LUMINITY Gas and solvent for dispersion for injection/infusion Ref.[27908] Active ingredients: Perflutren

Luminity should only be administered by trained physicians with technical expertise in performing and interpreting contrast echocardiograms, and appropriate resuscitation equipment should be available in case of cardiopulmonary or hypersensitivity reactions (see section 4.4).

Posology

Bolus intravenous injection using non-linear contrast imaging technique at rest and stress:

The recommended dose is multiple injections of 0.1 to 0.4 ml of dispersion, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection to maintain optimal contrast enhancement. The total dose of perflutren should not exceed 1.6 ml.

Bolus intravenous injection using fundamental imaging technique at rest:

The recommended dose is 10 microlitre dispersion/kg by slow bolus intravenous injection, followed by a 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. If necessary, a second 10 microlitre dispersion/kg dose followed by a second 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection may be administered 5 minutes after the first injection to prolong contrast enhancement.

Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest:

The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. The rate of infusion should be initiated at 4 ml/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/minute.

Paediatric population

The safety and efficacy of Luminity in children and adolescents below 18 years have not been established. No data are available.

Patients with hepatic impairment

Luminity has not been specifically studied in patients with hepatic impairment. Use in this patient group should be on the basis of a benefit risk assessment by the physician.

Patients with renal impairment

Luminity has not been specifically studied in patients with renal impairment. Use in this patient group should be on the basis of a benefit risk assessment by the physician.

Elderly patients

Luminity has not been specifically studied in elderly patients. Use in this patient group should be on the basis of a benefit risk assessment by the physician.

Method of administration

Intravenous use.

Before administering Luminity, the medicinal product must be activated by using a mechanical shaking device, the Vialmix, see section 6.6.

The clinical consequences of overdose with Luminity are not known. Single doses of up to 100 microlitres dispersion/kg and multiple doses up to 150 microlitres dispersion/kg were tolerated well in Phase I clinical trials. Treatment of an overdose should be directed towards the support of all vital functions and prompt institution of symptomatic therapy.

2 years.

The product should be used within 12 hours of activation. The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation.

After activation: Do not store above 30°C.

Store in a refrigerator (2°C-8°C)

For storage conditions after activation of the medicinal product, see section 6.3.

1.5 ml liquid in clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button.

Pack sizes of 1 or 4 vials.

Not all pack sizes may be marketed.

It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation. Like all parenteral products, the vials must be inspected visually for particulates and vial integrity. Before administering the product, it must be activated by using the Vialmix, a mechanical shaking device. The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.

Luminity is activated by using the Vialmix which has a programmed shaking time of 45 seconds. The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency. It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.

Activation process and administration

• The vial should be activated using the Vialmix. Immediately after activation, Luminity appears as a milky white dispersion.

Note: if the product is allowed to stand for more than 5 minutes after activation, it should be resuspended with 10 seconds of hand agitation prior to syringe withdrawal from the vial. Luminity should be used within 12 hours following activation. The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation, whether stored under refrigeration or at room temperature. Do not store the vial above 30°C following activation.

• The vial should be vented with a sterile syringe needle or a sterile non-siliconised mini-spike before withdrawing the dispersion.
• The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile needle or attached to a sterile non-siliconised mini-spike. When using a needle, it should be positioned to withdraw the material from the middle of the liquid in the inverted vial. No air should be injected into the vial. The product should be used immediately after its withdrawal from the vial.
• Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.

The contents of the vial are intended for single use only.

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