Table of Contents
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
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Pabrinex Intramuscular High Potency, Solution for injection
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Each presentation (carton) contains either 5ml or 2ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2.
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Each No. 1 ampoule contains: |
5ml ampoule |
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Thiamine Hydrochloride BP |
250mg |
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Riboflavin (as Phosphate Sodium BP) |
4mg |
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Pyridoxine Hydrochloride BP |
50mg |
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Each No. 2 ampoule contains: |
2ml ampoule |
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Ascorbic acid BP |
500mg |
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Nicotinamide BP |
160mg |
For a full list of excipients, see section 6.1.
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Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, after acute infections, post-operatively and in psychiatric states.
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Pabrinex is also available as an Intravenous High Potency Injection. Therefore before administration ensure that both the Summary of Product Characteristics and ampoule labels refer to the INTRAMUSCULAR injection.
The contents of one ampoule number 1 and one ampoule number 2 of Pabrinex Intramuscular High Potency (total 7ml) are drawn up into a syringe to mix them just before use, then injected slowly high into the gluteal muscle, 5cm below the iliac crest.
Adults: The contents of one pair of ampoules (7ml) twice daily for up to 7 days.
Elderly: As for adults.
Children: Pabrinex Intramuscular High Potency is rarely indicated for administration to children, however suitable doses are as follows:
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Under 6 years |
quarter of the adult dose |
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6-10 years |
third of the adult dose |
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10-12 years |
half to two thirds of the adult dose |
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14 years and over |
as for the adult dose |
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Known hypersensitivity to any of the active constituents or to the excipients.
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Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex Intramuscular, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex Intramuscular in patients who need treatment by this route of administration. Initial warning signs of a reaction to Pabrinex Intramuscular are sneezing or mild asthma, and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intramuscular High Potency is administered.
This medicine is for injection into a muscle only and should not be given by any other route
Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended – reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.
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The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.
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No adverse effects have been noted at recommended doses when used as clinically indicated.
However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown.
Caution should be exercised when prescribing to pregnant women.
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Adverse reactions reported as possibly associated to Pabrinex are presented in the following table by MedDRA System Organ Class (SOC), Preferred Term and frequency. The following frequency categories are used:
Very common (>1/10);
Common (>1/100, <1/10);
Uncommon (>1/1,000, <1/100);
Rare (>1/10,000, <1/1,000);
Very rare (<1/10,000), including isolated reports.
Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure. Therefore it is not possible to estimate the true incidence of adverse reactions and the frequency is “unknown”.
Tabulated summary of adverse reactions
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SYSTEM ORGAN CLASS (SOC)
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FREQUENCY
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ADVERSE REACTION
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Immune system disorders
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Unknown
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Hypersensitivity (including anaphylaxis, rash and urticaria)
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Nervous system disorders
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Unknown
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Paraesthesia
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Vascular disorders
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Unknown
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Hypotension
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General disorders and administration site conditions
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Unknown
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Injection site reactions (including pain and swelling)
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In the unlikely event of over dosage, treatment is symptomatic and supportive.
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Pabrinex Intramuscular High Potency contains vitamins B1, B2, B6, nicotinamide and vitamin C.
ATC code: A11EB
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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.
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Edetic acid
Sodium hydroxide
Benzyl alcohol
Water for Injections
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Store in a refrigerator at 2°C to 8°C. Keep the container in the outer carton. Do not freeze.
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Pabrinex Intramuscular High Potency is supplied in pairs of (5ml and 2ml) amber glass ampoules in packs of 10 pairs.
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In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.
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Archimedes Pharma UK Limited
250 South Oak Way
Green Park
Reading
Berkshire
RG2 6UG
UK
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Date of first authorisation: October 1993
Date of the latest renewal: October 2003
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