Vantonex concentrate for solution for infusion – patient leaflet, side effects, dosage

1. WHAT VANTONEX IS AND WHAT IT IS

USED FOR

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.

Vantonex concentrate for solution for infusion 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VANTONEX

You MUST NOT be given Vantonex:

• if you are allergic to any of the ingredients of

  this medicine (listed in section 6)

• if you have a history of sensitivity to vitamins B

  and/or C.

Warnings and precautions

Talk to your doctor before taking Vantonex.

Vantonex should be given with extreme caution if you have:

• ever had a mild allergic reaction (sneezing

  or mild asthma) to any previous injections of vitamin B1 (thiamine). This could mean that you may have become hypersensitive, and could have a more severe allergic reaction if given Vantonex.

Other medicines and Vantonex

Tell your doctor if you are taking, have recently taken, or might take, any other medicines.

• Levodopa (used in the treatment of Parkinson’s

  disease) – Vantonex interferes with the effects of this medicine.

  • Vitamin B1 (thiamine) injections - if you are on repeated injections of such preparations, Vantonex may cause sneezing or mild asthma (chest tightness and wheezing) or even anaphylactic shock if you have become hypersensitive.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, planning to become pregnant or breast-feeding. Ask your doctor or pharmacist before taking any medicine.

Driving and using machines

Vantonex is not expected to affect your ability to drive or operate machinery.

Vantonex contains sodium:

This medicine contains 65.8 mg sodium (main component of cooking/table salt) in each 1 pair of 5 ml ampoules. This is equivalent to 3.3% of the recommended daily dietary intake of sodium for an adult.

3. HOW VANTONEX IS GIVEN

Vantonex 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

  1. 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: Vantonex is not usually given to children; however, suitable doses according to the child’s age are:

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 Vantonex, speak to your doctor.

If you are given more Vantonex than you should This product will be given to you under medical supervision. It is therefore unlikely that you will be given too much. However, if you feel unwell, you should tell your doctor immediately.

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

4. POSSIBLE SIDE EFFECTS

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 Vantonex 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE VANTONEX

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

Vantonex should be stored below 25oC but not

frozen, and protected from light.

Once diluted in an infusion fluid Vantonex 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vantonex contains

The active ingredients are:

The other ingredients are: edetic acid, sodium hydroxide and water for injections.

What Vantonex looks like and contents of the pack

The product is supplied in pairs of amber coloured glass ampoules containing 5 ml of sterile solution. Each pack contains 6 pairs of 5 ml ampoules.

Marketing Authorisation Holder

Vantage Pharmaceuticals Ltd.

Ravalco House, Cleveland Way,

Hemel Hempstead, Hertfordshire, HP2 7DL United Kingdom

Manufacturer

Cubic Pharmaceuticals Limited

Unit 3, Sextant Park, Neptune Close

Medway City Estate

Rochester

ME2 4LU

United Kingdom

This leaflet was last revised: 02/2025

IPS VAN 0024