Consumer medicine information

1. Why am I using SmofKabiven Low Osmo?

SmofKabiven Low Osmo contains the active ingredients alanine, arginine, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride dihydrate, sodium glycerophosphate hydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate, zinc sulfate heptahydrate, glucose monohydrate, soya oil, medium chain triglycerides, olive oil and fish oil-rich in omega-3 acids.
SmofKabiven Low Osmo is used as parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.
For more information, see Section 1. Why am I using SmofKabiven Low Osmo? in the full CMI.

2. What should I know before I use SmofKabiven Low Osmo?

Do not use if you have ever had an allergic reaction to SmofKabiven Low Osmo or 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 SmofKabiven Low Osmo? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SmofKabiven Low Osmo 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 SmofKabiven Low Osmo?

• Your doctor will decide on the dose for you individually depending on your body weight and function. SmofKabiven Low Osmo will be given to you by a health care professional.

• Follow the instructions provided and use SmofKabiven Low Osmo until your doctor tells you to stop.

5. What should I know while using SmofKabiven Low Osmo?

6. Are there any side effects?

Less serious side effects have been reported during post-market monitoring. If you get any adverse effects, talk to your doctor or nurse. 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.

1 Name of Medicine

SmofKabiven Low Osmo is a three chamber bag system of amino acid solution with electrolytes, glucose solution and lipid emulsion for intravenous infusion.
The active ingredients are:
Amino acids 2.5%. Alanine, arginine, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine.
Electrolytes 0.4%. Calcium chloride dihydrate, sodium glycerophosphate hydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate, zinc sulfate heptahydrate.
Lipids 3.5%. Soya oil, fish oil - rich in omega-3 acids, medium-chain triglycerides, olive oil.
Glucose 6.8%. Glucose monohydrate.

2 Qualitative and Quantitative Composition

SmofKabiven Low Osmo consists of a three chamber bag system. Each bag contains the following partial volumes depending on the four pack sizes. See Table 1.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SMOLOS01.gif This corresponds to the following total compositions (see Table 2).
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SMOLOS02.gif Corresponding to (see Table 3):
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SMOLOS03.gif Excipients with known effect. Egg lecithin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Emulsion for intravenous infusion.
Glucose and amino acid solutions are clear and colourless to slightly yellow and free from particles. The lipid emulsion is white and homogenous.
Osmolality: Approx. 870 mOsmol/kg water.
Osmolarity: Approx. 750 mOsmol/L.
pH (after mixing): Approx. 5.6.

4 Clinical Particulars

4.9 Overdose

See Section 4.4 Special Warnings and Precautions for Use, Fat overload syndrome, Excess of amino acid infusion and Excess of glucose infusion.
If symptoms of overdose of lipids or amino acids occur, the infusion should be slowed down or discontinued. There is no specific antidote for overdose. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated appropriately.
If hyperglycaemia occurs, it should be treated according to the clinical situation either by appropriate insulin administration and/or adjustment of the infusion rate.
Additionally, overdose might cause fluid overload, electrolyte imbalances and hyperosmolality.
In some rare serious cases, haemodialysis, haemofiltration or haemodiafiltration may be considered.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of SmofKabiven Low Osmo has not been assessed. The lipid component of SmofKabiven Low Osmo, SMOFlipid, was not mutagenic or clastogenic in a battery of genotoxicity studies, including the Ames bacterial mutagenicity assay, a mammalian mutagenicity assay, a chromosome aberration assay in human peripheral lymphocytes, and an in vivo rat micronucleus assay.
Carcinogenicity. No carcinogenicity studies have been conducted with the combined components of SmofKabiven Low Osmo.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Chemical structures are included for the glucose and the electrolyte components only.
The amino acid and the lipid components are large molecules and therefore structures for these are not included.
Glucose monohydrate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGLUCMO.gif Empirical formula: C₆H₁₂O₆.H₂O.
Molecular weight: 198.17 g/mol.
Calcium chloride dihydrate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCACHDI.gif Empirical formula: CaCl₂.2H₂O.
Molecular weight: 147.01 g/mol.
Magnesium sulfate heptahydrate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMASUHE.gif Empirical formula: MgSO₄.7H₂O.
Molecular weight: 246.47 g/mol.
Potassium chloride. Empirical formula: KCl.
Molecular weight: 74.55 g/mol.
Sodium acetate trihydrate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSOACTR.gif Empirical formula: C₂H₉NaO₅.
Molecular weight: 136.08 g/mol.
Sodium glycerophosphate hydrate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSOGLHY.gif Empirical formula: C₃H₇Na₂O₆P.
Molecular weight: 216.04 g/mol.
Zinc sulfate heptahydrate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSZISUHE.gif Empirical formula: ZnSO₄.7H₂O.
Molecular weight: 287.58 g/mol.
CAS number. See Table 9.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SMOLOS09.gif

7 Medicine Schedule (Poisons Standard)

Not Scheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SMOLOSST.gif