Binocrit

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Epoetin alfa 84 µg/mL

थमां उपलब्ध:

Sandoz New Zealand Limited

INN (इंटरनेशनल नाम):

Epoetin alfa 84 µg/mL

डोज़:

84 mcg/mL

फार्मास्यूटिकल फॉर्म:

Solution for injection

रचना:

Active: Epoetin alfa 84 µg/mL Excipient: Dibasic sodium phosphate dihydrate Glycine Hydrochloric acid Monobasic sodium phosphate dihydrate Nitrogen Polysorbate 80 Sodium chloride Sodium hydroxide Water for injection

पैकेज में यूनिट:

Syringe, glass, 0.3 mL x1, 0.3 mL

वर्ग:

Prescription

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Rentschler Biotechnologie GmbH

चिकित्सीय संकेत:

Binocrit is indicated for: · the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis · anaemia associated with chronic renal failure in paediatric and adult patients on dialysis · anaemia in patients with non-myeloid malignancies where anaemia is due to the effect of concomitantly administered chemotherapy · adult patients with mild-to-moderate anaemia (haemoglobin > 100 to < 130 g/L) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 mL) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery · to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients undergoing major surgery who are not expected to pre-deposit their complete peri-operative blood needs.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Syringe, glass, 0.3 mL x1 - 0.3 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.4 mL x1 - 0.4 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.5 mL x1 - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.6 mL x1 - 0.6 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.7 mL x1 - 0.7 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.8 mL x1 - 0.8 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.9 mL x1 - 0.9 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 1 mL x1 - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.3 mL x6 - 1.8 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.4 mL x6 - 2.4 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.5 mL x6 - 3 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.6 mL x6 - 3.6 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.7 mL x6 - 4.2 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.8 mL x6 - 4.8 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 0.9 mL x6 - 5.4 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C - Syringe, glass, 1 mL x6 - 6 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. up to 3 days at or below 25°C

प्राधिकरण की तारीख:

2011-07-22

सूचना पत्रक

BINOCRIT
®
1
BINOCRIT
®
PREFILLED
SYRINGES
_epoetin alfa (rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Binocrit prefilled
syringes. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits.
Your doctor has weighed the risks of
you taking this medicine against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
IT IS IMPORTANT THAT YOU READ THIS
LEAFLET.
KEEP THIS LEAFLET.
You may need to
read it again.
WHAT BINOCRIT IS USED
FOR
The prefilled syringes contain the
active ingredient epoetin alfa, a
protein that stimulates bone marrow
to produce more red blood cells.
Red blood cells are responsible for
carrying oxygen to all parts of your
body. A decrease in the number of
red blood cells can cause anaemia.
Some symptoms of anaemia are
tiredness, breathlessness when
exercising and feeling cold.
Anaemia may have many causes
including decreased production of a
hormone called erythropoietin by the
kidneys due to kidney failure or as a
result of chemotherapy treatments for
cancer. This medicine is virtually
identical to your body’s
erythropoietin, and has a similar
effect to naturally occurring
erythropoietin in your body.
This medicine is used to treat:
_ _
•
anaemia associated with kidney
disease. If you have kidney
disease, your kidney may not
produce enough erythropoietin
(necessary for red blood cell
production) and your doctor may
wish to correct this by prescribing
this medicine. This medicine
stimulates your bone marrow to
produce more red blood cells,
helping to treat your anaemia.
•
anaemia and reduce the need for a
blood transfusion if you are
receiving chemotherapy for
cancer and your doctor decides
you may need a blood
transfusion.
•
mildly anaemic patients who are
going to have surgery and donate
blood before surgery, so that their
own blood can be given to t

उत्पाद विशेषताएं

NEW ZEALAND DATA SHEET
230320-Binocrit-ds
Page 1 of 20
NEW ZEALAND DATA SHEET
BINOCRIT (EPOETIN ALFA (RCH)) SOLUTION FOR INJECTION
USE IN CANCER
In some studies, use of Erythropoiesis Stimulating Agents (ESAs) to
treat anaemia in patients
with cancer has been associated with increased mortality. ESAs should
only be used to treat
anaemia that has developed as a result of concomitantly administered
chemotherapy, and only
when blood transfusion is not considered appropriate. Haemoglobin
levels should not exceed
120 g/L (see Section 4.4 Special warnings and precautions for use).
1
PRODUCT NAME
Binocrit 1,000 IU/0.5 mL solution for injection in pre-filled syringe.
Binocrit 2,000 IU/1.0 mL solution for injection in pre-filled syringe.
Binocrit 3,000 IU/0.3 mL solution for injection in pre-filled syringe.
Binocrit 4,000 IU/0.4 mL solution for injection in pre-filled syringe.
Binocrit 5,000 IU/0.5 mL solution for injection in pre-filled syringe.
Binocrit 6,000 IU/0.6 mL solution for injection in pre-filled syringe.
Binocrit 7,000 IU/0.7 mL solution for injection in pre-filled syringe.
Binocrit 8,000 IU/0.8 mL solution for injection in pre-filled syringe.
Binocrit 9,000 IU/0.9 mL solution for injection in pre-filled syringe.
Binocrit 10,000 IU/1.0 mL solution for injection in pre-filled
syringe.
Binocrit 20,000 IU/0.5 mL solution for injection in pre-filled
syringe.
Binocrit 30,000 IU/0.75 mL solution for injection in pre-filled
syringe.
Binocrit 40,000 IU/1.0 mL solution for injection in pre-filled
syringe.
Binocrit is a biosimilar medicine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Binocrit is a sterile, clear and colourless, preservative-free
buffered protein solution of epoetin
alfa (rch).
TABLE 1. BINOCRIT DOSE STRENGTHS AND THE CORRESPONDING QUANTITY OF
EPOETIN ALPHA PER ML
BINOCRIT DOSE
STRENGTH
FILLED VOLUME
TOTAL CONTENT OF
ACTIVE
CONCENTRATION
1000 IU
0.5 mL
8.4 microgram
16.8 microgram/mL
2000 IU
1.0 mL
16.8 microgram
16.8 microgram/mL
3000 IU
0.3 mL
25.2 microgram
84.0 microgram/mL
4000 IU
0.4 mL
33.6 microgr