Pabrinex Intramuscular High Potency, Solution for injection
Pabrinex
Vitamins and InfusionIntramuscular high-potency vitamin B and C injection
Certifications
- UK Licensed prescription Only medicinal product with Marketing Authorisation number PL 16508/0058.
- Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
- Classified pharmacotherapeutically as vitamin B Complex with vitamin C (ATC code A11EB).
- Manufactured and controlled in accordance with EU/UK Good Manufacturing Practice (GMP) for parenteral medicinal products.
- Subject to ongoing pharmacovigilance and safety monitoring through the MHRA Yellow Card scheme.
- UK Licensed prescription Only medicinal product with Marketing Authorisation number PL 16508/0058.
- Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
- Classified pharmacotherapeutically as vitamin B Complex with vitamin C (ATC code A11EB).
- Manufactured and controlled in accordance with EU/UK Good Manufacturing Practice (GMP) for parenteral medicinal products.
- Subject to ongoing pharmacovigilance and safety monitoring through the MHRA Yellow Card scheme.
Intramuscular high-potency vitamin B and C injection
Description
Pabrinex Intramuscular High Potency is a prescription-only (POM) solution for injection containing high doses of water-soluble vitamins B and C. It is presented as pairs of amber glass ampoules (one 5 ml and one 2 ml), labelled Pabrinex No. 1 and Pabrinex No. 2, which are mixed immediately before intramuscular injection. Pabrinex IM is indicated in adults and children for rapid therapy of severe depletion or malabsorption of vitamins B and C, particularly in alcoholism, after acute infections, post-operatively and in certain psychiatric states, where oral replacement is inadequate or not feasible.
Bnefits
- Provides rapid replacement of water-soluble vitamins B and C in states of severe depletion or malabsorption.
- High-potency combination of thiamine (B1), riboflavin (B2), pyridoxine (B6), nicotinamide and vitamin C in a single intramuscular preparation.
- Particularly important in alcoholism, where severe thiamine depletion can lead to Wernicke’s encephalopathy, helping support recommended treatment protocols.
- Useful after acute infections, in the post-operative period and in certain psychiatric states where nutritional intake and absorption may be compromised.
- Intramuscular route allows administration when intravenous access is not available and when oral therapy is unsuitable.
- Clear posology and method-of-administration guidance from an up-to-date SmPC support safe, standardised use in hospital and community settings.
- Reduces the need for multiple separate vitamin injections by providing a combined B- and C-vitamin product.
- Backed by long-standing clinical experience and included in numerous national and local guidelines for thiamine replacement in alcohol-related deficiency.
Indications
- Rapid therapy of severe depletion or malabsorption of the water-soluble vitamins B and C in adults and children:
- • particularly in alcoholism
- • after acute infections
- • post-operatively
- • in psychiatric states.
Composition
- Each presentation (carton) contains pairs of 5 ml and 2 ml ampoules, to be used together in treatment (one of each per dose), labelled Pabrinex No. 1 and Pabrinex No. 2.
- Each No. 1 ampoule (5 ml) contains: Thiamine hydrochloride (vitamin B1) 250 mg; Riboflavin (as phosphate sodium) (vitamin B2) 4 mg; Pyridoxine hydrochloride (vitamin B6) 50 mg.
- Each No. 2 ampoule (2 ml) contains: Ascorbic acid (vitamin C) 500 mg; Nicotinamide 160 mg.
- Excipients with known effect in the combined 7 ml dose (one pair of ampoules) include sodium (as phosphate sodium and/or sodium hydroxide) and benzyl alcohol.
- Each 7 ml dose (one pair of ampoules) contains approximately 67 mg sodium (about 3.4% of the WHO recommended maximum daily intake of 2 g for an adult) and approximately 139 mg benzyl alcohol (19.9 mg/ml).
Formulation
- Pharmaceutical form: Solution for injection.
- Colour: clear to pale yellow solution in amber glass ampoules.
- Pharmacotherapeutic group: Vitamin B-complex with vitamin C, ATC code A11EB.
- Presented as a pair of ampoules (5 ml and 2 ml) to be mixed in the syringe immediately before intramuscular administration.
- Intended exclusively for deep intramuscular injection; not for intravenous use or any other route.
Packaging
- Supplied as pairs of 5 ml (No. 1) and 2 ml (No. 2) amber glass ampoules in a single carton.
- Typical pack: 10 pairs of ampoules (10 × 5 ml No. 1 ampoules and 10 × 2 ml No. 2 ampoules).
- Each ampoule is labelled with the product name (Pabrinex Intramuscular High Potency), ampoule number (No. 1 or No. 2), volume, active ingredients and batch/expiry details.
- Outer carton carries the product name, strength, route of administration (intramuscular), pack size, Marketing Authorisation number, batch number, expiry date and storage instructions.
- Prescription Only Medicine (POM) in the UK.
Usage
- Pabrinex Intramuscular High Potency is for intramuscular injection only. Before administration, ensure both the SmPC and ampoule labels clearly refer to INTRAMUSCULAR injection.
- Visually inspect each ampoule before use. Do not use if particulates are present, if the solution is discoloured or if the ampoule is damaged.
- Adults and elderly: the usual dose is the contents of one pair of ampoules (total 7 ml) given twice daily for up to 7 days, or as clinically indicated.
- Paediatric population: Pabrinex IM is rarely indicated in children; where used, typical age-related doses are: under 6 years – one quarter of the adult dose; 6–10 years – one third of the adult dose; 10–14 years – half to two thirds of the adult dose; 14 years and over – adult dose. Use only if clearly indicated by a specialist.
- Immediately before injection, draw the contents of one No. 1 ampoule (5 ml) and one No. 2 ampoule (2 ml) into the same syringe to mix thoroughly.
- Administer the 7 ml mixture by slow deep intramuscular injection, high into the gluteal muscle, approximately 5 cm below the iliac crest, using an appropriate needle length for deep IM injection.
- Facilities for treating anaphylactic reactions must be available whenever Pabrinex IM is given. Discontinue the injection immediately if signs of hypersensitivity (e.g. sneezing, wheeze, rash) occur and initiate appropriate treatment.
- Take care to avoid inadvertent administration by the wrong route (e.g. intravenous) and always check the product and route before administration.
- Any unused solution remaining in the syringe after administration must be discarded; do not store or reuse.
- Dispose of used ampoules, syringes and sharps according to local clinical waste policies and regulations.
Contraindications
- Hypersensitivity to any of the active substances (thiamine, riboflavin, pyridoxine, ascorbic acid, nicotinamide) or to any of the excipients (including benzyl alcohol and sodium-containing excipients).
- History of sensitivity reactions to vitamins B and/or C injections.
- Because of the benzyl alcohol content, particular caution is required in premature infants, neonates and young children, and use should follow the detailed cautions given in the SmPC.
Adverse Effects
- Immune system disorders (frequency unknown): hypersensitivity reactions including anaphylaxis, rash and urticaria.
- Nervous system disorders (frequency unknown): paraesthesia.
- Vascular disorders (frequency unknown): hypotension.
- General disorders and administration site conditions (frequency unknown): injection site reactions including pain and swelling.
- Initial warning signs of a reaction may include sneezing or mild asthma (chest tightness and wheezing); further injections in such patients may lead to anaphylactic shock.
- As with all parenteral products, local discomfort at the injection site may occur.
- In the unlikely event of overdose, treatment is symptomatic and supportive.
Storage Conditions
- Store in a refrigerator at 2°C to 8°C.
- Keep the ampoules in the outer carton to protect from light.
- Do not freeze.
- Keep out of the sight and reach of children.
- Do not use after the expiry date stated on the carton and ampoules.
Duration
Treatment duration is determined by the prescribing clinician according to indication and clinical response. For rapid correction of deficiency states (e.g. alcohol-related thiamine deficiency), Pabrinex IM is commonly given at a dose of one pair of ampoules twice daily for up to 7 days before switching to oral vitamin supplementation, in line with local protocols.
Onset
Onset of vitamin replacement is rapid following intramuscular administration, with improvement in biochemical deficiency and clinical symptoms typically observed over hours to days depending on the severity of deficiency and underlying condition.
