100 mg / ml Solution for injection / infusion
Iron
WHAT MONOPS ARE AND WHAT IT IS USED FOR
Monofer contains a combination of iron and derisomaltose (a chain of sugar molecules). The type of iron found in Monofer is the same as that found naturally in the body and is called “ferritin”. This means that Monofer can be injected in high doses.
Monofers are given at low iron levels (sometimes called “iron deficiency” or “iron deficiency anemia”) if:
- Oral iron does not work or you can not tolerate it
- Your doctor believes that a fast iron supply is needed to build up iron stores
BEFORE YOU USE MONOFER
You must not be given Monofer:
- 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 (hypersensitivity) reactions to other injectable iron preparations
- if you have anemia that is not caused by iron deficiency
- if you have too much iron in your body or a disorder in your body’s use of iron
- if you have liver problems such as cirrhosis
Warnings and cautions
Talk to your doctor or nurse before giving Monofer:
- 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
- if you have an ongoing bacterial infection in your blood
- if you have impaired liver function
Improper administration of Monofer may cause product leakage at the injection site, which may lead to skin irritation and possible prolonged brown discoloration. The injection must be stopped immediately if this occurs.
Children and young people
Monofers are for adults only. It should not be given to children and adolescents.
Other medicines and Monofer
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If Monofer is given together with oral iron preparations, it may reduce the absorption of oral iron.
Pregnancy, breastfeeding and fertility
Monofers 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 breastfeeding, talk to your doctor before giving Monofer. Monofer is unlikely to pose a risk to the breast-fed baby.
Driving and using machines
Monofer is unlikely to impair the ability to drive and use machines.
HOW TO USE MONOFER
Before administration, your doctor will take a blood sample to determine which dose of Monofer you need.
Your doctor or nurse will give Monofer via injection or infusion into a vein.
- Monofer can be given as an intravenous injection up to 500 mg, no more than three times a week.
- Monographs can be given at the same time as dialysis is performed.
- Monofer can be given as an intravenous infusion of up to 20 mg / kg body weight or as a weekly infusion until the full dose has been administered.
Monofer 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.
If you are given too much Monofer
Monographs are provided by qualified healthcare professionals. It is unlikely that you are given too much. Healthcare professionals will monitor your dosage and your blood to avoid iron overload in the body.
POSSIBLE SIDE EFFECTS
Like all medicines, Monofer can cause side effects, although not everybody gets them.
Allergic reactions
Contact your doctor or nurse 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 to a potentially serious reaction known as Kuoni’s syndrome.
Common (may affect up to 1 in 10 people)
- Nausea
- Skin reactions at or near the injection site including reddening of the skin, swelling, burning sensation, pain, bruising, discoloration, leakage of tissue around the infusion site, irritation
- Rash
Uncommon (may affect up to 1 in 100 people)
- Hypersensitivity reaction with potential shortness of breath and bronchospasm
- Headache
- Numbness
- Taste changes
- Dimsyn
- Unconsciousness
- Dizziness
- Fatigue
- Increased heart rate
- Low or high blood pressure
- Chest pain, back pain, muscle or joint pain, muscle spasms
- Stomach pain, vomiting, indigestion, constipation, diarrhea
- Itching , hives , dermatitis
- Heat redness, sweating, fever, chills, chills
- Low levels of phosphate in the blood
- Infection
- Increased content of liver enzymes
- Local inflammation in a friend
- Deposition of skin
Rare (may affect up to 1 in 1,000 people)
- Irregular heartbeat
- Huskiness
- Seizures
- Shaking
- Changed mental status
- Feeling sick
Influenza-like illness (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.
Unknown frequency
- Discoloration of skin in other places on the body than the injection site
HOW TO STORE MONOFER
Keep out of sight and reach of children.
Use before the expiry date which is stated on the ampoule or vial after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions. Healthcare professionals ensure that the product is stored and disposed of properly.
CONTENTS OF THE PACKAGING AND OTHER INFORMATION
Content declaration
The active substance in Monofer is iron (in the form of iron (III) derisomaltose, a carbohydrate complex). The iron concentration in the product is 100 mg per milliliter. The other ingredients are sodium hydroxide ( pH regulator), hydrochloric acid ( pH regulator), and water for injections.
What the medicine looks like and contents of the pack
Monofer is a dark brown, opaque solution for injection/infusion.
Monofer is supplied in glass ampoules or glass vials containing:
- 1 ml solution contains 100 mg of iron in the form of iron (III) derisomaltose
- 2 ml solution contains 200 mg of iron in the form of iron (III) derisomaltose
- 5 ml of solution contains 500 mg of iron in the form of iron (III) derisomaltose
- 10 ml of solution contains 1000 mg of iron in the form of iron (III) derisomaltose
Available in the following pack sizes:
Pack sizes for ampoules:
5 x 1 ml, 10 x 1 ml, 5 x 2 ml, 10 x 2 ml, 2 x 5 ml, 5 x 5 ml, 2 x 10 ml, 5 x 10 ml
Pack sizes for vials:
1 x 1 ml, 5 x 1 ml, 10 x 1 ml, 5 x 2 ml, 10 x 2 ml, 1 x 5 ml, 2 x 5 ml, 5 x 5 ml, 1 x 10 ml, 2 x 10 ml, 5 x 10 ml
Not all pack sizes may be marketed.
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
Bulgaria: Monofer
Denmark: Monofer
Estonia: Monofer
Finland: Monofer
United Kingdom: Monofer
Greece: Monofer
Ireland: Moreover
Iceland: Monofer
Italy: Monoferric
Croatia: Monofer
Latvia: Monofer
Lithuania: Monofer
Luxembourg: Moreover
Netherlands: Monofer
Norway: Monofer
Poland: Moreover
Portugal: Monofar
Romania: Monofer
Slovenia: Monofer
Spain: Monoferro
Czech Republic: Moreover
Germany: Monofer
Austria: Monofer