ferric carboxymaltose




Agencia Lei Va Hong
Full Prescribing Info
Ferric carboxymaltose.
The active substance is iron (as ferric carboxymaltose, an iron carbohydrate compound). The concentration of iron present in the product is 50 mg per millilitre.
Excipients/Inactive Ingredients: The other ingredients are sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injection.
Ferinject is an antianaemic preparation, a medicine that is used to treat anaemia. It contains iron in the form of an iron carbohydrate. Iron is an essential element required for the oxygen-carrying capacity of haemoglobin in red blood cells and of myoglobin in muscle tissue. Moreover, iron is involved in many other functions necessary for maintenance of life in the human body.
Ferinject is used for the treatment of patients with iron deficiency, when oral iron preparations are ineffective or cannot be used. The aim of the therapy is to replenish body iron stores and to remedy anaemia, a lack of red blood cells due to iron deficiency.
Before administration, the doctor will perform a blood test to determine the dose of Ferinject required.
Dosage/Direction for Use
The doctor can administer Ferinject by three possible routes: undiluted by injection, during dialysis, or diluted by infusion.
By injection, the patient may receive up to 20 ml of Ferinject, corresponding to 1000 mg of iron, once a week directly into the vein.
If the patient is on dialysis, he/she may receive Ferinject during a haemodialysis session via the dialyser.
By infusion, the patient may receive up to 20 ml of Ferinject, corresponding to 1000 mg of iron, once a week directly into the vein. Because Ferinject is diluted with sodium chloride solution for the infusion, it may have a volume of up to 250 ml and appear as a brown solution.
If the patient receives more Ferinject than he/she should: The doctor will take responsibility for determining the appropriate dose and choosing the route, frequency and duration of the treatment.
Overdose can cause accumulation of iron in storage sites. The doctor will monitor iron parameters such as serum ferritin and transferrin to avoid iron accumulation.
The patient must not receive Ferinject: if he/she is allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in Description); if he/she has experienced serious allergic (hypersensitive) reactions to other injectable iron preparations; if he/she has anaemia not caused by iron deficiency; if he/she has an iron overload (too much iron in the body) or disturbances in utilisation of iron.
Special Precautions
The patient must talk to the doctor or nurse before receiving Ferinject: if he/she has a history of medicine allergy; if he/she has systemic lupus erythematosus; if he/she has rheumatoid arthritis; if he/she has severe asthma, eczema or other allergies; if he/she has an infection; if he/she has liver disorders.
Incorrect administration of Ferinject may cause leakage of the product at the injection site, which may lead to irritation of the skin and potentially long lasting brown discolouration at the site of injection. The administration must be stopped immediately when this occurs.
How Ferinject is given: The doctor or nurse will administer Ferinject undiluted by injection, during dialysis, or diluted by drip infusion. Ferinject will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.
The patient will be observed for at least 30 minutes by the doctor or nurse after each administration.
Important information about some of the ingredients of Ferinject: This medicinal product contains 0.24 mmol (or 5.5 mg) sodium per millilitre of undiluted solution. This has to be taken into account by patients on a sodium-controlled diet.
Driving and using machines: Ferinject is unlikely to impair the ability to drive or operate machines.
Use in Children: Ferinject should not be given to children under 14 years.
Use In Pregnancy & Lactation
Pregnancy: Ferinject has not been tested in pregnant women. It is important to tell the doctor if the patient is pregnant, thinks she may be pregnant, or is planning to have a baby.
If the patient becomes pregnant during treatment, she must ask the doctor for advice. The doctor will decide whether or not she should be given this medicine.
Breast feeding: If breast-feeding, ask the doctor for advice before being given Ferinject. It is unlikely that Ferinject represents a risk to the nursing child.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: Tell the doctor immediately if experiencing any of the following signs and symptoms that may indicate a serious allergic reaction: Rash (e.g. hives), itching, difficulty breathing, wheezing and/or swelling of the lips, tongue, throat or body.
In some patients these allergic reactions (affecting less than 1 in 1,000 people) may become severe or life-threatening (known as anaphylactoid reactions) and can be associated with heart and circulation problems and loss of consciousness.
The doctor is aware of these possible side effects and will monitor the patient during and after the administration of Ferinject.
Other side effects that the patient should tell the doctor about if they become serious: Common side effects (may affect up to 1 in 10 people): headache, dizziness, high blood pressure, nausea and injection site reactions (also see Precautions).
Uncommon side effects (may affect up to 1 in 100 people): numbness, tingling or prickling sensation on the skin, a change in taste sensation, high heart rate, low blood pressure, redness in the face, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhoea, itching, hives, redness of the skin, rash, muscle-, joint- and/or back pain, muscle spasms, fever, tiredness, chest pain, swelling of the hands and/or the feet, and chills.
Rare side effects (may affect up to 1 in 1,000 people): inflammation of a vein, shivering and a general feeling of discomfort, loss of consciousness, anxiety, fainting, feeling faint, wheeze, excessive wind (flatulence), rapid swelling of the deep layers of the skin, paleness and swelling of the face.
Some blood parameters may change temporarily, which could be detected in laboratory tests.
The following changes in blood parameters are common: decrease in blood phosphorus and increase of a certain liver enzyme called alanine aminotransferase.
The following changes in blood parameters are uncommon: increase in certain liver enzymes called aspartate aminotransferase, gamma-glutamyltransferase and alkaline phosphatase, and increase in an enzyme called lactate dehydrogenase.
Ask the doctor for more information.
Drug Interactions
Tell the doctor if using, have recently used or might use any other medicines, including medicines obtained without prescription. If Ferinject is given together with oral iron preparations, then these oral preparations could be less efficient.
Caution For Usage
Once the Ferinject vials have been opened, they should be used immediately. After dilution with sodium chloride solution, the diluted solution should be used immediately.
Store in the original package. Do not freeze.
ATC Classification
B03AC - Iron, parenteral preparations ; Used in the treatment of anemia
Soln for inj/infusion (vial) (dark brown, non-transparent solution) 500 mg/10 mL x 1's.
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