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Pabrinex Vitamin C & B Inj IV 5ml Pack of 6

Pabrinex Vitamin C & B Inj IV 5ml Pack of 6

Pabrinex

Vitamins and Infusion
  • UK prescription Only medicinal product (POM) regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Marketing Authorisation number: PL 21727/0116 (Vitamin B&C Intravenous High Potency, Concentrate for Solution for Infusion).
  • Pharmacotherapeutic group: 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 via the MHRA Yellow Card scheme.
Intravenous high-potency vitamin B and C concentrate for solution for infusion

Description

Pabrinex Vitamin C & B Inj IV 5ml Pack of 6 is a UK-licensed prescription-only presentation of Vitamin B&C Intravenous High Potency (IVHP), a high-dose combination of water-soluble vitamins B and C for intravenous use. Each pack contains 6 pairs of 5 ml amber glass ampoules (Ampoule 1 and Ampoule 2) that are mixed and diluted in an appropriate infusion fluid and administered by intravenous infusion over 30 minutes. Pabrinex IVHP is indicated in adults and children for the rapid treatment of severe depletion or malabsorption of vitamins B and C, particularly in alcoholism where thiamine deficiency may lead to Wernicke’s encephalopathy, as well as after acute infections, post-operatively, in certain psychiatric states, and to maintain vitamin levels in patients on chronic intermittent haemodialysis.

Bnefits

  • Provides rapid replacement of water-soluble vitamins B and C in patients with severe deficiency or malabsorption.
  • High-potency combination of thiamine (B1), riboflavin (B2), pyridoxine (B6), nicotinamide and vitamin C in a single intravenous preparation.
  • Crucial for patients with alcoholism who are at risk of Wernicke’s encephalopathy due to severe thiamine depletion.
  • Useful for correcting vitamin depletion after acute infections, in the post-operative period and in certain psychiatric states associated with poor intake or malabsorption.
  • Helps maintain adequate vitamin B and C levels in patients undergoing chronic intermittent haemodialysis.
  • Intravenous route and concentrate-for-infusion presentation allow controlled administration when oral therapy is not feasible or sufficient.
  • Clear SmPC and PIL guidance on posology and administration support safe, standardised use in hospitals and specialist clinics.
  • Reduces the need for multiple separate vitamin injections by providing a combined preparation of key B vitamins and vitamin C plus glucose.
  • Available in a convenient 6-pair pack size suitable for protocol-driven use in acute care and infusion settings.

Indications

  • Vitamin B&C Intravenous High Potency (Pabrinex IVHP) is indicated in adults and children for rapid therapy of severe depletion or malabsorption of the water-soluble vitamins B and C:
  • • particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke’s encephalopathy
  • • after acute infections
  • • post-operatively
  • • in psychiatric states
  • It is also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.

Composition

  • Each presentation (carton) contains pairs of 5 ml ampoules. Each pair of ampoules to be used in treatment is labelled Vitamin B&C No. 1 and Vitamin B&C 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 (5 ml) contains: Ascorbic acid (vitamin C) 500 mg; Nicotinamide 160 mg; Glucose (as monohydrate) 1000 mg.
  • Excipients (see SmPC for full list): edetic acid, sodium hydroxide, water for injections.
  • Excipients with known effect: This medicinal product contains 79 mg sodium per 1 pair of 5 ml ampoules, equivalent to approximately 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Formulation

  • Pharmaceutical form: Concentrate for solution for infusion.
  • Clear to pale yellow solution in amber glass ampoules for intravenous administration after dilution.
  • Pharmacotherapeutic group: Vitamin B-complex with vitamin C, ATC code A11EB.
  • Supplied as pairs of 5 ml amber glass ampoules (No. 1 and No. 2) which are mixed and diluted in an appropriate infusion fluid (e.g. 0.9% sodium chloride or 5% glucose) before administration by intravenous infusion over 30 minutes.

Packaging

  • Each pack contains 6 pairs of 5 ml amber glass ampoules (6 × No. 1 ampoules and 6 × No. 2 ampoules).
  • Ampoules are supplied in cardboard cartons, each ampoule labelled with ampoule number (No. 1 or No. 2), volume, active ingredients, batch number and expiry date.
  • Packs contain either six or ten pairs of 5 ml ampoules; this presentation is the 6-pair pack.
  • The outer carton is printed with the product name (Vitamin B&C Intravenous High Potency / Pabrinex IV), concentration, route of administration, pack size, Marketing Authorisation number, storage conditions and legal classification (Prescription Only Medicine).

Usage

  • For intravenous use only. Do not administer by any other route.
  • Before use, check that the product name and route of administration on the ampoules and carton match the intended intravenous route.
  • Visually inspect each ampoule; do not use if particulates are present, if the solution is discoloured or if the ampoule is damaged.
  • Adults and elderly (rapid therapy of severe depletion or malabsorption of vitamins B and C, particularly in alcoholism): 2 to 3 pairs of 5 ml ampoules (1 pair = Ampoule No. 1 + Ampoule No. 2) diluted with 50–100 ml of infusion solution (physiological saline 0.9% or 5% glucose) and administered by intravenous infusion over 30 minutes every 8 hours, or as decided by the physician.
  • Psychosis following narcosis or electroconvulsive therapy, or toxicity from acute infections: 1 pair of 5 ml ampoules diluted with 50–100 ml infusion solution and infused over 30 minutes, given twice daily for up to 7 days, according to clinical response.
  • Haemodialysis: 1 pair of 5 ml ampoules diluted with 50–100 ml infusion solution and infused over 30 minutes once every two weeks at the end of dialysis, or as directed by the clinician.
  • Paediatric population: Vitamin B&C IVHP is rarely indicated for administration to children; when used, typical dose reductions are: under 6 years – quarter of the adult dose; 6–10 years – third of the adult dose; 10–14 years – half to two-thirds of the adult dose; 14 years and over – adult dose. Paediatric use should be under specialist supervision.
  • Method of administration: Immediately before use, add equal volumes from Ampoule No. 1 and Ampoule No. 2 to 50–100 ml of suitable infusion fluid (0.9% sodium chloride or 5% glucose) and infuse over 30 minutes using standard intravenous infusion equipment.
  • This medicine should be administered in a setting where facilities for treating anaphylactic reactions are available. If signs of hypersensitivity occur (e.g. sneezing, wheeze, rash), stop the infusion immediately and initiate appropriate treatment.
  • From a microbiological point of view, diluted solutions should be used immediately; if not used immediately, in-use storage conditions are the responsibility of the user and should not normally exceed 24 hours at 2–8°C in controlled aseptic conditions.

Contraindications

  • Hypersensitivity to any of the active substances (thiamine, riboflavin, pyridoxine, ascorbic acid, nicotinamide, glucose monohydrate) or to any of the excipients (including sodium-containing excipients).
  • History of hypersensitivity reactions to parenteral vitamin B and/or vitamin C preparations.

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/infusion site reactions including pain and swelling.
  • Initial warning signs of a hypersensitivity reaction may include sneezing or mild asthma (chest tightness and wheezing); further administration in such patients may lead to anaphylactic shock.
  • In the event of suspected overdose, treatment is symptomatic and supportive.

Storage Conditions

  • Do not store above 25°C.
  • Keep the ampoules in the outer carton in order to protect from light.
  • Do not freeze.
  • From a microbiological point of view, diluted solutions should be used immediately; if storage is necessary, it should not normally exceed 24 hours at 2–8°C in controlled aseptic conditions and diluted solutions must not be frozen.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date shown on the carton and ampoules.

Duration

Treatment duration is determined by the prescribing clinician according to indication and clinical response. In acute deficiency states (e.g. suspected or established Wernicke\u2019s encephalopathy), therapy is typically given for several days and then replaced by oral thiamine and other vitamins once the patient is stabilised and able to tolerate oral medication.

Onset

Vitamin replacement begins rapidly after intravenous infusion, with improvement in biochemical deficiency and clinical symptoms typically occurring over hours to days depending on the severity of deficiency and underlying condition.

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