DIAFER Solution for injection Ref.[27657] Active ingredients:

Posology

Diafer may be administered as an up to 200 mg dosage with a maximum weekly administration of 1000 mg. If higher doses than 200 mg of iron are needed, other iron medicinal products intended for intravenous use should be used.

The iron dose must be individualised based on the clinical response to treatment including evaluation of haemoglobin, ferritin and tranferrin saturation, concommittant treatment with an erythropoiesis stimulating agent (ESA) and the dosis of ESA treatment. Targets may vary from patient to patient and depending on local guidelines.

Maintenance therapy with iv iron treatment may be given as small doses administered at regular intervals to maintain iron status tests stable within specific limits with the intent of avoiding development of iron deficiency or decline of iron test parameters below specific levels.

Paediatric population

Diafer is not recommended for use in children and adolescents <18 years due to insufficient data on safety and efficacy in children.

Method of administration

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

Diafer 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 Diafer injection (see section 4.4).

Adults and the elderly

Diafer can be administered either as an intravenous bolus injection or during a haemodialysis session directly into the venous limb of the dialyser. It may be administered undiluted or diluted in up to 20 ml sterile 0.9% sodium chloride.

Diafer should not be administered concomitantly with oral iron preparations, since the absorption of oral iron might be decreased (see section 4.5).

The ferric derisomaltose in Diafer has a low toxicity. The preparation is well tolerated and has a minimal risk of accidental overdosing.

Large doses of parenteral iron (500 mg or more) have been reported to give a brown colour to serum from a blood sample drawn four hours after administration.

Overdose may lead to accumulation of iron in storage sites eventually leading to haemosiderosis. Monitoring of iron parameters such as serum ferritin may assist in recognising iron accumulation. Supportive measures such as chelating agents can be used.

30 months.

Shelf life after first opening of the container (undiluted):

From a microbiological point of view the product should be used immediately.

Shelf life after dilution with sterile 0.9% sodium chloride:

Chemical and physical in-use stability has been demonstrated for 48 hours at 30°C in dilutions with up to 20 ml sterile 0.9% sodium chloride.

From a microbiological point of view, unless the method of opening/ reconstitution/ dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of user.

Do not freeze.

For storage conditions after first opening or after dilution of the medicinal product, see section 6.3.

Type 1 glass ampoule.

Pack sizes: 1 × 2 ml, 5 × 2 ml, 10 × 2 ml, 25 × 2 ml.

Not all pack sizes may be marketed.

Inspect ampoules visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution.

Diafer is for single use only and any unused solution or waste material should be disposed of in accordance with local requirements.

Diafer must only be mixed with sterile 0.9% sodium chloride. No other intravenous dilution solutions should be used. No other therapeutic agents should be added. For dilution instructions, see section 4.2.

The diluted solution for injection should be visually inspected prior to use. Use only clear solutions without sediment.