QARZIBA dinutuximab beta 4.5 mg/mL concentrate for solution for infusion, 20 mg/4.5 mL vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

dinutuximab beta, Quantity: 4.5 mg/mL

Disponible des:

Recordati Rare Diseases Australia Pty Ltd

formulario farmacéutico:

Solution

Composición:

Excipient Ingredients: polysorbate 20; hydrochloric acid; sucrose; water for injections; histidine

Vía de administración:

Intravenous Infusion

Unidades en paquete:

Each carton contains 1 vial

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

QARZIBA is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response.

Resumen del producto:

Visual Identification: Concentrate for solution for infusion - colourless to slightly yellow liquid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Restricted flow insert

Estat d'Autorització:

Registered

Data d'autorització:

2020-04-02

Informació per a l'usuari

QARZIBA PI v 4
Page 1 of 15
SPC – DIN – AU – 1171 – 04
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - QARZIBA (DINUTUXIMAB BETA)
1
NAME OF THE MEDICINE
QARZIBA (dinutuximab beta)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of concentrate contains 4.5 mg dinutuximab beta.
Each vial contains 20 mg dinutuximab beta in 4.5 mL.
Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody
produced in a
mammalian cell line (CHO) by recombinant DNA technology.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Colourless to slightly yellow liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
QARZIBA is indicated for the treatment of high-risk neuroblastoma in
patients who have
previously received induction chemotherapy and achieved at least a
partial response.
4.2
DOSE AND METHOD OF ADMINISTRATION
QARZIBA must be administered under the direction of a physician
experienced in the use of
oncological therapies. The infusion must be initiated by a healthcare
professional prepared to
manage severe allergic reactions including anaphylaxis in an
environment where full
resuscitation services are immediately available.
DOSAGE
Treatment with QARZIBA consists of 5 consecutive courses, each course
comprising
35 days.

For patients weighing >12 kg, the individual dose is determined based
on the body
surface area and should be a total of 100 mg/m2 per course.

For patients weighing >5 kg and ≤12 kg, the individual dose is
determined based on
body weight and should be a total of 3.3 mg/kg per course.
QARZIBA PI v 4
Page 2 of 15
SPC – DIN – AU – 1171 – 04
Two modes of administration are possible:

a continuous infusion over the first 10 days of each course (a total
of 240 hours) at the

Fitxa tècnica

QARZIBA PI v 4
Page 1 of 15
SPC – DIN – AU – 1171 – 04
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - QARZIBA (DINUTUXIMAB BETA)
1
NAME OF THE MEDICINE
QARZIBA (dinutuximab beta)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of concentrate contains 4.5 mg dinutuximab beta.
Each vial contains 20 mg dinutuximab beta in 4.5 mL.
Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody
produced in a
mammalian cell line (CHO) by recombinant DNA technology.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Colourless to slightly yellow liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
QARZIBA is indicated for the treatment of high-risk neuroblastoma in
patients who have
previously received induction chemotherapy and achieved at least a
partial response.
4.2
DOSE AND METHOD OF ADMINISTRATION
QARZIBA must be administered under the direction of a physician
experienced in the use of
oncological therapies. The infusion must be initiated by a healthcare
professional prepared to
manage severe allergic reactions including anaphylaxis in an
environment where full
resuscitation services are immediately available.
DOSAGE
Treatment with QARZIBA consists of 5 consecutive courses, each course
comprising
35 days.

For patients weighing >12 kg, the individual dose is determined based
on the body
surface area and should be a total of 100 mg/m2 per course.

For patients weighing >5 kg and ≤12 kg, the individual dose is
determined based on
body weight and should be a total of 3.3 mg/kg per course.
QARZIBA PI v 4
Page 2 of 15
SPC – DIN – AU – 1171 – 04
Two modes of administration are possible:

a continuous infusion over the first 10 days of each course (a total
of 240 hours) at the