Soluvit N PI

AUSTRALIAN PRODUCT INFORMATION - SOLUVIT® N
(THIAMINE NITRATE, RIBOFLAVINE SODIUM PHOSPHATE,

NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, SODIUM
PANTOTHENATE, SODIUM ASCORBATE, BIOTIN, FOLIC
ACID, CYANOCOBALAMIN)
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.
Active Ingredients Quantity in one vial 1 mL of reconstituted Soluvit N

contains:
Thiamine nitrate 3.1 mg 0.31 mg
Riboflavine sodium 4.9 mg 0.49 mg
phosphate
(corresponding to Vitamin
B2 3.6 mg)
Nicotinamide 40 mg 4.0 mg
Pyridoxine hydrochloride 4.9 mg 0.49 mg
(corresponding to Vitamin
B6 4.0 mg)
Sodium pantothenate 16.5 mg 1.65 mg
(corresponding to
Pantothenic acid 15.0 mg)
Sodium ascorbate 113 mg 11.3 mg
(corresponding to Vitamin C
100 mg)
Biotin 60 micrograms 6.0 micrograms
Folic acid 400 micrograms 40 micrograms
Cyanocobalamin 5.0 micrograms 0.5 micrograms
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
Page 1 of 11
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

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
Page 2 of 11
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
Page 3 of 11
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 Interaction 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.
Use in pregnancy
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.
Use in lactation
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.
Page 4 of 11
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
Excipients Quantity per vial
Glycine 300 mg
Page 5 of 11
Edetate sodium 500 micrograms
Methyl hydroxybenzoate (preservative) 500 micrograms
6.2 Incompatibilities
Soluvit N may only be added to or mixed with other medicinal products for which
compatibility has been documented, refer to section 4.2 - Dose and method of
administration. Please also refer to 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
Page 6 of 11
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

Chemical name: riboflavin 5′-(dihydrogen phosphate), monosodium salt, dihydrate
Nicotinamide
Empirical formula: C6H6N2O

Chemical name: 3-pyridinecarboxamide
Page 7 of 11
Pyridoxine hydrochloride
Empirical formula: C8H11NO3.HCl

Chemical name: 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-hydrochloride
Sodium pantothenate
Empirical formula: C9H16NNaO5

Chemical name: sodium (R)-3-(2,4-dihydroxy-3,3-dimethylbutanamido)propanoate
Sodium ascorbate
Empirical formula: C6H7NaO6

Chemical name: sodium (2R)-2-[(1S)-1,2-dihydroxyethyl]-4-hydroxy-5-oxo-2H-furan-3-olate
Page 8 of 11
Biotin
Empirical formula: C10H16N2O3S

Chemical name: 5-[(3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl]pentanoic
acid
Folic acid
Empirical formula: C19H19N7O6

Chemical name: (2S)-2-[[4-[(2-Amino-4-oxo-1H-pteridin-6 yl)methylamino]benzoyl]amino]
pentanedioic acid
Page 9 of 11
Cyanocobalamin
Empirical formula: C63H88CoN14O14P

Chemical name: cyanocobalamin
CAS number
Active Ingredient CAS number
Thiamine nitrate 532-43-4
Riboflavine sodium phosphate 130-40-5
Nicotinamide 98-92-0
Pyridoxine hydrochloride 58-56-0
Sodium pantothenate 867-81-2
Sodium ascorbate 134-03-2
Biotin 58-85-5
Folic acid 59-30-3
Cyanocobalamin 68-19-9
7 MEDICINE SCHEDULE (POISONS STANDARD)

Australia: Not Scheduled
New Zealand: General Sale Medicine
8 SPONSOR
Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai, NSW 2080
Australia.
Telephone: (02) 9391 5555
Page 10 of 11
9 DATE OF FIRST APPROVAL

21 August 1992
10 DATE OF REVISION
02 March 2022
Summary table of changes

Section Changed Summary of new information
4.4 (June 2019) Added safety updates - biotin and interference with clinical
laboratory tests
4.2 (Aug 2021) Change of wording from ‘sterile’ to ‘aseptic’ conditions
Page 11 of 11

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AUSTRALIAN PRODUCT INFORMATION - SOLUVIT® N

(THIAMINE NITRATE, RIBOFLAVINE SODIUM PHOSPHATE,

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients Quantity in one vial 1 mL of reconstituted Soluvit N

4.2 Dose and method of administration

Adults and children weighing 10 kg or more

Children and Infants weighing less than 10 kg

4.4 Special warnings and precautions for use

Use in renal impairment

Use in the elderly

Effects on laboratory tests

4.5 Interaction with other medicines and other forms of interactions

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Adverse effects (Undesirable effects)

Reporting suspected adverse effects

5.2 Pharmacokinetic properties

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

Glass vials (Type I)

6.6 Special precautions for disposal

Empirical formula: C12H17N5O4S

Riboflavine sodium phosphate

Empirical formula: C17H20N4NaO9P.2H2O

Empirical formula: C6H6N2O

Empirical formula: C8H11NO3.HCl

Empirical formula: C9H16NNaO5

Empirical formula: C6H7NaO6

Empirical formula: C10H16N2O3S

Empirical formula: C19H19N7O6

Empirical formula: C63H88CoN14O14P

7 MEDICINE SCHEDULE (POISONS STANDARD)

9 DATE OF FIRST APPROVAL

Summary table of changes

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