ILOMEDIN Solution for infusion Ref.[28118] Active ingredients: Iloprost

ILOMEDIN should be used only under strict monitoring in hospitals or out-patient clinics with adequate facilities.

Pregnancy must be excluded before the start of treatment in women.

ILOMEDIN is administered after dilution as an intravenous infusion over 6 hours daily via a peripheral vein or a central venous catheter. The dose is adjusted according to individual tolerability within the range of 0.5 to 2.0 ng iloprost/kg body weight/min.

The infusion solution should be made up freshly each day to ensure sterility.

The contents of the ampoule and the diluent should be mixed thoroughly.

The blood pressure and heart rate must be measured at the start of the infusion and after every increase of the dose.

During the first 2-3 days, the individually tolerated dose is established. For this purpose, treatment should be started at an infusion rate to deliver 0.5 ng/kg/min. for 30 minutes. The dose should then be increased at intervals of about 30 minutes in steps of 0.5 ng/kg/min. up to 2.0 ng/kg/min. The exact infusion rate should be calculated on the basis of body weight to effect an infusion within the range of 0.5 to 2.0 ng/kg/min (see tables below for use with infusion pump or for use with syringe driver).

Depending on the occurrence of side effects such as headache and nausea or an undesired drop of blood pressure, the infusion rate should be reduced until the tolerable dose is found. If the side effects are severe, the infusion should be interrupted. The treatment should then be continued – usually for 4 weeks – with the dose found to be tolerated in the first 2 to 3 days.

Depending on the infusion technique there are two different dilutions of one ampoule. One of those two dilutions is 10-fold less concentrated than the other (0.2 microgram/mL) and may only be applied with an infusion pump (e.g. Infusomat). On the contrary, the more concentrated solution is applied via a syringe driver (e.g. the Perfusor), see 6.6 Special precautions for disposal and other handling.

Infusion rates (mL/hour) for different doses for use with infusion pump

In general, the ready-to-use infusion solution is infused intravenously by means of an infusion pump (e.g. Infusomat). For instructions for dilution for use with infusion pump, see 6.6 Special precautions for disposal and other handling. In the case of an ILOMEDIN concentration of 0.2 microgram/mL, the required infusion rate should be determined according to the above described scheme to effect a dose within the range of 0.5 to 2.0 ng/kg/min.

The following table can be used to calculate the weight of the patient and the dose to be infused. (Please interpolate to match the patient’s actual body weight, then set the infusion rate to the target dose in ng/kg/min).

Infusion rates (mL/hour) for different doses for use with syringe driver

A syringe driver with a 50mL injection syringe (e.g. the Perfusor) may also be used. For instructions for dilution for use with syringe driver, see 6.6 Special precautions for disposal and other handling.

In the case of an ILOMEDIN concentration of 2 microgram/mL, the required infusion rate should be determined according to the above described scheme to effect a dose within the range of 0.5 to 2.0 ng/kg/min.

The following table can be used to calculate the infusion rate corresponding to the individual weight of the patient and the dose to be infused. (Please interpolate to match the patient’s actual body weight, then set the infusion rate to the target dose in ng/kg/min).

The duration of treatment is up to 4 weeks.

Shorter treatment periods (3 to 5 days) are often sufficient in Raynaud’s phenomenon to achieve improvement over several weeks.

The treatment of primary and secondary pulmonary hypertension (PHT) should be initiated and supervised by a physician experienced in the treatment of this condition. In each individual patient careful titration of the dose should be carried out under close haemodynamic monitoring.

In PHT, the dosage of iloprost should be titrated up to the maximum tolerated dose of 1-8 ng/kg/min.

Continuous infusion over several days is not recommended. This is because of the possible development of tachyphylaxis of platelet effects and the possibility of rebound platelet hyperaggregability at the end of treatment, although no clinical complications associated with these phenomena have been reported.

Patients with renal or hepatic impairment

It should be borne in mind that, in patients with renal failure requiring dialysis and in patients with liver cirrhosis, iloprost elimination is reduced. In these patients a dose reduction (e.g. half the recommended dose) is necessary.

Symptoms of Overdose

Hypotensive reaction might be anticipated as well as headache, flushing, nausea, vomiting and diarrhoea. An increase of blood pressure, bradycardia or tachycardia and limb or back pain might be possible.

Treatment of Overdose

A specific antidote is not known. In the event of myocardial ischaemia provoked by iloprost, the administration of 125 mg aminophylline i.v. has been shown to be an effective countermeasure. Interruption of iloprost administration, monitoring and symptomatic measures are recommended. For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

48 months.

Store all medicines properly and keep them out of reach of children.

Store below 30°C.

Pack of 5 ampoules each containing 0.5 mL concentrate for solution for infusion.

Any unused medicine or waste material should be disposed of in accordance with local requirements.

ILOMEDIN should be used only after dilution. Because of the possibility of interactions, no other medicine should be added to the ready-to-use infusion solution.

The ready-to-use infusion solution must be freshly prepared each day in order to guarantee sterility.

Instructions for dilution

The contents of the ampoule and the diluent should be mixed thoroughly.

Dilution of ILOMEDIN for use with an infusion pump

For this purpose, the contents of an ampoule of 1 mL ILOMEDIN (i.e. 100 micrograms) are diluted with 500 mL of a sterile physiological saline solution or a 5% glucose solution. Or the contents of an ampoule of 0.5 mL ILOMEDIN (i.e. 50 micrograms) are diluted with 250 mL of a sterile physiological saline solution or a 5% glucose solution.

Dilution of ILOMEDIN for use with a syringe driver

In this case, the contents of one ampoule ILOMEDIN of 1 mL (i.e. 100 micrograms) are diluted with 50 mL of sterile physiological saline solution or 5% glucose solution. Or the contents of one ampoule ILOMEDIN of 0.5 mL (i.e. 50 micrograms) are diluted with 25 mL of sterile physiological saline solution or 5% glucose solution.