APR FERRORED 5ml

INFORMATION FOR THE USER

Ferric hydroxide 20mg/ml Injection

Read all of this information carefully before you start taking this medicine because it contains important information for you.
• Keep this information. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.

1. COMPOSITION:
Eachml of vial contains:
Iron – 20mg as iron sucrose complex

For infusion only.

2. DESCRIPTION:
Ferric hydroxide is a hematinic and is used to increase the levels of iron to aid haematopoiesis in the body.

3. PHARMACOLOGICAL ACTION:
Iron sucrose, the active ingredient, is composed of a polynuclear iron(III)-hydroxide core surrounded by a large number of non-covalently bound sucrose molecules. The complex has a weight 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, utilisable iron for the iron transport and storage proteins in the body (i.e., transferrin and ferritin, respectively). Following IV administration, the polynuclear iron core from the complex is taken up predominantly by the reticuloendothelial system in the liver, spleen & bone marrow. In a second step, the iron is used for the synthesis of Hb, myoglobin & other iron-containing enzymes, or stored primarily in the liver in the form of ferritin.

4. CLINICAL PHARMACOKINETICS:
Following IV injection of a single 100mg iron dose of iron sucrose, maximum total serum iron concentrations were attained 10 minutes after injection & had an average concentration of 538 µmol/l. The volume of distribution of the central compartment corresponded well to the volume of plasma (approx. 3L). Upon injection, sucrose largely dissociates & the polynuclear iron core is mainly taken up by the reticuloendothelial system of the liver, spleen & bone marrow. At 4 weeks after administration, red cell iron utilization ranged from 59-97%. The iron sucrose complex has a weight average molecular weight (Mw) of approximately 43 kDa, which is sufficiently large to prevent renal elimination. Renal elimination of iron, occurring in the first 4 hrs after injection of 100 mg iron, corresponded to less than 5% of the dose. After 24 hrs, the total serum iron concentration was reduced to the pre-dose level. Renal elimination of sucrose was about 75% of the administered dose.

5. INDICATIONS:
Ferric hydroxide injection is indicated for the treatment of:
– Clinical need for a rapid iron supply
– Patients who cannot tolerate oral iron therapy or who are non-compliant
– Active inflammatory bowel disease where oral iron preparations are ineffective
– Chronic kidney disease when oral iron preparations are less effective.

6. CONTRAINDICATIONS:
– Hypersensitivity to the active substance or any of the excipients
– Known serious hypersensitivity to other parenteral iron products
– Anaemia not caused by iron deficiency
– Evidence of iron overload or hereditary disturbances in utilisation of iron.

7. WARNINGS AND PRECAUTIONS:
Parenterally administered iron preparations can cause hypersensitivity reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose.
The risk of hypersensitivity reactions is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus).
Should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
In patients with liver dysfunction, should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria CutaneaTarda.
Should be used with caution in the case of acute or chronic infection. It is recommended that the administration be stopped in patients with bacteraemia.
Paravenous leakage must be avoided as it can cause pain, inflammation & brown discoloration of the skin.

8. ADVERSE EFFECTS:
– Hypersensitivity reactions have been reported including skin reactions (e.g. rash, itching) and exceptionally anaphylaxis.
– Other symptoms reported include fever, chills, hot flushing, dizziness, malaise, nausea, acneiform and bullous eruptions, tremor and injection site reactions including injection site pain, injection site induration and injection site necrosis.
– Reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.

9. DRUG INTERACTIONS:
Should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should be started at least 5 days after the last injection.

10. DOSAGE:
Adults: 5-10ml (100-200mg iron) 1 to 3 times a week.
Children: Use has not been adequately studied in children, therefore, not recommended for use in children.

11. ADMINISTRATION:
For IV use only. Can be done as slow intravenous injection or intravenous drip infusion.
Administration to be done by a registered medical practitioner/nurse in a proper sterile and hospital setting only.

12. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight. Do not allow to freeze.

13. MANUFACTURED BY:

14. MARKETED BY:

Last revised on May 2019.