50 mg / ml solution for injection / infusion, 
iron (III)

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

In this leaflet you will find information about: 
1. WHAT COSMOFER IS AND WHAT IT IS USED FOR 
2. WHAT YOU SHOULD KNOW BEFORE YOU ARE GIVEN COSMOFER 
3. HOW COSMOFER IS GIVEN 
4. POSSIBLE SIDE EFFECTS 
5. HOW TO 
COSMOFER SKAN FAN FNAFEN

1. WHAT COSMOFER IS AND WHAT IT IS USED FOR

Cosmofer contains a combination of iron and dextran (a long chain of sugar molecules). The type of iron found in Cosmofer is the same as that found naturally in the body and is called ferritin. This means that you can inject Cosmofer in high doses.

Cosmofer is given at low iron values ​​(sometimes called iron deficiency) if:

  • you can not take iron preparations by mouth, for example, because you can not tolerate it
  • you have taken iron preparations by mouth and it has not had an effect
  • your doctor thinks that a fast iron supply is needed to build up iron stores.

2. WHAT YOU SHOULD KNOW BEFORE YOU ARE GIVEN COSMOFER

You must not be given Cosmofer:

  • 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 anemia that is not caused by iron deficiency e.g. hemolytic anemia
  • if you have too much iron in your body or a disorder in your body’s use of iron
  • if you have a liver diseases such as cirrhosis or hepatitis
  • in case of bacterial or viral infection
  • in kidney diseases such as acute renal failure

Warnings and cautions

Talk to your doctor or nurse before receiving Cosmofer:

Children

Cosmofer is intended for adults only. It should not be given to children under 14.

Other drugs and Cosmofer

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes over-the-counter medications and herbal remedies. This is because Cosmofer can affect the effects of other agents. Some other medicines can also affect the effect of Cosmofer. In particular, tell your doctor or nurse if you are taking any of the following:

  • vitamins and minerals
  • agents containing iron and taken orally. Iron should not be taken by mouth until five days after the end of Cosmofer treatment.

Pregnancy and breastfeeding

Cosmofer has 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.

Breast-feeding

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

Driving and using machines

Ask your doctor if you can drive and use machines after receiving Cosmofer.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Blood tests 
Cosmofer can affect the results of certain blood tests, eg bilirubin, and calcium. Therefore, tell your doctor if blood samples are taken during treatment with Cosmofer.

3. HUR COSMOFER GES

Your doctor or nurse will give Cosmofer via intravenous infusion or slow intravenous injection or you can get it as an injection into a muscle. Cosmofer is 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.

Dose one is based on iron values ​​( hemoglobin ) and your body weight. Your doctor will calculate the dose for you. Cosmofer is usually given two or three times a week.

If you use more Cosmofer than you should

A trained and educated person will give you Cosmofer. It is unlikely that you will get too much. They will control the dose so that not too much iron is stored in the body. If you suspect that you have been given too much medicine, talk to your doctor or nurse immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cosmofer can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Allergic reactions

Contact your doctor immediately if you experience any of the following signs and symptoms that may indicate a severe allergic reaction: shortness of breath, hives, swelling, rash, itching, nausea and chills, and chest pain, which may be a sign of a potentially severe allergic reaction. called Kouni’s syndrome.

More severe allergic reactions may occur within a few minutes of starting treatment (affects less than 1 in 10,000 patients treated) 
Signs of this may include:

  • sudden difficulty breathing
  • severe cardiovascular problems ( cardiovascular collapse)
  • deaths have been reported.

Delayed allergic reactions have also been reported. Such can occur a few hours up to four days after administration one. Signs of this may include:

  • pain in joints or muscles
  • sometimes fever.

Contact your doctor if you notice such symptoms.

Other side effects include

Uncommon (affects less than 1 in 100 people)

  • abdominal pain and vomiting
  • blurred vision
  • feeling of warmth
  • cramps
  • numbness

Rare (affects less than 1 in 1,000 people)

  • unconsciousness
  • mental impact
  • seizures
  • dizziness, restlessness, fatigue
  • low blood pressure
  • angioedema (a type of severe allergic reaction, may cause swelling)
  • irregular heartbeat, fast heartbeat, chest pain
  • diarrhea, sweating, and tremors.

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

  • the low number of red blood cells (seen during blood tests)
  • headache
  • ant crawls
  • high blood pressure
  • transient deafness
  • palpitation
  • during pregnancy; It has been reported that the fetal heart rate may slow down

Not known

  • 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

Other side effects that have been reported are that people with rheumatoid arthritis may have more joint pain.

Possible side effects after injection into a vein 
If you get Cosmofer injected into a vein, local reactions such as tenderness and swelling may occur. Inflammation of the vein has also been reported.

Possible side effects after injection into a muscle 
When injecting Cosmofer into a muscle, the following may occur; discoloration of the skin, bleeding, sterile abscesses, tissue damage (tissue death or wasting), and pain.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. HOW TO STORE COSMOFER

No special storage instructions. Do not freeze.

Check the ampoule for precipitation or damage before use. Use only the ampoules with a homogeneous solution and without precipitation.

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 carton and ampoule after EXP:

The expiration date is the last day of the specified month.

Keep out of sight and reach of children.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

Content declaration

  • The active substance is an iron (III) hydroxide dextran complex.
  • The other ingredients are water for injections, sodium hydroxide ( pH regulator), and hydrochloric acid ( pH regulator).

One 2 ml ampoule contains 100 mg of iron (III), one 5 ml ampoule contains 250 mg of iron (III) and one 10 ml ampoule contains 500 mg of iron (III).

What the medicine looks like and the contents of the pack

Cosmofer is packaged in glass ampoules and the contents are brown. The packages are available in sizes 5 x 2 ml, 10 x 2 ml, 10 x 5 ml, 2 x 10 ml and 5 x 10 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 info@pharmacosmos.com

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

Denmark: CosmoFer

Estonia: CosmoFer

Germany: CosmoFer

Ireland: CosmoFer

Latvia: CosmoFer

Lithuania: CosmoFer

Luxembourg: CosmoFer

The Netherlands: CosmoFer

Norway: Cosmofer

Portugal: Cosmofer

Spain: CosmoFer

United Kingdom: CosmoFer

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Muhammad Nadeem

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