Pabrinex Intravenous High Potency No.1 solution for injection 5ml ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Thiamine hydrochloride; Pyridoxine hydrochloride; Riboflavin sodium phosphate

Available from:

Kyowa Kirin International UK NewCo Ltd

ATC code:

A11EB

INN (International Name):

Thiamine hydrochloride; Pyridoxine hydrochloride; Riboflavin sodium phosphate

Dosage:

50mg/1ml ; 10mg/1ml ; 800microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF:

Patient Information leaflet

1
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

Summary of Product characteristics

OBJECT 1
PABRINEX INTRAVENOUS HIGH POTENCY INJECTION
Summary of Product Characteristics Updated 06-Feb-2017 | Kyowa Kirin
Ltd
1. Name of the medicinal product
Pabrinex Intravenous High Potency, Solution for injection
2. Qualitative and quantitative composition
Each presentation (carton) contains either 5ml or 10ml ampoules. Each
pair of ampoules to be used in
treatment is labelled Pabrinex No 1 and Pabrinex No 2.
EACH NO 1 AMPOULE CONTAINS:
5ML AMPOULE
10ML AMPOULE
Thiamine Hydrochloride
250mg
500mg
Riboflavin (as Phosphate Sodium)
4mg
8mg
Pyridoxine Hydrochloride
50mg
100mg
EACH NO 2 AMPOULE CONTAINS:
5ML AMPOULE
10ML AMPOULE
Ascorbic Acid
500mg
1000mg
Nicotinamide
160mg
320mg
Glucose (as Monohydrate)
1000mg
2000mg
Excipients with known effect:
This medicinal product contains approximately 3.4 mmol (or 79mg)
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.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
4. Clinical particulars
4.1 Therapeutic indications
Pabrinex is indicated in adults and children for rapid therapy of
severe depletion or malabsorption of the
water soluble vitamins B and C:
• particularly in alcoholism, where a severe depletion of thiamine
can lead to Wernicke's encephalopathy
• after acute infections
• post-operatively
• in psychiatric states
Also used to maintain levels of vitamin B and C in patients on chronic
intermittent haemodialysis.
4.2 Posology and method of administration
Pabrinex is also available as an Intramuscular High Potency Injection.
Therefore before administration,
ensure that both the Summary of Product Characteristics and ampoule
labels refer to the
INTRAVENOUS injection.
_Adults and elderly:_
_RAPID THERAPY OF SEVERE DEPLETION OR MALABSORPTION OF THE WATER
SOLUBLE VITAMINS B AN