Rienso
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
13-07-2015
Данни за продукта
(SPC)
13-07-2015
Доклад обществена оценка
(PAR)
13-07-2015
Активна съставка:
Ferumoxytol
Предлага се от:
Takeda Pharma A/S
АТС код:
B03
INN (Международно Name):
ferumoxytol
Терапевтична група:
Other antianemic preparations
Терапевтична област:
Anemia; Kidney Failure, Chronic
Терапевтични показания:
Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
Каталог на резюме:
Revision: 7
Статус Оторизация:
Withdrawn
Дата Оторизация:
2012-06-15
Листовка
23
B. PACKAGE LEAFLET
_ _
Medicinal product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
RIENSO 30 MG/ML SOLUTION FOR INFUSION
Iron as ferumoxytol
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 ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rienso is and what it is used for
2.
What you need to know before you receive Rienso
3.
How Rienso is given
4.
Possible side effects
5.
How to store Rienso
6.
Contents of the pack and other information
1.
WHAT RIENSO IS AND WHAT IT IS USED FOR
Rienso is an iron preparation, containing the active substance
ferumoxytol, which is given by infusion
into a vein. It is used to treat iron deficiency anaemia resulting
from a lack of stored iron, in adult
patients with reduced kidney function.
Iron is an essential element required to make haemoglobin, a molecule
in red blood cells that enables
oxygen to be carried around the body. When there is insufficient iron
in the body, haemoglobin
cannot be formed, resulting in anaemia (low levels of haemoglobin).
The aim of Rienso therapy is to replenish the body’s iron stores.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE RIENSO
Before you were prescribed Rienso, the doctor will have carried out a
blood test to make sure that you
have iron deficiency anaemia.
YOU MUST NOT RECEIVE RIENSO:
-
if you are allergic (hypersensitive) to the product or any of the
other ingredients of this
medicine (listed in section 6).
-
if you have a history of medicine allergy or h
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Данни за продукта
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
Medicinal product no longer authorised
2
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
Rienso 30 mg/ml solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 30 mg of iron as ferumoxytol.
Each vial of 17 ml solution contains 510 mg of iron as ferumoxytol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Black to reddish brown solution
Osmolality: 270-330 mosm/kg
pH: 6.5 to 8.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rienso is indicated for the intravenous treatment of iron deficiency
anaemia in adult patients with
chronic kidney disease (CKD).
The diagnosis of iron deficiency must be based on appropriate
laboratory tests (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Rienso 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.
Patients should be carefully monitored for signs and symptoms of
hypersensitivity reactions including
monitoring of blood pressure and pulse during and for at least 30
minutes following each infusion of
Rienso. In addition, patients should be placed in a reclining or
semi-reclining position during infusion
and for at least 30 minutes thereafter (see section 4.4).
Posology
_Treatment Course _
The recommended course of Rienso is based on the patient’s
pre-treatment haemoglobin and body
weight as provided in Table 1.
Each 510 mg dose is administered as an intravenous infusion for at
least 15 minutes. For patients
receiving two doses, the second 510 mg infusion is to be administered
2 to 8 days later as per Table1.
Med
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