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.
4.1 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.
The recommended daily dosage is the contents of one vial.
The contents of one vial are dissolved by the aseptic addition of 10 mL of one of the following: 1. Vitalipid N Adult/Infant*; 2. Intralipid 10%, 20% or 30%# lipid emulsion for infusion; 3. Water for Injections; 4. Sodium chloride 0.9% injection; 5. Glucose solution for infusion; 6. SMOFlipid.
* Vitalipid N Adult is only indicated for use in patients aged 11 years and above.
# Intralipid 30% is not recommended in children.
Children and infants weighing less than 10 kg.
Children and infants weighing less than 10 kg should be given 1/10 (1 mL) of the content of one vial per kg body weight per day.
The contents of one vial are dissolved by the aseptic addition of 10 mL of one of the following: 1. Vitalipid N Infant*; 2. Intralipid 10% or 20%; 3. Water for Injections; 4. Sodium chloride 0.9% injection; 5. Glucose solution for infusion; 6. SMOFlipid.
* The mixture Soluvit N and Vitalipid N Infant is not recommended for those 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.
No data available.
Use in renal impairment.
No data available.
Use in the elderly.
There have been no specific clinical studies conducted with Soluvit N in the elderly.
Paediatric use.
No data available.
Effects on laboratory tests.
Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results, depending on the assay. The risk of interference is higher in children and patients with renal impairment and increases with higher doses. When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves' disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin). Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected.
The laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.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.
The potential effects of Soluvit N on fertility and general reproductive performance have not been determined.
The requirement of vitamins in pregnant women may be insufficient due to the patient's altered needs. Soluvit N has been administered to pregnant women with no adverse reactions reported.
The requirement of vitamins in lactating women may be insufficient due to the patient's altered needs.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.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.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.
ATC code: B05X C00.
Soluvit N is a mixture of water-soluble vitamins in amounts normally absorbed from the oral diet and should have no pharmacodynamic effect besides maintaining the nutritional status in patients requiring home PN. Additional amounts of some vitamins may be needed e.g. surgery, malnutrition, burns to avoid certain diseases caused by deficiency.
Clinical trials.
No clinical data is available.
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.
No data available.
Distribution.
No data available.
Metabolism.
No data available.
Excretion.
No data available.
5.3 Preclinical Safety Data
Genotoxicity.
Studies with Soluvit N have not been performed to evaluate the genotoxic potential.
Carcinogenicity.
Studies with Soluvit N have not been performed to evaluate the carcinogenic potential.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.
Empirical formula: C12H17N5O4S.
Molecular weight: 327.36.
Chemical name: Thiazolium, 3-[(4-amino-2-methyl-5-pyrimidinyl) methyl]-5-(2-hydroxyethyl)-4-methyl-nitrate.
Riboflavine sodium phosphate.
Empirical formula: C17H20N4NaO9P.2H2O.
Molecular weight: 514.36.
Chemical name: riboflavin 5'-(dihydrogen phosphate), monosodium salt, dihydrate.
Nicotinamide.
Empirical formula: C6H6N2O.
Molecular weight: 122.12.
Chemical name: 3-pyridinecarboxamide.
Pyridoxine hydrochloride.
Empirical formula: C8H11NO3.HCl.
Molecular weight: 205.64.
Chemical name: 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-hydrochloride.
Sodium pantothenate.
Empirical formula: C9H16NNaO5.
Molecular weight: 241.22.
Chemical name: sodium (R)-3-(2,4-dihydroxy-3,3-dimethylbutanamido) propanoate.
Sodium ascorbate.
Empirical formula: C6H7NaO6.
Molecular weight: 198.11.
Chemical name: sodium (2R)-2-[(1S)-1,2-dihydroxyethyl]-4-hydroxy-5-oxo-2H-furan-3-olate.
Biotin.
Empirical formula: C10H16N2O3S.
Molecular weight: 244.31.
Chemical name: 5-[(3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d] imidazol-4-yl] pentanoic acid.
Folic acid.
Empirical formula: C19H19N7O6.
Molecular weight: 441.40.
Chemical name: (2S)-2-[[4-[(2-Amino-4-oxo-1H-pteridin-6 yl) methylamino] benzoyl] amino] pentanedioic acid.
Cyanocobalamin.
Empirical formula: C63H88CoN14O14P.
Molecular weight: 1355.37.
Chemical name: cyanocobalamin.
CAS number.
See Table 3.
7 Medicine Schedule (Poisons Standard)
Australia: Not Scheduled.
Summary Table of Changes
