PABRINEX N/A Solution for Inj/Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

THIAMINE HYDROCHLORIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, NICOTINAMIDE, ASCORBIC ACID, GLUCOSE (AS MONOHYDRATE)

Available from:

Archimedes Pharma UK Limited

ATC code:

A11EB

INN (International Name):

THIAMINE HYDROCHLORIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, NICOTINAMIDE, ASCORBIC ACID, GLUCOSE (AS MONOHYDRATE)

Dosage:

N/A

Pharmaceutical form:

Solution for Inj/Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Vitamin B-complex with vitamin C

Authorization status:

Authorised

Authorization date:

1997-08-20

Patient Information leaflet

PHARMACODE
POSITION GUIDE
DOES NOT PRINT
PHARMACODE
POSITION GUIDE
DOES NOT PRINT
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PABRINEX INTRAVENOUS HIGH POTENCY,
SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
ARE GIVEN 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 or nurse.
-
If you get any side effects talk to your
doctor or nurse. This includes any possible
side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Pabrinex Intravenous is and what it is
used for
2.
What you need to know before you are
given Pabrinex Intravenous
3.
How Pabrinex Intravenous is given
4.
Possible side effects
5.
How to store Pabrinex Intravenous
6.
Contents of the pack and other
information
1. WHAT PABRINEX INTRAVENOUS IS AND WHAT IT
IS USED FOR
Pabrinex Intravenous High Potency Solution
for Infusion (‘Pabrinex Intravenous’) provides
additional thiamine hydrochloride, riboflavin,
pyridoxine hydrochloride and nicotinamide
(B vitamins); ascorbic acid (vitamin C); and
glucose to correct deficiencies that may have
occurred:
•
in alcoholism
•
through unbalanced diet (malnutrition) or
•
poor absorption (malabsorption) of the
water soluble vitamins B and C.
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.
This medicine will be given to you by a healthcare
professional by drip infusion into a vein.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN PABRINEX INTRAVENOUS
YOU MUST NOT BE GIVEN PABRINEX INTRAVENOUS:
•
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 or nurse before you are
given Pabrinex Intravenous.
Pabrinex Intravenous should be given with
extreme caution if you have:
•
ever had a mild alle

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pabrinex Intravenous High Potency Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each presentation (carton) contains 5 ml ampoules. Each pair of
ampoules to be used in treatment is labelled Pabrinex
No 1 and Pabrinex No 2.
Each No. 1 ampoule (5 ml) contains:
Thiamine Hydrochloride 250 mg
Riboflavin (as Phosphate Sodium) 4 mg
Pyridoxine Hydrochloride 50 mg
Each No. 2 ampoule (5 ml) contains:
Ascorbic Acid 500 mg
Nicotinamide 160 mg
Glucose (as monohydrate) 1000 mg
Excipients with known effect:
This medicinal product contains approximately 3.4 mmol (or 79 mg)
sodium per dose (1 pair of 5 ml 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 infusion
Ampoule No 1
Yellow coloured solution in an amber glass ampoule
Ampoule No 2
Yellow coloured solution in an amber glass ampoule
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pabrinex is indicated in adults 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.
Wernicke’s encephalopathy may also occur as a consequence of other
medical conditions.
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