COSMOFER

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of CosmoFer®. CosmoFer® 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.

4).

Administration:

CosmoFer® solution for infusion and injection can be administered by an intravenous drip infusion or by a slow intravenous injection of which the intravenous drip infusion is the preferred route of administration, as this may help to reduce the risk of hypotensive episodes.

However, CosmoFer® may also be administered as undiluted solution intramuscularly. Adults and elderly The total cumulative dose of CosmoFer® is determined by haemoglobin level and body weight. The dose and dosage schedule for CosmoFer® must be individually estimated for each patient based on a calculation of the total iron deficit.

Children (under 14 years) CosmoFer® should not be used for children. There is no documentation for efficacy and safety.

Dosage:

The normal recommended dosage schedule is 100-200 mg iron corresponding to 2-4 ml, two or three times a week depending on the haemoglobin level. However, if clinical circumstances require rapid delivery of iron to the body iron stores CosmoFer® may be administered as a total dose infusion up to a total replacement dose corresponding to 20 mg iron/kg body weight.

5). 9% sodium chloride solution (normal saline) or in 5% glucose solution. CosmoFer® in a dose of 100-200 mg iron (2-4ml) may be diluted in 100 ml. On each occasion the first 25 mg of iron should be infused over a period of 15 minutes.

If no adverse reactions occur during this time the remaining portion of the infusion should be given at an infusion rate of not more than 100 ml in 30 minutes. 9% sodium chloride or 5% glucose solution. On each occasion before administering a slow intravenous injection, 25 mg of iron should be injected slowly over a period of 1 to 2 minutes.

If no adverse reactions occur within 15 minutes, the remaining portion of the injection may be given.

Total dose infusion:

Immediately before administration the total amount of CosmoFer® required, determined from the dosage table or by calculation, is added aseptically to the required volume, usually 500 ml of sterile normal sodium chloride or 5% glucose solutions.

The total amount of CosmoFer®, up to 20 mg/kg bodyweight, is infused intravenously over 4 – 6 hours. The first 25 mg of iron should be infused over a period of 15 minutes. The patient must be kept under close medical observation during this period.

If no adverse reactions occur during this time, then the remaining portion of the infusion should be given. The rate of infusion may be increased progressively to 45 – 60 drops per minute. Patients should be observed carefully during the infusion and for at least 30 minutes after completion.

Total Dose Infusion (TDI) has been associated with an increased incidence of adverse reactions, in particular delayed hypersensitivity–like reactions. The intravenous administration of CosmoFer® by the total dose infusion method should be restricted to hospital use only.

Injection into dialyser:

CosmoFer® may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as outlined for intravenous administration.

Intramuscular injection:

The total amount of CosmoFer® required is determined either from the dosage table or by calculation. 0 ml) each determined by the patient's body weight. If the patient is moderately active, injections may be given daily into alternate buttocks.

In inactive or bedridden patients, the frequency of injections should be reduced to once or twice weekly. CosmoFer® must be given by deep intramuscular injection to minimise the risk of subcutaneous staining. It should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas.

A 20 - 21 gauge needle at least 50 mm long should be used for normal adults. For obese patients the length should be 80 - 100 mm whereas for small adults a shorter and smaller needle (23 gauge x 32 mm) is used. The patient should be lying in the lateral position with the injection site uppermost, or standing bearing their weight on the leg opposite the injection site.

To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. CosmoFer® is injected slowly and smoothly. It is important to wait for a few seconds before withdrawing the needle to allow the muscle mass to accommodate the injection volume.

To minimise leakage up the injection track, the patient should be encouraged not to rub the injection site.

Calculation of dose: a) Iron replacement in patients with iron deficiency anaemia:

Factors contributing to the formula are shown below. The required dose has to be individually adapted according to the total iron deficit calculated by the following formula – haemoglobin in g/l or mmol/l. 24 is derived from the following assumptions: a) Blood volume 70 ml/kg of body weight ≈ 7% of body weight b) Iron content of […]

Approximately 5% of patients can be expected to experience adverse reactions. These are mainly dose dependent. Anaphylactoid reactions are uncommon and include urticaria, rashes, itching, nausea and shivering. Administration must be stopped immediately when signs of an anaphylactoid reaction are observed.

Acute, severe anaphylactoid reactions are very rare. They usually occur within the first few minutes of administration and are generally characterised by the sudden onset of respiratory difficulty and / or cardiovascular collapse; fatalities have been reported.

Delayed reactions are well described and may be severe. They are characterised by arthralgia, myalgia and sometimes fever. The onset varies from several hours up to four days after administration. Symptoms usually last two to four days and settle spontaneously or following the use of simple analgesics.

Exacerbation of joint pain in rheumatoid arthritis can occur. Local reactions reported are soreness and inflammation at or near injection site and local phlebitic reaction. Local complications at the injection site after intramuscular injection such as staining of the skin, bleeding, formation of sterile abscesses, tissue necrosis or atrophy and pain are observed.

Organ System Uncommon (>1/1,000, <1/100) Rare (>1/10,000, <1/1,000) Very rare <1/10,000 Not known Blood and lymphatic system disorders Haemolysis Cardiac disorders Arrythmia, tachycardia Foetal bradycardia, palpitations Kounis syndrome Ear and labyrinth disorders Transient deafness Gastrointestinal disorders Nausea, emesis, abdominal pain Diarrhoea General disorders and administration Feeling hot Fatigue Influenza like illness whose site conditions Pain and brown pigmentation at injection site onset may vary from a few hours to several days Immune system disorders Anaphylactoid reactions including dyspnoea, urticaria, rashes, itching, nausea and shivering Acute, severe anaphylactoid reactions (sudden onset of respiratory difficulty and / or cardiovascular collapse) Musculoskeletal and connective tissue disorders Cramps Myalgias Nervous system disorders Blurred vision, numbness Loss of consciousness, seizure, dizziness, restlessness, tremor Headache, paresthesia Respiratory, thoracic and mediastinal disorders Dyspnea Chest pain Psychiatric disorders Mental status changes Skin and subcutaneous tissue disorders Flushing, pruritus, rash Angioedema, Sweating Vascular disorders Hypotension Hypertension 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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. g. systemic lupus erythematosus, rheumatoid arthritis). CosmoFer 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 CosmoFer 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.

The intramuscular and subcutaneous injection of iron-carbohydrate complexes in very large doses under experimental conditions in animals produced sarcoma in rats, mice, rabbits, possibly hamsters but not in guinea pigs. Cumulative information and independent assessment indicate that the risk of sarcoma formation in man is minimal.

Hypotensive episodes may occur if intravenous injection is administered too rapidly.

1. Known serious hypersensitivity to other parenteral iron products. g. haemolytic anaemia). g. haemochromatosis, haemosiderosis). Decompensated liver cirrhosis and hepatitis. Acute or chronic infection, because parenteral iron administration may exacerbate bacterial or viral infections.

Acute renal failure.