Venofer IV Iron Sucrose


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Venofer IV Iron Sucrose


Vifor (International) Inc.

VENOFER 20 mg/ml injection

[Iron sucrose (iron (III) hydroxide sucrose complex)]

Please read this leaflet carefully. It contains a summary of the information available on Venofer 20 mg/ml injection which is part of your hospital treatment. If after reading this you have any questions ask the doctor or nurse.

In this leaflet 1. What Venofer is and what it is used for. 2. Before you receive Venofer. 3. How Venofer is administered. 4. Possible side effects of Venofer. 5. Storing Venofer. What Venofer is and what it is used for

Venofer is a sterile, dark brown, non transparent, aqueous solution of iron intended to be used only for intravenous injection or as a concentrate for solution for infusion which contains the active ingredient iron as a solution of iron sucrose (iron(III)-hydroxide sucrose complex). The solution also contains sodium hydroxide and water for injection.

Venofer is supplied in glass ampoules which contain 5ml of solution which is equivalent to 100mg of iron. The product is supplied in cardboard boxes each containing 5 ampoules.

Marketing authorisation holder: Vifor France SA 123, rue Jules Guesde 92300 Levallois-Perret France Manufacturer: ALTANA Pharma AG Byk-Gulden-Str. 2 D-78467 Konstanz Germany

Venofer provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency.

The product is intended for use only in the following circumstances:

in a patient known to be intolerant to iron preparations taken by mouth, in a patient where there is a specific clinical need to deliver iron rapidly to the iron stores, in a patient with active inflammatory bowel disease where iron preparations taken by mouth are ineffective or not tolerated. Before you receive Venofer You should be aware that: a blood test should have been carried out to ensure treatment with this medicine is appropriate, the product should not be given at the same time as other iron preparations taken by mouth, Venofer should not be administered during the first three months of pregnancy and it should be administered with caution during the fourth to ninth month. intramuscular or intravenous iron preparations can cause severe allergic or anaphylactoid reactions which may be potentially fatal. Therefore the medicine should only be given if there are appropriate medical facilities immediately available, allergic reactions, sometimes involving joint pain, have been more commonly observed when the recommended dose is exceeded. the product is not approved for use in children. You should not receive Venofer if: you are known to be sensitive (allergic) to any iron preparations intended for intramuscular or intravenous administration, you have a history of asthma, eczema or other atopic allergies because then you are more susceptible to experience allergic reactions, your anaemia is not due to a shortage of iron, you have a history of cirrhosis or hepatitis or have increased liver enzymes, you have any acute or chronic infections because these may be worsened by giving intramuscular or intravenous iron. How Venofer is administered

Venofer should only be administered by the intravenous route by slow intravenous injection or by intravenous drip infusion which is the preferred route. The product must not be administered by intramuscular or subcutaneous injection. For intravenous infusion the 5ml ampoule (100mg iron) should be diluted in 0.9% saline. No other intravenous dilution solutions or therapeutic agents should be used.

Before receiving your first dose, you should receive a small "test dose" which may help reduce the chance of a serious reaction occurring.

The total dose of Venofer you require is given in single doses of one ampoule not more than three times per week. This may be increased to two ampoules not more than three times per week depending on the severity of your iron deficiency. Your doctor will take responsibility for calculating the appropriate dose and frequency of injections.

Possible side effects of Venofer

The most commonly reported side effects of Venofer are temporary changes in taste, low blood pressure, fever, shivering, injection site reactions and nausea. Non-serious allergic reactions occurred rarely. In general, allergic reactions are potentially the most serious side effects. In these reactions, very rarely symptoms of low blood pressure, facial swelling and difficulty in breathing can be involved. See ‘Before you receive Venofer’ section 2.

The following possible side effects have been reported following the administration of Venofer:

Nervous system disorders

Common (greater than or equal to 1% and less than 10%): temporary changes in taste (in particular metallic taste).

Uncommon (greater than or equal to 0.1% and less than 1%) : headache; dizziness.

Rare (greater than or equal to 0.01% and less than 0.1%): tingling, “pins and needles”

Isolated cases: decreased alertness, light-headed feeling, confusion.

Heart and blood vessel disorders

Uncommon: low blood pressure and collapse; rapid heart beat, palpitations.

Lungs and airways disorders

Uncommon: wheezing, difficulty in breathing.

Stomach and intestine disorders

Uncommon: nausea; vomiting; abdominal (e.g. stomach) pain; diarrhoea.

Skin disorders

Uncommon: itching; hives; rash, redness.

Muscle, bone and joint disorders

Uncommon: muscle cramps, muscle pain.

Isolated cases: swelling of joints.

General disorders and administration site disorders

Uncommon: fever, shivering, flushing; chest pain and chest tightness. Burning, swelling and similar reactions (sometimes involving veins) around the site of injection.

Rare: allergic reactions (rarely involving joint pain); swelling of hands and feet; tiredness, weakness; general feeling of illness.

Isolated cases: face and tongue swelling.

Storing Venofer

Venofer is to be kept out of the reach and sight of children.

The product should not be used after the expiry date printed on the label. The ampoules should be stored below 25°C in the original cartons. The product should not be frozen. Once the ampoules have been opened they should be used immediately. After dilution with 0.9% saline the solution should be used immediately or within 3 hours if stored at room temperature.

Further information

This leaflet does not tell you everything about Venofer. If you have any questions or are not sure about receiving treatment with this medicine, then ask your doctor. Please keep this leaflet until your course of treatment with Venofer has been completed.

This Leaflet was approved:

United Kingdom: December 2003

Venofer IV Iron Sucrose

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