SBOFER-FCM® Injection

SBOFER-FCM® Injection
Generic Name:
Ferric Carboxymaltose
Therapeutic Group:
Haematology / Iron Replacement Therapy
Drug Category:
Parenteral Iron Preparation
Content / Composition:
Each ml contains:
Ferric Carboxymaltose equivalent to elemental iron …… 50 mg
(Available in single-dose vial as per pack)
Indications:
Indicated for the treatment of iron deficiency and iron deficiency anemia, particularly when:
* Oral iron therapy is ineffective or not tolerated
* Rapid iron replenishment is required
* Chronic kidney disease (CKD)
* Postpartum anemia
* Chronic blood loss
* Inflammatory bowel disease (IBD)-associated anemia
Dosage:
As directed by physician.
General guidance:
* Dose based on body weight and iron deficit
* Maximum single dose typically up to 1000 mg iron per week
* Administered as IV injection or infusion
Contraindications:
* Hypersensitivity to ferric carboxymaltose or any component
* Iron overload disorders (e.g., hemochromatosis)
* Non–iron deficiency anemia
* First trimester of pregnancy
Administration:
* For intravenous use only
* Administer by slow IV injection or infusion
* Must be given under medical supervision
* Emergency support should be available during administration
Interaction:
* Avoid concurrent use with oral iron (reduces absorption)
* Caution with other parenteral iron products
* No significant CYP-related drug interactions reported
Compatibility:
Do not mix with other medicinal products except normal saline (if required for infusion).
Administer separately under controlled conditions.
Stability / Storage:
Store below 25°C.
Do not freeze.
Protect from light.
Keep in original packaging.
Precautions:
* Monitor for hypersensitivity reactions during and after administration
* Risk of hypotension during infusion
* Monitor ferritin and transferrin saturation levels
* Use cautiously in liver disorders
* Pregnancy (2nd & 3rd trimester): only if clearly needed
Side Effects:
Common:
* Nausea
* Injection site reactions
* Headache
* Dizziness
Others:
* Hypertension or hypotension
* Flushing
Rare but serious:
* Hypersensitivity reactions (including anaphylaxis)
* Hypophosphatemia
* Severe allergic reactions
Website Note:
High-efficacy intravenous iron therapy.
For hospital and clinical use only.
Administered under strict medical supervision.