FERINJECT

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
FERRIC CARBOXYMALTOSE
Available from:
CTS LTD
Pharmaceutical form:
SOLUTION FOR INJECTION / INFUSION
Composition:
FERRIC CARBOXYMALTOSE 1800 MG/VIAL
Administration route:
I.V
Prescription type:
Required
Manufactured by:
VIFOR (INTERNATIONAL) INC, SWITZERLAND
Therapeutic indications:
Ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests.
Authorization number:
146 42 33331 00
Authorization date:
2016-06-30

ראורבפ

2019

,ה/אפור ,ה/דבכנ ת/חקור

:ןודנה ןוכדע

ןולע לש אפורל טק'גנירפ

Solution for injection/

infusion

ולעה יכ םכעידוהל םישקבמ ונא

אפורל כדוע ןודנבש רישכתה לש

ןולעה ןוכדע

.תורמחה ללוכ

:תרשואמה היוותהה

Ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used.

The diagnosis must be based on laboratory tests.

קזוחו בכרה

ליעפ רמוח

:

FERRIC CARBOXYMALTOSE 1800 MG/VIAL

ועצוב וב עדימה אבומ ןלהלש טוריפב דבלב םייתוהמ םייוניש

סקט וא טסקט תפסות יוניש לעב ט יתועמשמ מוסמ

.הצוח וקב תנמוסמ טסקט תקיחמ .עבצב

ל ןולעב םינוכדעה אפור :םיאבה םיפיעסב ושענ

4.4

Special warnings and precautions for use

Hypophosphataemia

Parenterally administered iron preparations can cause hypophosphataemia which in most cases is transient and

without clinical symptoms. Cases of hypophosphataemia requiring medical attention were reported, mainly in

patients with existing risk factors and after prolonged exposure to high-dose intravenous iron.

4.8 Undesirable effects

Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which >8,000 7,391

subjects received Ferinject, as well as those reported from the post-marketing experience (see table footnotes

for details)

.

The most commonly reported ADR is nausea (occurring in 2.9% of the subjects), followed by injection/infusion

site reactions, hypophosphatemia, headache, flushing, dizziness and hypertension. Injection/infusion site

reactions comprise several ADRs which individually are either uncommon or rare.

In clinical trials the minimum

serum phosphorous values were obtained after approximately 2 weeks, and 4 to 12 weeks following Ferinject

treatment the values had returned to those within the range of baseline. The most serious ADR is anaphylactoid

reactions (rare).

For subjects in clinical trials that showed a decrease in serum phosphorous, the minimum values were obtained

after approximately 2 weeks, and in most cases returned to baseline values by 12 weeks following Ferinject

treatment . The most serious ADR is anaphylactoid/anaphylactic reactions (rare); fatalities have been reported.

See section 4.4 for further details.

םינכדועמה םינולעה

חלשנ

ב םוסרפל תואירבה דרשמ רתאבש תופורתה רגאמ

http://www.health.gov.il

ןתינ םלבקל

ספדומ םי

חר ,מ"עב טצכ תרבחל הינפ ידי לע

שרחה

,ןורשה דוה

09-7626323

,הכרבב

ןייטש יחצ

חקור

הנוממ

מ"עב טצכ

The content of this leaflet was approved by the Ministry of Health in May 2017 and updated according to

the guidelines of the Ministry of Health in December 2019.

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Ferinject 50 mg iron/mL solution for injection/infusion.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One mL of solution contains 50 mg of iron as 180 mg ferric carboxymaltose.

Each 10 mL vial contains 500 mg of iron as 1800 mg ferric carboxymaltose.

One mL of solution contains up to 5.5 mg (0.24 mmol) sodium, see section 4.4.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Solution for injection/infusion.

Dark brown, non-transparent, aqueous solution inside a dark brown vial.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or

cannot be used.

The diagnosis of iron deficiency must be based on laboratory tests.

4.2 Posology and method of administration

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and

following each administration of Ferinject.

Ferinject 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 Ferinject administration (see section 4.4).

Posology

The posology of Ferinject follows a stepwise approach: [1] determination of the individual iron

need, [2] calculation and administration of the iron dose(s), and [3] post-iron repletion

assessments. These steps are outlined below:

Step 1: Determination of the iron need

The individual iron need for repletion using Ferinject is determined based on the patient's body

weight and haemoglobin (Hb) level. Refer to Table 1 for determination of the iron need:

Table 1: Determination of the iron need

Hb

Patient body weight

g/dL

mmol/L

below 35 kg

35 kg to <70 kg

70 kg and above

<10

<6.2

500 mg

1,500 mg

2,000 mg

10 to <14

6.2 to <8.7

500 mg

1,000 mg

1,500 mg

>14

>8.7

500 mg

500 mg

500 mg

Iron deficiency must be confirmed by laboratory tests as stated in 4.1.

Step 2: Calculation and administration of the maximum individual iron dose(s)

Based on the iron need determined above the appropriate dose(s) of Ferinject should be

administered taking into consideration the following:

A single Ferinject administration should not exceed:

15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg

body weight (for administration by intravenous infusion)

1,000 mg of iron (20 mL Ferinject)

The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL Ferinject)

per week.

Step 3: Post-iron repletion assessments

Re-assessment should be performed by the clinician based on the individual patient's condition.

The Hb level should be re-assessed no earlier than 4 weeks post final Ferinject administration to

allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further

iron repletion, the iron need should be recalculated using Table 1 above. (See section 5.1).

Special Population – patients with haemodialysis-dependent chronic kidney disease

A single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis-

dependent chronic kidney disease patients (see also section 4.4).

Paediatric population

The use of Ferinject has not been studied in children, and therefore is not recommended in

children under 14 years.

Method of administration

Ferinject must only be administered by the intravenous route:

by injection, or

by infusion, or

during a

haemodialysis

session undiluted directly into the venous limb of the dialyser.

Ferinject must not be administered by the subcutaneous or intramuscular route.

Intravenous injection

Ferinject may be administered by intravenous injection using undiluted solution. The maximum

single dose is 15 mg iron/kg body weight but should not exceed 1,000 mg iron. The

administration rates are as shown in Table 2:

Table 2: Administration rates for intravenous injection of Ferinject

Volume of Ferinject required

Equivalent iron dose

Administration rate /

Minimum administration time

2 to 4 mL

100 to 200 mg

No minimal prescribed time

>4 to 10 mL

>200 to 500 mg

100 mg iron/min

>10 to 20 mL

>500 to 1,000 mg

15 minutes

Intravenous infusion

Ferinject may be administered by intravenous infusion, in which case it must be diluted. The

maximum single dose is 20 mg iron/kg body weight, but should not exceed 1,000 mg iron.

For infusion, Ferinject must only be diluted in sterile 0.9% m/V sodium chloride solution as shown

in Table 3.

Note: for stability reasons, Ferinject should not be diluted to concentrations less than 2 mg

iron/mL (not including the volume of the ferric carboxymaltose solution).

Table 3: Dilution plan of Ferinject for intravenous infusion

Volume of Ferinject

required

Equivalent iron dose

Maximum amount of

sterile 0.9% m/V

sodium chloride

solution

Minimum

administration time

4 mL

200 mg

50 mL

No minimal

prescribed time

>4

10 mL

>200

500 mg

100 mL

6 minutes

>10

20 mL

>500

1,000 mg

250 mL

15 minutes

4.3

Contraindications

The use of Ferinject is contraindicated in cases of:

hypersensitivity to the active substance, to Ferinject or any of its excipients listed in section

6.1.

known serious hypersensitivity to other parenteral iron products.

anaemia not attributed to iron deficiency, e.g. other microcytic anaemia.

evidence of iron overload or disturbances in the utilisation of iron.

4.4

Special warnings and precautions for use

Hypersensitivity reactions

Parenterally administered iron preparations can cause hypersensitivity reactions including

serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions

have also been reported after previously uneventful doses of parenteral iron complexes.

The risk is enhanced for patients with known allergies including drug allergies, including patients

with a history of severe asthma, eczema or other atopic allergy.

There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in

patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid

arthritis).

Ferinject should only be administered when staff trained to evaluate and manage anaphylactic

reactions are immediately available, in an environment where full resuscitation facilities can be

assured. Each patient should be observed for adverse effects for at least 30 minutes following

each Ferinject administration. If hypersensitivity reactions or signs of intolerance occur during

administration, the treatment must be stopped immediately. Facilities for cardio respiratory

resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be

available, including an injectable 1:1000 adrenaline solution. Additional treatment with

antihistamines and/or corticosteroids should be given as appropriate.

Hypophosphataemia

Parenterally administered iron preparations can cause hypophosphataemia which in most cases

is transient and without clinical symptoms. Cases of hypophosphataemia requiring medical

attention were reported, mainly in patients with existing risk factors and after prolonged exposure

to high-dose intravenous iron.

Hepatic or renal impairment

In patients with liver dysfunction, parenteral iron should only be administered after careful

benefit/risk assessment. Parenteral iron administration should be avoided in patients with hepatic

dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda

(PCT). Careful monitoring of iron status is recommended to avoid iron overload.

No safety data on haemodialysis-dependent chronic kidney disease patients receiving single

doses of more than 200 mg iron are available.

Infection

Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema

or atopic allergies. It is recommended that the treatment with Ferinject is stopped in patients with

ongoing bacteraemia. Therefore, in patients with chronic infection a benefit/risk evaluation has to

be performed, taking into account the suppression of erythropoiesis.

Extravasation

Caution should be exercised to avoid paravenous leakage when administering Ferinject.

Paravenous leakage of Ferinject at the administration site may lead to irritation of the skin and

potentially long lasting brown discolouration at the site of administration. In case of paravenous

leakage, the administration of Ferinject must be stopped immediately.

Excipients

One mL of undiluted Ferinject contains up to 5.5 mg (0.24 mmol) of sodium. This has to be taken

into account in patients on a sodium-controlled diet.

Paediatric population

The use of Ferinject has not been studied in children.

4.5

Interaction with other medicinal products and other forms of interaction

The absorption of oral iron is reduced when administered concomitantly with parenteral iron

preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days

after the last administrationof Ferinject.

4.6

Fertility, pregnancy and lactation

Pregnancy

There are limited data from the use of Ferinject in pregnant women (see section 5.1). A careful

benefit/risk evaluation is required before use during pregnancy and Ferinject should not be used

during pregnancy unless clearly necessary.

Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with

oral iron. Treatment with Ferinject should be confined to the second and third trimester if the

benefit is judged to outweigh the potential risk for both the mother and the foetus.

Foetal bradycardia may occur following administration of parenteral irons. It is usually transient

and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be

carefully monitored during intravenous administration of parenteral irons to pregnant women.

Animal data suggest that iron released from Ferinject can cross the placental barrier and that its

use during pregnancy may influence skeletal development in the fetus (see section 5.3).

Breast-feeding

Clinical studies showed that transfer of iron from Ferinject to human milk was negligible (

1%).

Based on limited data on breast-feeding women it is unlikely that Ferinject represents a risk to

the breast-fed child.

Fertility

There are no data on the effect of Ferinject on human fertility. Fertility was unaffected following

Ferinject treatment in animal studies (see section 5.3).

4.7

Effects on ability to drive and use machines

Ferinject is unlikely to impair the ability to drive and use machines.

4.8 Undesirable effects

Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which

>8,000

subjects received Ferinject, as well as those reported from the post-marketing experience

(see table footnotes for details).

The most commonly reported ADR is nausea (occurring in 2.9% of the subjects), followed by

injection/infusion site reactions, hypophosphatemia, headache, flushing, dizziness and

hypertension. Injection/infusion site reactions comprise several ADRs which individually are

either uncommon or rare.

For subjects in clinical trials that showed a decrease in serum phosphorous, the minimum values

were obtained after approximately 2 weeks, and in most cases returned to baseline values by 12

weeks following Ferinject treatment . The most serious ADR is anaphylactoid/anaphylactic

reactions (rare); fatalities have been reported. See section 4.4 for further details.

Table 4: Adverse drug reactions observed during clinical trials and post-marketing experience

System Organ Class

Common

(≥1/100 to <1/10)

Uncommon (≥1/1,000 to

<1/100)

Rare

(≥1/10,000 to <1/1,000)

Immune system

disorders

Hypersensitivity

Anaphylactoid/anaphylactic

reactions

Metabolism and

nutritional disorders

Hypophosphataemia

Nervous system

disorders

Headache, dizziness

Paraesthesia, dysgeusia

Loss of consciousness

Psychiatric disorders

Anxiety

Cardiac disorders

Tachycardia

Vascular disorders

Flushing,

hypertension

Hypotension

Phlebitis, syncope

presyncope

Respiratory, thoracic

and mediastinal

disorders

Dyspnoea

Bronchospasm

Gastrointestinal

disorders

Nausea

Vomiting, dyspepsia, abdominal

pain, constipation, diarrhoea

Flatulence

Skin and subcutaneous

tissue disorders

Pruritus, urticaria, erythema,

rash

Angioedema

, pallor

and face oedema

Musculoskeletal and

connective tissue

disorders

Myalgia, back pain, arthralgia,

pain in extremity, muscle

spasms

General disorders and

administration site

conditions

Injection/infusion site

reactions

Pyrexia, fatigue, chest pain,

oedema peripheral, chills

Malaise, influenza like

illness (whose onset may

vary from a few hours to

several days)

Investigations

Alanine aminotransferase

increased, aspartate

aminostransferase increased,

gamma-glutamyltransferase

increased, blood lactate

dehydrogenase increased, blood

alkaline phosphatase increased

ADRs exclusively reported in the post-marketing setting.

ADRs reported in the post-marketing setting which are also observed in the clinical setting.

Includes the following preferred terms: rash (individual ADR determined to be uncommon) and rash erythematous, -

generalised, -macular, -maculo-papular, -pruritic (all individual ADRs determined to be rare).

Includes, but is not limited to,

the following preferred terms: injection/infusion site -pain, -haematoma, -discolouration, -

extravasation, -irritation, -reaction, (all individual ADRs determined to be uncommon) and -paraesthesia (individual ADR

determined to be rare).

Note: ADR = Adverse drug reaction.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form https://sideeffects.health.gov.il/

4.9

Overdose

Administration of Ferinject in quantities exceeding the amount needed to correct iron deficit at the time of

administration may lead to accumulation of iron in storage sites eventually leading to haemosiderosis.

Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognising

iron accumulation.

If iron accumulation has occurred, treat according to standard medical practice,

e.g. consider the use of an iron chelator.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Iron trivalent, parenteral preparation, ATC code: B03AC

Ferinject solution for injection/infusion is a colloidal solution of the iron complex ferric carboxymaltose.

The complex is designed to provide, in a controlled way, utilisable iron for the iron transport and storage

proteins in the body (transferrin and ferritin, respectively).

Red cell utilisation of

Fe from radio-labelled Ferinject ranged from 91% to 99% in subjects with iron

deficiency (ID) and 61% to 84% in subjects with renal anaemia at 24 days post-dose.

Ferinject treatment of patients with ID anaemia results in an increase in reticulocyte count and serum

ferritin levels to within normal ranges.

Clinical efficacy and safety

The efficacy and safety of Ferinject has been studied in different therapeutic areas necessitating

intravenous iron to correct iron deficiency. The main studies are described in more detail below.

Cardiology

Chronic heart failure

Study CONFIRM-HF was a double-blind, randomised, 2-arm study comparing Ferinject (n=150) vs.

placebo (n=151) in subjects with chronic heart failure and ID for a treatment period of 52 weeks. At Day 1

and Week 6 (correction phase), subjects received either Ferinject according to a simplified dosing grid

using baseline Hb and body weight at screening (see section 4.2), placebo or no dose. At Weeks 12, 24

and 36 (maintenance phase) subjects received Ferinject (500 mg iron) or placebo if serum ferritin was

<100 ng/mL or 100-299 ng/mL with TSAT < 20%, or no dose. The treatment benefit of Ferinject vs.

placebo was demonstrated with the primary efficacy endpoint, the change in the 6-minute walk test

(6MWT) from baseline to Week 24 (p=0.002). This effect was sustained throughout the study to Week 52

(p<0.001).

Nephrology

Haemodialysis-dependent chronic kidney disease

Study VIT-IV-CL-015 was an open-label, randomised parallel group study comparing Ferinject (n=97) to

iron sucrose (n=86) in subjects with ID anaemia undergoing haemodialysis. Subjects received Ferinject or

iron sucrose 2-3 times per week in single doses of 200 mg iron directly into the dialyser until the individually

calculated cumulative iron dose was reached (mean cumulative dose of iron as Ferinject: 1,700 mg). The

primary efficacy endpoint was the percentage of subjects reaching an increase in Hb of ≥1.0 g/dL at 4

weeks after baseline. At 4 weeks after baseline, 44.1% responded to treatment with Ferinject (i.e. Hb

increase of ≥1.0 g/dL) compared to 35.3% for iron sucrose (p=0.2254).

Non-dialysis-dependent chronic kidney disease

Study 1VIT04004 was an open-label, randomised active-control study, evaluating the safety and efficacy

of Ferinject (n=147) vs. oral iron (n=103). Subjects in the Ferinject group received 1,000 mg of iron at

baseline and 500 mg of iron at days 14 and 28, if TSAT was <30% and serum ferritin was <500 ng/mL at

the respective visit. Subjects in the oral iron arm received 65 mg iron TID as ferrous sulphate from baseline

to day 56. Subjects were followed-up until day 56. The primary efficacy endpoint was the percentage of

subjects achieving an increase in Hb of ≥1.0 g/dL anytime between baseline and end of study or time of

intervention. This was achieved by 60.54% of subjects receiving Ferinject vs. 34.7% of subjects in the oral

iron group (p<0.001). Mean haemoglobin change to day 56/end of study was 1.0 g/dL in the Ferinject group

and 0.7 g/dL in the oral iron group (p=0.034, 95% CI: 0.0, 0.7).

Gastroenterology

Inflammatory bowel disease

Study VIT-IV-CL-008 was a randomised, open-label study which compared the efficacy of Ferinject vs.

oral ferrous sulphate in reducing ID anaemia in subjects with inflammatory bowel disease (IBD). Subjects

received either Ferinject (n=111) in single doses of up to 1,000 mg iron once per week until the

individually calculated iron dose (per Ganzoni formula) was reached (mean cumulative iron dose: 1,490

mg), or 100 mg iron BID as ferrous sulphate (n=49) for 12 weeks. Subjects receiving Ferinject showed a

mean increase in Hb from baseline to Week 12 of 3.83 g/dL, which was non-inferior to 12 weeks of twice

daily therapy with ferrous sulphate (3.75 g/dL, p=0.8016).

Study FER-IBD-07-COR was a randomised, open-label study comparing the efficacy of Ferinject vs. iron

sucrose in subjects with remitting or mild IBD. Subjects receiving Ferinject were dosed according to a

simplified dosing grid using baseline Hb and body weight (see section 4.2) in single doses up to 1,000

mg iron, whereas subjects receiving iron sucrose were dosed according to individually calculated iron

doses using the Ganzoni formula in doses of 200 mg iron until the cumulative iron dose was reached.

Subjects were followed-up for 12 weeks. 65.8% of subjects receiving Ferinject (n=240; mean cumulative

iron dose: 1,414 mg) vs. 53.6% receiving iron sucrose (n=235; mean cumulative dose 1,207 mg;

p=0.004) had responded at Week 12 (defined as Hb increase ≥2 g/dL). 83.8% of Ferinject-treated

subjects vs. 75.9% of iron sucrose-treated subjects achieved a Hb increase ≥2 g/dL or had Hb within

normal limits at Week 12 (p=0.019).

Women's health

Post partum

Study VIT-IV-CL-009 was a randomised open-label non-inferiority study comparing the efficacy of

Ferinject (n=227) vs. ferrous sulphate (n=117) in women suffering from post-partum anaemia. Subjects

received either Ferinject in single doses of up to 1,000 mg iron until their individually calculated

cumulative iron dose (per Ganzoni formula) was reached, or 100 mg of iron as oral ferrous sulphate BID

for 12 weeks. Subjects were followed-up for 12 weeks. The mean change in Hb from baseline to Week

12 was 3.37 g/dL in the Ferinject group (n=179; mean cumulative iron dose: 1,347 mg) vs. 3.29 g/dL in

the ferrous sulphate group (n=89), showing non-inferiority between the treatments.

Pregnancy

Intravenous iron medicines should not be used during pregnancy unless clearly necessary. Treatment

with Ferinject should be confined to the second and third trimester if the benefit is judged to outweigh the

potential risk for both the mother and the foetus, see section 4.6.

Limited safety data in pregnant women are available from study FER-ASAP-2009-01, a randomised,

open-label, study comparing Ferinject (n=121) vs. oral ferrous sulphate (n=115) in pregnant women in

the second and third trimester with ID anaemia for a treatment period of 12 weeks. Subjects received

Ferinject in cumulative doses of 1,000 mg or 1,500 mg of iron (mean cumulative dose: 1,029 mg iron)

based on Hb and body weight at screening, or 100 mg of oral iron BID for 12 weeks. The incidence of

treatment related adverse events was similar between Ferinject treated women and those treated with

oral iron (11.4% Ferinject group; 15.3% oral iron group). The most commonly reported treatment-related

adverse events were nausea, upper abdominal pain and headache. Newborn Apgar scores as well as

newborn iron parameters were similar between treatment groups.

Ferritin monitoring after replacement therapy

There is limited data from study VIT-IV-CL-008 which demonstrates that ferritin levels decrease rapidly 2-

4 weeks following replacement and more slowly thereafter. The mean ferritin levels did not drop to levels

where retreatment might be considered during the 12 weeks of study follow up. Thus, the available data

does not clearly indicate an optimal time for ferritin retesting although assessing ferritin levels earlier than

4 weeks after replacement therapy appears premature. Thus, it is recommended that further re-

assessment of ferritin should be made by the clinician based on the individual patient's condition.

5.2

Pharmacokinetic properties

Positron emission tomography demonstrated that

Fe and

Fe from Ferinject was rapidly

eliminated from the blood, transferred to the bone marrow, and deposited in the liver and spleen.

After administration of a single dose of Ferinject of 100 to 1,000 mg of iron in ID subjects,

maximum total serum iron levels of 37 µg/mL up to 333 µg/mL are obtained after 15 minutes to

1.21 hours respectively. The volume of the central compartment corresponds well to the volume

of the plasma (approximately 3 litres).

The iron injected or infused was rapidly cleared from the plasma, the terminal half-life ranged

from 7 to 12 hours, the mean residence time (MRT) from 11 to 18 hours. Renal elimination of

iron was negligible.

5.3

Preclinical safety data

Preclinical data revealed no special hazard for humans based on conventional studies of safety

pharmacology, repeat dose toxicity and genotoxicity. Preclinical studies indicate that iron

released from Ferinject does cross the placental barrier and is excreted in milk in limited,

controlled amounts. In reproductive toxicology studies using iron replete rabbits Ferinject was

associated with minor skeletal abnormalities in the fetus. In a fertility study in rats, there were no

effects on fertility for either male or female animals. No long-term studies in animals have been

performed to evaluate the carcinogenic potential of Ferinject. No evidence of allergic or

immunotoxic potential has been observed. A controlled in-vivo test demonstrated no cross-

reactivity of Ferinject with anti-dextran antibodies. No local irritation or intolerance was observed

after intravenous administration.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Water for injections

6.2

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned

in section 6.6.

The compatibility with containers other than polyethylene and glass is not known.

6.3

Shelf-life

The expiry date of the product is indicated on the packaging materials.

Shelf-life after first opening of the container:

From a microbiological point of view, preparations for parenteral administration should be used

immediately.

Shelf-life after dilution with sterile 0.9%

m/V

sodium chloride solution:

From a microbiological point of view, preparations for parenteral administration should be used

immediately after dilution with sterile 0.9% m/V sodium chloride solution.

6.4

Special precautions for storage

Store in the original package in order to protect from light. Do not store above 30 °C. Do not

freeze.

6.5

Nature and contents of container

Ferinject is supplied in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium

cap as:

10 mL solution containing 500 mg iron. Avilable in pack sizes of 1 vial and 5 vials.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

Inspect vials visually for sediment and damage before use. Use only those containing sediment-

free, homogeneous solution.

Each vial of Ferinject is intended for single use only. Any unused product or waste material

should be disposed of in accordance with local requirements.

Ferinject must only be mixed with sterile 0.9% m/V sodium chloride solution. No other

intravenous dilution solutions and therapeutic agents should be used, as there is the potential for

precipitation and/or interaction. For dilution instructions, see section 4.2.

7.

MANUFACTURER

Vifor (International) Inc.

Rechenstrasse 37, St. Gallen, 9014,

Switzerland

8. LICENCE HOLDER AND IMPORTER

CTS Ltd.

4 Haharash st

Hod Hasharon 4524075

Israel

The content of this leaflet was approved by the Ministry of Health in May 2017 and updated according to

the guidelines of the Ministry of Health in December 2019.

ראוני

2020

,ה/אפור ,ה/דבכנ ת/חקור

:ןודנה ןוכדע

ןולע

ל

רישכתה לש אפור

solution for injection/infusion

Ferinject

שקבנ

כנכדע ולעה יכ ם

אפורל דוע ןודנבש רישכתה לש ןכ

:תרשואמ היוותה

Ferinject is indicated for treatment of iron deficiency when oral iron preparations are

ineffective or cannot be used.

The diagnosis of iron deficiency must be based on laboratory tests.

קזוחו בכרה

ליעפ רמוח

One mL of solution contains 50 mg of iron as 180 mg ferric carboxymaltose.

Each 10 mL vial contains 500 mg of iron as 1800 mg ferric carboxymaltose.

.תורמחה ללוכ ןוכדעה

םיגצומ ןלהלש טוריפב

םייוניש

דבלב םייתוהמ

תפסות טסקט

ןוכדע וא יתועמשמ )הרמחה( ונמוס טסקט תקיחמ .עבצב

יתועמשמ הנמוס .הצוח וקב

4.6

Fertility, pregnancy and lactation

Pregnancy

There are limited data from the use of Ferinject in pregnant women (see section 5.1). A careful benefit/risk

evaluation is required before use during pregnancy and Ferinject should not be used during pregnancy unless

clearly necessary.

Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with oral iron.

Treatment with Ferinject should be confined to the second and third trimester if the benefit is judged to outweigh

the potential risk for both the mother and the foetus.

al bradycardia may occur following administration of parenteral irons. It is usually transient and a

Foet

consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during

ns to pregnant women.

intravenous administration of parenteral iro

Animal data suggest that iron released from Ferinject can cross the placental barrier and that its use during

pregnancy may influence skeletal development in the fetus (see section 5.3).

ולעה

כדועמה

חלשנ

ב םוסרפל תואירבה דרשמ רתאבש תופורתה רגאמ

http://www.health.gov.il

,ןכ ומכ ןתינ םלבקל

ספדומ םי

חר ,מ"עב טצכ תרבחל הינפ ידי לע

שרחה

,ןורשה דוה

1-700-500-220

,הכרבב

ןודנול םתור

חקור

הנוממ

מ"עב טצכ

Similar products

Search alerts related to this product

View documents history

Share this information