FERROVIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IRON SUCROSE

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

B03AC03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

IRON SUCROSE 20 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

RAFARM S.A., GREECE

Therapeutic group:

IRON-SORBITOL-CITRIC ACID COMPLEX

Therapeutic area:

IRON-SORBITOL-CITRIC ACID COMPLEX

Therapeutic indications:

Ferrovin is indicated for the treatment of iron deficiency in the following indications:• Where there is a clinical need for a rapid iron supply,• In patients who cannot tolerate oral iron therapy or who are non-compliant,• In active inflammatory bowel disease where oral iron preparations are ineffective,• In chronic kidney disease when oral iron preparations are less effective.The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb (haemoglobin),serum ferritin, TSAT (transferrin saturation), serum iron, etc.).

Authorization date:

2014-06-30

Patient Information leaflet

25.06.2018
,ה/דבכנ ת/חקור ה/אפור
אפורל ןולעב ןוכדע לע ךעידוהל וננוצרב
FERROVIN, SOLUTION FOR INJECTION
: ליעפ רמוח
ONE MILLILITRE OF SOLUTION CONTAINS 20 MG OF IRON AS IRON SUCROSE
(IRON(III)-HYDROXIDE
SUCROSE COMPLEX).
ותועמשמ בוהצ ןמוסמ טסקט, ןוכדע ותועמשמ
קורי ןמוסמ טסקט( אפורל ןולעב םינוכדע
ןלהל
:)הקיחמ ותועמשמ טסקט ,הרמחה
FERROVIN
INJECTION SOLUTION
FERRIC HYDROXIDE SUCROSE COMPLEX, 20MG/ML
SUMMARY OF PRODUCT CHARACTERISTICS
(SPC)
1. NAME OF THE MEDICINAL PRODUCT
FERROVIN, solution for injection 20MG/ML
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
OF
ACTIVE
INGREDIENT
One millilitre of solution contains 20 mg of iron as iron sucrose
(iron(III)-hydroxide
sucrose complex).
Each 5mL ampoule of FERROVIN contains 20mg/mL Ferric (III) hydroxide
Complex
with sucrose, quantity equivalent to 100mg iron as iron sucrose
(iron(III)-hydroxide
sucrose complex)Ferric (III) per ampoule.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Injection solution or concentrated sSolution for infusioninjection. in
glass ampoule
(5mL).
FERROVIN is a dark brown, non-transparent, aqueous solution.
One carton box containing 5 ampoules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FERROVIN is indicated for the therapy of iron deficiency anaemia in
the following
cases:
Severe iron deficiency only when oral administration has been found
impossible. In
cases of gastro-intestinal malobsorption malabsorption which rules our
oral therapy,
patients on dialysis treated with erythropoietin.
4.2 DOSAGE POSOLOGY AND METHOD OF ADMINISTRATION
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during
and following each administration of FERROVIN.
FERROVIN 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 shoul

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT:
FERROVIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre of solution contains 20 mg of iron as iron sucrose
(iron(III)-hydroxide
sucrose complex).
Each 5ml ampoule of FERROVIN contains 100mg iron as iron sucrose
(iron(III)-
hydroxide sucrose complex).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
FERROVIN is a dark brown, non-transparent, aqueous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FERROVIN is indicated for the treatment therapy of iron deficiency in
the following
indications:
•
Where there is a clinical need for a rapid iron supply,
• In patients who cannot tolerate oral
iron therapy or who are non-compliant,
• In active inflammatory bowel disease
where oral iron preparations are ineffective,
• In chronic kidney diseas
e when oral iron preparations are less effective.
The diagnosis of iron deficiency must be based on appropriate
laboratory tests (e.g.
Hb, serum ferritin, TSAT, serum iron, etc.).
(Hb haemoglobin, TSAT transferrin saturation)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during
and following each administration of
FERROVIN.
FERROVIN 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 FERROVIN administration
(see section
4.4).
Posology
The cumulative dose of FERROVIN must be calculated for each patient
individually
and must not be exceeded.
Calculation of Dosage:
The total cumulative dose of FERROVIN, equivalent to the total iron
deficit (mg), is
determined by the haemoglobin level (Hb) and body weight (BW). The
dose of
FERROVIN must be individually calculated for each patient according to
the total iron
deficit calculated with the following