FeROSE Iron Sucrose 20mg / mL for Injection - Ampoule 5mL

Indications / Uses

FeROSE Iron Sucrose for Injection Ampoule is used for the management of iron deficiency anemia, a condition where the body lacks sufficient iron to produce healthy red blood cells. It is specifically indicated for individuals with chronic kidney disease (CKD) who require iron replacement to restore normal iron levels, often those undergoing chronic hemodialysis and receiving supplementary treatments. This method is typically employed when oral iron preparations are found to be ineffective or impractical due to intolerance or poor compliance.

Formulation / Ingredients
FeROSE Iron Sucrose for Injection Ampoule contains: Iron Sucrose 20mg / mL (100mg / 5mL)

Side Effects

FeROSE Iron Sucrose for Injection Ampoule common side effects include taste changes, such as a metallic taste, along with general discomforts like headache, dizziness, nausea, and vomiting. Other commonly reported issues are muscle cramps, diarrhea, and pain or irritation at the injection site. Serious adverse effects, though less common, can involve severe allergic reactions like swelling of the face, lips, or tongue, difficulty breathing, or a sudden drop in blood pressure which can lead to lightheadedness and fainting.

Directions and Dosage

The total dosage is determined by an individual's body weight and the degree of iron deficiency. The administration must only be through the intravenous route (slow intravenous injection or drip infusion). The total single dosage should not be more than 200 mg of iron, and this should not be given more than 3 times per week. If the total required amount exceeds the allowed single dosage, the administration must be divided.

• Dosage for Adults (18+ years) (Hemodialysis-dependent CKD): 100 mg elemental iron given per dialysis session. The total cumulative dose should not exceed 1000 mg divided into 3 doses per week.
• Dosage for Kids $\ge$ 2 years (Hemodialysis-dependent): 0.5 mg/kg administered every 2 weeks for 12 weeks. Do not exceed 100 mg per dose.
• Dosage for Kids $\ge$ 2 years (Non-dialysis dependent or peritoneal-dependent, on erythropoietin): 0.5 mg/kg administered every 4 weeks for 12 weeks. Do not exceed 100 mg per dose.

Safety and effectiveness have not been established in children under 2 years.

Contraindications

Do not use this product if there is a known serious sensitivity to the solution or any of its non-active components. It must not be administered in cases of anemia that are not caused by a lack of iron. The product is also not for use when there is evidence of iron overload in the body or hereditary disorders in how the body uses iron.

Use in Pregnancy and Lactation

Use during the period of carrying a child should only be considered if oral replacement is not tolerated or is ineffective, and the level of low iron poses a risk to the individual or the unborn child. It is not known if the substance passes into the milk of nursing individuals.

Special Precautions

• Before administration, a test dose must be given to check for potential severe allergic reactions, and full emergency resuscitation facilities must be available during administration.
• The solution is strongly alkaline and should never be injected into a muscle or under the skin.
• Observe caution when administering to individuals with pre-existing liver problems.
• Temporarily stop the administration of this product if there is an active infection in the blood (bacteremia).
• Monitor for a drop in blood pressure, as hypotension has been reported and may be related to the speed of administration and the amount given.

Is it safe to take it with other medications?

Do not administer concomitantly with oral products containing iron, as this will reduce the absorption and effectiveness of the oral iron. Oral iron therapy should be started at least 5 days following the last administration of this injectable product. Avoid using with products like deferoxamine and dimercaprol.

How should I store it?

Store the ampoules at a temperature not exceeding 30°C. Protect the product from light. Once opened or diluted, the solution should be used immediately.

Used For

Iron Deficiency Anemia

Age

2 years & up