- Approval Id
- 0cf10b42dced49d3
- Drug Name
- STEROFUNDIN ISO SOLUTION FOR INFUSION
- Product Name
- STEROFUNDIN ISO SOLUTION FOR INFUSION
- Approval Number
- SIN13890P
- Approval Date
- 2010-11-15
- Registrant
- B. BRAUN SINGAPORE PTE LTD
- Licence Holder
- B. BRAUN SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- GENERAL SALE LIST
- Dosage Form
- INFUSION, SOLUTION
- Dosage
- <p><strong>Dosage</strong><br>
<em>Adults, the elderly, adolescents and children:</em><br>
The dosage depends on the age, weight, clinical and biological conditions of the patient and concomitant therapy.</p>
<p>Recommended dosage:<br>
The recommended dosage is:</p>
<ul class="dash">
<li>for adults, the elderly and adolescents : 500 ml to 3 litres /24h, corresponding to 1 to 6 mmol sodium / kg / 24 h and 0.03 to 0.17 mmol potassium / kg / 24 h.</li>
<li>for babies and children : 20 ml to 100 ml / kg / 24 h, corresponding to 3 to 14 mmol sodium / kg / 24 h and 0.08 to 0.40 mmol potassium / kg / 24 h.</li>
</ul>
<p>Administration rate:<br>
The maximum infusion rate depends on the needs of the patient in fluid replacement and electrolytes, his weight, clinical condition, and biological status.<br>
In <em>paediatric patients</em> the infusion rate is 5 ml/kg/h on average but the value varies with age: 6–8 ml/kg/h for infants, 4–6 ml/kg/h for toddlers, and 2–4 ml/kg/h for schoolchildren.</p>
<p>Note:</p>
<ul class="dash">
<li>infants and toddlers: age ranges from about 28 days to 23 months (a toddler is an infant who can walk)</li>
<li>children and schoolchildren: age ranges from about 2 years to 11 years.</li>
</ul>
<p><em>Method of administration</em><br>
For intravenous use as infusion only.<br>
The solution has a pH of 5.1 – 5.9 and a theoretical osmolarity of 309 mosm/l. Therefore it can be infused into peripheral veins.<br>
If administration is by rapid infusion under pressure, all air must be withdrawn from the plastic container and infusion set prior to infusion, as otherwise there is a risk of producing air embolism during infusion.</p>
<p>Monitoring<br>
Fluid balance, plasma electrolyte concentrations and pH must be monitored during administration.<br>
Sterofundin ISO may be administered as long as there is an indication for fluid replacement.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Indications</strong><br>
Replacement of extracellular fluid losses in the case of isotonic dehydration, where acidosis is present or imminent.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<ul class="dash">
<li>Hypervolaemia</li>
<li>Severe congestive cardiac failure</li>
<li>Renal failure with oliguria or anuria</li>
<li>Severe general oedema</li>
<li>Hyperkalaemia</li>
<li>Hypercalcaemia</li>
<li>Metabolic alkalosis</li>
</ul>
- Pharma Manufacturer Name
- B. Braun Singapore Pte Ltd.
- Company Detail Path
- /organization/b-braun-singapore-pte-ltd
