Sacrofer 100 mg/5 ml IV solution 5 ampoules

Sacrofer 100 mg/5 ml IV Solution 5 ampoules

Composition:

Each 5 ml of solution contains:

Iron Hydroxide Sucrose complex (eq.to Elemental Iron 100 mg)

Inactive ingredients:

Water for injection, sodium hydroxide

Properties:

Iron sucrose, the active ingredient of Venofer, is composed of a polynuclear iron(III)-hydroxide core surrounded by a large number of non-covalently bound sucrose molecules. The complex has an average molecular weight (Mw) of approximately 43 kDa. The polynuclear iron core has a structure similar to that of the core of the physiological iron storage protein ferritin. The complex is designed to provide, in a controlled manner, utilizable iron for the iron transport and storage proteins in the body (i.e., transferrin and ferritin, respectively).

Following intravenous administration, the polynuclear iron core from the complex is taken up predominantly by the reticuloendothelial system in the liver, spleen, and bone marrow. In a second step, the iron is used for the synthesis of Hb, myoglobin and other iron-containing enzymes, or stored primarily in the liver in the form of ferritin.

Indications:

Iron sucrose injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in people with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working). Iron sucrose injection is in a class of medications called iron replacement products. It works by replenishing iron stores so that the body can make more red blood cells.

Dosage and administrations:

Always use the Sacrofer solution exactly as your doctor prescribed. 

•Adults:

-Hemodialysis Dependent-Chronic Kidney Disease 100 mg slow intravenous injection or infusion.

-Non-Dialysis Dependent-Chronic Kidney Disease 200 mg slow intravenous injection or infusion.

-Peritoneal Dialysis Dependent-Chronic Kidney Disease 300 mg or 400 mg intravenous infusion.

•Pediatric: 

-0.5 mg/kg slow intravenous injection or infusion.

Side effects:

Common: constipation, arm, leg, or back pain, muscle cramps, loss of energy, changes in taste, ear pain, fever, pain, redness, or swelling in the joints, especially the big toe soreness, redness, or burning at the injection site.

Rare: chest pain

Contraindications:

-Hypersensitivity to any ingredients;

-Anemia not caused by iron deficiency;

-Iron high levels.

Warnings and precautions:

Before receiving iron sucrose injection:

•tell your doctor if you are allergic to iron sucrose injection; any other iron injection such as ferumoxytol (Feraheme), iron dextran (Dexferrum, Infed, Proferdex), or sodium ferric gluconate (Ferrlecit); any other medications; or any of the ingredients in iron sucrose injection. 

•tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention iron supplements that are taken by mouth. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

•tell your doctor if you have or have ever had any medical condition.

•tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving iron sucrose injection treatment, call your doctor.

Storage:

Store at a temperature not exceeding 25°C. Do not freeze.

Package:

Carton box holds a plastic container of 5 ampoules, each of 5 ml.