CYRAMZA ramucirumab 100 mg/10 mL solution for intravenous infusion vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

ramucirumab, Quantity: 100 mg

제공처:

Eli Lilly Australia Pty Ltd

INN (International Name):

ramucirumab

약제 형태:

Injection, intravenous infusion

구성:

Excipient Ingredients: sodium chloride; polysorbate 80; glycine; histidine hydrochloride monohydrate; water for injections; histidine

관리 경로:

Intravenous Infusion

패키지 단위:

1 vial, 2 vials

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

CYRAMZA , in combination with paclitaxel, is indicated for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluropyrimidine chemotherapy. CYRAMZA, as monotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy when treatment in combination with paclitaxel is not appropriate.

제품 요약:

Visual Identification: clear to slightly opalescent and colourless to slightly yellow solution without visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2015-07-23

환자 정보 전단

CYRAMZA
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CYRAMZA?
CYRAMZA contains the active ingredient ramucirumab (rmc) and is used
to treat advanced stomach cancer (including cancer of the
junction between the oesophagus and the stomach).
For more information, see Section 1. Why am I using CYRAMZA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CYRAMZA?
Do not use if you have ever had an allergic reaction to ramucirumab or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CYRAMZA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CYRAMZA and affect how it works.
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING ANY OTHER MEDICINES,
including any medicines, vitamins or supplements that
you buy without a prescription from your pharmacy, supermarket or
health food shop and CHECK WITH YOUR DOCTOR OR PHARMACIST IF
YOU ARE NOT SURE IF THESE WILL AFFECT CYRAMZA.
4.
HOW WILL CYRAMZA BE GIVEN?
•
CYRAMZA is given as an infusion (drip) into your veins over
approximately 60 minutes.
•
CYRAMZA is given once every two weeks as part of the treatment cycle.
Your doctor will advise how many treatment cycles you
need.
More instructions can be found in Section 4. How will CYRAMZA be
given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CYRAMZA?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if you become pregnant while being
treated with CYRAMZA.
•
Tell your doctor immediately if you notice any changes in your
movement or behaviour.
•
Remind any doctor, dentist or pharmacist you visit that you are being
treated with CYRAMZA, especially
if you are about to start a new medicine.
•
If

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION
vA8.0_Aug22
SUPERSEDES: vA7.0_Aug22
Page 1 of 20
CYRAMZA® (RAMUCIRUMAB) CONCENTRATE FOR INTRAVENOUS
INFUSION
1.
NAME OF THE MEDICINE
Ramucirumab [rmc].
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CYRAMZA is available as a concentrate in 10 mL or 50 mL single-use
vials. Each vial contains
either 100 mg ramucirumab in 10 mL (10 mg/mL) or 500 mg ramucirumab in
50 mL (10
mg/mL). CYRAMZA contains the excipients histidine, histidine
hydrochloride monohydrate,
glycine, sodium chloride, polysorbate 80 and water for injections.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Solution for intravenous infusion vial.
CYRAMZA is a sterile, clear to slightly opalescent and colourless to
slightly yellow solution
without visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CYRAMZA, in combination with paclitaxel, is indicated for the
treatment of adult patients
with advanced or metastatic gastric or gastro-oesophageal junction
adenocarcinoma with
disease progression after prior platinum and fluoropyrimidine
chemotherapy.
CYRAMZA, as monotherapy, is indicated for the treatment of adult
patients with advanced or
metastatic gastric or gastro-oesophageal junction adenocarcinoma with
disease progression
after prior platinum or fluoropyrimidine chemotherapy when treatment
in combination with
paclitaxel is not appropriate.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
DO NOT ADMINISTER RAMUCIRUMAB AS AN INTRAVENOUS PUSH OR BOLUS.
After dilution and preparation, CYRAMZA is administered as an
intravenous infusion.
Only use sterile sodium chloride (0.9%) solution for injection as a
diluent. Do not use
dextrose as a diluent.
vA8.0_Aug22
SUPERSEDES: vA7.0_Aug22
Page 2 of 20
It is recommended that treatment be continued until progression of the
underlying disease
or until unacceptable toxicity.
PREMEDICATION
Premedication is recommended with a histamine H1 antagonist (e.g.
promethazine)
intravenously prior to administration of ramucirumab.
If a pati