Pabrinex® Intravenous High Potency, Concentrate for Solution for Infusion

(Vitamins B & C)

Vitamins B and C are important for a number of bodily functions including releasing energy from food and in the formation of healthy skin, bones and teeth.

Pabrinex Intravenous High Potency, Concentrate for Solution for Infusion (‘Pabrinex IVHP’) provides additional vitamins B and C to correct deficiencies that may have occurred, for example:

• in alcoholism
• after infections
• after operations
• in certain psychiatric states.

The product is also used to maintain levels of vitamins B and C in patients who are on long-term intermittent haemodialysis.

Pabrinex IVHP will be given to you by a healthcare professional by drip infusion into a vein. The product comes in two ampoules, the contents of which are first diluted with either saline or 5% glucose solution and then given over a period of 30 minutes.

This medicine is for injection into a vein only and should not be given by any other route.

Dilute before use.

Dosage for adults including the elderly:

• For rapid therapy of severe depletion or malabsorption of water soluble vitamins B and C, particularly in alcoholism: 2 to 3 pairs of 5 ml ampoules (1 pair = ampoule 1 + ampoule 2) diluted with 50 ml to 100 ml of infusion solution and injected over 30 minutes at intervals decided by your doctor (typically every 8 hours).
• For psychosis following unconsciousness from a narcotic drug (narcosis) or electroconvulsive therapy, or poisoning from infection: 10 ml of the mixed ampoules (1 pair) diluted with 50 ml to 100 ml of infusion solution and injected over 30 minutes. Injected twice daily for up to 7 days.
• For haemodialysis patients: 10 ml of the mixed ampoules (1 pair) diluted with 50 ml to 100 ml of infusion solution and injected over 30 minutes. Injected at the end of dialysis, once every 2 weeks.

Use in children and adolescents: Pabrinex IVHP is not usually given to children; however, suitable doses according to the child’s age are:

Age Dose

under 6 years 1/4 of the adult dose

6-10 years 1/3 of the adult dose

10-14 years 1/2 to 2/3 of the adult dose

14 years and older one adult dose

The exact dose you will be given will be decided by your doctor who will monitor your condition and determine what treatment you need. If you feel that you have been given an inappropriate dose or if you would like more information about Pabrinex IVHP, speak to your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Allergic reaction - if following your injection you experience symptoms such as sneezing or mild asthma (chest tightness and wheezing) tell your doctor immediately. This may be an indication that you are sensitive to Pabrinex IVHP and should not be given a repeat dose.
• Severe allergic reaction (anaphylactic shock) - may result from repeated injections of this medicine. Symptoms may include: swelling of the face and or throat, rash, severe itching, difficulty in breathing and loss of consciousness due to very low blood pressure.
• Low blood pressure and feeling of ‘pins and needles’ (mild paraesthesia) can occur in some patients.
• Mild ache at the site of the injection - some swelling may develop at the site of injection.

Keep this medicine out of the sight and reach of children.

Pabrinex IVHP should be stored below 25°C but not frozen, and protected from light.

Once diluted in an infusion fluid Pabrinex IVHP should normally be used immediately.

If necessary the diluted product can be kept at room temperature:

For 7 hours in the following infusion fluids:

• Glucose 5%
• Physiological saline (sodium chloride 0.9%)
• Sodium lactate M/6;

For 4 hours in the following infusion fluids:

• Glucose 4.3% with sodium chloride 0.18%
• Glucose 5% with potassium chloride 0.3%

Do not freeze diluted solution.

Do not use this medicine after the expiry date which is stated on the outer carton and ampoule labels after “EXP”. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.