PRODUCT INFORMATION

NAME OF MEDICINE
SOLUVIT N
Water-soluble vitamins. Solution for intravenous infusion.

DESCRIPTION
Soluvit N is a lyophilised, sterile, yellow mixture of water-soluble vitamins for intravenous
infusion.

One vial contains:

Thiamine nitrate 3.1 mg

Sodium riboflavine phosphate 4.9 mg
(corresponding to Vitamin B2 3.6 mg)
Nicotinamide 40 mg
Pyridoxine hydrochloride 4.9 mg
(corresponding to Vitamin B6 4.0 mg)
Sodium pantothenate 16.5 mg
(corresponding to Pantothenic acid 15.0 mg)
Sodium ascorbate 113 mg
(corresponding to Vitamin C 100 mg)
Biotin 60 microgram
Folic acid 400 micrograms
Cyanocobalamin 5.0 microgram
Glycine 300 mg
Edetate sodium 500 micrograms

(with preservative, 500 micrograms methyl hydroxybenzoate)

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 and children 11 years of age and
older. Soluvit N is not recommended for use in children aged under 11 years. Fat-
soluble vitamins should also be administered to patients receiving prolonged parenteral
nutrition.

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

PRECAUTIONS
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 total parenteral

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nutrition 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 or Vitalipid N if Soluvit N is dissolved in these products.

Use in pregnancy
The requirement of vitamins in pregnant and lactating women may be insufficient due to
the patient's altered needs. Soluvit N has been administered to pregnant women with no
adverse reactions reported.

Interactions with other drugs

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 or Vitalipid N, due to the possibility of physical incompatibilities (see product
information for Intralipid and Vitalipid N).

ADVERSE EFFECTS
Allergic reactions may occur in patients hypersensitive to any component in the
preparation, for example, methyl parahydroxybenzoate or thiamine. 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
and pruritus and CNS reactions including headache, dizziness and agitation.

DOSAGE AND ADMINISTRATION

The daily requirements of adult patients and children (11 years and over) weighing 10 kg
or more are met by the contents of one vial.

Adults and children aged 11 years and over

The contents of one vial are dissolved by the aseptic addition of 10 mL of one of the
following:

1. Vitalipid N Adult
2. Intralipid 10% or 20%
3. Water for Injections
4. Glucose solution, electrolyte-free (5% to 60%)

The reconstituted mixtures 1 and 2 must be added aseptically to Intralipid only. The
reconstituted mixtures 3 and 4 are added aseptically to Intralipid or glucose solutions
(5% to 60%) for infusion.

OVERDOSAGE
The possibility of hypervitaminosis A and D should be considered if the contents of the
Soluvit vial is dissolved in Vitalipid N.
PRESENTATION

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Soluvit N is a sterile, lyophilised 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. Soluvit N can
be dissolved in Vitalipid N Adult, Intralipid, electrolyte-free glucose solutions (5% to 60%)
or Water for Injections.

Vials: box of 10

STORAGE CONDITIONS
Store below 25oC, protected from light. The reconstituted Soluvit N should be added to
the infusion solution aseptically, 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.

NAME AND ADDRESS OF THE SPONSOR

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way, Mount Kuring-gai NSW 2080
Australia
Telephone: (02) 9391 5555

Fresenius Kabi New Zealand Limited

60 Pavilion Drive
Airport Oaks, Auckland 2022
New Zealand
Freecall: 0800 144 892

POISON SCHEDULE
Australia: Not Scheduled
New Zealand: General Sale Medicine

DATE OF TGA APPROVAL: 30th November, 2009

Date of recent amendment: 2nd August 2016

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