CosmoFer 50mg/ml solution for infusion and injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iron

Available from:

Lexon (UK) Ltd

ATC code:

B03AC

INN (International Name):

Iron

Dosage:

50 milligram(s)

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

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

Therapeutic area:

Iron, parenteral preparations

Authorization status:

Authorised

Authorization date:

2018-02-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
COSMOFER 50MG/ML SOLUTION FOR INFUSION AND INJECTION
®
Ref: 1097/034/001/151117/1/F
▼This medicine is subject to additional monitoring. This will allow
quick
identification of new safety information. You can help by reporting
any side
effects you may get. See the end of section 4 for how to report side
effects.
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
What CosmoFer is and what it is used for
What you need to know before you receive CosmoFer
How CosmoFer is given
Possible side effects
How to store CosmoFer
Content of the pack and other information
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.
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

Summary of Product characteristics

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 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
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
_Product imported from Greece_
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 opening of the container.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_2_
_/_
_0_
_2_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_1_
_9_
_8_
_3_
_1_
_5_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_