FLEBOGAMMA DIF SOLUTION FOR INFUSION 5%

INSTITUTO GRIFOLS, S.A. (SPAIN)🇸🇬 Health Sciences Authority

Approval Date: May 20, 2011
Approval ID: f3557308df2f41b3
Company: INSTITUTO GRIFOLS, S.A. (SPAIN)
Type: Therapeutic

Approval Details

Approval Id: f3557308df2f41b3
Drug Name: FLEBOGAMMA DIF SOLUTION FOR INFUSION 5%
Product Name: FLEBOGAMMA DIF SOLUTION FOR INFUSION 5%
Approval Number: SIN13960P
Approval Date: 2011-05-20
Registrant: GRIFOLS ASIA PACIFIC PTE. LTD.
Licence Holder: GRIFOLS ASIA PACIFIC PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INFUSION, SOLUTION
Dosage: Posology and method of administration Posology The dose and dosage regimen is dependent on the indication. In replacement therapy, the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline. Replacement therapy in primary immunodeficiency syndromes The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4 – 6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4 – 0.8 g/kg followed by at least 0.2 g/kg every three weeks. The dose required to achieve a trough level of 6 g/l is of the order of 0.2 – 0.8 g/kg/month. The dosage interval when steady state has been reached varies from 2 – 4 weeks. Trough levels should be measured in order to adjust the dose and dosage interval. Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections. The recommended dose is 0.2 – 0.4 g/kg every three to four weeks. Idiopathic thrombocytopenic purpura For the treatment of an acute episode, 0.8 – 1 g/kg on day one, which may be repeated once within 3 days, or 0.4 g/kg daily for two to five days. The treatment can be repeated if relapse occurs. Guillain Barré syndrome 0.4 g/kg/day for 3 to 7 days. Experience in children is limited. Kawasaki disease 1.6 – 2.0 g/kg should be administered in divided doses over two to five days or 2.0 g/kg as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid. Allogeneic bone marrow transplantation Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant. For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. The starting dose is normally 0.5 g/kg/week, starting seven days before transplantation and for up to 3 months after transplantation. In case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal. The dosage recommendations are summarised in the following table: <img src="/TGIF/Flebogamma5-Table1.png" alt="Flebogamma 5% Dosage Table 1" /> Method of administration Flebogamma® 5% DIF should be infused intravenously at an initial rate of 0.01 – 0.02 ml/kg/min for the first thirty minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 ml/kg/min.
Route Of Administration: INTRAVENOUS
Indication Info: Therapeutic indications Flebogamma® 5% DIF is indicated for: Replacement therapy in: Primary immunodeficiency syndromes such as: <ul class="dash"> <li>congenital agammaglobulinaemia and hypogammaglobulinaemia</li> <li>common variable immunodeficiency</li> <li>severe combined immunodeficiency</li> <li>Wiskott Aldrich syndrome</li> </ul> Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. Children with congenital AIDS and recurrent infections. Immunomodulation Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. Guillain Barré syndrome. Kawasaki disease. Allogeneic bone marrow transplantation
Contraindications: Contraindications Hypersensitivity to any of the components (see section “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA. Fructose intolerance (see section “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: J06BA02
Atc Item Name: immunoglobulins, normal human, for intravascular adm.
Pharma Manufacturer Name: GRIFOLS ASIA PACIFIC PTE. LTD.

Active Ingredients

HUMAN NORMAL IMMUNOGLOBULIN

50 mg/ml

HUMAN NORMAL IMMUNOGLOBULIN

50 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 20, 2011

Approval ID

f3557308df2f41b3

Type

Therapeutic

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