Biopoin

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

epoetin theta

Saatavilla:

Teva GmbH

ATC-koodi:

B03XA01

INN (Kansainvälinen yleisnimi):

epoetin theta

Terapeuttinen ryhmä:

Other antianemic preparations

Terapeuttinen alue:

Kidney Failure, Chronic; Anemia; Cancer

Käyttöaiheet:

Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-10-23

Pakkausseloste

54
B. PACKAGE LEAFLET
55
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIOPOIN 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
BIOPOIN 2,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
BIOPOIN 3,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
BIOPOIN 4,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
BIOPOIN 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
BIOPOIN 10,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
BIOPOIN 20,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
BIOPOIN 30,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
epoetin theta
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Biopoin is and what it is used for
2.
What you need to know before you use Biopoin
3.
How to use Biopoin
4.
Possible side effects
5.
How to store Biopoin
6.
Contents of the pack and other information
7.
Information for injecting yourself
1.
WHAT BIOPOIN IS AND WHAT IT IS USED FOR
WHAT BIOPOIN IS
Biopoin contains the active substance epoetin theta, which is almost
identical to erythropoietin, a
natural hormone produced by your body. Epoetin theta is a protein
produced by biotechnology. It
works in exactly the same way as erythropoietin. Erythropoietin is
produced in your kidneys and
stimulates your bone marrow to produce red blood cells. Red blood
cells are very important for
distributing oxygen within your body.
WHAT BIOPOIN IS USED FOR
Biopoin is used for the treatment of anaemia accompanied by symptoms
(for example

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 1,000 international units (IU) (8.3
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 2,000 IU (16.7 µg) epoetin theta per
ml.
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 2,000 international units (IU) (16.7
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 4,000 IU (33.3 µg) epoetin theta per
ml.
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 3,000 international units (IU) (25
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 6,000 IU (50 µg) epoetin theta per ml.
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 4,000 international units (IU) (33.3
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 8,000 IU (66.7 µg) epoetin theta per
ml.
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 5,000 international units (IU) (41.7
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per
ml.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 10,000 international units (IU) (8