RECORMON 4000 IU

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

EPOETIN BETA

Beschikbaar vanaf:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC-code:

B03XA01

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

EPOETIN BETA 4000 IU / 0.3 ML

Toedieningsweg:

I.V, S.C

Prescription-type:

Required

Geproduceerd door:

ROCHE DIAGNOSTICS GmbH ,GERMANY

Therapeutische categorie:

ERYTHROPOIETIN

Therapeutisch gebied:

ERYTHROPOIETIN

therapeutische indicaties:

Treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. Treatment of symptomatic renal anemia in patients not yet undergoing dialysis. Increasing the yield of autologous blood from patients in a pre-donation program. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anemia (Hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving 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). Treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia (cisplatin 75 mg/m2/cycle carboplatin: 350 mg/m2/cycle). Treatment of anemia in adult patients with multiple myeloma low grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency and are receiving anti-tumor therapy.

Autorisatie datum:

2014-05-31

Bijsluiter

•
كلهتسملل ةرشن
:ةوبعلا يف ةلومشم ريغ
•
لوحك ةدامض
•
مقعم شاش
•
ناتلمعتسملا ةنقحملاو ةربلإل نمآ
ءاقللإ ةنمآو ةبلص ةبلع
ةنقحلا ريضحت
1
.
.داربلا جراخ ةربلإاو ةنقحملا عم
نوتركلا ةوبع جرخأ .يوتسمو فيظن ،ءاضم
لمع حطس رايتخاب مق
2
.
تطقس اذإ ،ةيحلاصلا تذفن اذإ ءاودلا
لامعتسا زوجي لا .ةوبعلا رهظ ىلع ددحملا
ةيحلاصلا خيرات ءاهتنا مدع نم دكأتو
ةوبعلا ررضت مدع نم دكأت
.كجلاعي يذلا يبطلا مقاطلا عم لصاوتو 17
ةلحرملا ىتح لمكأ ،ةلاحلا هذه يف
.ةررضتم نوتركلا ةوبع نأ كل ادب اذإ وأ
تررضت وأ ةنقحملا
3
.
رهاظ وه امك ةنقحملا كسمت كنأ نم دكأت
.ةنقحملا جارخإ دنع رذحلا يخوت بجي
.ةربلإا ةبلع نم ةدحاو ةربإو نوتركلا
ةوبع نم ةدحاو ةنقحم جرخأ
.هاندأ ةروصلا يف
•
.ةنقحملا جارخإ لجأ نم ةوبعلا بل
ْ
قَ زوجي لا
•
.ةربلإا ءاطغ وأ سبكملا نم ةنقحملا
كاسمإ زوجي لا
•
.داربلا ىلإ ةيقبتملا ربلإاو نقاحملا عم
نوتركلا ةوبع ةداعإب مق ،ةوبعلا لخاد
نقاحم تقبت اذإ
4
.
.ةيانعب ةربلإاو ةنقحملا صحفا
•
.ا
ً
ررضتم ودبي ةنقحملا نم ءزج ناك اذإ وأ
تطقس يتلا ةنقحم لامعتسا زوجي لا
.ةربلإاو ةنقحملا ررضت مدعو ةملاس نم
دكأت
•
.ةيحلاصلا تذفن اذإ ةربلإا وأ ةنقحملا
لامعتسا زوجي لا .ةربلإاو ةنقحملا رهظ
ىلع ةيحلاصلا ءاهتنا خيرات نم دكأت
•
وأ هنول ريغت اذإ ،ا
ً
ركع لولحملا ناك اذإ ةنقحملا ل

Productkenmerken

Page 1 of 12
Ref: EU SPC and PIL EMEA/H/C/000116/IAIN/0097
Recormon_PI_Ver.2.0
_ _
Recormon_PI_Version 2.0
The content of this leaflet was approved by the Ministry of Health in
January 2016 and updated
according to the guidelines of the Ministry of Health in April 2018
RECORMON
®

_ _
_Epoetin beta _
PRE-FILLED SYRINGE FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION
_ _
1.
NAME OF THE MEDICINAL PRODUCT
RECORMON

4000 IU SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RECORMON

5000 IU SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RECORMON

6000 IU SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RECORMON

10,000 IU SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RECORMON

30,000 IU SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Recormon 4000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
4000 international units (IU) corresponding to 33.2
micrograms epoetin beta)/, * (recombinant human erythropoietin).
One ml solution for injection contains 13,333 IU epoetin beta.
Recormon 5000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
5000 international units (IU) corresponding to 41.5
micrograms epoetin beta/ * (recombinant human erythropoietin).
One ml solution for injection contains 16,667 IU epoetin beta
Recormon 6000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
6000 international units (IU) corresponding to 49.8
micrograms epoetin beta, * (recombinant human erythropoietin). One ml
solution for injection contains 20,000 IU
epoetin beta.
Recormon 10,000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.6 ml solution for injection contains
10,000 international units (IU) corresponding to 83
micrograms epoetin beta * (recombinant human erythropoietin). One ml
solution for injection contains 16,667 IU
epoetin beta.
Recormon 30,000 IU solution for inje