Iron Sucrose Solution for Injection 20mg iron/ml, USP in Prefilled Syringe Taj Pharma

  1. Name of the medicinal product

Iron Sucrose Solution for Injection 20mg iron/ml, USP in Prefilled Syringe Taj Pharma

  1. Qualitative and quantitative composition

One millilitre of solution contains 20 mg of iron as iron sucrose (iron(III)-hydroxide sucrose complex).

Each 5 ml prefilled syringe of Iron Sucrose Injection contains 100 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex).

Each 2.5 ml prefilled syringe of Iron Sucrose Injection contains 50 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex).

Each 5 ml prefilled syringe of Iron Sucrose Injection contains 100 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex).

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Solution for injection or concentrate for solution for infusion in a prefilled syringe.

Iron Sucrose Injection is a dark brown, non transparent, aqueous solution.

  1. Clinical particulars

4.1 Therapeutic indications

Iron Sucrose Injection 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 Iron Sucrose Injection.

Iron Sucrose 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 Iron Sucrose Injection administration (see section 4.4).

Posology

The cumulative dose of Iron Sucrose Injection must be calculated for each patient individually and must not be exceeded.

Calculation of dosage

The total cumulative dose of Iron Sucrose Injection, equivalent to the total iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW). The dose of Iron Sucrose Injection must be individually calculated for each patient according to the total iron deficit calculated with the following Ganzoni formula, for example:

Total iron deficit [mg] = BW [kg] x (target Hb – actual Hb) [g/dl] x 2.4* + storage iron [mg]

• Below 35 kg BW:

• 35 kg BW and above:

Target Hb = 13 g/dl and storage iron = 15 mg/kg BW

Target Hb = 15 g/dl and storage iron = 500 mg

* Factor 2.4 = 0.0034 (iron content of Hb = 0.34%) x 0.07 (blood volume = 7% of BW) x 1000 (conversion of [g] to [mg]) x 10

Total amount of Iron Sucrose Injection (ml) to be administered according to body weight, actual Hb level and target Hb level*:

BW Total amount of Iron Sucrose Injection (20 mg iron per ml) to be administered
Hb 6.0 g/dl Hb 7.5 g/dl Hb 9.0 g/dl Hb 10.5 g/dl
30 kg 47.5 ml 42.5 ml 37.5 ml 32.5 ml
35 kg 62.5 ml 57.5 ml 50 ml 45 ml
40 kg 67.5 ml 60 ml 55 ml 47.5 ml
45 kg 75 ml 65 ml 57.5 ml 50 ml
50 kg 80 ml 70 ml 60 ml 52.5 ml
55 kg 85 ml 75 ml 65 ml 55 ml
60 kg 90 ml 80 ml 67.5 ml 57.5 ml
65 kg 95 ml 82.5 ml 72.5 ml 60 ml
70 kg 100 ml 87.5 ml 75 ml 62.5 ml
75 kg 105 ml 92.5 ml 80 ml 65 ml
80 kg 112.5 ml 97.5 ml 82.5 ml 67.5 ml
85 kg 117.5 ml 102.5 ml 85 ml 70 ml
90 kg 122.5 ml 107.5 ml 90 ml 72.5 ml
* Below 35 kg BW: Target Hb = 13 g/dl
35 kg BW and above: Target Hb = 15 g/dl

To convert Hb (mM) to Hb (g/dl), multiply the former by 1.6.

If the total necessary dose exceeds the maximum allowed single dose, then the administration must be divided.

Posology

Adults

5 – 10 ml of Iron Sucrose Injection (100 – 200 mg iron) 1 to 3 times a week. For administration time and dilution ratio see “Method of administration”.

Paediatric population

The use of Iron Sucrose Injection has not been adequately studied in children and, therefore, Iron Sucrose Injection is not recommended for use in children.

Method of administration

Iron Sucrose Injection must only be administered by the intravenous route. This may be by a slow intravenous injection, by an intravenous drip infusion or directly into the venous line of the dialysis machine.

Intravenous drip infusion

Iron Sucrose Injection must only be diluted in sterile 0.9% m/V sodium chloride (NaCl) solution. Dilution must take place immediately prior to infusion and the solution should be administered as follows:

Iron Sucrose Injection dose

(mg of iron)

Iron Sucrose Injection dose

(ml of Iron Sucrose Injection)

Maximum dilution volume of sterile 0.9% m/V NaCl solution Minimum Infusion Time
50 mg 2.5 ml 50 ml 8 minutes
100 mg 5 ml 100 ml 15 minutes
200 mg 10 ml 200 ml 30 minutes

For stability reasons, dilutions to lower Iron Sucrose Injection concentrations are not permissible.

Intravenous injection

Iron Sucrose Injection may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml Iron Sucrose Injection (200 mg iron) per injection.

Injection into venous line of dialysis machine

Iron Sucrose Injection may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.

4.3 Contraindications

The use of Iron Sucrose Injection is contraindicated in the following conditions:

  • Hypersensitivity to the active substance, to Iron Sucrose Injection or any of its excipients listed in section 6.1
  • Known serious hypersensitivity to other parenteral iron products
  • Anaemia not caused by iron deficiency
  • Evidence of iron overload or hereditary disturbances in utilisation of iron.

4.4 Special warnings and precautions for use

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 including iron sucrose. 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). In several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, Iron Sucrose Injection was shown to be well tolerated. For known serious hypersensitivity to other parenteral iron product see section 4.3.

The risk of hypersensitivity reactions 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).

Iron Sucrose 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. Each patient should be observed for adverse effects for at least 30 minutes following each Iron Sucrose Injection injection. 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.

In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit 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.

Parenteral iron should be used with caution in the case of acute or chronic infection. It is recommended that the administration of Iron Sucrose Injection is stopped in patients with bacteraemia. In patients with chronic infection, a risk/benefit evaluation should be performed.

Paravenous leakage must be avoided because leakage of Iron Sucrose Injection at the injection site can lead to pain, inflammation and brown discoloration of the skin.

4.5 Interaction with other medicinal products and other forms of interaction

As with all parenteral iron preparations, Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should be started at least 5 days after the last injection of Iron Sucrose Injection.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no data from the use of iron sucrose in pregnant women in the first trimester. Data (303 pregnancy outcomes) from the use of Iron Sucrose Injection in pregnant women in the second and third trimester showed no safety concerns for the mother or newborn.

A careful risk/benefit evaluation is required before use during pregnancy and Iron Sucrose Injection should not be used during pregnancy unless clearly necessary (see section 4.4).

Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with Iron Sucrose Injection should be confined to 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 studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Breast-feeding

There is limited information on the excretion of iron in human milk following administration of intravenous iron sucrose. In one clinical study, 10 healthy breast-feeding mothers with iron deficiency received 100 mg iron in the form of iron sucrose. Four days after treatment, the iron content of the breast milk had not increased and there was no difference from the control group (n=5). It cannot be excluded that newborns/infants may be exposed to iron derived from Iron Sucrose Injection via the mother’s milk, therefore the risk/benefit should be assessed.

Preclinical data do not indicate direct or indirect harmful effects to the nursing child. In lactating rats treated with 59Fe-labelled iron sucrose, low secretion of iron into the milk and transfer of iron into the offspring was observed. Non metabolised iron sucrose is unlikely to pass into the mother’s milk.

Fertility

No effects of iron sucrose treatment were observed on fertility and mating performance in rats.

4.7 Effects on ability to drive and use machines

In the case of symptoms of dizziness, confusion or light headedness following the administration of Iron Sucrose Injection, patients should not drive or use machinery until the symptoms have ceased.

4.8 Undesirable effects

The most commonly reported adverse drug reaction in clinical trials with Iron Sucrose Injection was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions associated with Iron Sucrose Injection are hypersensitivity reactions, which occurred with a rate of 0.25 events per 100 subjects in clinical trials. Anaphylactoid/anaphylactic reactions were reported only in the post-marketing setting (estimated as rare); fatalities have been reported. See section 4.4.

The adverse drug reactions reported after the administration of Iron Sucrose Injection in 4,064 subjects in clinical trials as well as those reported from the post-marketing setting are presented in the table below.

System Organ Class Common (≥1/100, <1/10) Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000) Frequency not known1)
Immune system disorders Hypersensitivity Anaphylactoid/anaphylactic reactions, angioedema
Nervous system disorders Dysgeusia Headache, dizziness, paraesthesia, hypoaesthesia Syncope, somnolence Depressed level of consciousness, confusional state, loss of consciousness, anxiety, tremor
Cardiac disorders Palpitations Bradycardia, tachycardia, Kounis syndrome
Vascular disorders Hypotension, hypertension Flushing, phlebitis Circulatory collapse, thrombophlebitis
Respiratory, thoracic and mediastinal disorders Dyspnoea Bronchospasm
Renal and urinary disorders Chromaturia
Gastrointestinal disorders Nausea Vomiting, abdominal pain, diarrhoea, constipation
Skin and subcutaneous tissue disorders Pruritus, rash Urticaria, erythema
Musculoskeletal and connective tissue disorders Muscle spasm, myalgia, arthralgia, pain in extremity, back pain
General disorders and administration site conditions Injection/infusion site reaction2) Chills, asthenia, fatigue, oedema peripheral, pain Chest pain, hyperdrosis, pyrexia Cold sweat, malaise, pallor, influenza like illness3)
Investigations Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, serum ferritin increased Blood lactate dehydrogenase increased

1) Spontaneous reports from the post-marketing setting; estimated as rare

2)The most frequently reported are: injection/infusion site pain, -extravasation, -irritation, -reaction, -discolouration, -haematoma, -pruritus.

3) Onset may vary from a few hours to several days.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdose can cause iron overload which may manifest itself as haemosiderosis. Overdose should be treated, as deemed necessary by the treating physician, with an iron chelating agent or according to standard medical practice.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anti-anaemic preparation, iron, parenteral preparation, ATC code: B03AC

Mechanism of action

Iron sucrose, the active ingredient of Iron Sucrose Injection, is composed of a polynuclear iron(III)-hydroxide core surrounded by a large number of non-covalently bound sucrose molecules. The complex has a weight average molecular weight (Mw) of approximately 43 kDa. The polynuclear iron core has a structure similar to that of the core of the physiological iron storage protein ferritin. The complex is designed to provide, in a controlled manner, utilisable iron for the iron transport and storage proteins in the body (i.e., transferrin and ferritin, respectively).

Following intravenous administration, the polynuclear iron core from the complex is taken up predominantly by the reticuloendothelial system in the liver, spleen, and bone marrow. In a second step, the iron is used for the synthesis of Hb, myoglobin and other iron-containing enzymes, or stored primarily in the liver in the form of ferritin.

Clinical efficacy and safety

Chronic kidney disease

Study LU98001 was a single arm study to investigate the efficacy and safety of 100 mg iron as Iron Sucrose Injection for up to 10 sessions over 3-4 weeks in haemodialysis patients with iron deficiency anaemia (Hb >8 and <11.0 g/dl, TSAT <20%, and serum ferritin ≤300 μg/l) who were receiving rHuEPO therapy. A Hb ≥11 g/dl was attained in 60/77 patients. The mean increase in serum ferritin and TSAT was significant from baseline to the end of treatment (Day 24) as well as to the 2 and 5 weeks follow-up visit.

Study 1VEN03027 was a randomised study comparing Iron Sucrose Injection (1000 mg in divided doses over 14 days) and oral ferrous sulphate (325 mg 3 times daily for 56 days) in non-dialysis dependent chronic kidney disease patients (Hb ≤11.0 g/dl, serum ferritin ≤300 μg/l, and TSAT ≤25%) with or without rHuEPO. A clinical response (defined as Hb increase ≥1.0 g/dl and serum ferritin increase ≥160 μg/l) was more frequently observed in patients treated with Iron Sucrose Injection (31/79; 39.2%) compared to oral iron (1/82; 1.2%); p<0.0001.

Inflammatory Bowel Disease

A randomised, controlled study compared Iron Sucrose Injection (single IV dose of 200 mg iron once per week or every second week until the cumulative dose was reached) with oral iron (200 mg twice daily for 20 weeks) in patients with inflammatory bowel disease and anaemia (Hb <11.5 g/dl). At the end of treatment, 66% of patients in the Iron Sucrose Injection group had an increase in Hb ≥2.0 g/dl compared to 47% in the oral iron group (p=0.07).

Postpartum

A randomised, controlled trial in women with postpartum iron deficiency anaemia (Hb <9 g/dl and serum ferritin <15 μg/l at 24–48 hours post-delivery) compared 2 × 200 mg iron given as Iron Sucrose Injection on Days 2 and 4 (n=22) and 200 mg of oral iron given as ferrous sulphate twice daily for 6 weeks (n=21). The mean increase in Hb from baseline to Day 5 was 2.5 g/dl in the Iron Sucrose Injection group and 0.7 g/dl in the oral iron group (p<0.01).

Pregnancy

In a randomised, controlled study, women in their third trimester of pregnancy with iron deficiency anaemia (Hb 8 to 10.5 g/dl and serum ferritin <13 µg/l) were randomised to Iron Sucrose Injection (individually calculated total dose of iron administered over 5 days) or oral iron polymaltose complex (100 mg 3× daily until delivery). The increase in Hb from baseline was significantly greater in the Iron Sucrose Injection group compared to the oral iron group at Day 28 and at delivery (p<0.01).

5.2 Pharmacokinetic properties

Distribution

The ferrokinetics of iron sucrose labelled with 52Fe and 59Fe were assessed in 6 patients with anaemia and chronic renal failure. In the first 6–8 hours, 52Fe was taken up by the liver, spleen and bone marrow. The radioactive uptake by the macrophage-rich spleen is considered to be representative of the reticuloendothelial iron uptake.

Following intravenous injection of a single 100 mg iron dose of iron sucrose in healthy volunteers, maximum total serum iron concentrations were attained 10 minutes after injection and had an average concentration of 538 µmol/l. The volume of distribution of the central compartment corresponded well to the volume of plasma (approximately 3 litres).

Biotransformation

Upon injection, sucrose largely dissociates and the polynuclear iron core is mainly taken up by the reticuloendothelial system of the liver, spleen, and bone marrow. At 4 weeks after administration, red cell iron utilization ranged from 59 to 97%.

Elimination

The iron sucrose complex has a weight average molecular weight (Mw) of approximately 43 kDa, which is sufficiently large to prevent renal elimination. Renal elimination of iron, occurring in the first 4 hours after injection of a Iron Sucrose Injection dose of 100 mg iron, corresponded to less than 5% of the dose. After 24 hours, the total serum iron concentration was reduced to the pre-dose level. Renal elimination of sucrose was about 75% of the administered dose.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity and toxicity to reproduction and development.

  1. Pharmaceutical particulars

6.1 List of excipients

Water for injections

Sodium hydroxide (for pH adjustment)

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. There is the potential for precipitation and/or interaction if mixed with other solutions or medicinal products. The compatibility with containers other than glass, polyethylene and PVC is not known.

6.3 Shelf life

Shelf life of the product as packaged for sale

3 years.

Shelf life after first opening of the container

From a microbiological point of view, the product should be used immediately.

Shelf life after dilution with sterile 0.9% m/V sodium chloride (NaCl) solution

From a microbiological point of view, the product should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution.

6.4 Special precautions for storage

Do not store above 25°C. Do not freeze. Store in the original package.

For storage conditions after dilution or first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

5 ml solution in one ampoule (type I glass) in pack sizes of 5.

2.5 ml solution in one vial (type I glass) in pack sizes of 5.

5 ml solution in one vial (type I glass) in pack sizes of 5.

Not all pack-sizes may be marketed.

6.6 Special precautions for disposal and other handling

Pre-filled Syringes or Pre-filled Syringes should be visually inspected for sediment and damage before use. Use only those containing a sediment-free and homogenous solution.

Iron Sucrose Injection must not be mixed with other medicinal products except sterile 0.9% m/V sodium chloride solution for dilution. For instructions on dilution of the product before administration, see section 4.2.

The diluted solution must appear as brown and clear.

Each prefilled syringe of Iron Sucrose Injection is intended for single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

Iron Sucrose Solution for Injection 20mg iron/ml, USP in Prefilled Syringe Taj Pharma

Read all of this leaflet carefully before you are given this medicine because it contains

important information for you.

 Keep this leaflet. You may need to read it again.

 If you have any further questions, ask your doctor.

 If you get any side effects, talk to your doctor. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

  1. What Iron sucrose injection is and what it is used for
  2. What you need to know before Iron sucrose injection is given to you
  3. How Iron sucrose injection is given
  4. Possible side effects
  5. How to store Iron sucrose injection
  6. Contents of the pack and other information
  7. What Iron sucrose injection is and what it is used for

Iron sucrose injection is a medicine that contains iron.

Medicines that contain iron are used when you do not have enough iron in your body. This is

called “iron deficiency”.

Iron sucrose injection is given when:

 You cannot take iron by mouth – such as when iron tablets make you feel ill.

 You have taken iron by mouth – and it has not worked.

  1. What you need to know before Iron sucrose injection is given to you

You must not receive Iron sucrose injection if:

 You are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).

 You have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations.

 You have anaemia which is not caused by a shortage of iron.

 You have too much iron in your body or a problem in the way your body uses iron.

You must not be given Iron sucrose injection if any of the above apply to you. If you are not sure, talk to your doctor before having Iron sucrose injection.

Warnings and precautions

Talk to your doctor or nurse before receiving Iron sucrose injection if:

 You have a history of medicine allergy.

 You have systemic lupus erythematosus.

 You have rheumatoid arthritis.

 You have severe asthma, eczema or other allergies.

 You have any infections.

 You have liver problems.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before you are given Iron sucrose injection.

Other medicines and Iron sucrose injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

This is because Iron sucrose injection can affect the way some other medicines work. Also some other medicines can affect the way Iron sucrose injection works.

In particular tell your doctor or pharmacist if you are taking:

 Medicines that contain iron which you take by mouth. These may not work if they are taken at the same time that Iron sucrose injection is given to you.

Pregnancy and breast-feeding

Iron sucrose injection has not been tested in women who are in the first three months of their pregnancy. It is

important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.

If you become pregnant during treatment, you must ask your doctor for advice.

Your doctor will decide whether or not you should be given this medicine.

If you are breast-feeding, ask your doctor for advice before you are given Iron sucrose injection.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines

You may feel dizzy, confused or light-headed after being given Iron sucrose injection. If this happens, do not

drive or use any tool or machines. Ask your doctor if you are not sure.

  1. How Iron sucrose injection is given

Your doctor will decide how much Iron sucrose injection to give you. He or she will also decide how often you need it and for how long. Your doctor will do a blood test to help work out the dose.

Your doctor or nurse will administer Iron sucrose injection in one of the following ways:

 Slow injection into your vein – 1 to 3 times per week.

 As an infusion (drip) into your vein – 1 to 3 times per week.

 During dialysis – it will be put into the venous line of the dialysis machine.

Iron sucrose injection will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.

You will be observed for at least 30 minutes by your doctor or nurse after each administration.

Iron sucrose injection is a brown liquid and so the injection or infusion will look brown.

Use in children

Iron sucrose injection is not recommended for use in children.

  1. Possible side effects
    Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions (uncommon)

If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include:

 Low blood pressure (feeling dizzy, light-headed or faint).

 Swelling of your face.

 Difficulty breathing.

 Chest pain which can be a sign of a potentially serious allergic reaction called Kounis

syndrome.

In some patients these allergic reactions (rare) may become severe or life-threatening (known as

anaphylactoid/anaphylactic reactions).

Tell your doctor or nurse straight away if you think you are having an allergic reaction.

Other side effects include:

Common (may affect up to 1 in 10 people)

 Changes in your taste such as a metallic taste. This does not usually last very long.

 Low blood pressure or high blood pressure.

 Feeling sick (nausea).

 Reactions around the site of injection/ infusion such as pain, irritation, itching, haematoma or

discolouration following the leakage of the injection into the skin.

Uncommon (may affect up to 1 in 100 people)

 Headache or feeling dizzy.

 Stomach pain or diarrhoea.

 Being sick (vomiting).

 Wheezing, difficulty in breathing.

 Itching, rash.

 Muscle spasms, cramps or pain.

 Tingling or “pins and needles”.

 Reduced sensation of touch.

 Vein inflammation.

 Flushing burning sensation.

 Constipation.

 Joint pain.

 Pain in limbs.

 Back pain.

 Chills.

 Weakness, tiredness.

 Swelling of hands and feet.

Pain.

 Increased levels of liver enzymes (ALT, AST, GGT) in the blood.

 Increased serum ferritin levels.

Rare (may affect up to 1 in 1,000 people)

 Fainting.

 Sleepiness or drowsiness.

 Pounding heart beat (palpitations).

 Changes to the colour of your urine.

 Chest pain.

 Increased sweating.

 Fever.

 Increased lactate dehydrogenase in the blood.

Other side effects with unknown frequency include: feeling less alert, feeling confused; loss of consciousness; anxiety; trembling or shaking; swelling of your face, mouth, tongue or throat which may cause difficulty in breathing; low pulse rate; fast pulse rate; circulatory collapse; vein inflammation causing the formation of a blood clot; acute narrowing of the airways; itching, hives, rash or skin redness; cold sweat; general feeling of illness; pale skin; sudden life-threatening allergic reactions. Flu-like illness may occur a few hours to several days after injection and is typically characterised by symptoms such as high temperature, and aches and pains in muscles and joints.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Iron sucrose injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP.

Do not store above 25oC. Do not freeze. Keep the Pre-filled Syringes or Pre-filled Syringes in the outer carton.

Once the Iron sucrose injection Pre-filled Syringes or Iron sucrose injection Pre-filled Syringes have been opened, they should be used immediately.

After dilution with sodium chloride solution, the diluted solution should be used immediately.

Iron sucrose injection will normally be stored for you by your doctor or the hospital.

  1. Contents of the pack and other information

What Iron sucrose injection contains

The active substance is iron (as iron sucrose). Each millilitre contains 20 mg iron.

 The other ingredients are water for injections and sodium hydroxide.

What Iron sucrose injection looks like and contents of the pack

Iron sucrose injection is a dark brown, non-transparent, aqueous solution.

Iron sucrose injection comes in following pack-sizes:

 5 Glass Pre-filled Syringes of 2 ml. Each ampoule of 5 ml corresponds to 40 mg of iron.

 5 Glass Pre-filled Syringes of 5 ml. Each vial of 5 ml corresponds to 100 mg of iron.

Not all pack-sizes may be marketed.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com