RECORMON PRE-FILLED SYRINGE 2000 iu0.3 ml

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

EPOETIN BETA

Tillgänglig från:

ROCHE SINGAPORE PTE. LTD.

ATC-kod:

B03XA01

Dos:

2000 iu/0.3 ml

Läkemedelsform:

INJECTION

Sammansättning:

EPOETIN BETA 2000 iu/0.3 ml

Administreringssätt:

INTRAVENOUS, SUBCUTANEOUS

Receptbelagda typ:

Prescription Only

Tillverkad av:

ROCHE DIAGNOSTICS GMBH

Bemyndigande status:

ACTIVE

Tillstånd datum:

2000-11-01

Bipacksedel

RECORMON
®
 PRE-FILLED SYRINGES

Epoetin beta 

__________________________________________________________________ 
1. 
P
HARMACEUTICAL 
F
ORM

Solution for injection. 
Appearance: clear colourless to slightly opalescent solution. 
2. 
Q
UALITATIVE AND 
Q
UANTITATIVE 
C
OMPOSITION

_Active ingredient:_ epoetin beta (synonyms: rhEPO, recombinant human erythropoietin). 
_Recormon 500 _
1 pre-filled syringe contains 500 international units (IU) (corresponding to 4.15 µg ) epoetin beta in 0.3 ml water 
for injections.  
_Recormon 2000 _
1 pre-filled syringe contains 2000 international units (IU) (corresponding to 16.6 µg ) epoetin beta in 0.3 ml water 
for injections.  
_Recormon 3000 _
1 pre-filled syringe contains 3000 international units (IU) (corresponding to 24.9 µg
) epoetin beta in 0.3 ml water 
for injections.  
_Recormon 4000 _
1 pre-filled syringe contains 4000 international units (IU) (corresponding to 33.2 µg ) epoetin beta in 0.3 ml water 
for injections. _ _
_Recormon 5000 _
1 pre-filled syringe contains 5000 international units (IU) (corresponding to 41.5 µg ) epoetin beta in 0.3 ml water 
for injections.  
_Recormon 6000 _
1 pre-filled syringe contains 6000 international units (IU) (corresponding to 49.8 µg ) epoetin beta in 0.3 ml water 
for injections.  
_Recormon 10 000 _
1 pre-filled syringe contains 10 000 international units (IU) (corresponding to 83 µg ) epoetin beta in 0.6 ml water 
for injections.  
_Recormon 20 000 _
1 pre-filled syringe contains 20 000 international units (IU) (corresponding to 166 µg ) epoetin beta in 0.6 ml water 
for injections.  
_Recormon 30 000 _
1 pre-filled syringe contains 30 000 international units (IU) (corresponding to 250 µg ) epoetin beta in 0.6 ml water 
for injections.  

CLINICAL

Produktens egenskaper

PLEASE VISIT WWW.ROCHE.COM.SG/PHARMA/RECORMON FOR A PRINTABLE VERSION
OF THIS LEAFLET.
PFS-REC-2023-04-0
RECORMON
®
PRE-FILLED SYRINGES
Epoetin beta
__________________________________________________________________
1.
P
HARMACEUTICAL
F
ORM
Solution for injection (pre-filled syringes) (s.c. or i.v.).
Appearance: clear colourless to slightly opalescent solution.
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
_Active ingredient:_
epoetin beta (synonyms: rhEPO, recombinant human erythropoietin).
_Recormon 2000 _
1 pre-filled syringe contains 2000 international units (IU)
(corresponding to 16.6 µg) epoetin beta in 0.3 ml water
for injections.
_Recormon 4000 _
1 pre-filled syringe contains 4000 international units (IU)
(corresponding to 33.2 µg) epoetin beta in 0.3 ml water
for injections.
_ _
_Recormon 10 000 _
1 pre-filled syringe contains 10 000 international units (IU)
(corresponding to 83 µg) epoetin beta in 0.6 ml water
for injections.
_Recormon 30 000 _
1 pre-filled syringe contains 30 000 international units (IU)
(corresponding to 250 µg) epoetin beta in 0.6 ml water
for injections.
_List of excipients: _
All presentations contain up to 0.3mg phenylalanine per pre-filled
syringe (see section 2.4 Special Warnings and
Precations for Use)
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
Recormon is indicated for:
-
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.
-
Treatment of symptomatic anemia in adult patients with non-myeloid
malignancies receiving chemotherapy.
-
Increasing the yield of autologous blood from patients in a
predonation programme. 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 to 13 g/dl [6.2 to 8.1
mmol/l], no iron deficiency) if blood
conserving procedures are not available or insufficient when the
scheduled major elective surgery