MONOFER iron (as ferric derisomaltose) 1000 mg/10 mL solution for injection vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

ferric derisomaltose, Quantity: 4170 mg (Equivalent: iron, Qty mg)

Dostupné z:

A Menarini Australia Pty Ltd

Forma lieku:

Injection, solution

Zloženie:

Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid

Spôsob podávania:

Intravenous Bolus, Intravenous Infusion

Počet v balení:

1, 2 or 5 x 10 mL

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Monofer is indicated for the treatment of iron deficiency in adults, under 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.

Prehľad produktov:

Visual Identification: Sterile, dark brown, non-transparent solution, practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2017-12-04

Príbalový leták

MONOFER
®
_ferric derisomaltose_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Monofer.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
THOSE UPDATES MAY CONTAIN
IMPORTANT INFORMATION ABOUT THE
MEDICINE AND ITS USE OF WHICH YOU
SHOULD BE AWARE.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Monofer
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MONOFER IS
USED FOR
Monofer is a medicine that is used to
treat iron deficiency resulting in
anaemia when oral iron preparations
are ineffective or cannot be used. It
contains iron in the form of ferric
derisomaltose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Monofer is only available with a
doctor's prescription. It is not
addictive.
BEFORE YOU ARE GIVEN
MONOFER
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT HAVE MONOFER IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO FERRIC DERISOMALTOSE, THE ACTIVE
INGREDIENT IN MONOFER.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
YOU MUST NOT HAVE MONOFER IF:
•
you have anaemia that is not
caused by iron deficiency
•
you have too much iron
(overload) or a problem with the
way your body uses iron
There is not enough information to
recommend the use of Monofer in
children.
_BEFORE YOU ARE GIVEN IT_
TELL YOU

Súhrn charakteristických

Version: pfpmonfi11021
Supersedes: pfpmonfi10421
Page 1 of 15
AUSTRALIAN
PRODUCT
INFORMATION
–
MONOFER
® (FERRIC DERISOMALTOSE)
1.
NAME OF THE MEDICINE
Ferric derisomaltose
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ferric derisomaltose is a dark reddish brown powder containing 24%
iron (III).
Each 1 mL of MONOFER contains 100 mg of iron as ferric derisomaltose.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
MONOFER is a sterile, dark brown, non-transparent solution with pH
5.0-7.0 containing ferric
derisomaltose
dissolved
in
water
for
injection.
The
pH
may
have
been
adjusted
with
hydrochloric acid or sodium hydroxide, and the product is filled under
nitrogen gas.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MONOFER is indicated for the treatment of iron deficiency in adults,
under 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 DOSE 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 Special warnings and precautions for use).
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.
Version: pfpmonfi11021
Supersedes: pfpmonfi10421
Page 2 of 15
DOSAGE
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