Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042, Paris La Défense Cedex, France Tel. +33 (0)1 41 06 58 90 Fax +33 (0)1 41 06 58 99
Venofer is indicated for the treatment of iron deficiency in the following indications:
The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, TSAT, serum iron, etc.).
(Hb haemoglobin, TSAT transferrin saturation)
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Venofer.
Venofer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Venofer administration (see section 4.4).
The cumulative dose of Venofer must be calculated for each patient individually and must not be exceeded.
The total cumulative dose of Venofer, equivalent to the total iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW). The dose of Venofer must be individually calculated for each patient according to the total iron deficit calculated with the following Ganzoni formula, for example:
Total iron deficit [mg] = BW [kg] x (target Hb – actual Hb) [g/dl] x 2.4* + storage iron [mg]
* Factor 2.4 = 0.0034 (iron content of Hb = 0.34%) x 0.07 (blood volume = 7% of BW) x 1000 (conversion of [g] to [mg]) x 10
Total Venofer to be administered (in ml) = Total iron deficit [mg] / 20 mg iron/ml
Total amount of Venofer (ml) to be administered according to body weight, actual Hb level and target Hb level*:
| BW | Total amount of Venofer (20 mg iron per ml) to be administered | |||
|---|---|---|---|---|
| Hb 6.0 g/dl | Hb 7.5 g/dl | Hb 9.0 g/dl | Hb 10.5 g/dl | |
| 30 kg | 47.5 ml | 42.5 ml | 37.5 ml | 32.5 ml |
| 35 kg | 62.5 ml | 57.5 ml | 50 ml | 45 ml |
| 40 kg | 67.5 ml | 60 ml | 55 ml | 47.5 ml |
| 45 kg | 75 ml | 65 ml | 57.5 ml | 50 ml |
| 50 kg | 80 ml | 70 ml | 60 ml | 52.5 ml |
| 55 kg | 85 ml | 75 ml | 65 ml | 55 ml |
| 60 kg | 90 ml | 80 ml | 67.5 ml | 57.5 ml |
| 65 kg | 95 ml | 82.5 ml | 72.5 ml | 60 ml |
| 70 kg | 100 ml | 87.5 ml | 75 ml | 62.5 ml |
| 75 kg | 105 ml | 92.5 ml | 80 ml | 65 ml |
| 80 kg | 112.5 ml | 97.5 ml | 82.5 ml | 67.5 ml |
| 85 kg | 117.5 ml | 102.5 ml | 85 ml | 70 ml |
| 90 kg | 122.5 ml | 107.5 ml | 90 ml | 72.5 ml |
* Below 35 kg BW: Target Hb = 13 g/dl
35 kg BW and above: Target Hb = 15 g/dl
To convert Hb (mM) to Hb (g/dl), multiply the former by 1.6.
If the total necessary dose exceeds the maximum allowed single dose, then the administration must be divided.
5-10 ml of Venofer (100-200 mg iron) 1 to 3 times a week. For administration time and dilution ratio see “Method of administration”.
The use of Venofer has not been adequately studied in children and, therefore, Venofer is not recommended for use in children.
Venofer must only be administered by the intravenous route. This may be by a slow intravenous injection, by an intravenous drip infusion or directly into the venous line of the dialysis machine.
Venofer must only be diluted in sterile 0.9% m/V sodium chloride (NaCl) solution. Dilution must take place immediately prior to infusion and the solution should be administered as follows:
| Venofer dose (mg of iron) | Venofer dose (ml of Venofer) | Maximum dilution volume of sterile 0.9% m/V NaCl solution | Minimum Infusion Time |
|---|---|---|---|
| 50 mg | 2.5 ml | 50 ml | 8 minutes |
| 100 mg | 5 ml | 100 ml | 15 minutes |
| 200 mg | 10 ml | 200 ml | 30 minutes |
For stability reasons, dilutions to lower Venofer concentrations are not permissible.
Venofer may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml Venofer (200 mg iron) per injection.
Venofer may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.
Overdose can cause iron overload which may manifest itself as haemosiderosis. Overdose should be treated, as deemed necessary by the treating physician, with an iron chelating agent or according to standard medical practice.
Shelf life of the product as packaged for sale: 3 years.
Shelf life after first opening of the container: From a microbiological point of view, the product should be used immediately.
Shelf life after dilution with sterile 0.9% m/V sodium chloride (NaCl) solution: From a microbiological point of view, the product should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution.
Do not store above 25°C. Do not freeze. Store in the original package.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3.
5 ml solution in one ampoule (type I glass) in pack sizes of 5.
2.5 ml solution in one vial (type I glass) in pack sizes of 5.
5 ml solution in one vial (type I glass) in pack sizes of 5.
Not all pack-sizes may be marketed.
Ampoules or vials should be visually inspected for sediment and damage before use. Use only those containing a sediment free and homogenous solution.
Venofer must not be mixed with other medicinal products except sterile 0.9% m/V sodium chloride solution for dilution. For instructions on dilution of the product before administration, see section 4.2.
The diluted solution must appear as brown and clear.
Each ampoule or vial of Venofer is intended for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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