FERRLECIT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IRON AS IRON III SODIUM FERRIC GLUGONATE COMPL.

Available from:

SANOFI ISRAEL LTD

ATC code:

B03AE10

Pharmaceutical form:

SOLUTION FOR INJECTION/ CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IRON AS IRON III SODIUM FERRIC GLUGONATE COMPL. 62.5 MG / 5 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

SANOFI S.P.A., ITALY

Therapeutic group:

VARIOUS COMBINATIONS

Therapeutic area:

VARIOUS COMBINATIONS

Therapeutic indications:

Ferrlecit is indicated in adults and children 6 years and above.Severe iron deficiency states only when oral administration has been found impossible; in cases of gastrointestinal malabsorption which rules out oral iron therapy; patients treated by dialysis getting Erythropoietin.

Authorization date:

2022-05-31

Patient Information leaflet

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
__ ךיראת
04.02.14
_______
_ םושירה רפסמו תילגנאב רישכת םש
1256728020
_
FERRLECIT
__________ םושירה לעב םש
SANOFI AVENTIS ISRAEL LTD
עדימ ,תוחיטב עדימב םייוניש ושענ םהבש
םיפיעסה יתת קר םירכזומ ספוטב
אלמה ןולעב אוצמל ןתינ אלמ
.
!דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
טסקט
יחכונ
שדח טסקט
NAME
OF
THE
MEDICINAL
PRODUCT
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.
THERAPEUTIC
INDICATIONS
Ferrlecit is indicated in adults and children 6 years and above.
/////////////////////////
POSOLOGY AND
METHOD OF
ADMINISTRATION
//////////////////////////
Monitor carefully patients for signs and symptoms of
hypersensitivity reactions during and following each
administration of Ferrlecit.
Ferrlecit 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
Ferrlecit injection
(see section 4.4).
_Pediatric population_
Due to lack of clinical data on safety and efficacy, Ferrlecit
solution for injection is not recommended in children
younger
than the age
6 years.
//////////////////////
CONTRAINDICATIO
NS
Ferrlecit should not be used in
-
Hypersensitivity to the active substance, to Ferrlecit
or any of its
one of the excipients
listed in section
6.1.
-
Known serious hypersensitivity to other parenteral
iron products.
-
iron overload (haemochromatosis, chronic haemolysis)
or iron utilisation disorders (sideroblastic anaemia,
lead anaemia, thalassaemia),
severe inflammatory diseases of the liver or

Summary of Product characteristics

1
FERRLECIT-V-21.0
1.
NAME OF THE MEDICINAL PRODUCT
Ferrlecit
Active substance: Iron as sodium ferric gluconate complex 62.5 mg/5ml
Solution for injection or concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 5 ml contains:
Sodium ferric gluconate complex equivalent to: 62.5 mg iron (III) ion,
manufactured from:
Sodium carbonate decahydrate
Ferric chloride hexahydrate
Sodium gluconate
Sodium carbonate, anhydrous
Water for injection
Excipients with known effect:
Contains 45 mg benzyl alcohol per ampoule (5 ml), equivalent to 9
mg/ml,
975 mg of sucrose per 5 ml ampoule
(see sections 4.3, 4.4 and 4.8).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for infusion.
Clear, dark brown solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Ferrlecit is indicated in adults and children from 6 years and above.
Severe iron deficiency states only when oral administration has been
found impossible; in cases of
gastrointestinal malabsorption which rules out oral iron therapy;
patients treated by dialysis getting
erythropoietin.
4.2
Posology and method of administration
Unless otherwise ordered, depending on the degree of iron deficiency,
adults are given one ampoule
daily of 5 ml by infusion after dilution with physiological saline
solution or by slow intravenous
injection.
Not more than one ampoule should be given, even in exceptional cases
such as marked iron deficiency
after repeated autologous blood donation.
For preference, the product can be given as an intravenous infusion
over 20 to 30 minutes, diluted with
100 to 250 ml of physiological saline solution.
I.V. injections must always be given very slowly with the patient
supine.
2
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and following
each administration of Ferrlecit.
Ferrlecit should only be administered when staff trained to evaluate
and manage anaphylactic
reactions is immediately available, in