MonoFer 100 mg/ml Injektions-/infusionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

järn(III)derisomaltos

Tillgänglig från:

Paranova Läkemedel AB

ATC-kod:

B03AC

INN (International namn):

järn(III)derisomaltos

Dos:

100 mg/ml

Läkemedelsform:

Injektions-/infusionsvätska, lösning

Sammansättning:

järn(III)derisomaltos 417 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Injektionsflaska, 5 x 1 ml

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2020-11-03

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOFER
® 100 MG/ML SOLUTION FOR INJECTION/INFUSION _ _
ferric derisomaltose
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 you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Monofer is and what it is used for
2.
What you need to know before you receive Monofer
3.
How to use Monofer
4.
Possible side effects
5.
How to store Monofer
6.
Contents of the pack and other information
1.
WHAT MONOFER IS AND WHAT IT IS USED FOR
Monofer contains a combination of iron and derisomaltose (a chain of
sugar molecules). The type of iron in
Monofer is the same as that found naturally in the body called
‘ferritin’. This means that you can have
Monofer by injection in high doses.
Monofer is used for low levels of iron (sometimes called ‘iron
deficiency’ and ‘iron deficiency anaemia’) if:
•
Oral iron does not work or you cannot tolerate it
•
Your doctor decides you need iron very quickly to build up your iron
stores
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE MONOFER
YOU MUST NOT RECEIVE MONOFER:
•
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
NOT
caused by iron deficiency
•
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’
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Monofer:
•
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 o

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Monofer 100 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre of solution contains 100 mg iron as ferric
derisomaltose
1 ml vial/ampoule contains 100 mg iron as ferric derisomaltose
2 ml vial/ampoule contains 200 mg iron as ferric derisomaltose
5 ml vial/ampoule contains 500 mg iron as ferric derisomaltose
10 ml vial/ampoule contains 1,000 mg iron as ferric derisomaltose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Dark brown, non-transparent solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Monofer is indicated for the treatment of iron deficiency in the
following conditions:
•
When oral iron preparations are ineffective or cannot be used
•
Where there is a clinical need to deliver iron rapidly
The diagnosis must be based on laboratory tests.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and following each
administration of Monofer. Monofer 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 Monofer
injection (see section 4.4).
Each IV iron administration is associated with a risk of a
hypersensitivity reaction. Thus, to minimise risk the
number of single IV iron administrations should be kept to a minimum.
Posology
2
The posology of Monofer follows a stepwise approach: [1] determination
of the individual iron need and [2]
calculation and administration of the iron dose(s). The steps can be
repeated after [3] post-iron repletion
assessments.
_Step 1: Determination of the iron need:_
The iron need can be determined using either the Simplified Table (i)
or the Ganzoni formula below (ii).
The iron need is expressed i