- Approval Id
- 827c56437f8b5bd5
- Drug Name
- HAEMOCOMPLETTAN P POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL
- Product Name
- HAEMOCOMPLETTAN P POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL
- Approval Number
- SIN15895P
- Approval Date
- 2020-02-28
- Registrant
- CSL BEHRING PTE. LTD.
- Licence Holder
- CSL BEHRING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders.</p>
<p><strong>Posology</strong><br>
The dosage and duration of the substitution therapy depend on the severity of the disorder, location and extent of bleeding and the patient’s clinical condition.</p>
<p>The (functional) fibrinogen level should be determined in order to calculate individual dosage and the amount and frequency of administration should be determined on an individual patient basis by regular measurement of plasma fibrinogen level and continuous monitoring of the clinical condition of the patient and other replacement therapies used.</p>
<p>Normal plasma fibrinogen level is in the range of 1.5 – 4.5 g/l. The critical plasma fibrinogen level below which haemorrhages may occur is approximately 0.5 – 1.0 g/l.<br>
In case of major surgical intervention, precise monitoring of replacement therapy by coagulation assays is essential.</p>
<ol>
<li><p><u>Prophylaxis in patients with congenital hypo- or afibrinogenaemia and known bleeding tendency.</u></p>
<p>To prevent excessive bleeding during surgical procedures, prophylactic treatment is recommended to raise fibrinogen levels to 1 g/l and maintain fibrinogen at this level until haemostasis is secure and above 0.5 g/l until wound healing is complete.</p>
<p>In case of surgical procedures or treatment of a bleeding episode, the dose should be calculated as follows:</p>
<img src="/TGIF/HaemocomplettanP-Formula1.png" alt="Haemocomplettan P Dosage Formula 1" /><br><br>
<p>Subsequent posology (doses and frequency of injections) should be adapted based on the patient’s clinical status and laboratory results.</p>
<p>The biological half-life of fibrinogen is 3–4 days. Thus, in the absence of consumption, repeated treatment with human fibrinogen is not usually required. Given the accumulation that occurs in case of repeated administration for a prophylactic use, the dose and the frequency should be determined according to the therapeutic goals of the physician for a given patient.</p>
<p><u>Treatment of bleeding</u></p>
<p>Adults<br>
For perioperative bleeding generally 2 g (or 30 mg/kg body weight) is administered, with subsequent infusions as required. In case of severe haemorrhage i.e. obstetric use / abruption placenta, large amounts (4 – 8 g) of fibrinogen may be required.</p>
<p>Paediatric patients<br>
No recommendation on a posology can be made in children. The dosage should be determined according to the body weight and clinical need.</p>
</li>
</ol>
<p><strong>Method of Administration</strong><br>
Intravenous infusion or injection.<br>
Haemocomplettan should be reconstituted according to section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>. The reconstituted solution should be warmed to room or body temperature before administration, then injected or infused slowly at a rate which the patient finds comfortable. The injection or infusion rate should not exceed approx. 5 ml per minute.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Therapy and prophylaxis of haemorrhagic diatheses in:</p>
<ul>
<li>Congenital hypo- or afibrinogenaemia</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to 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>.</p>
- Atc Code
- B02BB01
- Atc Item Name
- fibrinogen, human
- Pharma Manufacturer Name
- CSL BEHRING PTE. LTD.
