- Approval Id
- f99078702a8463bb
- Drug Name
- GELASPAN SOLUTION FOR INFUSION
- Product Name
- GELASPAN SOLUTION FOR INFUSION
- Approval Number
- SIN15336P
- Approval Date
- 2017-10-04
- Registrant
- B. BRAUN SINGAPORE PTE LTD
- Licence Holder
- B. BRAUN SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>Dosage and infusion rate are adjusted according to the amount of blood loss and to individual needs for restoration and maintenance of a stable haemodynamic situation, respectively. The dose administered is initially 500 to 1000 ml on average, in case of severe blood loss higher doses have to be applied.</p>
<p><em>Adults</em><br>
In adults, 500 ml is administered at an appropriate rate depending on the haemodynamic status of the patient. In the case of more than 20 percent blood loss usually blood or blood components should be given in addition to Gelaspan.</p>
<p><em>Paediatric population</em><br>
The safety and efficacy of Gelaspan in children have not yet been completely established. Therefore, no recommendation on a posology can be made. Gelaspan should only be administered to these patients if the expected benefits clearly outweigh potential risks. In those cases the patient's prevailing clinical condition should be taken into account and the therapy should be monitored especially carefully. (See also section 4.4. – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p><em>Maximum dose:</em></p>
<p>The maximum daily dose is determined by the degree of haemodilution. Care must be taken to avoid a decrease of the haematocrit below critical values, see section <strong>4.4</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>If necessary, blood or packed red cells must be transfused additionally.</p>
<p>Attention must also be paid to the dilution of plasma proteins (e.g. albumin and coagulation factors), which must be adequately substituted if necessary.</p>
<p><em>Infusion rate:</em></p>
<p>The infusion rate depends on the actual haemodynamic situation.</p>
<p>The first 20 – 30 ml of solution should be infused slowly in order to detect anaphylactoid reactions as early as possible. See also sections <strong>4.4</strong> and <strong>4.8</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>In shock situations, Gelaspan may be infused rapidly by pressure infusion, 500 ml within 5 – 10 min.</p>
<p><em>Method of administration</em></p>
<p>Intravenous use</p>
<p>When given rapidly Gelaspan should be warmed to not more than 37°C if possible.</p>
<p>In case of pressure infusion, which might be necessary in vital emergencies, all air must be removed from the container and the infusion set before the solution is administered.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Gelaspan is a colloidal plasma volume substitute in an isotonic, fully balanced electrolyte solution for:</p>
<ul>
<li>Prophylaxis and treatment of hypotension caused by relative hypovolaemia during induction of epidural or spinal anaesthesia or due to imminent significant blood loss in a surgical setting</li>
<li>Procedures involving extracorporeal circulation as a component of priming fluid in combination with crystalloid solutions (e.g. priming of heart-lung machines)</li>
<li>Acute normovolaemic haemodilution</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Gelaspan must not be used in the following situations:</p>
<ul>
<li>hypersensitivity to gelatine solutions or to any of the other ingredients of Gelaspan</li>
<li>hypervolaemia</li>
<li>hyperhydration</li>
<li>hyperkalaemia</li>
</ul>
- Atc Code
- B05AA06
- Atc Item Name
- gelatin agents
- Pharma Manufacturer Name
- B. Braun Singapore Pte Ltd.
- Company Detail Path
- /organization/b-braun-singapore-pte-ltd
