SUMMARY CMI

Soluvit^® N

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Soluvit N?

Soluvit N contains the active ingredients thiamine nitrate, riboflavine sodium phosphate, nicotinamide, pyridoxine hydrochloride, sodium pantothenate, sodium ascorbate, folic acid, biotin and cyanocobalamin. Soluvit N is a water-soluble vitamins supplement to parenteral nutrition which provides your body with nutrition by the intravenous route. It is usually given together with carbohydrates, amino acids and salts to provide an intravenous diet.

For more information, see Section 1. Why am I using Soluvit N? in the full CMI.

2. What should I know before I use Soluvit N?

Do not use if you have ever had an allergic reaction to any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Soluvit N? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Soluvit N and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Soluvit N?

This medicine is given an infusion into a vein. The dose of Soluvit N which you or your child will require will be determined by your doctor or pharmacist. Your doctor will supervise your or your child's treatment with Soluvit N.

More instructions can be found in Section 4. How do I use Soluvit N? in the full CMI.

5. What should I know while using Soluvit N?

For more information, see Section 5. What should I know while using Soluvit N? in the full CMI.

6. Are there any side effects?

Adverse reactions may be expected based on experience with other water-soluble vitamins compounds administered intravenously which include allergic reactions.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Soluvit^® N

Active ingredient(s): thiamine nitrate, riboflavine sodium phosphate, nicotinamide, pyridoxine hydrochloride, sodium pantothenate, sodium ascorbate, folic acid, biotin and cyanocobalamin

Consumer Medicine Information (CMI)

This leaflet provides important information about using Soluvit N. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Soluvit N.

Where to find information in this leaflet:

1. Why am I using Soluvit N?
2. What should I know before I use Soluvit N?
3. What if I am taking other medicines?
4. How do I use Soluvit N?
5. What should I know while using Soluvit N?
6. Are there any side effects?
7. Product details

1. Why am I using Soluvit N?

Soluvit N contains the active ingredients thiamine nitrate, riboflavine sodium phosphate, nicotinamide, pyridoxine hydrochloride, sodium pantothenate, sodium ascorbate, folic acid, biotin and cyanocobalamin.

When the intake of nutrients or food into the mouth or directly into the gut is not possible or not enough to supply the needs, then intravenous nutrients or foods can be given. This is especially important for people under physical stress from illness or recent surgery.

Soluvit N is intended as a supplement in intravenous nutrition to meet the daily requirements of the water-soluble vitamins in adults, adolescents, children and infants. Soluvit N is usually given together with fats, amino acids, glucose and trace elements to provide a complete intravenous diet. Fat-soluble vitamins should also be administered to patients receiving prolonged parenteral nutrition.

2. WHAT SHOULD I KNOW BEFORE I USE SOLUVIT N?

Warnings

Do not use Soluvit N if your or your child:

• are allergic or has known hypersensitivity to to the ingredients of this medicine..

Always check the ingredients to make sure you can use this medicine

Check with your doctor if you or your child:

• have any other medical conditions such as liver or kidney disease
• have severe vitamin deficiency as Soluvit N dose may be insufficient
• have allergies are or your child is allergic to any other medicines or any other substances, such as foods, preservatives or dyes

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Soluvit N can be used by pregnant and breast-feeding women. Check with your doctor if Soluvit N is sufficient to meet the altered requirements in pregnancy and breastfeeding,

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Use in elderly

No data is available for use of Soluvit N in elderly patients. Your doctor will decide what to do.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Soluvit N and affect how it works. These include levodopa and phenytoin.
Other drugs should not be added to Soluvit N dissolved in Intralipid, SMOFlipid or Vitalipid N, due to the possibility of physical incompatibilities.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Soluvit N.

4. How do I use Soluvit N?

How much is given

Your doctor will determine the dose of Soluvit N which you or your child require and will supervise your or your child's treatment with Soluvit N.

How to take Soluvit N

Soluvit N should be dissolved first and then diluted in a bag of amino acids, glucose and/or fats or in clear standard solution. This should be done immediately before the start of the infusion and used within 24 hours. An electronic pump may be used to control the speed of the infusion of drip. The bag containing Soluvit N should be protected from light.

If you forget to use Soluvit N

This rarely happens as Soluvit N is usually administered under the care of a trained health care professional in a hospital or clinic setting.

If you use too much Soluvit N

This rarely happens as Soluvit N is usually administered under the care of a trained professional in a hospital or clinic setting. However, if you think that you have received too much Soluvit N, inform your doctor or nurse immediately.

Your doctor has information on how to recognize and treat an overdose. Ask your doctor if you have any concerns.

If you think that you have used too much Soluvit N, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Soluvit N?

Things you should do

Remind any doctor, dentist, pharmacist or nurse you visit that you are being treated with Soluvit N.

If you are about to have any blood or urine test, tell your health care professional that you are being treated with Soluvit N. It may interfere with the results of some laboratory tests.

Call your doctor straight away if you have signs and symptoms of allergic reactions. In case of an allergic reaction, the infusion should be stopped immediately, and appropriate measures need to be taken.

Looking after your medicine

Soluvit N is usually administered under the care of a trained health care professional in a hospital or clinic setting.

Soluvit N is recommended to be stored below 25°C in a cool dry place, protected from light and away from moisture or heat. Do not freeze.

Do not use after the expiry date which is stated on the carton label and the vial..

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Information below are adverse reactions that may be expected based on other intravenous water-soluble vitamins. Since Soluvit N has to be diluted with other nutrient solutions, these also may cause unwanted effects in some people. If you need to, ask your doctor or nurse if you have any further questions about side effects

Less serious side effects

Serious side effects

Tell your doctor or nurse if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Soluvit N contains

Do not take this medicine if you are allergic to any of these ingredients.

Soluvit N does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Soluvit N comes in carton of 10 glass vials. (Aust R 40145)

What Soluvit N looks like

Soluvit N is a yellow lyophilised powder in a glass vial

Who distributes Soluvit N

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Telephone: 1300 361 004

This leaflet was prepared in March 2023

Published by MIMS April 2024

1 Name of Medicine

Thiamine nitrate, riboflavine sodium phosphate, nicotinamide, pyridoxine hydrochloride, sodium pantothenate, sodium ascorbate, folic acid, biotin, cyanocobalamin.

2 Qualitative and Quantitative Composition

Soluvit N is a lyophilised, sterile, yellow mixture of water-soluble vitamins for intravenous infusion. See Table 1.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for Injection, vial.
A yellow, porous freeze-dried cake.
Osmolality in 10 mL of water: approx. 490 mOsm/kg water.
pH in 10 mL of water: 5.8.

4 Clinical Particulars

4.1 Therapeutic Indications

Soluvit N is intended as a supplement in intravenous nutrition in order to meet the daily requirements of the water-soluble vitamins in adults, adolescents, children and infants. Fat-soluble vitamins should also be administered to patients receiving prolonged parenteral nutrition.

4.2 Dose and Method of Administration

Soluvit N may be added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes, and trace elements, provided that compatibility and stability have been confirmed.
Soluvit N must not be given undiluted. The reconstituted Soluvit N should be added to the infusion solution under aseptic conditions, immediately before the start of the infusion and used within 24 hours. Clear admixtures (e.g. glucose solution or Water for Injections) containing Soluvit N should be protected from light.
The reconstituted mixtures with Vitalipid, Intralipid and SMOFlipid must be added under aseptic conditions to Intralipid only. The reconstituted mixtures with Water, Sodium Chloride 0.9% and Glucose are added under aseptic conditions to Intralipid or glucose solutions for infusion.

Adults and children weighing 10 kg or more.

Children and infants weighing less than 10 kg.

4.3 Contraindications

Known hypersensitivity to any of the components, for example, thiamine or methyl hydroxybenzoate.

4.4 Special Warnings and Precautions for Use

Administering folic acid may obscure pernicious anaemia. The Soluvit N doses recommended are insufficient to correct severe vitamin deficiency states and may be insufficient in patients with markedly increased vitamin requirements. In patients receiving total parenteral nutrition (TPN), routine supplementation with both fat-soluble and water-soluble vitamins is recommended to prevent deficiency states and to obviate the need to speculate on individual vitamin status. Daily vitamin requirements must be calculated to avoid overdosage and toxic effects, especially with regards to vitamins A and D, and particularly in paediatric patients. In patients for whom TPN is continued for prolonged periods (months or years), periodic monitoring of blood vitamin levels should be considered.
To prevent excessive excretion of water-soluble vitamins, and for reasons of safety, daily dosage should be administered over a number of hours. See also the product information for Intralipid, SMOFlipid or Vitalipid N if Soluvit N is dissolved in these products.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Vitamin B₆ can reduce the effect of levodopa. Folic acid may lower the serum concentration of phenytoin. Other drugs should not be added to Soluvit N dissolved in Intralipid, SMOFlipid or Vitalipid N, due to the possibility of physical incompatibilities (see product information for Intralipid, SMOFlipid and Vitalipid N).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Allergic reactions including anaphylactic reactions may occur in patients hypersensitive to any component in the preparation, for example, folic acid, methyl hydroxybenzoate or thiamine (frequency not known). There have been rare reports of anaphylactoid reactions following repeated injection of preparations containing thiamine. Flushing, itching or burning of the skin may occur in patients susceptible to the effects of nicotinamide. Evaluable safety data from clinical trials with Soluvit N are limited. Adverse reactions that may be expected based on experience with other water-soluble vitamin compounds administered intravenously include: allergic reactions, including anaphylaxis; dermatological reactions including flushing, erythema, pruritus, and CNS reactions including headache, dizziness, and agitation.

Reporting suspected adverse effects.

4.9 Overdose

Adverse effects caused by an overdose of water soluble vitamins have been reported and are unlikely to occur when administered as recommended. In cases of suspected overdose, symptomatic and supportive therapy should be instituted as appropriate, and further administration of the product discontinued.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

When infused intravenously the water-soluble vitamins in Soluvit N are utilised in a generally similar way to water-soluble vitamins from an oral diet.

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Table 2.

6.2 Incompatibilities

Soluvit N may only be added to or mixed with other medicinal products for which compatibility has been documented, see Section 4.2 Dose and Method of Administration. Please also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for incompatibilities of the product.

6.3 Shelf Life

Approved shelf life: 18 months.
The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Soluvit N is a sterile, lyophilised powder containing a mixture of the water-soluble vitamin B₁, vitamin B₂, nicotinamide, vitamin B₆, pantothenic acid, vitamin C, biotin, folic acid, and vitamin B₁₂. Methyl hydroxybenzoate and edetate sodium are included as stabilisers.
Glass vials (Type I). Stopper for injection vial, chlorobutyl rubber. Vials: box of 10. AUST R 40145.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Thiamine nitrate.

Riboflavine sodium phosphate.

Nicotinamide.

Pyridoxine hydrochloride.

Sodium pantothenate.

Sodium ascorbate.

Biotin.

Folic acid.

Cyanocobalamin.

CAS number.

7 Medicine Schedule (Poisons Standard)

Australia: Not Scheduled.

Summary Table of Changes