Luminity 225microlitres1.5ml solution for dispersion for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Perflutren-containing lipid microspheres

Available from:

Lantheus MI UK Ltd

INN (International Name):

Perflutren-containing lipid microspheres

Dosage:

150microlitre/1ml

Pharmaceutical form:

Solution for dispersion for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LUMINITY 150 MICROLITRES/ML GAS AND SOLVENT FOR DISPERSION FOR
INJECTION/INFUSION
perflutren
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Luminity is and what it is used for
2.
What you need to know before you use Luminity
3.
How to use Luminity
4.
Possible side effects
5.
How to store Luminity
6.
Further information
1.
WHAT LUMINITY IS AND WHAT IT IS USED FOR
Luminity is an ultrasound contrast agent that contains microspheres
(tiny bubbles) of
perflutren gas as the active substance.
Luminity is for diagnostic use only. It is a contrast agent (a
medicine that helps to make
internal body structures visible during imaging tests).
Luminity is used in adults to obtain a clearer scan of the chambers of
the heart, especially of
the left ventricle, during echocardiography (a diagnostic test where
an image of the heart is
obtained using ultrasound). Luminity is used in patients with
suspected or confirmed coronary
artery disease (obstruction of the blood vessels supplying the heart
muscle), when the image
obtained with non-contrast echocardiography is not optimal.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LUMINITY
_ _
DO NOT USE LUMINITY
-
if you are allergic to perflutren or any of the other ingredients of
Luminity.
(listed in section 6).
If you have had an allergic reaction in the past with Luminity or any
other ultrasound contrast
agent tell your doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Luminity
- if you have been told you have a heart shunt
- if you have severe heart or lung diseases or if you need mechanical
help to breathe
- if you have an artificial valve in your h

Summary of Product characteristics

OBJECT 1
LUMINITY 150 MICROLITRES/ML GAS AND SOLVENT FOR
DISPERSION FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 22-May-2018 | Lantheus MI
UK Limited
1. Name of the medicinal product
Luminity 150 microlitres/ml gas and solvent for dispersion for
injection/infusion
2. Qualitative and quantitative composition
Each ml contains a maximum of 6.4 x 10
9
perflutren-containing lipid microspheres, with a mean diameter
range of 1.1-2.5 micrometres (μm). The approximate amount of
perflutren gas in each ml is 150
microlitres (μl).
Excipient(s) with known effect
Each ml contains 2.679 mg sodium
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gas and solvent for dispersion for injection/infusion
Colourless, uniformly clear to translucent liquid.
4. Clinical particulars
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
Luminity is an ultrasound contrast-enhancing agent for use in adult
patients in whom non-contrast
echocardiography was suboptimal (suboptimal is considered to indicate
that at least two of six segments
in the 4- or 2-chamber view of the ventricular border were not
evaluable) and who have suspected or
established coronary artery disease, to provide opacification of
cardiac chambers and improvement of left
ventricular endocardial border delineation at both rest and stress.
4.2 Posology and method of administration
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 perflutre