Ferracin IV

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

Iron sucrose complex

Dostępny od:

Rafarm S.A.

INN (International Nazwa):

Iron sucrose complex

Dawkowanie:

20mg/ml

Forma farmaceutyczna:

solution for injection

Typ recepty:

Prescription

Ulotka dla pacjenta

Patient information leaflet
Ferracin IV
solution for injection/concentrate for solution for infusion
Iron
Read all of this leaflet carefully before you start using
this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or
pharmacist.
-
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Ferracin IV is and what it is used for
2. Before you use Ferracin IV
3. How to use Ferracin IV
4. Possible side effects
5. How to store Ferracin IV
6. Further information
1. WHAT FERRACIN IV IS AND WHAT IT IS USED FOR
Ferracin IV (iron hydroxide sucrose complex 20 mg/ml)
belongs to the so-called iron preparations. It is adminis-
tered directly into a vein.
Ferracin IV is used to fill up iron reserves in the body, in
patients with iron deficiency. This medicine is used only in
the following cases:
-
In patients who cannot tolerate iron preparations
taken by mouth.
-
In patients who cannot take iron preparations by
mouth as recommended.
-
In patients whose iron reserves need to be filled up
quickly with iron.
-
In patients who cannot adequately absorb iron taken
orally (by mouth), such as those with bowel inflamma-
tion.
Before treatment is started, a blood test must be done to
see whether this medicine is suitable.
2. BEFORE YOU USE FERRACIN IV
Do not use Ferracin IV
-
if you are allergic (hypersensitive) to iron prepara-
tions via injection or infusion, or any of the other in-
gredients of Ferracin IV.
-
if you have ever had
-
asthma, narrowing of the airways with chest tight-
ness.
-
skin rash or other allergic skin inflammation
with itching and dry skin.
In these cases, you will be more sensitive to allergic
reactions.
-
if your anaemia (excessively low number of red blood
cells) is not caused by iron deficiency.
-
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Charakterystyka produktu

30720 v02, 17-Dec-2013
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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
Ferracin IV, solution for injection/concentrate for solution for
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution contains 20 mg iron as iron(III) hydroxide
sucrose complex.
Each 5 ml ampoule contains 100 mg iron as iron(III) hydroxide sucrose
complex.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/concentrate for solution for infusion.
Ferracin IV is a dark brown, non-transparent, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ferracin IV is indicated for the parenteral treatment of iron
deficiency in those cases where oral iron
preparations are inadequate.
This may include:
•
Patients unable to tolerate oral iron preparations,
•
Patients unable to take oral iron therapy correctly,
•
Disorders where it is clinically necessary to rapidly replenish iron
reserves,
•
Patients unable to absorb oral iron preparations sufficiently (e.g. as
a result of active
inflammatory bowel disease).
The diagnosis of iron deficiency must be based on appropriate
laboratory tests (e.g. serum ferritin,
serum iron, transferrin saturation, haemoglobin, haematocrit,
erythrocyte count and hypochromic red
cells or red blood cell indicators: MCV, MCH, MCHC).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Patients must be closely monitored for signs and symptoms of
hypersensitivity reactions during and
after each administration of Ferracin IV.
Ferracin IV may only be administered when a staff member with
experience in assessing and treating
anaphylactic reactions is immediately available, and in an environment
in which all resuscitation
facilities are available. The patient must be observed for undesirable
effects for at leas