50 mg Iron / ml Solution for injection / infusion. 
iron carboxymaltose

1. What Ferinject is and what it is used for

Ferinject is a medicine that contains iron.

Medicines that contain iron are used when you do not have enough iron in your body. This is called an iron deficiency.

Ferinject is used to treat iron deficiency when:

  • iron given by mouth is not enough.
  • you do not tolerate iron given by mouth.
  • Your doctor decides that you need iron very quickly to replenish your iron stores.

Your doctor will determine if you have an iron deficiency by performing a blood test.

2. What you need to know before you receive Ferinject

Ferinject must not be given to you

  • if you are allergic (hypersensitive) to iron carboxymaltose or any of the other ingredients of this medicine (listed in section 6).
  • if you have had severe allergic reactions to other injectable iron preparations.
  • if you have anemia that is not due to iron deficiency,
  • if you have too much iron in your body or if the iron is not used properly,

Warnings and cautions

Talk to your doctor or nurse before giving Ferinject:

  • if you have previously been allergic to medicines.
  • if you have systemic lupus erythematosus.
  • if you have rheumatoid arthritis.
  • if you have severe asthma, eczema, or other allergies.
  • if you have an infection.
  • if you have liver problems.
  • if you have or have had low levels of phosphate in your blood.

Ferinject should not be given to children under 14 years of age.

Improper administration of Ferinject may cause leakage of the product at the site of administration, which may lead to skin irritation or possible prolonged brown discoloration at the site of administration. The administration must be stopped immediately when this occurs.

Other medicines and Ferinject

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. If Ferinject is given together with oral iron preparations, the effect of the oral preparations may be impaired.

Pregnancy

There are limited data from the use of Ferinject in pregnant women. It is important that you tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.

If you become pregnant during treatment, you must consult your doctor. Your doctor will decide if you should receive this medicine or not.

Breast-feeding

If you are breast-feeding, talk to your doctor before giving Ferinject.

It is unlikely that Ferinject poses a risk to the breast-fed baby.

Driving and using machines

Ferinject is unlikely to affect your ability to drive or use machines.

Important information about some of the ingredients of Ferinject

This medicine contains 0.24 mmol (or 5.5 mg) sodium per milliliter of undiluted solution. This should be considered by patients prescribed a low-salt diet.

3. How to get Ferinject

Your doctor will decide how much Ferinject is given to you, how often you need it, and for how long. Your doctor will take a blood test to determine the dose you need. Your doctor or nurse will administer Ferinject undiluted by injection, dialysis, or diluted by infusion:

  • As an injection, you can receive up to 20 ml of Ferinject, equivalent to 1,000 mg of iron, once a week, directly into a vein.
  • If you are undergoing dialysis, you can get Ferinject during hemodialysis via the dialysis machine.
  • As an infusion, you can receive up to 20 ml of Ferinject, equivalent to 1,000 mg of iron, once a week directly into a vein.
  • For infusion, Ferinject is diluted with sodium chloride solution and the amount can therefore amount to 250 ml and look like a brown solution.

Ferinject is administered in an environment where appropriate and prompt care can be given for immune allergic reactions. You will be observed for at least 30 minutes by your doctor or nurse after each administration.

If you take more Ferinject than you should

As this medicine is given to you by trained healthcare professionals, it is unlikely that you will be given too much of this medicine.

An overdose can cause an accumulation of iron in your body. Doctors will monitor for signs of too much iron to avoid iron buildup.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Talk to your doctor immediately if you experience any of the following signs and symptoms that may indicate a severe allergic reaction: skin rash (eg, hives ), itching, difficulty breathing, wheezing or wheezing, and/or swelling of the lips, tongue, pharynx or body and chest pain, which may be a sign of a potentially serious allergic reaction called Kuoni’s syndrome.

In some patients, these allergic reactions (which occur in less than 1 in 1,000 users) can be severe or life-threatening (so-called anaphylactoid/anaphylactic reactions) and may be associated with cardiovascular problems and loss of consciousness.

Tell your doctor if you experience increasing fatigue, muscle or skeletal pain (pain in arms or legs, joints or back). These symptoms can be a sign of a decrease in phosphorus in the blood, which can lead to your bone becoming soft (osteomalacia). This condition can sometimes lead to bone fractures. Your doctor may also check your blood phosphate levels, especially if you need several iron treatments over time.

Your doctor is aware of these possible side effects and will monitor you during and after you receive Ferinject.

Other side effects that you should talk to your doctor about if they become serious:

Common (may affect up to 1 in 10 people): headache, dizziness, feeling hot (swelling), high blood pressure, nausea, and reactions at the injection/infusion site (see also section 2).

Uncommon (may affect up to 1 in 100 people): numbness, tingling or stinging sensation in the skin, taste disturbances, high heart rate, low blood pressure, difficulty breathing, vomiting, indigestion, stomach pain, constipation, diarrhea, itching, hives, redness of the skin, skin rash, muscle aches, joint and/or back pain, pain in arms or legs, muscle cramps, fever, fatigue, chest pain, swelling of hands and/or feet, and chills.

Rare (may affect up to 1 in 1,000 people): inflammation of a vein, a general feeling of discomfort, anxiety, fainting, weakness, tingling, flatulence, rapid swelling of the face, mouth, tongue, or throat which may cause difficulty breathing and paleness.

No known frequency (can not be calculated from the available data): loss of consciousness and swelling of the face.

Influenza-like illness (which may affect up to 1 in 1,000 people) can occur for a few hours up to several days after injection and is usually characterized by symptoms such as high temperature, and aches and pains in muscles and joints.

Some blood parameters (values) can be changed temporarily, which can be detected during laboratory tests.

The following change in blood parameters is common: decrease in phosphorus in the blood.

The following changes in blood parameters are less common: an increase in certain liver enzymes called alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, and alkaline phosphatase, and an increase in an enzyme called lactate dehydrogenase.

Ask your doctor for more information.

5. How to store Ferinject

Keep this medicine out of the sight and reach of children.

Ferinject is used before the expiry date which is stated on the label. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light. Do not store above 30 ° C. Do not freeze.

Once a vial of Ferinject has been opened, it should be used immediately. After dilution with sodium chloride solution, the diluted solution should be used immediately.

Ferinject is usually stored by your doctor or hospital.

6. Contents of the packaging and other information

Content declaration

The active substance is iron (in the form of iron carboxymaltose, an iron carbohydrate composition). The concentration of iron in the medicine is 50 mg per milliliter. The other ingredients are sodium hydroxide (for pH adjustment ), hydrochloric acid (for pH adjustment ), and water for injections.

What the medicine looks like and the contents of the pack

Ferinject is a dark brown, opaque solution for injection/infusion.

Ferinject is delivered in glass bottles that contain:

  • 2 ml of solution corresponds to 100 mg of iron. Available in pack sizes of 1, 2, and 5 bottles
  • 10 ml of solution corresponds to 500 mg of iron. Available in pack sizes of 1, 2, and 5 bottles
  • 20 ml of solution corresponds to 1,000 mg of iron. Available in a pack size of 1 bottle.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Vifor France 
100-101 Terrace Boieldieu

Franklin La Défense Tour 8

92042 Paris La Défense Cedex

France 
Tel: +33 (0) 1 41 06 58 90 
Fax: +33 (0) 1 41 06 58 99 
e-mail: contact-fr@viforpharma.com

This medicinal product is authorized under the European Economic Area under the following names :

Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Ireland, Iceland, Italy, Croatia, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, UK, Czech Republic, Germany, Hungary Austria: Ferinject .

Belgium, Luxembourg: Injectafer. Slovenia: Iroprem

Muhammad Nadeem

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