Pabrinex IV 5ml ampoules (Vitamin B&C Intravenous High Potency)
Pabrinex
Vitamins and InfusionIntravenous high-potency vitamin B and C concentrate for solution for infusion (5 ml ampoules)
Certifications
- UK prescription Only medicinal product with Marketing Authorisation number PL 21727/0116.
- Regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
- Complies with European and UK requirements for parenteral vitamin preparations, including quality, safety and efficacy standards.
- Pharmacotherapeutic group: Vitamin B Complex with vitamin C, ATC code A11EB.
- UK prescription Only medicinal product with Marketing Authorisation number PL 21727/0116.
- Regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
- Complies with European and UK requirements for parenteral vitamin preparations, including quality, safety and efficacy standards.
- Pharmacotherapeutic group: Vitamin B Complex with vitamin C, ATC code A11EB.
Intravenous high-potency vitamin B and C concentrate for solution for infusion (5 ml ampoules)
Description
Pabrinex IV (Vitamin B&C Intravenous High Potency) is a prescription-only concentrate for solution for infusion containing high doses of water-soluble vitamins B and C. It is supplied as pairs of 5 ml amber glass ampoules (No. 1 and No. 2), which are mixed and diluted in an appropriate infusion fluid and administered by intravenous drip over 30 minutes. Pabrinex IV is indicated in adults and children for rapid therapy of severe depletion or malabsorption of vitamins B and C, particularly in alcoholism where thiamine deficiency can lead to Wernicke’s encephalopathy, and in other conditions such as after acute infections, post-operatively, and in certain psychiatric states. It is also used to maintain vitamin B and C levels in patients receiving chronic intermittent haemodialysis.
Bnefits
- Provides rapid replacement of water-soluble vitamins B and C in situations of severe depletion or malabsorption.
- High-potency combination of thiamine (B1), riboflavin (B2), pyridoxine (B6), nicotinamide and vitamin C in a single IV preparation.
- Particularly important in alcoholism where severe thiamine deficiency can lead to Wernicke’s encephalopathy, helping to prevent or treat this serious complication.
- Useful after acute infections, post-operatively and in certain psychiatric states where vitamin depletion is common.
- Helps maintain adequate vitamin B and C levels in patients on chronic intermittent haemodialysis.
- Intravenous route and concentrate-for-infusion presentation allow controlled administration in patients who cannot tolerate or absorb oral vitamins.
- Single product avoids the need for multiple separate vitamin injections, simplifying treatment and improving adherence to protocols.
- Clear, up-to-date SmPC and PIL support safe prescribing and administration in hospital and specialist settings.
Indications
- Rapid therapy of severe depletion or malabsorption of the water-soluble vitamins B and C in adults and children, particularly in alcoholism, where severe depletion of thiamine can lead to Wernicke’s encephalopathy.
- Rapid vitamin B and C replacement after acute infections.
- Rapid vitamin B and C replacement in the post-operative period.
- Rapid vitamin B and C replacement in certain psychiatric states associated with poor intake or malabsorption.
- Maintenance of vitamin B and C levels in patients on chronic intermittent haemodialysis.
Composition
- Each 5 ml No. 1 ampoule contains: Thiamine hydrochloride (vitamin B1) 250 mg; Riboflavin (as phosphate sodium) (vitamin B2) 4 mg; Pyridoxine hydrochloride (vitamin B6) 50 mg.
- Each 5 ml No. 2 ampoule contains: Ascorbic acid (vitamin C) 500 mg; Nicotinamide 160 mg; Glucose (as monohydrate) 1000 mg.
- Excipients: edetic acid, sodium hydroxide, water for injections.
- Each pair of 5 ml ampoules contains 79 mg sodium (approximately 4% of the recommended maximum daily intake of 2 g sodium for an adult).
Formulation
- Pharmaceutical form: Concentrate for solution for infusion.
- Supplied as pairs of amber glass 5 ml ampoules labelled Vitamin B&C No. 1 and Vitamin B&C No. 2.
- After mixing and dilution with a suitable infusion fluid (e.g. 0.9% sodium chloride or 5% glucose), the solution is administered by intravenous drip infusion.
- Pharmacotherapeutic group: Vitamin B-complex with vitamin C, ATC code A11EB.
Packaging
- Pairs of 5 ml amber glass ampoules (one No. 1 ampoule and one No. 2 ampoule) supplied in cartons.
- Pack sizes commonly include 6 pairs or 10 pairs of 5 ml ampoules; not all pack sizes may be marketed in all territories.
- Each carton and ampoule is labelled with the product name (Vitamin B&C Intravenous High Potency / Pabrinex IV), contents, batch number and expiry date.
- Prescription only medicine (POM) supplied through licensed pharmacies and hospital pharmacies.
Usage
- Pabrinex IV is for intravenous use only and must not be given by any other route.
- The contents of a No. 1 ampoule and a No. 2 ampoule (one pair) should be mixed immediately before use and then diluted in 50–100 ml of an appropriate infusion fluid (physiological saline 0.9% or 5% glucose).
- The diluted solution should be administered by intravenous drip infusion over a period of 30 minutes.
- Adult dosing for rapid therapy of severe depletion or malabsorption of vitamins B and C (particularly in alcoholism) is typically 2–3 pairs of 5 ml ampoules (1 pair = ampoule 1 + ampoule 2) every 8 hours, diluted and infused over 30 minutes, or at the discretion of the prescribing physician.
- For psychosis following narcosis or electroconvulsive therapy, or toxicity from acute infections, a typical regimen is 1 pair of 5 ml ampoules diluted in 50–100 ml infusion solution and infused over 30 minutes twice daily for up to 7 days, according to clinical response.
- For maintenance during haemodialysis, a typical regimen is 1 pair of 5 ml ampoules diluted and infused over 30 minutes at the end of dialysis every two weeks, as directed by the clinician.
- Paediatric doses are reduced according to age: 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, and should only be used in children when clearly indicated.
- Each ampoule should be visually inspected prior to use; do not use if particulates are present or if the solution is discoloured.
- Facilities for treating anaphylactic reactions must be available whenever Pabrinex IV is administered; infusion should be stopped immediately if signs of a hypersensitivity reaction occur.
- 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.
Contraindications
- Known hypersensitivity to any of the active substances (thiamine, riboflavin, pyridoxine, ascorbic acid, nicotinamide or glucose) or to any of the excipients.
- History of sensitivity to vitamin B and/or C injections where further exposure could provoke a more severe reaction.
Adverse Effects
- Immune system disorders: hypersensitivity reactions including rash, urticaria and anaphylaxis (very rare but potentially serious).
- Nervous system disorders: paraesthesia.
- Vascular disorders: hypotension.
- General disorders and administration site conditions: injection/infusion site reactions including pain and swelling.
- Initial warning signs of a reaction may include sneezing or mild asthma (chest tightness and wheezing); further doses in such patients may lead to anaphylactic shock.
- In the event of suspected overdose, treatment is symptomatic and supportive.
Storage Conditions
- Store unopened ampoules below 25°C.
- Keep ampoules in the outer carton to protect from light.
- Do not freeze.
- After dilution, chemical and physical in-use stability has been demonstrated for up to 24 hours at 2–8°C or 25°C protected from light in specified infusion fluids, but from a microbiological point of view the product should be used immediately unless prepared under controlled aseptic conditions.
- Do not freeze diluted solutions.
- Keep out of the sight and reach of children.
Duration
Duration of treatment is determined by the prescribing clinician based on indication and clinical response. For rapid correction of deficiency (e.g. in suspected or established Wernicke\u2019s encephalopathy), treatment is typically given for several days and then switched to oral thiamine and/or oral vitamin supplements once the patient is stabilised and able to tolerate oral therapy.
Onset
Onset of vitamin replacement is rapid following intravenous infusion, with improvement in biochemical deficiency markers and clinical symptoms typically occurring over hours to days, depending on severity and underlying condition.
