500 mg powder for solution for injection / infusion 
deferoxamine mesylate

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Desferal is and what it is used for 
2. What you need to know before you get Desferal 
3. How to use Desferal 
4. Possible side effects 
5. How to store Desferal 
6. Contents of the packaging and other information 

1. What Desferal is and what it is used for

Desferal contains the active substance deferoxamine mesylate, which is a so-called iron chelate complexing agent. It is used to remove an excess of iron from the body.

Repeated blood transfusions may be necessary for patients with various types of anemia ( anemia ). Repeated blood transfusions can, however, give rise to an accumulation of excess iron. This is because blood contains iron and the body has no natural way of removing the excess iron obtained through blood transfusions. Over time, excess iron can damage important organs e.g. liver and heart. Desferal is used in children and adults to remove excess iron and reduce the risk of it causing organ damage.

Desferal can also be used for:

  • treatment of acute iron poisoning
  • diagnosis of conditions with excess iron

Talk to your doctor if you have any questions about how Desferal works or why you have been prescribed this medicine.

2. What You Need to Know Before You Get Desferal

Follow your doctor’s instructions carefully. They may differ from the general information in this leaflet.

Do not use Desferal

If you are allergic (hypersensitive) to deferoxamine mesylate 

Warnings and cautions

Talk to your doctor before receiving Desferal if you have

  • Impaired renal function.

If you get any of the following symptoms during treatment with Desferal, tell your doctor immediately:

  • Low blood pressure and shortness of breath may be due to too rapid administration when Desferal is given as an infusion into a vein. See also section 3 “If you have used too much Desferal”.
  • Visual and hearing disorders. See also section 4 “Possible side effects”.
  • Symptoms of renal failure. See also section 4 “Possible side effects”.
  • Acute respiratory distress syndrome (ARDS) has occurred after treatment with unusually high doses of Desferal. Therefore, the recommended daily dose should not be exceeded. See also section 4 “Possible side effects”.
  • Symptoms of fungal or bacterial infection. See also “Possible side effects”.
  • If you are experiencing fatigue, palpitations, shortness of breath, or swelling ( edema ) in the legs, ankles, or feet (signs of heart disorders), which can occur in patients receiving concomitant treatment with Desferal and high dose s of vitamin C . See also “Other medicines and Desferal”.

Your urine may change color to reddish-brown during treatment with Desferal because the urine contains more iron.

Elderly people (65 years and older)

Desferal can be used by elderly patients. Dose one should be determined by the attending physician.

Children and young people

Desferal can be used by children and adolescents. In rare cases, growth retardation has been reported in children treated with Desferal. Weight and height will therefore be checked carefully.

Other medicines and Desferal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially true:

  • medicines containing prochlorperazine (used to treat neurological diseases)
  • Vitamin C in higher doses than 200 mg per day for adults, 50 mg/day for children under 10 years, and 100 mg/day for children over 10 years during treatment with Desferal. If your doctor tells you a C-vitamin supplement, make sure that you have been using Desferal regularly for at least a month before you start taking vitamin C . Take vitamin C only in the doses recommended by your doctor. Do not exceed the daily doses of vitamin C listed above (see also section “Warnings and Precautions”).
  • gallium-67, a pre-imaging drug used in the diagnosis of certain diseases.

Your doctor may need to change the dosage of one of the other medicines or end your treatment with it altogether.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Desferal if you are pregnant or breast-feeding unless your doctor tells you to. Your doctor will discuss with you the potential risks of using Desferal during pregnancy.

Driving and using machines

Desferal can affect your vision and hearing, cause dizziness and reduce your ability to react. If you experience such symptoms, do not drive or use any tools or machines until you feel normal again.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Desferal

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Do not exceed the recommended dose.

Treatment of chronic iron deficiency

Your doctor will adjust the dose to your needs. For most patients, the daily dose is between 20-60 mg per kilogram of body weight.

Desferal can be given as a slow infusion under the skin ( subcutaneous infusion via infusion pump), as an infusion into a vein, or as an injection into a muscle.

Concomitant use of vitamin C.

After receiving Desferal for at least one month, your doctor may decide that you should take vitamin C supplements. See also “Other medicines and Desferal”.

Sampling and controls during treatment with Desferal

You may need to take certain blood and urine samples before and during treatment.

The amount of iron in the body (the level of ferritin in the blood) will be measured to see how well Desferal works. Your vision and hearing will also be checked. Height and weight are checked regularly in children. Your doctor will consider the results of these tests when deciding which dose of Desferal is right for you.

Other uses of Desferal

Treatment of acute iron poisoning

  • Desferal is used in cases of poisoning with iron preparations. This treatment takes place in a hospital.

Test for increased iron storage

  • If you need to undergo iron storage tests, you will receive an intramuscular injection of Desferal and then be asked to collect urine samples for 6 hours. The iron content of the urine will then be determined.

If you use more Desferal than you should 

Accidental overdose of Desferal can lead to local side effects at the injection site as well as other side effects such as low blood pressure, abnormally fast or slow heart rate, gastrointestinal disorders, impaired vision, speech difficulties, anxiety, headache, nausea, and greatly reduced urine output ( acute renal failure). ).

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. You may need medical treatment.

If you forget to use Desferal

Tell your doctor immediately if you have missed a dose of Desferal.

If you stop using Desferal

Do not stop using Desferal unless your doctor tells you to. If you stop using Desferal, the excess iron will no longer be removed from your body.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them. If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

Some side effects can be serious. Tell your doctor immediately if you experience any of the following side effects:

Less common side effects are (may affect up to 1 in 100):

  • Sudden difficulty breathing and feeling of tightness in the chest with wheezing or coughing ( asthma )

Rare side effects are (may affect up to 1 in 1000)

  • Hearing disorders, such as ringing or wheezing ( tinnitus ), hearing loss
  • Visual disturbances, such as blurred vision, changes in color vision, cloudiness of the eye lens, night blindness , black spots in the visual field , loss of vision, decreased visual acuity , an area in the visual field with total or impaired visual acuity
  • High fever, shortness of breath, bloody cough, diarrhea, abdominal pain, vomiting, nausea or sore throat (symptoms of fungal infection)
  • Dizziness, dizziness (symptoms of low blood pressure that may be due to too fast administration of the drug)
  • Rash, itching , hives, difficulty breathing or difficulty swallowing, feeling of tightness in the chest with wheezing or coughing, dizziness, swelling of the face and throat in particular (signs of severe allergic reaction )
  • Shortness of breath due to disorders of lung function (ARDS, acute respiratory distress syndrome)
  • Bleeding or bruising that occurs more easily than normal (symptoms of low platelet count )
  • Effects on speech, learning, behavior and mobility (symptoms of nervous system disorders).

Very rare (may affect up to 1 in 10,000 people)

  • Fever, sore throat or cold sores caused by infection (symptoms of low white blood cell count )
  • Fever, abdominal pain and diarrhea, blood in the stool may occur (symptoms of bacterial infection)

Has been reported (occurs in an unknown number of users)

  • Significantly reduced urine production (symptoms of renal impairment, acuterenal injury)
  • Seizures with convulsions or twitching (convulsions), mainly in patients on dialysis

Other possible side effects are listed below

Tell your doctor if you experience any of the following side effects in severe form:

Very common side effect are (can occur in more than 1 in 10):

Joint pain, muscle pain

Common side effects are (may affect up to 1 in 10):

Headache, stunted growth and skeletal disease in young children at high doses , fever, chills, general malaise after infusion or injection , pain, swelling, redness , scabies, burning, itching and rash at the infusion or injection site

Rare side effects are (may affect up to 1 in 1000):

Nausea, vomiting, diarrhea, abdominal pain, calf cramps, leg pain, nerve damage, growth retardation, dizziness, changes in test results of liver values

Very rare side effects are (may affect up to 1 in 10 000 users):

Tingling ( paresthesia )

Has been reported (occurs in an unknown number of users):

Muscle spasms, changes in test results of kidney values, palpitations and shock

5. How to store Desferal

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiration date is the last day of the specified month.

The reconstituted solution can be stored for 12 hours at a maximum of 25 ° C.

Only clear solutions should be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is deferoxamine mesilate
  • Does not contain excipients

What the medicine looks like and the contents of the pack

Desferal is supplied as a powder in a vial . One glass bottle contains 500 mg

deferoxamine mesilate.

One pack contains 10 vials.

Marketing Authorization Holder and Manufacturer

Novartis Sverige AB

Box 1218

164 28 Kista

Muhammad Nadeem

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