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Pabrinex Intramuscular High Potency, Solution for Injection (5 ml + 2 ml ampoules)

Pabrinex Intramuscular High Potency, Solution for Injection (5 ml + 2 ml ampoules)

Pabrinex

Medicinal Products
  • UK marketing authorisation for Pabrinex Intramuscular High Potency, Solution for injection held by Kyowa Kirin Limited (PL 16508/0058).
  • Product information (SmPC and PIL) published on the electronic Medicines Compendium (emc) and kept up to date in collaboration with the MHRA.
  • Classified as a prescription Only medicine (POM) in the United Kingdom.
  • Manufactured in accordance with Good Manufacturing Practice (GMP) for parenteral medicinal products.
  • ATC classification A11EB (vitamin B Complex with vitamin C, parenteral preparations).
  • Subject to UK pharmacovigilance, including reporting of suspected adverse reactions via the MHRA Yellow Card scheme.
  • Distributed and dispensed only through licensed pharmaceutical wholesalers and GPhC Registered pharmacies in accordance with UK medicines legislation.
Intramuscular high-potency vitamin B and C solution for injection

Description

Pabrinex Intramuscular High Potency, Solution for injection is a prescription-only parenteral vitamin preparation that provides high doses of water-soluble vitamins B and C for rapid correction of severe depletion or malabsorption. Each presentation (carton) contains pairs of amber glass ampoules: one 5 ml ampoule (Pabrinex No. 1) containing thiamine (vitamin B1), riboflavin (vitamin B2) and pyridoxine (vitamin B6), and one 2 ml ampoule (Pabrinex No. 2) containing ascorbic acid (vitamin C) and nicotinamide, together with excipients including sodium and benzyl alcohol. The product is indicated in adults and children for rapid therapy of severe deficiency or malabsorption of water-soluble vitamins B and C, particularly in alcoholism (where thiamine depletion can lead to Wernicke’s encephalopathy), after acute infections, post-operatively and in certain psychiatric states. For intramuscular use, the contents of one 5 ml No. 1 ampoule and one 2 ml No. 2 ampoule (total 7 ml) are drawn up into a syringe, mixed immediately before use and injected slowly deep into the gluteal muscle. Adult dosing is typically one pair of ampoules twice daily for up to 7 days, with paediatric doses based on fractions of the adult dose. In aesthetic and wellness practice, Pabrinex IM is sometimes incorporated into clinician-prescribed vitamin injection protocols to support patients at risk of deficiency, but it remains a hospital-grade medicine that must only be administered by trained healthcare professionals with facilities to manage anaphylaxis.

Bnefits

  • Provides rapid parenteral replacement of key water-soluble vitamins B1, B2, B6, nicotinamide (B3) and C in patients with severe depletion or malabsorption.
  • Particularly important for prevention and treatment of thiamine deficiency in patients with alcohol dependence and risk of Wernicke’s encephalopathy.
  • Supports normal carbohydrate metabolism, energy production and nervous system function through high-dose B-complex vitamins.
  • Delivers a high dose of vitamin C, contributing to antioxidant activity, immune support and tissue repair.
  • Administered intramuscularly, bypassing the gastrointestinal tract and providing an option for patients unable to take or absorb oral vitamins.
  • Dosing regimens for rapid therapy in alcoholism, post-infectious states, post-operative care, psychiatric states and haemodialysis patients are clearly defined in the SmPC.
  • Can be used in adults and children (with age-adjusted doses) when rapid vitamin replacement is clinically indicated.
  • Widely used and well-established in hospital protocols and guidelines for rapid treatment of vitamin B and C deficiency and for high-risk patients (e.g. malnutrition, refeeding risk, alcohol-related presentations).
  • Recognised and used within aesthetic/wellness medicine settings (under prescription) to support patients with poor nutritional status or high demand for B and C vitamins as part of broader treatment plans.

Indications

  • Rapid therapy of severe depletion or malabsorption of the water-soluble vitamins B and C in adults and children.
  • Particularly indicated in alcoholism, where severe thiamine depletion can lead to Wernicke’s encephalopathy.
  • Use after acute infections, when increased requirements or losses of vitamins may predispose to deficiency.
  • Use post-operatively in patients at risk of or with established vitamin B and C deficiency.
  • Use in certain psychiatric states where deficiency of these vitamins may contribute to clinical presentation.
  • Used to correct significant deficiency states associated with malnutrition, poor diet or malabsorption where oral supplementation is inadequate or not feasible.
  • Use in patients on chronic intermittent haemodialysis to maintain appropriate levels of vitamins B and C (often IV formulations are used; IM can be used where clinically appropriate and stocked).

Composition

  • Each presentation (carton) contains pairs of 5 ml and 2 ml amber glass ampoules: one No. 1 ampoule (5 ml) and one No. 2 ampoule (2 ml) to be used together for treatment.
  • Each Pabrinex No. 1 ampoule (5 ml) contains: Thiamine hydrochloride (vitamin B1) 250 mg; Riboflavin (as riboflavin sodium phosphate, vitamin B2) 4 mg; Pyridoxine hydrochloride (vitamin B6) 50 mg.
  • Each Pabrinex No. 2 ampoule (2 ml) contains: Ascorbic acid (vitamin C) 500 mg; Nicotinamide 160 mg.
  • Excipients with known effect: sodium (from sodium phosphate and/or sodium hydroxide) and benzyl alcohol.
  • Full list of excipients (both ampoules): edetic acid, sodium hydroxide, benzyl alcohol and water for injections.
  • Each 7 ml adult dose (one pair of ampoules) contains approximately 67 mg sodium (around 3.4% of WHO recommended maximum daily sodium intake for an adult) and approximately 139 mg benzyl alcohol (about 19.9 mg/ml).

Formulation

  • Pharmaceutical form: solution for injection.
  • Parenteral vitamin preparation combining high concentrations of water-soluble vitamins B1, B2, B6, nicotinamide and vitamin C.
  • Supplied as two separate amber glass ampoules per dose (5 ml and 2 ml) that must be mixed in a single syringe immediately before administration.
  • Route of administration: deep intramuscular injection only; not for intravenous use (a separate Pabrinex Intravenous High Potency product exists for IV administration).
  • ATC code: A11EB (vitamin B-complex with vitamin C, parenteral preparations).
  • Prescription-only medicine (POM) intended for use under the supervision of healthcare professionals familiar with parenteral vitamin therapy.

Packaging

  • Amber Type I glass ampoules: one 5 ml No. 1 ampoule and one 2 ml No. 2 ampoule per dose.
  • Pack size: typically cartons containing 10 pairs of 5 ml and 2 ml ampoules (10 x 5 ml + 10 x 2 ml), although wholesalers and pharmacies may list products by 5 ml ampoules or pairs for ordering purposes.
  • Ampoules are supplied in outer cartons to protect from light and are labelled with product name, strength, route of administration (Intramuscular High Potency), batch number and expiry date.
  • Outer carton clearly differentiates intramuscular high-potency injection from the intravenous high-potency formulation to minimise risk of administration by the wrong route.
  • Supplied to hospital pharmacies, community pharmacies and aesthetic/medical wholesalers as a prescription-only medicine.

Usage

  • For intramuscular use only. Pabrinex Intramuscular High Potency must not be administered intravenously; a separate Pabrinex Intravenous High Potency product exists for IV use.
  • Before administration, confirm that both the Summary of Product Characteristics (SmPC) and ampoule labels state INTRAMUSCULAR injection to ensure the correct formulation is used.
  • Adults and elderly: the usual dose is the contents of one pair of ampoules (5 ml No. 1 + 2 ml No. 2; total 7 ml) given twice daily for up to 7 days, or as directed by hospital protocol and the prescribing clinician.
  • Paediatric population (IM use is rarely indicated; dosing must follow specialist guidance): - 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: as per the adult dose.
  • Method of preparation: immediately before use, draw the contents of one 5 ml No. 1 ampoule and one 2 ml No. 2 ampoule into a single syringe to mix.
  • Method of administration: inject the mixed 7 ml solution slowly, deep into the gluteal muscle, approximately 5 cm below the iliac crest, using an appropriate gauge and length of needle.
  • Each ampoule should be visually inspected prior to use; do not use if particulate matter, discolouration or damage to the ampoule is observed.
  • Administration should be performed by healthcare professionals trained in IM injection techniques and with immediate access to facilities and medicines for the management of anaphylactic reactions.
  • In aesthetic/wellness practice, use must remain within the licensed indication (rapid therapy of deficiency) or under appropriate specialist oversight if used off-label; a prescription and full clinical assessment are required.
  • Do not mix Pabrinex Intramuscular High Potency in the same syringe with other medicinal products unless compatibility has been established.

Contraindications

  • Hypersensitivity to any of the active substances (thiamine, riboflavin, pyridoxine, nicotinamide, ascorbic acid) or to any of the excipients, including benzyl alcohol and sodium-containing components.
  • History of severe allergic or anaphylactic reaction to Pabrinex or similar parenteral vitamin B and C preparations.
  • Use in patients where intramuscular injection is contraindicated (for example, severe thrombocytopenia or bleeding disorders) unless the expected benefit clearly outweighs the risk and an alternative route is not feasible.
  • Caution in neonates, infants and young children because of benzyl alcohol content (risk of serious adverse events and ‘gasping syndrome’ with benzyl alcohol; accumulation risk is higher in children and in patients with liver or kidney impairment).
  • Caution in patients with impaired hepatic or renal function due to risk of benzyl alcohol accumulation and metabolic acidosis if high volumes are used.
  • Caution in patients on strict sodium-controlled diets, as each adult dose (pair of ampoules) contains approximately 67 mg sodium.
  • Use during pregnancy and breastfeeding should be based on careful benefit–risk assessment; no specific adverse effects have been reported at recommended doses when used as clinically indicated, but caution is advised.
  • Any additional contraindications, warnings and precautions stated in the most recent UK Summary of Product Characteristics must be followed.

Adverse Effects

  • Immune system disorders: hypersensitivity reactions including rash, urticaria and, rarely, severe allergic reactions such as anaphylaxis and anaphylactic shock.
  • Nervous system disorders: paraesthesia (tingling or pins-and-needles sensations) reported with unknown frequency.
  • Vascular disorders: hypotension (low blood pressure) reported with unknown frequency, particularly with rapid administration or in susceptible individuals.
  • General disorders and administration site conditions: injection site reactions including pain, swelling or local irritation at the injection site.
  • As with other parenteral products, there is a risk of serious allergic adverse reactions during or shortly after injection; facilities to treat anaphylaxis should be available whenever Pabrinex IM is used.
  • Overdose is unlikely in routine clinical use; if it occurs, management is supportive and symptomatic.
  • In general, when Pabrinex IM is used as recommended (correct route, careful IM technique, appropriate dosing) and in settings with appropriate monitoring, adverse reactions are uncommon relative to its benefits in treating severe vitamin B and C deficiency.

Storage Conditions

  • Store in a refrigerator at 2°C to 8°C.
  • Keep the ampoules in the outer carton in order to protect from light.
  • Do not freeze.
  • Shelf life: 24 months when stored under recommended conditions; refer to the expiry date on the carton and ampoules.
  • As with all parenteral products, ampoules should be visually inspected before use and not used if particulate matter, discolouration or damage is present.
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements for pharmaceutical and sharps waste.
  • Store out of the sight and reach of children and restrict access to authorised healthcare staff in clinical settings.

Duration

Typical treatment duration for rapid therapy of severe depletion or malabsorption is up to 7 days in adults (for example, one pair of ampoules twice daily), after which patients are usually switched to oral supplementation once clinically appropriate. In some hospital protocols for alcohol-related presentations or refeeding risk, shorter or slightly longer courses may be used based on clinical response. Maintenance of vitamin status after the acute phase is normally achieved with oral vitamin preparations rather than ongoing intramuscular Pabrinex.

Onset

Because Pabrinex is administered intramuscularly, absorption of the vitamin components into the systemic circulation is relatively rapid. Plasma concentrations of vitamins B and C rise shortly after injection, giving prompt correction of deficiency. Clinical improvement in deficiency-related symptoms (for example, in alcohol-related presentations or post-infectious states) may be observed over hours to days depending on baseline status and co-morbidities.

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