Retacrit 5,000units0.5ml solution for injection pre-filled syringes

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Hent Indlægsseddel (PIL)
13-06-2018
Hent Produktets egenskaber (SPC)
13-06-2018

Aktiv bestanddel:

Epoetin zeta

Tilgængelig fra:

Pfizer Ltd

ATC-kode:

B03XA01

INN (International Name):

Epoetin zeta

Dosering:

10000unit/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Intravenous; Subcutaneous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 09010300; GTIN: 5015997013532

Indlægsseddel

                                Page 1 of 17
PACKAGE LEAFLET: INFORMATION FOR THE USER
RETACRIT 1 000 IU/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 2 000 IU/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 3 000 IU/0.9 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 4 000 IU/0.4 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 5 000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 6 000 IU/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 8 000 IU/0.8 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 10 000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 20 000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 30 000 IU/0.75 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
RETACRIT 40 000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Epoetin zeta
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 Retacrit is and what it is used for
2.
What you need to know before you use Retacrit
3.
How to use Retacrit
4.
Possible side effects
5.
How to store Retacrit
6.
Contents of the pack and other information
1.
WHAT RETACRIT IS AND WHAT IT IS USED FOR
Retacrit contains a protein called epoetin zeta that stimulates the
bone marrow to produce more red
blood cells, which carry haemoglobin (a substance that transports
oxygen). Epoetin zeta is a copy of the
human protein erythropoietin and acts in the same way.
RETACRIT IS USED

in adults, children and adolescents on haemodialysis to treat
symptomatic anaemia (
                                
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Produktets egenskaber

                                OBJECT 1
RETACRIT SOLUTION FOR INJECTION IN PRE FILLED SYRINGE
Summary of Product Characteristics Updated 03-Nov-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe
Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe
Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe
Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe
Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe
Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe
Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe
Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled
syringe
Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe
2. Qualitative and quantitative composition
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe
1 pre-filled syringe with 0.3 ml solution for injection contains 1 000
international units (IU) epoetin zeta*
(recombinant human erythropoietin). The solution contains 3 333 IU
Epoetin zeta per ml.
_Excipient with known effect: _
Each pre-filled syringe contains 0.15 mg phenylalanine.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe
1 pre filled syringe with 0.6 ml solution for injection contains 2 000
international units (IU) epoetin zeta*
(recombinant human erythropoietin). The solution contains 3 333 IU
Epoetin zeta per ml.
_Excipient with known effect: _
Each pre-filled syringe contains 0.30 mg phenylalanine.
Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe
1 pre filled syringe with 0.9 ml solution for injection contains 3 000
international units (IU) epoetin zeta*
(recombinant human erythropoietin). The solution contains 3 333 IU
Epoetin zeta per ml.
_Excipient with known effect: _
Each pre-filled syringe contains 0.45 mg phenylalanin
                                
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