Cosmofer 50 mg/ml solution for injection/infusion, iron (III)
1. WHAT COSMOFER IS AND WHAT IS COSMOFER USED FOR
It contains a combination of iron and dextran (a long chain of sugar molecules). The type of iron found in it is the same as that found naturally in the body and is called ferritin. This means that you can inject it in high doses.
It 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 Medicine:
- 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 disease 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 using:
- If you have previously been allergic to medicines
- If you have systemic lupus erythematosus ( SLE )
- If you have rheumatoid arthritis
- If you have severe asthma, eczema, or other allergies you
Children
Cosmofer injection 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 it 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 its treatment.
Pregnancy And Breastfeeding
Cosmofer injection 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 breastfeeding, talk to your doctor before giving this medicine.
Driving And Using Machines
Ask your doctor if you can drive and use machines after getting this medicine.
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
It can affect the results of certain blood tests, eg bilirubin, and calcium. Therefore, tell your doctor if blood samples are taken during treatment with it.
3. HUR COSMOFER GES
Your doctor or nurse will give Iron Dextran 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. This medicine is usually given two or three times a week.
If You Use More Cosmofer Than You Should
A trained and educated person will guide you about Cosmofer uses. 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 COSMOFER SIDE EFFECTS
Cosmofer infusion side effects
Like all medicines, Cosmofer uses 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 Cosmofer allergic reaction
- Shortness of breath
- Hives
- Swelling
- Rash
- Itching
- Nausea and chills
- Chest pain
which may be a sign of a potentially severe allergic reaction. called Kuoni’s syndrome.
More severe Cosmofer allergic reaction may occur within a few minutes of starting treatment (affects less than 1 in 10,000 patients treated)
Signs of Cosmofer side effects 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. 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 cosmofer side effects (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, that may cause swelling)
- Irregular heartbeat, fast heartbeat, chest pain
- Diarrhea
- Sweating
- 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 it 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 IT
- 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
- It 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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