BINOCRIT 10000 I.U 1 ML

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

EPOETIN ALFA

Disponibbli minn:

NOVARTIS ISRAEL LTD

Kodiċi ATC:

B03XA01

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

EPOETIN ALFA 10000 IU / 1 ML

Rotta amministrattiva:

I.V, S.C

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

SANDOZ GmbH, AUSTRIA

Grupp terapewtiku:

ERYTHROPOIETIN

Żona terapewtika:

ERYTHROPOIETIN

Indikazzjonijiet terapewtiċi:

Binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis .- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients. Binocrit® is indicated in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.Binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).Binocrit® is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.Use should be restricted to patients with moderate anaemia (e.g. Hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Data ta 'l-awtorizzazzjoni:

2016-12-31

Fuljett ta 'informazzjoni

1986 - ו"משתה )םירישכת( םיחקורה תונקת יפל
ןכרצל ןולע
דבלב אפור םשרמ יפ לע תקוושמ הפורתה
ל"מ 0.5/ל"בחי 1,000 טירקוניב
ל"מ 1/ל"בחי 2,000 טירקוניב
ל"מ 0.3/ל"בחי 3,000 טירקוניב
ל"מ 0.4/ל"בחי 4,000 טירקוניב
ל"מ 0.5/ל"בחי 5,000 טירקוניב
ל"מ 0.6/ל"בחי 6,000 טירקוניב
ל"מ 0.8/ל"בחי 8,000 טירקוניב
ל"מ 1/ל"בחי 10,000 טירקוניב
ל"מ 0.5/ל"בחי 20,000 טירקוניב
ל"מ 0.75/ל"בחי 30,000 טירקוניב
ל"מ 1/ל"בחי 40,000 טירקוניב
שארמ אלוממ קרזמב הקרזהל הסימת
_ EPOETIN ALFA אפלא ןיטאופא - ליעפה רמוחה_
_:ל"מ 0.5/ל"בחי 1,000 טירקוניב_
תודיחי 1,000 הליכמה הקרזהל הסימת ל"מ 0.5
ליכמ שארמ אלוממ דחא קרזמ
.אפלא ןיטאופא לש םרגורקימ 8.4 -ל
תוליבקמה )ל"בחי( תוימואלניב
_:ל"מ 1/ל"בחי 2,000 טירקוניב_
תודיחי 2,000 הליכמה הקרזהל הסימת ל"מ 1
ליכמ שארמ אלוממ דחא קרזמ
.אפלא ןיטאופא לש םרגורקימ 16.8 -ל
תוליבקמה )ל"בחי( תוימואלניב
_:ל"מ 0.3/ל"בחי 3,000 טירקוניב_
תודיחי 3,000 הליכמה הקרזהל הסימת ל"מ 0.3
ליכמ שארמ אלוממ דחא קרזמ
.אפלא ןיטאופא לש םרגורקימ 25.2 -ל
תוליבקמה )ל"בחי( תוימואלניב
_:ל"מ 0.4/ל"בחי 4,000 טירקוניב_
תודיחי 4,000 הליכמה הקרזהל הסימת ל"מ 0.4
ליכמ שארמ אלוממ דחא קרזמ
.אפלא ןיטאופא לש םרגורקימ 33.6 -ל
תוליבקמה )ל"בחי( תוימואלניב
_:ל"מ 0.5/ל"בחי 5,000 טירקוניב_
תודיחי 5,000 הליכמה הקרזהל הסימת ל"מ 0.5
ליכמ שארמ אלוממ דחא קרזמ
.אפלא ןיטאופא לש םרגורקימ 42.0 -ל
תוליבקמה )ל"בחי( תוימואלנ

Karatteristiċi tal-prodott

BIN API MAR20 CLV1
PRESCRIBING INFORMATION
Binocrit is a biosimilar medicinal product.
1. NAME OF THE MEDICINAL PRODUCT
BINOCRIT 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 2,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
BINOCRIT 3,000 IU/0.3 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 4,000 IU/0.4 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 6,000 IU/0.6 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 8,000 IU/0.8 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 10,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
BINOCRIT 20,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 30,000 IU/0.75 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 40,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Binocrit 1,000 IU/0.5 ml:
Each ml of solution contains 2,000 IU of epoetin alfa* corresponding
to 16.8 micrograms per ml
1 pre-filled syringe of 0.5 ml contains 1,000 international units (IU)
corresponding to 8.4
micrograms epoetin alfa
Binocrit 2,000 IU/1 ml:
Each ml of solution contains 2,000 IU of epoetin alfa* corresponding
to 16.8 micrograms per ml
1 pre-filled syringe of 1 ml contains 2,000 international units (IU)
corresponding to 16.8
micrograms epoetin alfa
Binocrit 3,000 IU/0.3 ml:
Each ml of solution contains 10,000 IU of epoetin alfa* corresponding
to 84.0 micrograms per
ml
1 pre-filled syringe of 0.3 ml contains 3,000 international units (IU)
corresponding to 25.2
micrograms epoetin alfa
Binocrit 4,000 IU/0.4 ml:
Each ml of solution contains 10,000 IU of epoetin alfa* corresponding
to 84.0 micrograms per
ml
1 pre-filled syringe of 0.4 ml contains 4,000 international units (IU)
corresponding to 33.6
micrograms epoetin alfa
Binocrit 5,000 IU/0.5 ml:
Each ml of solution contains 10,000 IU of epoetin alfa* corresponding
to 84.0 micrograms per
ml
1 pre-filled syringe o