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Pabrinex Intramuscular High Potency Solution For Injection

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SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT

Pabrinex Intramuscular High Potency, Solution for injection

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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.

Each No. 1 ampoule contains:

5ml ampoule

Thiamine Hydrochloride

250mg

Riboflavin (as Phosphate Sodium)

4mg

Pyridoxine Hydrochloride

50mg

Each No. 2 ampoule contains:

2ml ampoule

Ascorbic acid

500mg

Nicotinamide

160mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

4.    CLINICAL PARTICULARS

4.1 Therapeutic indications

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, after acute infections, postoperatively and in psychiatric states.

4.2 Posology and method of administration

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:

Under 6 years 6-10 years 10-12 years 14 years and over


quarter of the adult dose

third of the adult dose

half to two thirds of the adult dose

as for the adult dose

4.3 Contraindications

Known hypersensitivity to any of the active constituents or to the excipients.

4.4 Special warnings and precautions for use

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.

4.5 Interactions 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.

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.

None stated.

4.8 Undesirable effects

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

SYSTEM ORGAN CLASS (SOC)

FREQUENCY

ADVERSE REACTION

Immune system disorders

Unknown

Hypersensitivity (including anaphylaxis, rash and urticaria)

Nervous system disorders

Unknown

Paraesthesia

Vascular disorders

Unknown

Hypotension

General disorders and administration site conditions

Unknown

Injection site reactions (including pain and swelling)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9


Overdose

In the unlikely event of over dosage, treatment is symptomatic and supportive.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pabrinex Intramuscular High Potency contains vitamins B1, B2, B6, nicotinamide and vitamin C.

ATC code: A11EB

5.2 Pharmacokinetic properties

None supplied.

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 Benzyl alcohol Water for Injections

6.2 Incompatibilities

None stated.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Store in a refrigerator at 2°C to 8°C. Keep the container in the outer carton. Do not freeze.

6.5 Nature and contents of container

Pabrinex Intramuscular High Potency is supplied in pairs of (5ml and 2ml) amber glass ampoules in packs of 10 pairs.

6.6    Special precautions for disposal

In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

7    MARKETING AUTHORISATION HOLDER

Archimedes Pharma UK Limited Galabank Business Park Galashiels TD1 1QH United Kingdom

8.


MARKETING AUTHORISATION NUMBER

PL 12406/0004

9.


10


DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION

Date of first authorisation: October 1993 Date of the latest renewal: October 2003

DATE OF REVISION OF THE TEXT

18/05/2015