Brand Name: Cosmofer Ampoule.
Composition:
Each CosmoFer 50 mg/ml for injection and for infusion contains: iron dextran ....... 50 mg / ml
Therapeutic Indications:
- an iron replacement product is indicated for the treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have an intolerance to oral iron or unsatisfactory response to oral iron
Dosage and Administration:
- The normal recommended dosage schedule is 100200 mg iron corresponding to 24 ml, two or three times a week depending on the hemoglobin 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.
- The CosmoFer injection should not be administered concomitantly with oral iron preparations as the absorption of oral iron will be reduced (please refer to section 4.5).
- Intravenous drip infusion:
○ CosmoFer® must be diluted only in 0.9% sodium chloride solution (normal saline) or in 5% glucose solution.
○ CosmoFer® in a dose of 100200 mg iron (24ml) 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.
○ CosmoFer® may be administered in a dose of 100 – 200 mg iron (24
○ ml) by slow intravenous injection (0.2 ml/min) preferably diluted in 10 – 20 ml 0.9% 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.
○ 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 body weight, 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.
○ 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.
○ The total amount of CosmoFer® required is determined either from the dosage table or by calculation. It is administered as a series of undiluted injections of up to 100 mg iron (2.0 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 minimize 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 minimize leakage up the injection track, the patient should be encouraged not to rub the injection site.
Contraindications:
- Hypersensitivity to the active substance, to CosmoFer® or any of its excipients listed in section
- Known serious hypersensitivity to other parenteral iron products.
- Non Iron deficiency anemia (e.g. haemolytic anemia).
- Iron overload or disturbances in utilization of iron (e.g. haemochromatosis, hemosiderosis).
- Decompensated liver cirrhosis and hepatitis.
- Acute or chronic infection, because parenteral iron administration may exacerbate bacterial or viral infections.
- Acute renal failure.
Warnings and precautions:
- 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).
- 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 cardiorespiratory 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.
Undesirable Effects:
- 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.
Pharmacological Properties:
Cosmofer Ampoule contains a combination of iron and dextran (a long chain of sugar molecules).
The type of iron in CosmoFer is the same as that found naturally in the body called ‘ferritin’.
This means that you can have CosmoFer by injection in high doses.
Packaging:
Cosmofer Ampoule: Box containing 5 ampoules 2ml .
