Neorecormon

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Epoetin beta 10000 [iU] (in 0.6mL)

Pieejams no:

Roche Products (NZ) Ltd

SNN (starptautisko nepatentēto nosaukumu):

Epoetin beta 10000 IU (in 0.6mL)

Deva:

10000 IU/0.6mL

Zāļu forma:

Solution for injection

Kompozīcija:

Active: Epoetin beta 10000 [iU] (in 0.6mL) Excipient: Calcium chloride dihydrate Dibasic sodium phosphate dodecahydrate Glutamic acid Glycine Isoleucine Leucine Monobasic sodium phosphate dihydrate Phenylalanine Polysorbate 20 Sodium chloride Threonine Urea Water for injection

Vienības iepakojumā:

Syringe, glass, Type I glass 6x0.6ml, 3.6 mL

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Roche Diagnostics GmbH

Ārstēšanas norādes:

- for the treatment of anaemia associated with chronic kidney disease in patients on dialysis and symptomatic patients not yet undergoing dialysis - for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks - for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. - to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood

Produktu pārskats:

Package - Contents - Shelf Life: Syringe, glass, Type I glass 6x0.6ml + needles - 3.6 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 days not refrigerated stored at or below 25°C

Autorizācija datums:

2001-07-23

Lietošanas instrukcija

NeoRecormon
® 20230720
1
NEORECORMON®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING NEORECORMON?
NeoRecormon contains the active ingredient _epoetin beta_. NeoRecormon
is used to
treat anaemia caused by chonic kidney
disease. Anaemia is caused by a lack of red blood cells or haemoglobin
which transport oxygen in the blood.
For more information, see Section 1. Why am I using NeoRecormon?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NEORECORMON?
Do not use if you have ever had an allergic reaction to NeoRecormon or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
NeoRecormon?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NeoRecormon and affect how it works.
For more information, see Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE NEORECORMON?
●
Your doctor will tell you how much and how often to inject NeoRecormon
according to your individual needs.
●
NeoRecormon can be given by your doctor or nurse. Alternatively your
doctor, nurse or pharmacist may teach you or your
carer how to inject NeoRecormon.
More instructions can be found in Section 4. How do I use NeoRecormon?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEORECORMON?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NeoRecormon.
•
If you have blood pressure problems it is important to follow all your
doctor’s instructions to
control your blood pressure, including any changes to your diet, while
using NeoRecormon.
THINGS YOU
SHOULD

Produkta apraksts

NeoRecormon 220120
1
NEW ZEALAND DATA SHEET
NEORECORMON
® (EPOETIN BETA (RECOMBINANT HUMAN ERYTHROPOIETIN))
1.
PRODUCT NAME /NAME OF THE MEDICINE
NeoRecormon 2000 IU solution for injection in pre-filled syringe
NeoRecormon 3000 IU solution for injection in pre-filled syringe
NeoRecormon 4000 IU solution for injection in pre-filled syringe
NeoRecormon 5000 IU solution for injection in pre-filled syringe
NeoRecormon 10,000 IU solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NeoRecormon 2000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
2000 international units (IU)
epoetin beta
NeoRecormon 3000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
3000 international units (IU)
epoetin beta
NeoRecormon 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)
epoetin beta
NeoRecormon 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)
epoetin beta
NeoRecormon 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) epoetin beta
EXCIPIENTS WITH KNOWN EFFECT
Phenylalanine
Sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless, clear to slightly opalescent solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NeoRecormon 220120
2
NeoRecormon is indicated;
-
for the treatment of anaemia associated with chronic kidney disease
(CKD) in patients
on dialysis and symptomatic patients not yet undergoing dialysis,
-
to increase the yield of autologous blood from patients in a
pre-donation programme
initiated to avoid the use of homologous blood,
-
for the prevention of anaemia of prematurity in infants with a b