Product Information:

FEROTEIN-S 100 mg/5 mL Ampoules contain Iron Sucrose as the active ingredient, an intravenous (IV) iron preparation used to treat iron deficiency anemia when oral iron is ineffective, intolerable, or contraindicated. Each 5 mL ampoule delivers 100 mg of elemental iron in a stable complex that minimizes free iron release, reducing the risk of oxidative stress and adverse reactions compared to older IV iron formulations.

Uses of (FEROTEIN-S 100 MG / 5 ML AMPOULES):

1. Iron deficiency anemia in patients with chronic kidney disease (CKD), on dialysis or not
2. Iron deficiency anemia due to inflammatory bowel disease (IBD), celiac disease, or post-bariatric surgery
3. Intolerance or poor response to oral iron therapy
4. Preoperative anemia correction in surgical candidates
5. Postpartum or post-hemorrhagic iron deficiency when rapid repletion is needed

Key Benefits of (FEROTEIN-S 100 MG / 5 ML AMPOULES):

1. Rapid replenishment of iron stores (vs. weeks with oral iron)
2. Well-tolerated with low risk of hypersensitivity reactions
3. Can be administered as slow IV injection or infusion
4. No requirement for a test dose (unlike iron dextran)
5. Effective in functional iron deficiency (e.g., in CKD with ESA therapy)

How To Use (FEROTEIN-S 100 MG / 5 ML AMPOULES):

1. Administered only by a healthcare professional in a clinical setting.
2. IV route:
3. Slow IV injection: 100 mg undiluted over 2–5 minutes
4. IV infusion: Dilute in 0.9% NaCl (100 mg in 100 mL) and infuse over 15–30 minutes
5. Maximum single dose: 100 mg per session
6. Weekly dosing: Typically 100–200 mg once or twice weekly until target iron stores are achieved
7. Total cumulative dose calculated based on hemoglobin, weight, and iron deficit

When Not to Use (FEROTEIN-S 100 MG / 5 ML AMPOULES):

Do not use if you have:

1. Hypersensitivity to iron sucrose or any excipients
2. Iron overload (e.g., hemochromatosis) or disturbances in iron utilization (e.g., sideroblastic anemia)
3. Non-iron deficiency anemias (e.g., hemolytic, aplastic)
4. First trimester of pregnancy (unless clearly needed—use only if benefits outweigh risks)

Side Effects of (FEROTEIN-S 100 MG / 5 ML AMPOULES):

Common: Hypotension, nausea, headache, dizziness, injection site discoloration, muscle cramps.

Rare: Rash, abdominal pain, dysgeusia (metallic taste).

Serious (very rare):

1. Anaphylaxis or severe hypersensitivity (symptoms: bronchospasm, hypotension, angioedema)—monitor during and after administration
2. Iron overload with excessive dosing
3. Discontinue immediately and provide emergency care if signs of anaphylaxis occur.

Dosage: (FEROTEIN-S 100 MG / 5 ML AMPOULES):

1. Adults: 100–200 mg per week (divided doses if >100 mg)
2. Maximum per session: 100 mg via slow IV push
3. Total dose: Calculated using Ganzoni formula or clinical assessment
4. Pediatric use: Dose based on body weight (not commonly used in children <2 years)

Who It’s For (FEROTEIN-S 100 MG / 5 ML AMPOULES):

Adults with iron deficiency anemia who cannot tolerate or absorb oral iron, particularly those with CKD, IBD, postpartum hemorrhage, or preoperative anemia.

Warnings & Precautions:

1. Monitor blood pressure during and after infusion—hypotension may occur
2. Observe patient for at least 30 minutes post-administration for allergic reactions
3. Do not mix with other medications in the same infusion line
4. Avoid extravasation—may cause long-lasting brown discoloration at injection site
5. Assess ferritin and transferrin saturation before and during therapy to avoid iron overload

Drug Interactions:

1. Oral iron supplements: Discontinue during IV iron therapy (no added benefit)
2. Antihypertensives: May potentiate hypotensive effects
3. ACE inhibitors: Theoretical risk of enhanced bradykinin-mediated reactions (rare)
4. Always inform your doctor about all medications.

Additional Information:

Store below 25°C, protected from light. Do not freeze. Discard if solution is discolored or contains particles. For single-use only—discard unused portion. Available by prescription in Pakistan. Keep out of reach of children.