RAUTEVENE Solution for injection Ref.[51237] Active ingredients: Iron sucrose

RAUTEVENE should not be administered in combination with oral iron preparations.

RAUTEVENE must not be mixed with other medicines for simultaneous administration.

The only recommended diluent for an infusion is a 0,9% m/v sodium chloride solution.

RAUTEVENE is for single use only – Please discard any unused portion.

Ampoules should be visually inspected for damage before use and only those with a sediment free solution may be used.

From a microbiological point of view, the product should be used immediately after first opening the container or after dilution with sterile 0,9% m/v sodium chloride.

Residual solvents must be discarded, once the ampoule has been opened.

Administration

RAUTEVENE must be administered by slow intravenous injection, by an intravenous drip infusion or, in patients receiving haemodialysis, into the venous limb of the dialyser (see Warnings and special precautions).

RAUTEVENE is a strongly alkaline solution and must never be administered by the subcutaneous or intramuscular route.

Paravenous leakage must be avoided because leakage of RAUTEVENE at the injection site may lead to pain, inflammation, tissue necrosis, and brown discolouration of the skin.

RAUTEVENE is not suitable for intramuscular use or for TDI (Total Dose Infusion).

TEST DOSE:

Before administration of the first therapeutic dose of RAUTEVENE in all patients, a test dose of 1 to 2,5 ml RAUTEVENE (20 to 50 mg iron) should be given by the chosen method of administration (see below).

If no adverse reaction occurs within a waiting period of at least 15 minutes after administration, the remaining portion of the initial dose may be given.

Monitor patients carefully for signs and symptoms of hypersensitivity reactions during and following each administration of RAUTEVENE.

RAUTEVENE should only be administered in an environment where full resuscitation facilities can be assured and when staff trained to evaluate and manage anaphylactic reactions is immediately available. The patient should be observed for adverse effects for at least 30 minutes following each RAUTEVENE injection (see Warnings and special precautions).

Infusion

The content of one ampoule has to be diluted exclusively in 100 ml of sterile 0,9 % m/v sodium chloride solution, immediately prior to infusion (i.e. 2 ampoules in 200 ml sterile 0,9% m/v NaCl).

The first 25 mg of iron (i.e. 25 ml of solution) should be infused as a test dose over a period of 15 minutes (see above TEST DOSE). If no adverse reaction occurs during this time then the remaining portion of the infusion should be given.

Dilution must take place immediately prior to infusion and the solution should be administered as follows:

• 100 mg iron (5 ml RAUTEVENE) in at least 15 minutes
• 200 mg iron (10 ml RAUTEVENE) in at least 30 minutes

Intravenous injection

As an intravenous injection RAUTEVENE must be administered slowly at a rate of 1 ml undiluted solution per minute (i.e. 5 minutes per ampoule), not exceeding 2 ampoules RAUTEVENE (200 mg iron) per injection. Before administering a slow intravenous injection, a test dose of 1 ml (20 mg of iron) should be injected slowly over a period of 1 to 2 minutes.

If within 15 minutes of completing the test dose no adverse event occurs, the remaining portion of the injection may be given.

Injection into dialyser

RAUTEVENE may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.

Dosage

Calculation of dosage

Adults and the elderly

The total cumulative dose of RAUTEVENE is determined by the haemoglobin level and body weight.

The dose and dosage schedule for RAUTEVENE must be individually estimated for each patient based on a calculation of the total iron deficit.

Total iron deficit [mg] = body weight [kg] x (target Hb – actual Hb) [g/dl] x 2,4* + depot iron [mg].

Below 35 kg weight: Target Hb = 13 g/dl resp. depot iron = 15 mg/kg body weight

Above 35 kg body weight: Target Hb = 15 g/dl resp. depot iron = 500 mg * Factor 2,4 = 0,0034 × 0,07 × 1000 × 10

Where:

0,0034 = Iron content of haemoglobin = 0,34%

0,07 = Blood volume = 7% of body weight

1000 = Factor = conversion from g to mg

10 = Factor = conversion from g/dl to g/l

TOTAL NUMBER OF RAUTEVENE AMPOULES TO BE ADMINISTERED:

Total ampoules of RAUTEVENE to be administered = Total iron deficit (mg) / 100 mg

The total single dose must not exceed 200 mg of iron given not more than three times per week. If the total necessary dose exceeds the maximum allowed single dose, then the administration has to be split.

Children

RAUTEVENE is not recommended for use in children since the use of RAUTEVENE in children has not been adequately studied.

Known symptoms of overdosage and particulars of its treatment

Overdosage can cause acute iron overloading which may manifest itself as haemosiderosis.

Particular caution should be exercised to avoid iron overload where anaemia, non-response to treatment, has been incorrectly diagnosed as iron deficiency anaemia (see Contraindications).

Overdosage should be treated, if required, with an iron chelating agent.

Store at or below 25°C, in the original carton until required for use.

Do not refrigerate or freeze.

Solution for injection: Once the ampoules have been opened they should be used immediately.

Concentrate for solution for infusion: Once prepared (diluted), the solution for infusion should be used immediately.

5 ml clear glass ampoules in packs of 5 ampoules.

KEEP OUT OF REACH OF CHILDREN.