Magnetolux 469mg/ml (500micromol/ml) solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

gadopentetic acid (gadopentetate dimeglumine)

Available from:

Sanochemia Pharmazeutika AG

ATC code:

V08CA01

INN (International Name):

gadopentetic acid (gadopentetate dimeglumine)

Dosage:

469mg/ml (500micromol/ml)

Pharmaceutical form:

solution for injection

Units in package:

(1) glass vial 20ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-02-20

Patient Information leaflet

1
FOR REGISTRATION AND TRANSLATION IN THE SCIENTIFIC CENTRE OF DRUG AND
MEDICAL TECHNOLOGY EXPERTISE OF ARMENIA
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAGNETOLUX 500 MICROMOL/ML, SOLUTION FOR INJECTION
Gadopentetate dimeglumine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you personally and you should
not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Magnetolux is and what it is used for
2.
Before you are given Magnetolux
3.
How to use Magnetolux
4.
Possible side effects
5.
How to store Magnetolux
6.
Further information
1.
WHAT MAGNETOLUX IS AND WHAT IT IS USED FOR
Magnetolux contains gadopentetate dimeglumine, a product which
enhances contrast.
This medicine is for diagnostic use only.
Magnetolux is used in examinations with Magnetic Resonance Imaging
(MRI).
Magnetolux is used during cranial (head), spinal and whole body MRI
scans including head and
neck region, the chest including heart and female breast, the belly
including pancreas and liver, the
kidneys, the pelvis including prostatic gland, bladder and womb, the
muscles and the bones.
It may be used to facilitate the visualization, detection and
characterisation of_ _several different
types of tumours (growths) or lesions in the head, spine and various
sites of the body.
In addition the visualisation of all blood vessels (MR-angiography) is
possible (with exception of the
arteries of the heart), especially for diagnosis of narrowing or
obstructions of the vessels.
The blood supply to the heart muscle under stress conditions, for
example induced by drugs, can
be measured and viability of the heart muscle can be diagnosed
("delayed enhancement").
2.
BEFORE YOU ARE

Summary of Product characteristics

MAGNETOLUX
®
SUMMARY OF PRODUCT CHARACTERISTICS
the region to be investigated the maximum
dose may be necessary in adults to visualize
blood vessels (e.g. angiography).
Maximum dose: 0.6 ml/kg body weight in
adults or 0.4 ml/kg body weight in children.
SPECIAL POPULATIONS
RENAL IMPAIRMENT
Magnetolux is contraindicated in patients with
severe renal impairment (GFR < 30 ml/min/
1.73 m
2
) and in patients in the perioperative
liver transplantation period (see section 4.3).
Magnetolux should only be used after careful
risk/benefit evaluation in patients with moderate
renal impairment (GFR 30 - 59 ml/min/1.73 m
2
) at
a dose not exceeding 0.2 ml/kg body weight
(see section 4.4). More than one dose should
not be used during a scan. Because of the lack
of information on repeated administration,
Magnetolux injections should not be repeated
unless the interval between injections is at
least 7 days. NEONATES UP TO 4 WEEKS OF AGE AND INFANTS
UP TO 1 YEAR OF AGE
Magnetolux is contraindicated in neonates
up to 4 weeks of age (see section 4.3). Due
to immature renal function in infants up to
1 year of age, Magnetolux should only be used
in these patients after careful consideration at
a dose not exceeding 0.2 ml/kg body weight.
More than one dose should not be used dur-
ing a scan. Because of the lack of informa-
tion on repeated administration, Magnetolux
injections should not be repeated unless the
interval between injections is at least 7 days.
The required dose of Magnetolux should be
administered by hand to avoid overdosage
by mistake and must not be administered in
combination with an autoinjector.
Please refer also to section 4.4 for Special
Warnings and Precautions (newborns and
infants).
ELDERLY (AGED 65 YEARS AND ABOVE)
No dosage adjustment is considered necessary.
Caution should be exercised in elderly patients
(see section 4.4).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to
any of the excipients.
Magnetolux is contraindicated in patients with
severe renal impairment (GFR < 30 ml/min/
1.73 m