CARMUSTINE LUPIN carmustine 100 mg powder for injection vial with diluent vial

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

carmustine, Quantity: 100 mg

থেকে পাওয়া:

Southern Cross Pharma Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Injection, powder for

রচনা:

Excipient Ingredients:

প্রশাসন রুট:

Intravenous

প্যাকেজ ইউনিট:

8 vial powder for injection + 8 vial diluent, 1 vial powder for injection + 1 vial diluent

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Carmustine Lupin is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:,1. Malignant Glioma,2. Multiple Myeloma - in combination with prednisone.,3. Hodgkin?s Disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.,4. Non-Hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

পণ্য সারাংশ:

Visual Identification: Pale yellow granule or congealed mass; Container Type: Multiple containers; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2021-09-10

তথ্য লিফলেট

Carmustine Lupin v1
1
CARMUSTINE LUPIN
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 BEING GIVEN CARMUSTINE LUPIN?
Carmustine Lupin contains the active ingredient carmustine. Carmustine
Lupin is used to treat certain
cancers.
For more information, see Section 1. Why am I being given Carmustine
Lupin? in the full CMI.
2. WHAT SHOULD I KNOW BEFORE I AM GIVEN CARMUSTINE LUPIN?
You should not be given this medicine if you have ever had an allergic
reaction to carmustine.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, ARE
TAKING OTHER MEDICINES, ARE PREGNANT OR PLAN TO BECOME
PREGNANT, ARE BREASTFEEDING, OR IF YOU ARE MALE AND YOUR PARTNER
INTENDS TO BECOME PREGNANT.
For more information, see Section 2. What should I know before I use
Carmustine Lupin? in the full CMI.
3. WHAT IF I AM TAKING OTHER MEDICINES?
Some chemotherapy medicines may interfere with Carmustine Lupin and
affect how it works.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4. HOW AM I GIVEN CARMUSTINE LUPIN?
•
Your doctor will decide the dosage of Carmustine Lupin that you will
receive, depending on your condition.
•
Carmustine Lupin is given as a slow infusion into your vein over 1 to
2 hours, by your doctor in the hospital. It iis
usually
given each six weeks, known as a cycle. You doctor will decide how
many treatment cycles you will require.
More instructions can be found in Section 4. How do I use Carmustine
Lupin? in the full CMI.
5. WHAT SHOULD I KNOW WHILE I AM GIVEN CARMUSTINE LUPIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are being
given Carmustine Lupin.
•
Keep all of your doctor’s appointments to monitor your progress,
including blood tests, and to have
follow- up doses of Carmustine Lupin.
•
Avoid people who have infections.
•
Be careful using razors, toothpicks, dental floss, nail cutters or
other sharp objects that can injure

পণ্য বৈশিষ্ট্য

AUSTRALIAN PRODUCT INFORMATION – CARMUSTINE LUPIN
(CARMUSTINE) POWDER FOR INJECTION WITH DILUENT
1
NAME OF THE MEDICINE
Carmustine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each carton of Carmustine Lupin contains either:
•
one vial containing 100 mg carmustine and one vial containing 3 mL
sterile diluent; or
•
eight vials each containing 100 mg carmustine and eight vials each
containing 3 mL sterile diluent.
The vials are stored co-packed within an HDPE ‘Combi Kit Guard’,
each containing one vial of the powder
for injection product and one vial of the diluent to minimise the risk
of contact with the drug substance
and should not be removed from this packaging.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Carmustine Lupin is a lyophilised powder, pale yellow in an amber
glass vial. The diluent is clear sterile
ethanol in a clear glass vial.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carmustine Lupin is indicated as palliative therapy as a single agent
or in established combination
therapy with other approved chemotherapeutic agents in the following:
1.
Malignant Glioma.
2.
Multiple Myeloma - in combination with prednisone.
3.
Hodgkin’s Disease - as secondary therapy in combination with other
approved drugs in patients
who relapse while being treated with primary therapy, or who fail to
respond to primary therapy.
4.
Non-Hodgkin’s Lymphomas - as secondary therapy in combination with
other approved drugs for
patients who relapse while being treated with primary therapy or who
fail to respond to primary
therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
Carmustine Lupin is administered by slow intravenous infusion.
Carmustine Lupin should not be given
by rapid intravenous infusion.
Carmustine Lupin v2
Page 2 of 9
(carmustine) powder for injection with diluent
The recommended dose of Carmustine Lupin as single agent in previously
untreated in patients is
200 mg/m
2
intravenously every 6 weeks. This may be given as a single dose or
divided into daily
in