- Approval Id
- 3da643305322e1c1
- Drug Name
- PELGRAZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML
- Product Name
- PELGRAZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML
- Approval Number
- SIN16249P
- Approval Date
- 2021-06-24
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.</p>
<p><u>Posology</u></p>
<p>One 6 mg dose (a single pre-filled syringe) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.</p>
<p><u>Special populations</u></p>
<p>Paediatric population</p>
<p>The safety and efficacy of Pelgraz in children and adolescents has not yet been established.</p>
<p>Patients with renal impairment</p>
<p>No dose change is recommended in patients with renal impairment.</p>
<p><u>Method of administration</u></p>
<p>Pelgraz is for subcutaneous use. The injections should be given subcutaneously into the thigh, abdomen or upper arm.</p>
<p>For instructions on handling of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance 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
- L03AA13
- Atc Item Name
- pegfilgrastim
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
