50 mg / ml injection solution 
Iron

Read all of this leaflet carefully before you start using 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

– If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

This medicine is subject to extended monitoring. This will make it possible to quickly identify new security information. You can help by reporting any side effects you may have. Information on how to report side effects can be found at the end of section 4.

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

1. What Diafer is and what it is used for

Diaphragms contain a combination of iron and derisomaltose (a chain of sugar molecules). The type of iron found in Diafer is the same as that found naturally in the body.

Diaphragms are given at low iron levels (called “iron deficiency”) if you have a chronickidney disease and are on dialysis, provided that oral iron cannot be used.

Diaphragms are used to replenish and maintain the body’s iron stores through repeated treatment.

Iron found in Diafer may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Diafer

You must not be given Diafer

  • if you have anemia that is not caused by low iron values ​​(iron deficiency) e.g. “Hemolytic anemia”
  • if you have too much iron in your body (overload) or disorders in your body’s use of iron
  • if you are allergic (hypersensitive) to the product 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 an active liver disease

Warnings and cautions

Talk to your doctor or nurse before giving Diafer:

  • 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 you
  • if you have an ongoing bacterial infection in your blood

One ml of undiluted Diafer contains up to 4.6 mg (0.2 mmol) of sodium. This should be considered by patients on a low-salt diet.

Children and young people

Diaphragms have not been tested in children and adolescents. For this reason, children and adolescents should not take Diafer.

Other medicines and Diafer

If Diafer is given together with oral iron preparations (by mouth) this may reduce the uptake of the oral iron preparation. Tell your doctor if you are taking or have recently taken or will take any other medicines. This also includes over-the-counter and herbal remedies. This is because Diafer may affect the effectiveness of other medicines. Some other medicines may also affect the effect of Diafer.

Pregnancy, breastfeeding, and fertility

Diaphragms have not been tested on 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.

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

Driving and using machines

Diafer is unlikely to impair the ability to drive or use machines.

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 Diafer

Your doctor or nurse will give you Diafer by injection into a vein or in the dialyzer. Diaphragms are given in an environment where allergic reactions can be treated immediately.

You will be observed for at least 30 minutes by your doctor or nurse after each administration.

If you received too much

Diaphragms are given by a qualified person. It is unlikely that you will get too much. Your dose and your blood will be controlled to prevent iron from accumulating in your body.

4. Possible side effects

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

Allergic reactions

Contact your doctor immediately if you experience any of the following signs and symptoms that may indicate a severe allergic reaction: swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing, and chest pain, which may be a sign of a potentially serious allergic reaction called Kuoni’s syndrome.

Very common (affects more than 1 user in 10):

  • no

Common (affects less than 1 user in 10 and more than 1 user in 100):

  • no

Uncommon (affects 1 to 10 users in 1,000):

  • dimsyn
  • numbness
  • huskiness
  • nausea, vomiting, constipation, pain in and around the abdomen
  • cramps
  • hypersensitivity ( redness, itching, rash, shortness of breath)
  • feeling hot (or fever)
  • tenderness and swelling around the injection site

Rare (affects 1 to 10 users in 10,000):

  • heart rhythm disorders
  • chest pain
  • unconsciousness
  • seizures
  • dizziness, restlessness, fatigue
  • diarrhea, sweating, trembling
  • angioedema (severe allergic reaction causing swelling of the face and throat)
  • pain in muscles or joints
  • low blood pressure with the mental impact

Very rare (affects less than 1 user in 10,000):

  • slow pulse in the fetus
  • palpitation
  • the lower number of red blood cells than usual (seen during blood tests)
  • headache
  • strange feeling in the skin
  • transient deafness
  • high blood pressure
  • acute and severe allergic reaction

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

  • Flu-like illness 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.

If you get any side effects, talk to your doctor. This includes any side effects not mentioned in this leaflet.

5. How to store Diafer

Keep diapers out of the reach and sight of children.

Do not freeze.

Healthcare professionals ensure that the product is stored and disposed of properly. Do not use this medicine after the expiry date which is stated on the ampoule and carton. EXP is an abbreviation for the expiration date. The expiration date is the last day of the specified month.

6. Contents of the packaging and other information

Content declaration

The active substance in Diafer is iron (III) derisomaltose. One milliliter solution contains 50 mg of iron in the form of iron (III) derisomaltose. One ampoule of 2 ml contains 100 mg of iron in the form of ferric derisomaltose.

The other ingredients are water for injections, sodium chloride, sodium hydroxide ( pH regulator), and hydrochloric acid ( pH regulator).

What the medicine looks like and the contents of the pack

Diafer is a dark brown solution for injection in a glass ampoule.

Available in the following pack sizes:

Pack sizes for ampoules: 1 x 2 ml, 5 x 2 ml, 10 x 2 ml, 25 x 2 ml

Marketing Authorization Holder and Manufacturer

Pharmacosmos A / S

Roervangsvej 30

DK-4300 Holbaek

Denmark

Tel .: +45 59 48 59 59

Fax: +45 59 48 59 60

Email Address: info@pharmacosmos.com

Muhammad Nadeem

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