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HSA Product

NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION

Product approved by Health Sciences Authority (SG)

Basic Information

NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION

INJECTION, EMULSION

Regulatory Information

SIN16734P

March 7, 2023

Prescription Only

Therapeutic

INTRAVENOUS

August 10, 2023

June 4, 2025

XB05BA10

Company Information

B. BRAUN SINGAPORE PTE LTD

B. BRAUN SINGAPORE PTE LTD

Active Ingredients

Calcium chloride dihydrate

Strength: 0.623g/1000ml

Glucose monohydrate

Strength: 158.4g/1000ml

Isoleucine

Strength: 3.284g/1000ml

Valine

Strength: 3.604g/1000ml

Zinc acetate dihydrate

Strength: 7.024mg/1000ml

Methionine

Strength: 2.736g/1000ml

Potassium acetate

Strength: 3.689g/1000ml

Glycine

Strength: 2.312g/1000ml

Serine

Strength: 4.200g/1000ml

Sodium chloride

Strength: 0.378g/1000ml

Glutamic acid

Strength: 4.908g/1000ml

Arginine

Strength: 3.780g/1000ml

Phenylalanine

Strength: 4.916g/1000ml

Lysine hydrochloride

Strength: 3.980g/1000ml

Soya-bean oil, refined

Strength: 16.00g/1000ml

Triglycerides, medium chain

Strength: 20.00g/1000ml

Tryptophan

Strength: 0.800g/1000ml

Omega-3-acid triglycerides

Strength: 4.000g/1000ml

Magnesium acetate tetrahydrate

Strength: 0.910g/1000ml

Aspartic acid

Strength: 2.100g/1000ml

Leucine

Strength: 4.384g/1000ml

Proline

Strength: 4.760g/1000ml

Threonine

Strength: 2.540g/1000ml

Sodium hydroxide

Strength: 1.171g/1000ml

Sodium acetate trihydrate

Strength: 0.250g/1000ml

Alanine

Strength: 6.792g/1000ml

Detailed Information

Contraindications

**4.3 Contraindications** - hypersensitivity to the active substances, to egg, fish, peanut or soya protein or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ - inborn errors of amino acid metabolism - severe hypertriglyceridaemia (≥ 1000 mg/dL or 11.4 mmol/L) - severe coagulopathy - hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour - acidosis - intrahepatic cholestasis - severe hepatic insufficiency - severe renal insufficiency in absence of renal replacement therapy - aggravating haemorrhagic diatheses - acute thromboembolic events, lipid embolism On account of its composition Nutriflex® Omega Special B. Braun Emulsion for Infusion must not be used in newborn infants, infants and toddlers under 2 years of age. General contraindications to parenteral nutrition include: - unstable circulatory status with vital threat (states of collapse and shock) - acute phases of cardiac infarction and stroke - unstable metabolic condition (e.g. severe postaggression syndrome, coma of unknown origin) - inadequate cellular oxygen supply - disturbances of the electrolyte and fluid balance - acute pulmonary oedema - decompensated cardiac insufficiency.

Indication Information

**4.1 Therapeutic indications** Supply of energy, essential fatty acids including omega-3 and omega-6 fatty acids, amino acids, electrolytes and fluids for parenteral nutrition of patients in states of moderate to severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated. Nutriflex® Omega Special B. Braun Emulsion for Infusion is indicated in adults.

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