Darzalex 100mg5ml concentrate for solution for infusion vials

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Daratumumab

থেকে পাওয়া:

Janssen-Cilag Ltd

এটিসি কোড:

L01XC24

INN (International Name):

Daratumumab

ডোজ:

20mg/1ml

ফার্মাসিউটিকাল ফর্ম:

Solution for infusion

প্রশাসন রুট:

Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 08010500; GTIN: 5012674902899

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DARZALEX 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
daratumumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What DARZALEX is and what it is used for
2.
What you need to know before you are given DARZALEX
3.
How DARZALEX is given
4.
Possible side effects
5.
How to store DARZALEX
6.
Contents of the pack and other information
1.
WHAT DARZALEX IS AND WHAT IT IS USED FOR
WHAT DARZALEX IS
DARZALEX is a cancer medicine that contains the active substance
daratumumab. It belongs to a
group of medicines called “monoclonal antibodies”. Monoclonal
antibodies are proteins that have
been designed to recognise and attach to specific targets in the body.
Daratumumab has been designed
to attach to specific cancer cells in your body, so that your immune
system can destroy the cancer
cells.
WHAT DARZALEX IS USED FOR
DARZALEX is used in adults 18 years or older, who have a type of
cancer called “multiple
myeloma”. This is a cancer of your bone marrow. DARZALEX is used if
your cancer has not
responded to, or has come back after treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DARZALEX
YOU MUST NOT BE GIVEN DARZALEX:
-
if you are allergic to daratumumab or any of the other ingredients of
this medicine (listed in
section 6).
Do not use DARZALEX if the above applies to you. If you are not sure,
talk to your doctor or nurse
before you are given DARZALEX.
WARNINGS AND PRECAUTIONS
Talk to your

পণ্য বৈশিষ্ট্য

OBJECT 1
DARZALEX 20 MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Summary of Product Characteristics Updated 29-Jun-2018 | Janssen-Cilag
Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
DARZALEX 20 mg/mL concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per
mL).
Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per
mL).
Daratumumab is a human monoclonal IgG1κ antibody against CD38
antigen, produced in a mammalian
cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA
technology.
Excipients with known effect
Each 5 mL and 20 mL vial of DARZALEX contains 0.4 mmol and 1.6 mmol
(9.3 mg and 37.3 mg)
sodium, respectively.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
The solution is colourless to yellow.
4. Clinical particulars
4.1 Therapeutic indications
DARZALEX is indicated:
• as monotherapy for the treatment of adult patients with relapsed
and refractory multiple myeloma,
whose prior therapy included a proteasome inhibitor and an
immunomodulatory agent and who have
demonstrated disease progression on the last therapy.
• in combination with lenalidomide and dexamethasone, or bortezomib
and dexamethasone, for the
treatment of adult patients with multiple myeloma who have received at
least one prior therapy
4.2 Posology and method of administration
DARZALEX should be administered by a healthcare professional, in an
environment where resuscitation
facilities are available.
Posology
Pre- and post-infusion medications should be administered to reduce
the risk of infusion-related reactions
(IRRs) with daratumumab. See below “Recommended concomitant
medications”, “Management of
infusion-rela