Approvals/HSA/NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION

Approved

THERAPEUTIC

NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION

B. BRAUN MELSUNGEN AG (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Apr 23, 2018
Approval ID: 75e6ac135d14f78e
Company: B. BRAUN MELSUNGEN AG (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: 75e6ac135d14f78e
Drug Name: NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION
Product Name: NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION
Approval Number: SIN15468P
Approval Date: 2018-04-23
Registrant: B. BRAUN SINGAPORE PTE LTD
Licence Holder: B. BRAUN SINGAPORE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
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 plus 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 40 ml/ kg body weight, corresponding to <table class="borderless-100"> <tbody> <tr> <td>1.54 g amino acids</td> <td>/ kg body weight per day</td> </tr> <tr> <td>4.8 g glucose</td> <td>/ kg body weight per day</td> </tr> <tr> <td>1.6 g lipid </td> <td>/ kg body weight per day.</td> </tr> </tbody> </table> The maximum rate of infusion is 2.0 ml/ kg body weight per hour, corresponding to <table class="borderless-100"> <tbody> <tr> <td>0.08 g amino acids</td> <td>/ kg body weight per hour</td> </tr> <tr> <td>0.24 g glucose</td> <td>/ kg body weight per hour</td> </tr> <tr> <td>0.08 g lipid</td> <td>/ kg body weight per hour.</td> </tr> </tbody> </table> For a patient weighing 70 kg, this corresponds to a maximum infusion rate of 140 ml per hour. The amount of substrate administered is then 5.4 g of amino acids per hour, 16.8 g of glucose per hour and 5.6 g of lipids per hour. Paediatric population Nutriflex Omega plus is contraindicated in newborn infants, infants and toddlers < 2 years of age (see section 4.3). Safety and efficacy in children > 2 years and adolescents have not been established. 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 plus 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 plus is indicated in adults.
Contraindications: 4.3 Contraindications <ul class="dash"> <li>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</li> <li>Inborn errors of amino acid metabolism</li> <li>Severe hypertriglyceridaemia (≥ 1000 mg/dl or 11.4 mmol/l)</li> <li>Severe coagulopathy</li> <li>Hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour</li> <li>Acidosis</li> <li>Intrahepatic cholestasis</li> <li>Severe hepatic insufficiency</li> <li>Severe renal insufficiency in absence of renal replacement therapy</li> <li>Aggravating haemorrhagic diatheses</li> <li>Acute thrombo-embolic events, lipid embolism</li> </ul> On account of its composition, Nutriflex Omega plus must not be used in newborn infants, infants and toddlers under 2 years of age. General contraindications to parenteral nutrition include: <ul class="dash"> <li>Unstable circulatory status with vital threat (states of collapse and shock)</li> <li>Acute phases of cardiac infarction and stroke</li> <li>Unstable metabolic condition (e.g. severe postaggression syndrome, coma of unknown origin)</li> <li>Inadequate cellular oxygen supply</li> <li>Disturbances of the electrolyte and fluid balance</li> <li>Acute pulmonary oedema</li> <li>Decompensated cardiac insufficiency</li> </ul>
Atc Code: B05BA10
Atc Item Name: combinations
Pharma Manufacturer Name: B. Braun Singapore Pte Ltd.
Company Detail Path: /organization/b-braun-singapore-pte-ltd

Active Ingredients

Valine

2.496g/1000ml

Serine

2.880g/1000ml

Potassium acetate

2.747g/1000ml

Triglycerides, medium chain

20.00g/1000ml

Tryptophan

0.544g/1000ml

Zinc acetate dihydrate

5.264mg/1000ml

Sodium chloride

0.402g/1000ml

Lysine hydrochloride eqv to lysine 2.184g/1000ml

2.728g/1000ml

Calcium chloride dihydrate

0.470g/1000ml

Phenylalanine

3.368g/1000ml

Arginine

2.592g/1000ml

Methionine

1.880g/1000ml

Isoleucine

2.256g/1000ml

Soya-bean oil, refined

16.00g/1000ml

Glucose monohydrate eqv to anhydrous glucose 120.0g/1000ml

132.0g/1000ml

Glycine

1.584g/1000ml

Glutamic acid

3.368g/1000ml

Threonine

1.744g/1000ml

Proline

3.264g/1000ml

Alanine

4.656g/1000ml

Aspartic acid

1.440g/1000ml

Omega-3-acid triglycerides

4.00g/1000ml

Magnesium acetate tetrahydrate

0.686g/1000ml

Histidine hydrochloride monohydrate eqv to histidine 1.20g/1000ml

1.624g/1000ml

Leucine

3.008g/1000ml

Sodium hydroxide

0.781g/1000ml

Sodium acetate trihydrate

0.222g/1000ml

Sodium dihydrogen phosphate dihydrate

1.872g/1000ml

ALANINE

4.656 G/1,000 ML

ARGININE

2.592 G/1,000 ML

ASPARTIC ACID

1.44 G/1,000 ML

CALCIUM CHLORIDE DIHYDRATE

0.47 G/1,000 ML

GLUCOSE MONOHYDRATE EQV TO ANHYDROUS GLUCOSE 120 G/1,000 ML

132 G/1,000 ML

GLUTAMIC ACID

3.368 G/1,000 ML

GLYCINE

1.584 G/1,000 ML

HISTIDINE HYDROCHLORIDE MONOHYDRATE EQV TO HISTIDINE 1.2 G/1,000 ML

1.624 G/1,000 ML

ISOLEUCINE

2.256 G/1,000 ML

LEUCINE

3.008 G/1,000 ML

LYSINE HYDROCHLORIDE EQV TO LYSINE 2.184 G/1,000 ML

2.728 G/1,000 ML

MAGNESIUM ACETATE TETRAHYDRATE

0.686 G/1,000 ML

METHIONINE

1.88 G/1,000 ML

OMEGA-3-ACID TRIGLYCERIDES

4 G/1,000 ML

PHENYLALANINE

3.368 G/1,000 ML

POTASSIUM ACETATE

2.747 G/1,000 ML

PROLINE

3.264 G/1,000 ML

SERINE

2.88 G/1,000 ML

SODIUM ACETATE TRIHYDRATE

0.222 G/1,000 ML

SODIUM CHLORIDE

0.402 G/1,000 ML

SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE

1.872 G/1,000 ML

SODIUM HYDROXIDE

0.781 G/1,000 ML

SOYA-BEAN OIL, REFINED

16 G/1,000 ML

THREONINE

1.744 G/1,000 ML

TRIGLYCERIDES, MEDIUM CHAIN

20 G/1,000 ML

TRYPTOPHAN

0.544 G/1,000 ML

VALINE

2.496 G/1,000 ML

ZINC ACETATE DIHYDRATE

5.264 MG/1,000 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 23, 2018

Approval ID

75e6ac135d14f78e

Type

Therapeutic

Back to HSA Approvals