Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
HUMAN NORMAL IMMUNOGLOBULIN
TAKEDA ISRAEL LTD
J06BA02
SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN 100 MG / 1 ML
S.C
Required
BAXALTA BELGIUM MANUFACTURING SA, BELGIUM
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Replacement therapy in adults, children and adolescents (0-18 years) in:• Primary immunodeficiency syndromes with impaired antibody production • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.• Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.• Hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (HSCT).
2023-02-28
03 PRODUCT HYQVIA SIZE 297 X 210 MM (W) x (H) PRODUCT SPEC STEP BY STEP TECH REF English FONT (TYPE & MIN. SIZE / LANGUAGE) Helvetica (TT) 8 p (eng) HyQvia 24p new copy. indd COLOR CMYK TYPE Brochure DATE 29/08/2023 ARTWORK OPERATOR Nurit Assayag JOB NO. 23000794 Takeda Israel Ltd. | 25 Efal St., Kiryat Arie, Petach Tikva 4951125 | Tel. 03-3733140 | www.takeda.com C-ANPROM/IL/HYQ/001802/23 REFERENCE HyQvia Patient Leaflet, approved by the Ministry of Health, June 2020 ©2019 Takeda Israel Ltd. All rights reserved. Takeda and the Takeda logo are registered trademarks of Takeda Israel Ltd., and their use is licensed. HyQvia is a registered trademark of Baxalta, which is currently a part of Takeda and remains the registration holder. The information is correct as of December 2022. For patient leaflet DOR-Hyq_en-BR-0823-03 Additional information following training by healthcare professionals HYQVIA is prescribed as replacement therapy to patients (including children and adolescents aged 0-18 years and adult patients) with: • Primary immunodeficiency syndromes with impaired antibody production. • Deficiency of antibody production (hypogammaglobulinaemia) and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contraindicated. • Deficiency of antibody production (hypogammaglobulinaemia) and recurrent bacterial infections in multiple myeloma (MM) patients. • Deficiency of antibody production (hypogammaglobulinaemia) in patients pre- and post- allogeneic hematopoietic stem cell transplantation (HSCT). 'STEP-BY-STEP' – A USER MANUAL FOR HYQVIA INFUSION USING A PERISTALTIC INFUSION PUMP For further questions, contact your doctor or pharmacist 2 GENERAL OVERVIEW ON THE INFUSION Coping with primary immunodeficiency involves numerous challenges. Treatment administration should not be one of them. This Step-by-Step guide is designed to help you learn how to use HYQVIA with a peristaltic infusion pump. Get familiar with the 5 steps wh Soma hati kamili
HYQ SPC AUG22 V0 EU PI JUN 2021 & SEP 2021 Page 1 of 16 1. NAME OF THE MEDICINAL PRODUCT HyQvia 100 mg/mL solution for infusion for subcutaneous use 2. QUALITATIVE AND QUANTITATIVE COMPOSITION HyQvia is a dual vial unit consisting of one vial of human normal immunoglobulin (Immune Globulin 10% or IG 10%) and one vial of recombinant human hyaluronidase (rHuPH20). Human normal immunoglobulin (SCIg)* One mL contains: Human normal immunoglobulin. 100 mg (purity of at least 98% IgG) Each vial of 25 mL contains: 2.5 g of human normal immunoglobulin Each vial of 50 mL contains: 5 g of human normal immunoglobulin Each vial of 100 mL contains: 10 g of human normal immunoglobulin Each vial of 200 mL contains: 20 g of human normal immunoglobulin Each vial of 300 mL contains: 30 g of human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG 1 ≥ 56.9% IgG 2 ≥ 26.6% IgG 3 ≥ 3.4% IgG 4 ≥ 1.7% The maximum IgA content is 140 micrograms/mL. * Produced from the plasma of human donors. Excipients with known effects: • Recombinant human hyaluronidase (rHuPH20) Recombinant human hyaluronidase is a purified glycoprotein of 447 amino acids produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. • Sodium (as chloride and as phosphate) The total sodium content of recombinant human hyaluronidase is 4.03 mg/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion (infusion). IG 10% is a clear or slightly opalescent and colourless or pale yellow solution. The solution has a pH of 4.6-5.1 and an osmolality of 240-300 mOsmol/kg. Recombinant human hyaluronidase is a clear, colourless solution. The solution has a pH of 6.5-8.0 and an osmolality of 290-350 mOsmol/kg. HYQ SPC AUG22 V0 EU PI JUN 2021 & SEP 2021 Page 2 of 16 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in adults, children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). • Hypogam Soma hati kamili