20 mg iron/ml Injection fluid, solution or concentrate for infusion fluid, solution
iron sucrose
What Venofer is and what it is used for
Venofer is a medicine that contains iron.
Medicines containing iron are given to people who do not have sufficient amounts of iron in their bodies. This is called an iron deficiency.
Venofer is given when:
- you cannot take iron by mouth, for example, because you feel ill if you take iron tablets,
- you have taken iron by mouth without any effect.
What you need to know before Venofer is given to you
You must not be given Venofer:
- if you are allergic (hypersensitive) to the product or any other ingredient in this medicine (listed in section 6),
- if you have had severe allergic reactions to other injectable iron preparations,
- if your anemia is due to something other than a lack of iron,
- if you have too much iron in the body or a disturbance in the body’s utilization of iron.
You cannot receive Venofer if any of the above conditions apply to you. If you are not sure, talk to your doctor before receiving Venofer.
Warnings and precautions
Talk to your doctor or nurse before you are given Venofer:
- 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,
- if you have an infection,
- if you have liver problems.
If you are unsure about infection or liver problems, talk to your doctor or pharmacist before receiving Venofer.
Other medicines and Venofer
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines such as herbal medicines.
Namely, Venofer can affect the effectiveness of other medicines and other medicines can affect Venofer.
You should be especially careful to talk to your doctor or pharmacist if you are already taking:
- Medicines containing iron are taken by mouth as these preparations may be less effective if taken at the same time as Venofer.
Pregnancy and breastfeeding
Venofer has not been tested in women who are in the first three months of pregnancy. You must tell the 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 whether you should receive this medicine or not.
If you are breastfeeding, consult your doctor before you are given Venofer.
Consult a doctor or pharmacist before using any medicine if you are pregnant or breastfeeding.
Driving ability and use of machinery
You may feel dizzy, confused, or blacked out after receiving Venofer. In this case, you should not drive a car or use machinery. Talk to your doctor if you are unsure.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Venofer contains sodium
Venofer contains up to 7 mg of sodium (the main ingredient in common/table salt) per ml. This corresponds to 0.4% of the maximum recommended daily intake of sodium for adults.
How to get Venofer
The doctor decides how much Venofer you will receive. He/she also determines how often and for how long you need the medicine and takes a blood sample to calculate the dose.
The doctor or nurse gives Venofer in one of the following ways:
- slow injection into a vein – 1 to 3 times a week
- as an infusion (drip) into a vein – 1 to 3 times a week
- during dialysis – it will be delivered into the dialysis machine’s venous tubing
Venofer is given in an environment where allergic reactions can be treated immediately.
You will be observed for at least 30 minutes by the doctor or nurse after each administration.
Venofer is a brown liquid and therefore the injection or infusion solution also looks brown.
Use for children
Venofer is not recommended for use in children.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (uncommon)
If you have an allergic reaction, tell the doctor or nurse immediately. Signs of allergic reactions can be:
- Low blood pressure (you feel dizzy, light-headed, or weak)
- Swelling of the face
- Difficulty breathing
- Chest pain, which can be a sign of a potentially serious allergic reaction called Kuoni’s syndrome.
In some patients, these allergic reactions (rare) can become serious or life-threatening (known as anaphylactoid/anaphylactic reactions).
Tell the doctor or nurse immediately if you think you are having an allergic reaction.
Other side effects include:
Common (may affect up to 1 in 10 users)
- Temporary taste changes (especially metallic taste)
- Low blood pressure or high blood pressure
- Nausea
- Reactions around the injection/infusion site, such as pain, irritation, itching, bleeding, or discoloration after leakage of injection into the skin.
Uncommon (may affect up to 1 in 100 users)
- Headache or dizziness
- Stomach pain or diarrhea
- Vomiting
- Wheezing, difficulty breathing
- Itching, rash
- Spasms, cramps, or pain in the muscles
- Tingling or numbness
- Decreased sense of touch
- Vanities
- Flushing, burning sensation
- Constipation
- Joint pain
- Pain in arms and legs
- Back pain
- Overindulge
- Weakness, fatigue
- Swollen hands and feet
- Pain
- Increased levels of liver enzymes ( ALT, AST , GT) in the blood
- Increased serum ferritin levels.
Rare (may affect up to 1 in 1,000 users)
- Fainting
- Drowsiness, drowsiness
- Rapid heartbeats ( palpitations )
- Changes in the color of your urine
- Chest pain
- Increased sweating
- Fever
- Increased levels of lactate dehydrogenase in the blood.
Other side effects that have been reported (in an unknown number of users) include decreased attention; confusion; unconsciousness; anxiety, tremors, or shaking; swelling of the face, mouth, tongue, or throat that may cause difficulty breathing; slow pulse; rapid pulse; the collapse of the circulatory system; inflammation of the vein that causes a blood clot to form; acute airway narrowing; itching, hives, other skin rashes or redness; cold sweat; general malaise; pallor; sudden life-threatening allergic reactions. Flu-like illness can occur a few hours to several days after injection and is usually characterized by symptoms such as high temperature, and aches and pains in muscles and joints.
How Venofer should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label after EXP.
Store at a maximum of 25°C. Do not freeze. Store the ampoules or vials in the original packaging.
Once the Venofer ampoules or Venofer vials have been opened, they should be used immediately. After dilution with sodium chloride solution, the diluted solution should be used immediately.
Venofer is usually kept by the doctor or hospital for you.
Contents of the packaging and other information
Contents declaration
- The active substance is iron (as iron sucrose). 1 ml contains 20 mg of iron.
- Other ingredients are water for injection and sodium hydroxide.
Appearance and package sizes of the medicine
Venofer is a dark brown, opaque aqueous solution.
Venofer is supplied in the following pack sizes:
- 5 glass ampoules of 5 ml. An ampoule of 5 ml corresponds to 100 mg of iron.
- 5 glass vials of 5 ml. A vial of 5 ml corresponds to 100 mg of iron.
Not all pack sizes may be marketed.
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