HYQVIA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

HUMAN NORMAL IMMUNOGLOBULIN

متاح من:

TAKEDA ISRAEL LTD

ATC رمز:

J06BA02

الشكل الصيدلاني:

SOLUTION FOR INFUSION

تركيب:

HUMAN NORMAL IMMUNOGLOBULIN 100 MG / 1 ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAXALTA BELGIUM MANUFACTURING SA, BELGIUM

المجال العلاجي:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

الخصائص العلاجية:

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).

تاريخ الترخيص:

2023-02-28

نشرة المعلومات

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. [phone] | 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

خصائص المنتج

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