- Approval Id
- b2caaf1f50ac302d
- Drug Name
- AMINOPLASMAL-15% INFUSION
- Product Name
- AMINOPLASMAL-15% INFUSION
- Approval Number
- SIN08352P
- Approval Date
- 1995-09-14
- Registrant
- B. BRAUN SINGAPORE PTE LTD
- Licence Holder
- B. BRAUN SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- GENERAL SALE LIST
- Dosage Form
- INJECTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>The dosage has to be adjusted according to the individual need of amino acids and fluid, depending on the clinical condition of the patient (nutritional status and/or degree of nitrogen catabolism due to underlying disease).</p>
<p><em>Adults and adolescents from 14 to 17 years</em></p>
<table class="borderless-100">
<tbody>
<tr>
<td><u>Daily dose:</u></td>
</tr>
<tr>
<td>1.0 – 2.0 g amino acids/kg body weight</td>
<td>
<p>≙ 6.7 – 13.3 ml/kg body weight</p>
<p>≙ 469 – 931 ml for a 70 kg patient</p>
</td>
</tr>
<tr>
<td><u>Maximum infusion rate:</u></td>
</tr>
<tr>
<td>0.1 g amino acids/kg body weight/h</td>
<td>
<p>≙ 0.67 ml/kg body weight/h</p>
<p>≙ 0.78 ml/min for a 70 kg patient</p></td>
</tr>
</tbody>
</table>
<p><em>Paediatric population</em></p>
<p><em>Newborn infants, infants and toddlers less than two years of age</em></p>
<p>Aminoplasmal 15% is contraindicated in newborn infants, infants and toddlers less than 2 years of age (see section 4.3).</p>
<p><em>Children and adolescents 2 to 13 years</em></p>
<p>The dosages for the age groups stated below are average values for guidance. The exact dosage should be adjusted individually according to age, developmental stage and prevailing disease.</p>
<p><u>Daily dose for children 2 to 4 years:</u><br>
1.5 g amino acids/kg body weight ≙ 10 ml/kg body weight</p>
<p><u>Daily dose for children 5 to 13 years:</u><br>
1.0 g amino acids/kg body weight ≙ 6.7 ml/kg body weight</p>
<p><u>Critically ill children:</u> For critically ill patients the advisable amino acid intake may be higher (up to 3.0 g amino acids/kg body weight per day).</p>
<p><u>Maximum infusion rate:</u><br>
0.1 g amino acids/kg body weight/h ≙ 0.67 ml/kg body weight /h</p>
<p>In the case of amino acid requirements of 1.0 g/kg body weight/day or more, particular attention should be paid to the limitations of fluid input. To avoid fluid overload, amino acid solutions with higher amino acid content may have to be used in such situations.</p>
<p><em>Patients with renal/hepatic impairment</em><br>
The doses should be adjusted individually in patients with hepatic or renal insufficiency (see also section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Aminoplasmal 15% is contraindicated in severe hepatic insufficiency and severe renal insufficiency in absence of renal replacement therapy (see section 4.3).</p>
<p><em>Duration of use</em></p>
<p>This solution can be administered as long as parenteral nutrition is indicated.</p>
<p><u>Method of administration</u></p>
<p>Intravenous use.<br>
For central venous infusion only.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Supply of amino acids for parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contraindicated. For adults, adolescents and children over 2 years of age.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em></li>
<li>Inborn errors of amino acid metabolism</li>
<li>Severe circulation disorders with vital risk (e.g. shock)</li>
<li>Hypoxia</li>
<li>Metabolic acidosis</li>
<li>Severe hepatic insufficiency</li>
<li>Severe renal insufficiency in absence of renal replacement therapy</li>
<li>Decompensated cardiac insufficiency</li>
<li>Acute pulmonary oedema</li>
<li>Disturbances of the electrolyte and fluid balance</li>
</ul>
<p>The medicinal product must not be administered to newborn infants, infants and toddlers less than two years of age, because the amino acid composition does not properly meet the special requirements of this paediatric age group.</p>
- Atc Code
- B05BA01
- Atc Item Name
- amino acids
- Pharma Manufacturer Name
- B. Braun Singapore Pte Ltd.
- Company Detail Path
- /organization/b-braun-singapore-pte-ltd
