Monover 100 mg/ml solution for injection/infusion (ampoules)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iron

Available from:

Pharmacosmos A/S

ATC code:

B03AC

INN (International Name):

Iron

Dosage:

100 milligram(s)/millilitre

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:

Not marketed

Authorization date:

2010-04-09

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOVER
® 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 Monover is and what it is used for
2.
What you need to know before you receive Monover
3.
How Monover is administered
4.
Possible side effects
5.
How to store Monover
6.
Contents of the pack and other information.
1.
WHAT MONOVER IS AND WHAT IT IS USED FOR
Monover contains a combination of iron and derisomaltoside (a chain of
sugar molecules). The type of iron
in Monover is the same as that found naturally in the body called
‘ferritin’. This means that you can have
Monover by injection in high doses.
Monover 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 MONOVER
YOU MUST NOT RECEIVE MONOVER:
•
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 Monover:
•
if you have a history of medicine allergy
•
if you have systemic lupus erythematosus
•
if you have rheumatoid arthritis
•
if you have severe asth

Summary of Product characteristics

Health Products Regulatory Authority
07 March 2023
CRN00DG98
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monover 100 mg/ml solution for injection/infusion (ampoules)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre of solution contains 100 mg iron as ferric
derisomaltose
1 ml ampoule contains 100 mg iron as ferric derisomaltose
2 ml ampoule contains 200 mg iron as ferric derisomaltose
5 ml ampoule contains 500 mg iron as ferric derisomaltose
10 ml 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
Monover 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
Monover. Monover 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 Monover
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
The posology of Monover 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