Cosmofer 50mg/ml for inf. 5 amps. 5706020020053

Cosmofer 50mg/ml for inf. 5 amps. 5706020020053

Description:

Cosmofer 50mg/ml for infusion is a prescription iron medicine used for the treatment of iron deficiency anemia when oral iron supplements are ineffective, not tolerated, or cannot be used. It contains iron in the form of iron(iii)-hydroxide dextran complex, administered by intravenous infusion under strict medical supervision. Each pack contains 5 ampoules designed for hospital or clinic use to rapidly replenish depleted iron stores, improve hemoglobin levels, and relieve symptoms of anemia such as fatigue, weakness, and shortness of breath.

Indications:

• Treatment of iron deficiency anemia when oral iron therapy is ineffective or cannot be used (e.g., due to intolerance, malabsorption, or poor adherence).
• Iron deficiency associated with chronic blood loss, heavy menstrual bleeding, gastrointestinal bleeding, or post-surgical blood loss, as assessed by a physician.
• Iron deficiency in patients with chronic kidney disease, especially those receiving erythropoiesis-stimulating agents, when parenteral iron is indicated.
• Iron deficiency in patients with inflammatory bowel disease or malabsorption syndromes where oral iron is poorly absorbed.
• Rapid replenishment of iron stores when a quick response is clinically required and oral therapy is not suitable.

Active Ingredients / Key Components:

• Iron (as iron(iii)-hydroxide dextran complex) – 50 mg iron per 1 ml solution for infusion.
• Each ampoule: the exact volume per ampoule and total iron content per ampoule are not specified in the available data and are therefore unavailable here. Refer to the official package insert for full quantitative composition.
• Excipients: Full list of inactive ingredients (e.g., water for injections and stabilizers) is not available in the provided information. Please consult the official leaflet for complete excipient details.

Dosage & Administration / How to Use:

• Cosmofer 50mg/ml is for intravenous use only and must be administered by a healthcare professional experienced in the use of intravenous iron preparations.
• The total iron dose and number of ampoules required are calculated individually based on body weight, hemoglobin level, and total iron deficit, according to standard medical dosing formulas.
• Administration is usually by slow intravenous infusion diluted in a suitable volume of sterile solution (e.g., 0.9% sodium chloride), following the instructions in the official prescribing information.
• A test dose is typically given prior to the first full therapeutic dose to monitor for hypersensitivity or anaphylactoid reactions, as per clinical guidelines.
• Infusion rate must be slow and carefully controlled; the maximum rate and total daily dose are determined by the physician based on the product’s official recommendations.
• Patients should be monitored during and for a period after the infusion for signs of allergic or adverse reactions (e.g., rash, difficulty breathing, hypotension).
• Do not self-administer. Do not use intramuscularly, subcutaneously, or orally. Use only as directed by a doctor.

Clinical Benefits:

• Rapidly replenishes depleted iron stores in patients with iron deficiency anemia who cannot tolerate or do not respond to oral iron.
• Supports restoration of normal hemoglobin levels, helping to reduce fatigue, weakness, dizziness, and shortness of breath associated with anemia.
• By providing iron directly into the bloodstream, it bypasses gastrointestinal absorption issues and avoids many digestive side effects of oral iron.
• Enables controlled, predictable iron delivery in hospital or clinic settings, improving treatment adherence and clinical outcomes in moderate to severe iron deficiency.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity to iron dextran complexes or any component of the product.
• Do not use in patients with iron overload (e.g., hemochromatosis, hemosiderosis) or in anemia not caused by iron deficiency (e.g., hemolytic anemia) unless clearly indicated by a specialist.
• Use with extreme caution in patients with a history of asthma, eczema, other atopic allergies, or previous reactions to parenteral iron products due to increased risk of serious hypersensitivity reactions.
• Risk of serious and potentially life-threatening anaphylactoid reactions: Cosmofer must be administered only where resuscitation equipment and trained staff are immediately available.
• Monitor blood pressure and pulse during and after infusion; hypotension, collapse, or shock may occur if given too rapidly or in hypersensitive individuals.
• Consult your doctor before use if pregnant or breastfeeding; intravenous iron should be used in pregnancy only if clearly needed and under specialist supervision.
• Use with caution in patients with liver disease, active infections, or inflammatory conditions; parenteral iron may worsen certain infections or hepatic overload.
• Interactions: Concomitant use with oral iron is generally not recommended at the same time; your doctor may advise stopping oral iron during parenteral treatment.
• Consult your doctor before use if you have kidney disease, cardiovascular disease, or are taking other medications that may affect blood pressure or cause allergic reactions.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical supervision.
• Keep out of reach of children.

Side Effects:

• Common side effects may include transient taste disturbances (metallic taste), nausea, vomiting, abdominal discomfort, headache, flushing, muscle or joint pain, and mild fever or chills.
• Infusion-related reactions such as hypotension, dizziness, or flushing can occur, especially if the infusion is given too rapidly.
• Allergic or hypersensitivity reactions may present with rash, itching, hives, wheezing, chest tightness, or swelling of the face, lips, or throat.
• Serious anaphylactoid reactions, including severe hypotension, shock, or collapse, are rare but require immediate medical attention and emergency treatment.
• Delayed reactions (e.g., joint pain, muscle pain, fever) may occur hours to days after administration.
• If you experience difficulty breathing, severe dizziness, chest pain, rapid heartbeat, or any severe or unusual symptoms during or after the infusion, seek emergency medical help immediately.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Do not freeze. Keep ampoules in the original packaging until use to protect from light. Keep container tightly closed and out of the sight and reach of children. Do not use after the expiry date stated on the pack. Discard any unused portion according to local regulations; do not store partially used ampoules.

Specifications:

• Form: Sterile solution for intravenous infusion.
• Strength: 50 mg iron per 1 ml.
• Pack size: 5 ampoules for infusion (exact volume per ampoule not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.)).
• Route of administration: Intravenous infusion under medical supervision only.
• Intended use: Treatment of iron deficiency anemia when oral iron is unsuitable or ineffective.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.