Approvals/HSA/NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION

Approved

THERAPEUTIC

NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION

B. Braun Melsungen AG🇸🇬 Health Sciences Authority

Approval Date: Mar 7, 2023
Approval ID: 3f395781edb9e4ec
Company: B. Braun Melsungen AG
Type: Therapeutic

Approval Details

Approval Id: 3f395781edb9e4ec
Drug Name: NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION
Product Name: NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION
Approval Number: SIN16734P
Approval Date: 2023-03-07
Registrant: B. BRAUN SINGAPORE PTE LTD
Licence Holder: B. BRAUN SINGAPORE PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, EMULSION
Dosage: **4.2 Posology and method of administration** Posology The dosage should be adapted to the patients’ individual requirements. It is recommended that Nutriflex® Omega Special B. Braun Emulsion for Infusion be administered continuously. A stepwise increase of the infusion rate over the first 30 minutes up to the desired infusion rate avoids possible complications. _Adults_ The maximum daily dose amounts to 35 mL/ kg body weight, corresponding to 2.0 g amino acids/kg body weight per day5.04 g glucose/kg body weight per day1.4 g lipid/kg body weight per day. The maximum rate of infusion is 1.7 ml/kg body weight per hour, corresponding to 0.1 g amino acids/kg body weight per hour0.24 g glucose/kg body weight per hour0.07 g lipid/kg body weight per hour. For a patient weighing 70 kg this corresponds to a maximum infusion rate of 119 mL per hour. The amount administered is then 6.8 g of amino acids per hour, 17.1 g of glucose per hour and 4.8 g of lipids per hour. _Paediatric population_ Nutriflex® Omega Special B. Braun Emulsion for Infusion is contraindi-cated in newborn infants, infants and toddlers under 2 years of age (see section 4.3). The safety and efficacy in children over 2 years and adolescents have not been established yet. No data are available. _Patients with renal/hepatic impairment_ The doses should be adjusted individually in patients with hepatic or renal insufficiency (see also section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Duration of treatment The duration of treatment for the indications stated is not limited. During the administration of Nutriflex® Omega Special B. Braun Emulsion for Infusion it is necessary to provide an appropriate amount of trace elements and vitamins. _Duration of infusion of one single bag_ The recommended duration of infusion for a parenteral nutrition bag is maximum 24 h. Method of administration Intravenous use. For central venous infusion only.
Route Of Administration: INTRAVENOUS
Indication Info: **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.
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.
Atc Code: B05BA10
Atc Item Name: combinations
Pharma Manufacturer Name: B. Braun Singapore Pte Ltd.
Company Detail Path: /organization/8a1bb7e472d90365/b-braun-singapore-pte-ltd

Active Ingredients

Calcium chloride dihydrate

0.623g/1000ml

Glucose monohydrate

158.4g/1000ml

Isoleucine

3.284g/1000ml

Valine

3.604g/1000ml

Zinc acetate dihydrate

7.024mg/1000ml

Methionine

2.736g/1000ml

Potassium acetate

3.689g/1000ml

Glycine

2.312g/1000ml

Serine

4.200g/1000ml

Sodium chloride

0.378g/1000ml

Glutamic acid

4.908g/1000ml

Arginine

3.780g/1000ml

Phenylalanine

4.916g/1000ml

Lysine hydrochloride

3.980g/1000ml

Soya-bean oil, refined

16.00g/1000ml

Triglycerides, medium chain

20.00g/1000ml

Tryptophan

0.800g/1000ml

Omega-3-acid triglycerides

4.000g/1000ml

Magnesium acetate tetrahydrate

0.910g/1000ml

Histidine hydrochloride monohydrate

2.368g/1000ml

Aspartic acid

2.100g/1000ml

Leucine

4.384g/1000ml

Proline

4.760g/1000ml

Sodium dihydrogen phosphate dihydrate

2.496g/1000ml

Threonine

2.540g/1000ml

Sodium hydroxide

1.171g/1000ml

Sodium acetate trihydrate

0.250g/1000ml

Alanine

6.792g/1000ml

ALANINE

6.792 G/1,000 ML

ARGININE

3.78 G/1,000 ML

ASPARTIC ACID

2.1 G/1,000 ML

CALCIUM CHLORIDE DIHYDRATE

0.623 G/1,000 ML

GLUCOSE MONOHYDRATE

158.4 G/1,000 ML

GLUTAMIC ACID

4.908 G/1,000 ML

GLYCINE

2.312 G/1,000 ML

HISTIDINE HYDROCHLORIDE MONOHYDRATE

2.368 G/1,000 ML

ISOLEUCINE

3.284 G/1,000 ML

LEUCINE

4.384 G/1,000 ML

LYSINE HYDROCHLORIDE

3.98 G/1,000 ML

MAGNESIUM ACETATE TETRAHYDRATE

0.91 G/1,000 ML

METHIONINE

2.736 G/1,000 ML

OMEGA-3-ACID TRIGLYCERIDES

4 G/1,000 ML

PHENYLALANINE

4.916 G/1,000 ML

POTASSIUM ACETATE

3.689 G/1,000 ML

PROLINE

4.76 G/1,000 ML

SERINE

4.2 G/1,000 ML

SODIUM ACETATE TRIHYDRATE

0.25 G/1,000 ML

SODIUM CHLORIDE

0.378 G/1,000 ML

SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE

2.496 G/1,000 ML

SODIUM HYDROXIDE

1.171 G/1,000 ML

SOYA-BEAN OIL, REFINED

16 G/1,000 ML

THREONINE

2.54 G/1,000 ML

TRIGLYCERIDES, MEDIUM CHAIN

20 G/1,000 ML

TRYPTOPHAN

0.8 G/1,000 ML

VALINE

3.604 G/1,000 ML

ZINC ACETATE DIHYDRATE

7.024 MG/1,000 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 7, 2023

Approval ID

3f395781edb9e4ec

Type

Therapeutic

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