For the use of Registered Medical Practitioner of Hospital or a Laboratory only
Ferric Carboxymaltose Solution for Injection 50mg/ml
COMPOSITION
Each ml contains:
Ferric Carboxymaltose
Eq. to Elemental Iron 50mg
Water for Injection USP q.s.
CLINICAL PHARMACOLOGY
Pharmacodynamic properties
Pharmacotherapeutic group: Iron trivalent, parenteral preparation
ATC code: B03AC
Mechanism of action
Ferric Carboxymaltose Solution for Injection 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 59Fe from radio-labelled Ferric Carboxymaltose Solution for Injection 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.
Ferric Carboxymaltose Solution for Injection treatment results in an increase in reticulocyte count, serum ferritin levels and TSAT levels to within normal ranges.
Clinical efficacy and safety
The efficacy and safety of Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection (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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection (500 mg iron) or placebo if serum ferritin was <100 ng/mL or 100–300 ng/mL with TSAT <20%. The treatment benefit of Ferric Carboxymaltose Solution for Injection vs. placebo was demonstrated with the primary efficacy endpoint, the change in the 6-minute walk test (6MWT) from baseline to Week 24 (33 ±11 metres, p=0.002). This effect was sustained throughout the study to Week 52 (36 ±11 metres, p<0.001).
Study EFFECT-HF was an open-label (with blinded endpoint evaluation), randomised, 2-arm study comparing Ferric Carboxymaltose Solution for Injection (n=86) vs. standard of care (n=86) in subjects with chronic heart failure and ID for a treatment period of 24 weeks. At Day 1 and Week 6 (correction phase), subjects received either Ferric Carboxymaltose Solution for Injection according to a simplified dosing grid using baseline Hb and body weight at screening (see section 4.2) or standard of care. At Week 12, (maintenance phase) subjects received Ferric Carboxymaltose Solution for Injection (500 mg iron) or standard of care if serum ferritin <100 ng/mL or 100 to 300 ng/mL and TSAT <20%. The treatment benefit of Ferric Carboxymaltose Solution for Injection vs. standard of care was demonstrated with the primary efficacy endpoint, the change in weight-adjusted peak VO2 from baseline to Week 24 (LS Mean 1.04 ±0.44, p=0.02).
Nephrology
Haemodialysis-dependent chronic kidney disease
Study VIT-IV-CL-015 was an open-label, randomised parallel group study comparing Ferric Carboxymaltose Solution for Injection (n=97) to iron sucrose (n=86) in subjects with ID anaemia undergoing haemodialysis. Subjects received Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection: 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 Ferric Carboxymaltose Solution for Injection (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 Ferric Carboxymaltose Solution for Injection (n=147) vs. oral iron (n=103). Subjects in the Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection vs. oral ferrous sulphate in reducing ID anaemia in subjects with inflammatory bowel disease (IBD). Subjects received either Ferric Carboxymaltose Solution for Injection (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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection vs. iron sucrose in subjects with remitting or mild IBD. Subjects receiving Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection (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 Ferric Carboxymaltose Solution for Injection-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 Ferric Carboxymaltose Solution for Injection (n=227) vs. ferrous sulphate (n=117) in women suffering from post-partum anaemia. Subjects received either Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection (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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection treated women and those treated with oral iron (11.4% Ferric Carboxymaltose Solution for Injection 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.
Pharmacokinetic properties
Distribution
Positron emission tomography demonstrated that 59Fe and 52Fe from Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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).
Elimination
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.
INDICATION AND USAGE
Ferric Carboxymaltose Solution for Injection is indicated for the treatment of iron deficiency when (see section 5.1):
– oral iron preparations are ineffective.
– oral iron preparations cannot be used.
– there is a clinical need to deliver iron rapidly.
The diagnosis of iron deficiency must be based on laboratory tests.
CONTRA-INDICATION
The use of Ferric Carboxymaltose Solution for Injection is contraindicated in cases of:
• hypersensitivity to the active substance, to Ferric Carboxymaltose Solution for Injection or any of its excipients listed.
• 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.
DRUG INTERACTIONS
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 administration of Ferric Carboxymaltose Solution for Injection.
WARNINGS AND PRECAUTIONS
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. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8).
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).
Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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.
Hypophosphataemic osteomalacia
Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention including surgery has been reported in the post marketing setting. Patients should be asked to seek medical advice if they experience worsening fatigue with myalgias or bone pain.Serum phosphate should be monitored in patients who receive multiple administrations at higher doses or long-term treatment, and those with existing risk factors for hypophosphataemia. In case of persisting hypophosphataemia, treatment with ferric carboxymaltose should be re-evaluated.
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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection. Paravenous leakage of Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection must be stopped immediately.
Excipients
Ferric Carboxymaltose Solution for Injection contains up to 5.5 mg (0.24 mmol) sodium per mL of undiluted solution, equivalent to 0.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Paediatric population
The use of Ferric Carboxymaltose Solution for Injection has not been studied in children.
SIDE EFFECTS
Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which >8,000 subjects received Ferric Carboxymaltose Solution for Injection, 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, hypophosphataemia, headache, flushing, dizziness and hypertension. Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare.
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) |
Frequency not known(1) |
|
Immune system disorders |
Hypersensitivity |
Anaphylactoid/anaphylactic reactions |
||
|
Metabolism and nutritional disorders |
Hypophosphataemia |
|||
|
Nervous system disorders |
Headache, dizziness |
Paraesthesia, dysgeusia |
Loss of consciousness(1) |
|
|
Psychiatric disorders |
Anxiety(2) |
|||
|
Cardiac disorders |
Tachycardia |
Kounis syndrome(1) |
||
|
Vascular disorders |
Flushing, hypertension |
Hypotension |
Phlebitis, syncope(2), presyncope(2) |
|
|
Respiratory, thoracic and mediastinal disorders |
Dyspnoea |
Bronchospasm(2) |
||
|
Gastrointestinal disorders |
Nausea |
Vomiting, dyspepsia, abdominal pain, constipation, diarrhoea |
Flatulence |
|
|
Skin and subcutaneous tissue disorders |
Pruritus, urticaria, erythema, rash(3) |
Angioedema(2), pallor(2), distant skin discolouration(2) |
Face oedema(1) |
|
|
Musculoskeletal and connective tissue disorders |
Myalgia, back pain, arthralgia, pain in extremity, muscle spasms |
Hypophosphataemic osteomalacia(1) |
||
|
General disorders and administration site conditions |
Injection/infusion site reactions(4) |
Pyrexia, fatigue, chest pain, oedema peripheral, chills |
Malaise, influenza like illness (whose onset may vary from a few hours to several days) (2) |
|
|
Investigations |
Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased |
1 ADRs exclusively reported in the post-marketing setting; estimated as rare.
2 ADRs reported in the post-marketing setting which are also observed in the clinical setting.
3 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).
4 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.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Ferric Carboxymaltose Solution for Injection is unlikely to impair the ability to drive and use machines.
OVERDOSE
Administration of Ferric Carboxymaltose Solution for Injection 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.
DOSAGE & MODE OF ADMINISTRATION
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferric Carboxymaltose Solution for Injection.
Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection administration (see section 4.4).
Posology
The posology of Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection should be administered taking into consideration the following:
A single Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection)
The maximum recommended cumulative dose of Ferric Carboxymaltose Solution for Injection is 1,000 mg of iron (20 mL Ferric Carboxymaltose Solution for Injection) 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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection has not been studied in children, and therefore is not recommended in children under 14 years.
Method of administration
Ferric Carboxymaltose Solution for Injection 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.
Ferric Carboxymaltose Solution for Injection must not be administered by the subcutaneous or intramuscular route.
Intravenous injection
Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection
|
Volume of Ferric Carboxymaltose Solution for Injection 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
Ferric Carboxymaltose Solution for Injection 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, Ferric Carboxymaltose Solution for Injection must only be diluted in sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Ferric Carboxymaltose Solution for Injection should not be diluted to concentrations less than 2 mg iron/mL (not including the volume of the ferric carboxymaltose solution). For further instructions on dilution of the medicinal product before administration, see section 6.6.
Table 3: Dilution plan of Ferric Carboxymaltose Solution for Injection for intravenous infusion
|
Volume of Ferric Carboxymaltose Solution for Injection required |
Equivalent iron dose |
Maximum amount of sterile 0.9% m/V sodium chloride solution |
Minimum administration time |
||||
|
2 |
to |
4 mL |
100 |
to |
200 mg |
50 mL |
No minimal prescribed time |
|
>4 |
to |
10 mL |
>200 |
to |
500 mg |
100 mL |
6 minutes |
|
>10 |
to |
20 mL |
>500 |
to |
1,000 mg |
250 mL |
15 minutes |
PREGNANCY AND LACTATION
Pregnancy
There are limited data from the use of Ferric Carboxymaltose Solution for Injection in pregnant women (see section 5.1). A careful benefit/risk evaluation is required before use during pregnancy and Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection 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 Ferric Carboxymaltose Solution for Injection to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that Ferric Carboxymaltose Solution for Injection represents a risk to the breast-fed child.
Fertility
There are no data on the effect of Ferric Carboxymaltose Solution for Injection on human fertility. Fertility was unaffected following Ferric Carboxymaltose Solution for Injection treatment in animal studies (see section 5.3).
STORAGE CONDITION
Protect from light. Do not store above 30 °C.
Do not freeze.
KEEP OUT OF REACH OF CHILDREN
PRESENTATION
5ml Vial & 5ml Vial packed in cardboard carton along with pack insert.
MANUFACTURED IN INDIA
INDUS PHARMA PRIVATE LIMITED
A 181, RIICO Ghiloth, Alwar, Rajasthan 301705
A WHO GMP Certified Company