CosmoFer 50mg/ml solution for infusion and injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Iron (III) hydroxide dextran complex

Tersedia dari:

Pharmacosmos A/S

Kode ATC:

B03AC

INN (Nama Internasional):

Iron (III) hydroxide dextran complex

Dosis:

50 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection/infusion

Jenis Resep:

Product subject to prescription which may not be renewed (A)

Area terapi:

Iron, parenteral preparations

Status otorisasi:

Marketed

Tanggal Otorisasi:

2001-06-29

Selebaran informasi

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSMOFER
®
, 50 MG/ML
SOLUTION FOR INJECTION AND FOR INFUSION
IRON(III)
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 or nurse.
•
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or nurse.
WHAT IS IN THIS LEAFLET
1.
What CosmoFer is and what it is used for
2.
What you need to know before you receive CosmoFer
3.
How to CosmoFer is given
4.
Possible side effects
5.
How to store CosmoFer
6.
Contents of the pack and other information
1.
WHAT COSMOFER IS AND WHAT IT IS USED FOR
CosmoFer contains a combination of iron and dextran (a long chain of
sugar molecules).
The type of iron in CosmoFer is the same as that found naturally in
the body called
‘ferritin’. This means that you can have CosmoFer by injection in
high doses.
CosmoFer is used for low levels of iron (sometimes called ‘iron
deficiency’) if:
•
you cannot take iron by mouth, for example you cannot tolerate it
•
you have taken iron by mouth and it has not worked
•
your doctor decides you need iron very quickly to build up your iron
stores.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE COSMOFER
YOU MUST NOT RECEIVE COSMOFER:
•
if you are allergic (hypersensitive) to the product or any of the
other ingredients of this medicine
(listed in section 6)
•
if you have experienced serious allergic (hypersensitive) reactions to
other injectable iron
preparations
•
if you have anaemia that is not caused by low levels of iron
(deficiency), such as ‘haemolytic’
anaemia
•
if you have too much iron (overload) or a problem in the way your body
uses iron
•
if you have liver problems such as ‘cirrhosis’ or ‘hepatitis’
•
if you have a bacterial or viral infection
•
if you have kidney problems, such as acute kidney failure.
WARNINGS AND

Karakteristik produk

Health Products Regulatory Authority
31 March 2023
CRN00DHKS
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CosmoFer 50mg/ml solution for infusion and injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2 ml ampoule containing 100 mg iron(III) as Iron(III)-hydroxide
dextran complex
5 ml ampoule containing 250 mg iron(III) as Iron(III)-hydroxide
dextran complex
10 ml ampoule containing 500 mg iron(III) as Iron(III)-hydroxide
dextran complex
Each ml contains 50 mg Iron (III).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion and injection
A dark brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
· For adults only
CosmoFer
®
is indicated for the treatment of iron deficiency in the following
indications:
· When oral iron preparations cannot be used, e.g. due to
intolerance, or in case of demonstrated lack of effect of oral iron
therapy
· Where there is a clinical need to deliver iron rapidly to iron
stores.
The diagnosis of iron deficiency must be based on appropriate
laboratory tests (e.g. Serum ferritin, serum iron, transferrin
saturation and hypochromic red cells).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and following each administration of
CosmoFer.
CosmoFer should only be administered when staff trained to evaluate
and manage anaphylactic reactions is immediately
available, in an environment where full resuscitation facilities can
be assured. The patient should be observed for adverse
effects for at least 30 minutes following each CosmoFer injection (see
section 4.4).
ADMINISTRATION:
CosmoFer solution for infusion and injection can be administered by an
intravenous drip infusion or by a slow intravenous
injection of which the intravenous drip infusion is the preferred
route of administration, as this may help to reduce the risk of
hypotensive episodes. However, CosmoFer may also be administered as
undiluted solution intramuscular