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Ferinject 1000mg Inj
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Product information
- Manufacturer
- Lupin Ltd
- Category
- Other
- Composition
- Not provided
- Packaging
- 20ML
- Box / case pack
- 1 / —
Description
FERINJECT 1000MG INJECTION
FERINJECT 1000MG INJECTION, manufactured by Lupin Ltd., is an intravenous iron preparation used to treat iron deficiency. It is presented as a dark brown, non-transparent solution.
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Name:
- Brand Name: FERINJECT
- Common Name: Ferric Carboxymaltose
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Composition:
- Active Ingredient: Each 20 mL vial contains 1000 mg of iron in the form of Ferric Carboxymaltose.
- Other Ingredients: Sodium hydroxide (for pH adjustment), hydrochloric acid, and water for injection.
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Uses: FERINJECT is indicated for the treatment of iron deficiency and iron deficiency anemia in adults, adolescents aged 14 years and older, and children aged 1-13 years. It is prescribed when:
- Oral iron preparations are ineffective or cannot be used.
- There is a clinical need to deliver iron rapidly.
- Adults with long-term kidney disease not on dialysis have iron deficiency anemia. Diagnosis of iron deficiency must be confirmed by laboratory tests.
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Dosage and Administration: FERINJECT is administered intravenously via injection or infusion in a hospital or clinic setting by a healthcare professional. The dose is determined by the patient's body weight and haemoglobin levels.
- Maximum Single Dose: 1000 mg of iron, or 15 mg iron/kg body weight (for IV injection), or 20 mg iron/kg body weight (for IV infusion).
- Maximum Cumulative Dose: 1000 mg of iron per week for adults. Higher total iron needs may require doses to be split at least 7 days apart.
- Patients are monitored for adverse effects for at least 30 minutes following administration.
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Side Effects:
- Common: Headache, dizziness, high blood pressure, flushing, nausea, injection/infusion site reactions, and low blood phosphate levels.
- Serious (Rare): Severe hypersensitivity reactions, including anaphylactoid reactions which can be fatal. Symptoms may include chest pain, breathing difficulty, wheezing, swelling (angioedema), lightheadedness, fast heartbeat, and fainting.
- Other reported effects: Anxiety, loss of consciousness, skin discoloration distant to the injection site, and influenza-like illness.
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Precautions:
- Do not use if allergic to ferric carboxymaltose or any excipients.
- Contraindicated in anemia not caused by iron deficiency, iron overload, or disturbances in iron utilization.
- Caution is advised in patients with infections, asthma, eczema, other allergies, or liver disorders.
- Facilities for cardiopulmonary resuscitation must be available due to the risk of severe allergic reactions.
- Oral iron preparations may be less effective if given concurrently with FERINJECT; oral iron should not be started for at least 5 days after the last FERINJECT dose.
- Use during pregnancy, especially in the first trimester, is generally not recommended unless clearly necessary and the benefit outweighs the risk.
- Not recommended for children under 1 year of age.
- Care should be taken to avoid paravenous leakage, which can cause long-lasting brown skin discoloration.
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Storage:
- Store in the original package at temperatures not exceeding 30°C.
- Do not refrigerate or freeze.
- Vials are for single use only; any unused portion should be discarded.
- Once diluted with sodium chloride solution, the product should be used as soon as possible, or stored at 2-8°C for no more than 12 hours.
Frequently asked questions
FERINJECT 1000MG INJ: Frequently Asked Questions
FERINJECT 1000MG Injection, containing ferric carboxymaltose, is an intravenous iron preparation used to treat iron deficiency conditions. It is administered by a healthcare professional in a hospital or clinic setting.
What is FERINJECT 1000MG INJ used for?
FERINJECT 1000MG INJ is used to treat iron deficiency and iron deficiency anemia in adults, adolescents aged 14 years and older, and children aged 1 to 13 years. It is typically prescribed when oral iron preparations are ineffective, cannot be tolerated, or when there is a clinical need to replenish iron stores rapidly. The diagnosis of iron deficiency must be confirmed by laboratory tests.
How does FERINJECT 1000MG INJ work?
FERINJECT contains ferric carboxymaltose, an iron carbohydrate complex. This solution provides iron in a stable ferric state that is then utilized by the body to replenish iron stores. Iron is crucial for the formation of hemoglobin in red blood cells, which carries oxygen throughout the body, and myoglobin in muscle tissue. It also plays a vital role in many other bodily processes.
What is the usual dosage of FERINJECT 1000MG INJ?
The dosage of FERINJECT is determined by your doctor based on your individual iron needs, body weight, and hemoglobin levels. It is given intravenously (into a vein) either as an undiluted injection, diluted infusion, or during a hemodialysis session. For adults, the maximum single dose is typically 1000 mg of iron, but it should not exceed 15 mg iron/kg body weight for intravenous injection or 20 mg iron/kg body weight for intravenous infusion. The maximum recommended cumulative dose is 1000 mg of iron per week. For children aged 1 to 13 years, Ferinject is typically administered in two intravenous doses of 15 mg iron (0.3 mL) per kg body weight, with at least a 7-day interval, and a maximum single dose not exceeding 750 mg iron. If a higher total iron need is identified, additional doses should be administered at least 7 days apart.
What are the possible side effects of FERINJECT 1000MG INJ?
Common side effects can include headache, dizziness, high blood pressure, flushing, nausea, and reactions at the injection or infusion site. Persistent bone pain and joint pain may indicate low blood phosphate levels. Serious but rare side effects include allergic reactions, which can sometimes be life-threatening, manifesting as breathing difficulties, swelling, lightheadedness, fast heartbeat, sweating, and nausea (anaphylactic reactions). If any pain or swelling occurs at the infusion site, or if extravasation (leakage of the drug outside the vein) occurs, the administration should be stopped immediately as it can lead to long-lasting brown discoloration.
Is FERINJECT 1000MG INJ safe during pregnancy or breastfeeding?
A careful risk/benefit evaluation is required before using Ferinject during pregnancy, and it should only be used when clearly necessary. Iron deficiency in the first trimester can often be managed with oral iron. If intravenous iron is needed, treatment is generally confined to the second and third trimesters. Fetal bradycardia (slow heartbeat in the unborn baby) may occur following parenteral iron administration, usually as a consequence of a maternal hypersensitivity reaction. Very little Ferinject passes into breast milk, making it generally considered safe to breastfeed while receiving this medication.
Can FERINJECT 1000MG INJ be taken with other medications?
If FERINJECT is given concomitantly with oral iron preparations, the absorption of oral iron is reduced, making it less effective. Therefore, if oral iron therapy is required, it should not be started for at least 5 days after the last administration of Ferinject. You should inform your doctor about all medications, vitamins, and supplements you are taking.
What precautions should be taken with FERINJECT 1000MG INJ?
Patients should be carefully monitored for signs of hypersensitivity reactions during and for at least 30 minutes following each administration of Ferinject, as severe allergic reactions can occur. Facilities for cardiopulmonary resuscitation should be available. Caution is advised for patients with a history of medicine allergies, systemic lupus erythematosus, rheumatoid arthritis, severe asthma, eczema, other atopic allergies, or liver disorders. Iron status will be monitored in patients with liver disorders to prevent iron overload. Treatment should be stopped in patients with ongoing bacteremia, and a risk/benefit evaluation is performed for those with chronic infections. Caution should be exercised to avoid paravenous leakage during administration, which can cause skin irritation and long-lasting discoloration.
How should FERINJECT 1000MG INJ be stored?
FERINJECT is typically stored by your doctor or hospital. It should be kept in its original packaging and not stored above 30°C. It should not be refrigerated or frozen. Once a vial has been opened, it should be used immediately. If diluted with sodium chloride solution, the diluted solution should be administered as soon as possible, or stored at 2-8°C for no more than 12 hours if storage is necessary.