Monofer 100mg/1ml solution for injection vials

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Ferric derisomaltose

זמין מ:

Pharmacosmos UK Ltd

קוד ATC:

n/a

INN (שם בינלאומי):

Ferric derisomaltose

כמות:

100mg/1ml

טופס פרצבטיות:

Solution for injection

מסלול נתינה (של תרופות):

Intravenous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: ; GTIN: 5706020044516

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOFER
® 100 MG/ML SOLUTION FOR INJECTION/INFUSION _ _
Iron
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 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 isomaltoside 1000 (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 t

מאפייני מוצר

OBJECT 1
MONOFER 100MG/ML SOLUTION FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 09-Jun-2017 | Pharmacosmos
UK Limited
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
Monofer 100 mg/ml solution for injection/infusion
2. Qualitative and quantitative composition
One millilitre of solution contains 100 mg iron as iron(III)
isomaltoside 1000
1 ml vial/ampoule contains 100 mg iron as iron(III) isomaltoside 1000
2 ml vial/ampoule contains 200 mg iron as iron(III) isomaltoside 1000
5 ml vial/ampoule contains 500 mg iron as iron(III) isomaltoside 1000
10 ml vial/ampoule contains 1,000 mg iron as iron(III) isomaltoside
1000
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
Calculation of the cumulative iron need:
_Iron replacement in patients with iron deficiency:_
The dose of Monofer is expressed in mg of elemental iron. The iron
need and the administration schedule
for Monofer must be individually established for each patient. The
optimal haemoglobin target level and
iron stores may vary in different patient groups and between patients.
Please refer to official guidelines.
Iron deficiency anaemia will not appear until essentially all iron
stores have been depleted. Iron therapy
should therefore replenish both haemoglobin iron and iron stores.
After the current iron deficit has been corrected, patients may
require continued t