoules). To be taken into consideration by
patients on a controlled sodium diet.
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 ampoules, the contents of
which are first diluted with either saline or 5% glucose
solution and then given over a period of 30 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 ampoules (1 pair)
diluted with 50ml to 100ml of infusion solution and
injected over 30 minutes. Injected twice daily for up
to 7 days.
• For haemodialysis patients: 10ml of the mixed
ampoules (1 pair) diluted with 50ml to 100ml of
infusion solution and injected over 30 minutes.
Injected at the end of dialysis, once every 2 weeks.
Use in children and adolescents: Pabrinex Intravenous
injection is not usually given to children; however,
suitable doses according to the child’s age are:
Age
under 6 years
6-10 years
10-14 years
14 years and older

Dose
1/4 of the adult dose
1/3 of the adult dose
1/2 to 2/3 of the adult dose
one adult dose

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
medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 injection and should
not be given a repeat dose.
• Severe allergic reaction (anaphylactic shock) - may
result from repeated injections of this medicine.
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.
• Mild ache at the site of the injection - some swelling
may develop at the site of injection.
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.
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 this medicine out of the sight and reach of
children.
Pabrinex should be stored below 25ºC but not frozen,
and protected from light.
Once diluted in an infusion fluid Pabrinex should
normally be used immediately.
If necessary the diluted product can be kept at room
temperature:
For 7 hours in the following infusion fluids:
• Glucose 5%
• Physiological saline (sodium chloride 0.9%)
• Sodium lactate M/6;
For 4 hours in the following infusion fluids:
• Glucose 4.3% with sodium chloride 0.18%
• Glucose 5% with potassium chloride 0.3%
Do not freeze diluted solution.

Do not use this medicine after the expiry date which
is stated on the outer carton and ampoule labels after
“EXP”. The expiry date refers to the last day of that
month.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Pabrinex Intravenous injection contains
The active ingredients are:
AMPOULE 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

glucose (as monohydrate)

1000mg

2000mg

AMPOULE 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 amber coloured glass
ampoules containing 5ml or 10ml of sterile solution.
Each pack contains 6 or 10 pairs of 5ml ampoules or
5 pairs of 10ml ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Kyowa Kirin Limited
Galabank Business Park
Galashiels
TD1 1QH
United Kingdom.
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landstraße 18
D-31028 Gronau/Leine
Germany.
This leaflet was last revised: 09/2016
LFT-PAB-GB-005