Pabrinex Intramuscular 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:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF:

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PABRINEX® INTRAMUSCULAR 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.
WHAT IS IN THIS LEAFLET
:
1.
What Pabrinex Intramuscular injection is and what it is used for
2.
What you need to know before you are given Pabrinex Intramuscular
injection
3.
How Pabrinex Intramuscular injection is given
4.
Possible side effects
5.
How to store Pabrinex Intramuscular injection
6.
Contents of the pack and other information
1.
WHAT PABRINEX INTRAMUSCULAR 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 Intramuscular 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PABRINEX
INTRAMUSCULAR INJECTION
YOU MUST NOT BE GIVEN PABRINEX INTRAMUSCULAR 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 Intramuscular injection.
Pabrinex 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 Intramuscular injection

Summary of Product characteristics

OBJECT 1
PABRINEX INTRAMUSCULAR HIGH POTENCY INJECTION
Summary of Product Characteristics Updated 12-Dec-2017 | Kyowa Kirin
Ltd
1. Name of the medicinal product
Pabrinex Intramuscular High Potency, Solution for injection
2. Qualitative and quantitative composition
Each presentation (carton) contains pairs of 5 ml and 2 ml ampoules.
Each pair of ampoules consists of
one 5 ml and one 2 ml ampoule to be used in treatment, labelled as
Pabrinex No. 1 and Pabrinex No. 2.
EACH NO. 1 AMPOULE CONTAINS:
5 ml ampoule
Thiamine Hydrochloride
250 mg
Riboflavin (as Phosphate Sodium)
4 mg
Pyridoxine Hydrochloride
50 mg
EACH NO. 2 AMPOULE CONTAINS:
2 ml ampoule
Ascorbic acid
500 mg
Nicotinamide
160 mg
Excipients with known effect:
This medicinal product contains:
- approximately 3 mmol (or 67 mg) sodium per dose (1 pair of
ampoules). To be taken into consideration
by patients on a controlled sodium diet.
- approximately 139 mg benzyl alchohol per 7 ml dose (1 pair of
ampoules). Must not be given to
premature babies or neonates. May cause toxic reactions and
anaphylactoid reactions in infants and
children up to 3 years old.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Pabrinex IM 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
• after acute infections
• post-operatively
• in psychiatric states.
4.2 Posology and method of administration
Pabrinex is also available as an Intravenous High Potency, Solution
for Injection. Therefore before
administration ensure that both the Summary of Product Characteristics
and ampoule labels refer to the
INTRAMUSCULAR injection.
Posology
Adults and elderly:
The contents of one pair of ampoules (7ml) twice daily for up to 7
days.
Paediatric population:
Pabrinex Intramuscular High Potency is rarely indicated for
administration
to children, however suitable doses are as follows:
Under