SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Solivito N

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Thiamine Mononitrate    3.1 mg

Sodium Riboflavine Phosphate    4.9mg

Nicotinamide    40.0mg

Pyridoxine Hydrochloride    4.9mg

Sodium Pantothenate    16.5mg

Sodium Ascorbate    113.0mg

Biotin    0.06 mg

Folic Acid    0.4mg

Cyanocobalamin    0.005mg

3    PHARMACEUTICAL FORM

Lyophilised Powder

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Solivito N is intended for use as a supplement in intravenous nutrition, providing the daily requirements of water and soluble vitamins in adults and children.

4.2    Posology and method of administration

Route of administration: Intravenous

Recommended dosage for adults and children weighing 10kg or more:

The contents of one vial of Solivito N are dissolved by the aseptic addition of 10ml of one of the following:

(i)    Vitlipid N adult or for children under 11 years of age Vitlipid N infant.

(ii)    Intralipid 10% or 20%.

(iii)    Glucose intravenous infusion    (5%    - 60%).

(iv)    Water for injections.

The reconstituted mixtures (i) and (ii) should be aseptically transferred to Intralipid 10% or 20% for infusion. The reconstituted mixtures (iii) and (iv) should be added to either glucose solution (5% - 60%) or Intralipid 10% or 20%. In this way the basal requirements of the water-soluble vitamins are provided.

Recommended dosage for infants and children under 10kg:

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

(i)    Vitlipid N infant.

(ii)    Intralipid 10% or 20%.

(iii)    Glucose Intravenous Infusion    (5%    - 60%).

(iv)    Water for Injection

The basal requirements for water-soluble vitamins in children are provided by 1.0ml of this reconstituted mixture per kg bodyweight.

The reconstituted mixtures (i) and (ii) should be aseptically transferred to Intralipid 10% or 20% for infusion. The reconstituted mixtures (iii) and (iv) should be added to either glucose solution (5% - 60%) or to Intralipid 10% or 20%.

One vial of Solivito N should be infused over a minimum period of two to three hours. In patients with normal renal function so as to minimise renal losses.

Recommended dosage for the elderly:

No adjustment of the adult dosage should be required.

4.3 Contraindications

Known hypersensitivity to any of the components e.g. thiamine (Vitamin B₁) or methylhydroxybenzoate.

4.4 Special warnings and precautions for use

For special precautions during pregnancy, see under 4.6.

4.5 Interaction with other medicinal products and other forms of interaction

Pyridoxine (Vitamin B₆) can reduce the effect of levodopa. Some of the optic neuropathies appear to respond to massive doses of hydroxocobalamin and have been claimed to be adversely affected by administration of cyanocobalamin. Folic acid may lower the serum concentration of phenytoin and obscure pernicious anaemia.

4.6    Pregnancy and lactation

Solivito N is a supplement in TPN regimens, providing water-soluble vitamins. No hazard is expected if used in pregnancy at the recommended dosage, covering the daily requirements of vitamins B1, B2, B6, B12 and C.

4.7    Effects on ability to drive and use machines

Not applicable.

4.8    Undesirable effects

None known.

4.9    Overdose

In general overdosage with Solivito N is unlikely. No clinically significant effects are envisaged if overdose should occur. However, treatment would be symptomatic.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Solivito N is formulated to supply water-soluble vitamins as part of a total parenteral nutrition regimen.

5.2    Pharmacokinetic properties

Solivito N is a product without interest for pharmacokinetic studies.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to that already included in other sections of the Summary of Product Characteristics.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Aminoacetic Acid Methyl Parahydroxybenzoate Disodium Edetate Water for Injections

6.2    Incompatibilities

None known.

6.3    Shelf life

18 months

6.4    Special precautions for storage

Store below 25°C Protect from light.

6.5    Nature and contents of container

10ml Glass Vial (Ph.Eur - Type I) Butyl rubber stopper.

6.6    Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park

Runcorn Cheshire WA7 1NT UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 08828/0116

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/03/2009

10 DATE OF REVISION OF THE TEXT

26/07/2013