CosmoFer 50 mg/ml solution for infusion and injection

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

IRON (III)

Հասանելի է:

Originalis B.V.

ATC կոդը:

B03AC

INN (Միջազգային անվանումը):

IRON (III)

Դոզան:

50 milligram(s)/millilitre

Դեղագործական ձեւ:

Solution for injection/infusion

Թերապեւտիկ տարածք:

Iron, parenteral preparations

Հաստատման ամսաթիվը:

2019-10-18

Տեղեկատվական թերթիկ

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 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 PRECAUTIONS
Talk to your doctor or nurse before receiving CosmoFer:
•
if you have a history of medicine allergy
•
if you have systemic lupus erythematosus
•
if you have rheumatoid arthritis
•
if you have severe asthma, eczema or allergies
CHILDREN
CosmoFer is for adults only. Children under 14 should not have this
medicine.
OTHER MEDICINES AND COSMOFER
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines.
This includes medicines obtained without a pr

Ապրանքի հատկությունները

Health Products Regulatory Authority
18 October 2019
CRN0095X4
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
▼ This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse
reactions.
1 NAME OF THE MEDICINAL PRODUCT
CosmoFer 50 mg/ml solution for infusion and injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 50 mg iron (III) as iron (III)-hydroxide dextran
complex.
Each ampoule of 2 ml contains 100 mg iron (III) as iron
(III)-hydroxide dextran complex.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
_Product imported from Bulgaria _
A dark brown solution
4 CLINICAL PARTICULARS
As per PA0982/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0982/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Water for injections
Sodium hydroxide (pH adjuster)
Hydrochloric acid (pH adjuster)
6.2 INCOMPATIBILITIES
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the ampoules and outer package of the product on the
market in the country of origin.
From a microbiological point of view, the product should be used
immediately.
After dilution:
Chemical and physical in-use stability has been demonstrated for 24
hours at 25 °C.
From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times
and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to 8 °C,
unless dilution has taken place in controlled and validated aseptic
conditions.
Health Products Regulatory Authority
18 October 2019
CRN0095X4
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicine does not require any special storage conditions.
Do not f