Summary of Product Characteristics
复合维生素BC注射液
1 NAME OF THE MEDICINAL PRODUCT
Pabrinex Intravenous High Potency Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or 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
In the management of alcoholism for rapid therapy of severe depletion or malabsorption of the water soluble vitamins
B and C.
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.
Facilities for resuscitation and for treating anaphylactic reactions should be available whenever Pabrinex Intravenous
High Potency is administered.
The preferred method of administration of Pabrinex Intravenous High Potency is by drip infusion.
The contents of each pair of ampoules should be diluted with 50 to 100ml physiological saline or 5% glucose and
infused over 15 to 30 minutes (see “Special Precautions and Storage” section).
Alternatively the contents of each pair of ampoules (total 10ml) are drawn up into a syringe to mix them just before
use, then injected slowly, over a period of not less than 10 minutes, into a vein.
Adults:
Each No. 1 5 ml ampoule contains:
Thiamine Hydrochloride 250 mg
Riboflavine (as Phosphate Sodium) 4 mg
Pyridoxine Hydrochloride 50 mg
Each No. 2 5ml ampoule contains:
Ascorbic Acid 500 mg
Nicotinamide 160 mg
Anhydrous Glucose 1 gm
Irish Medicines Board
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Date Printed 05/09/2011 CRN 2105163 page number: 1
Coma or delirium from alcohol. The contents of 2 to 3 pairs of ampoules injected at intervals of 8 hours or at the
discretion of the physician.
Elderly: As for adults.
4.3 Contraindications
Known hypersensitivity to any of the active constituents.
4.4 Special warnings and precautions for use
Injections of preparations containing high concentrations of vitamin B1 (thiamine) may give rise to anaphylactic shock.
Mild allergic reactions such as sneezing or mild asthma are warning signs that further injections may give rise to
anaphylactic shock, although this may also occur with the first injection. Use should be restricted to patients in whom
parenteral treatment is essential.
Not for intramuscular use.
4.5 Interaction with other medicinal products and other forms of interaction
The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.
4.6 Fertility, pregnancy and lactation
No adverse effects have been noted at recommended doses when used as clinically indicated.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Skin rash, sweating, nausea, vomiting, bronchospasm, hypotension and anaphylaxis have been reported. Paraesthesia
and occasionally mild ache at local site of injection.
4.9 Overdose
In the unlikely event of overdosage, treatment is symptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pabrinex Intravenous High Potency contains vitamins B1, B2, B6, nicotinamide and vitamin C.
ATC code: A11EB.
5.2 Pharmacokinetic properties
Not supplied.
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5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other
sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Edetic acid
Sodium hydroxide
Water for injections
6.2 Incompatibilities
None reported.
6.3 Shelf life
2 years.
Once mixed or diluted, it should be used immediately.
6.4 Special precautions for storage
Do not store above 25°C. Protect from light. Do not freeze.
6.5 Nature and contents of container
Pabrinex Intravenous High Potency is supplied in pairs of 5ml amber Type I glass ampoules in packs of 10 pairs.
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from
such medicinal product and other handling of the product
The two 5ml ampoules (a No.1 and a No.2) each containing sterile yellow coloured aqueous solutions are to be mixed
prior to administration. If it is necessary to administer Pabrinex Intravenous High Potency in infusion, the mixed
solution should be further diluted in physiological saline or 5% glucose.
Once diluted in either of these solutions, it should be used immediately.
7 MARKETING AUTHORISATION HOLDER
Archimedes Pharma UK Limited
250 South Oak Way
Green Park
Reading
Berkshire
RG2 6UG
UK
8 MARKETING AUTHORISATION NUMBER
PA 757/7/1
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9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20 August 1987
Date of last renewal: 20 August 2007
10 DATE OF REVISION OF THE TEXT
October 2010
Irish Medicines Board