VENOFER

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

FERROUS AS IRON III HYDROXIDE SUCROSE COMPLEX

Disponibbli minn:

CTS LTD

Kodiċi ATC:

B03AC03

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

FERROUS AS IRON III HYDROXIDE SUCROSE COMPLEX 100 MG / 5 ML

Rotta amministrattiva:

I.V

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

VIFOR (INTERNATIONAL) INC, SWITZERLAND

Grupp terapewtiku:

IRON-SORBITOL-CITRIC ACID COMPLEX

Żona terapewtika:

IRON-SORBITOL-CITRIC ACID COMPLEX

Indikazzjonijiet terapewtiċi:

Venofer 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, serum ferritin, TSAT, serum iron, etc.)(Hb haemoglobin, TSAT transferrin saturation)

Data ta 'l-awtorizzazzjoni:

2013-03-31

Fuljett ta 'informazzjoni

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
VENOFER SOLUTION FOR INJECTION 100 MG / 5ML
THE ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each 5 ml of solution contains 100 mg of iron (as an iron III
hydroxide sucrose complex)
For a list of the inactive and allergenic ingredients in the
preparation - see section 6 and the "Important
information about some of the ingredients of the medicine" section.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them even if it
seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For 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., haemoglobin, serum
ferritin, TSAT (transferrin saturation), serum iron, etc.).
THERAPEUTIC GROUP: Iron, preparations for the treatment of anaemia
2. BEFORE USING THE MEDICINE:
X DO NOT USE THE MEDICINE IF:

You are sensitive (allergic) to iron (FERROUS) or to any of the other
ingredients contained in the
medicine (see section 6).

You have had a severe allergic reaction (hypersensitivity) to other
injectable iron preparations.

You have anaemia that is not caused by a shortage of iron.

Your body has an excess of iron or improperly uses iron.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
! BEFORE COMMENCING THE TREATMENT WITH VENOFER, INFORM THE DOCTOR IF
YOU HAVE:

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT:
Venofer, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre of solution contains 20 mg of iron as iron sucrose
(iron(III)-hydroxide sucrose
complex).
Each 5 ml ampoule of Venofer contains 100 mg iron as iron sucrose
(iron(III)-hydroxide
sucrose complex).
Excipient with known effect
Venofer contains up to 7 mg sodium per ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Venofer is a dark brown, non-transparent, aqueous solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Venofer 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,
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 Venofer.
Venofer 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 Venofer administration (see section 4.4).
Posology
The cumulative dose of Venofer must be calculated for each patient
individually and must not
be exceeded.
Calculation of dosage:
2
The total cumulative dose of Venofer, equivalent to the total iron
deficit (mg), is determined
by the haemoglobin level (Hb) and body weight (BW). The dose of
Venofer must be
individually calculated f