MULTIHANCE 0.5 M Инъекционный раствор

Содержание инструкции

1. MultiHance 0,5 M injectable solution
   1. WHAT IS MULTIHANCE AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MULTIHANCE
   3. HOW TO USE MULTIHANCE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MULTIHANCE
   6. CONTENT OF THE PACK AND OTHER INFORMATION
2. MultiHance 529 mg/ml injectable solution in pre-filled syringes
   1. WHAT IS MULTIHANCE AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MULTIHANCE
   3. HOW TO USE MULTIHANCE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MULTIHANCE
   6. CONTENT OF THE PACK AND OTHER INFORMATION

MultiHance 0,5 M injectable solution

Gadobenate dimeglumine
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you personally. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What MultiHance is and what it is used for
• 2. What you need to know before you are given MultiHance
• 3. How to use MultiHance
• 4. Possible side effects
• 5. How to store MultiHance
• 6. Contents of the pack and other information

1. WHAT IS MULTIHANCE AND WHAT IS IT USED FOR

MultiHance is a contrast agent that contains gadolinium, a metal belonging to the family
of rare earth elements that improves the accuracy of liver images during magnetic resonance imaging (MRI) procedures and helps the doctor to identify abnormalities present in the
liver.
This medicine is only for diagnostic use.
The use of MultiHance is approved in children over the age of 2 years.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MULTIHANCE

MultiHance must be used only within hospital facilities or clinical facilities
equipped with equipment and medical personnel capable of managing possible allergic reactions.

Accumulation in the body
The action of MultiHance is due to a metal called gadolinium. Studies have shown that
small amounts of gadolinium can remain in the body, including the brain. No undesirable effects due to the persistence of gadolinium in the brain have been observed.

Do not use MultiHance

• if you are allergic to the active ingredient gadobenate dimeglumine or to any of the other ingredients of this medicine (listed in section 6).
• if you have had allergic reactions (hypersensitivity reactions) such as skin rash, itching, hives or difficulty breathing following the administration of contrast agents for Magnetic Resonance Imaging in the past. Tell your doctor if you think any of the above points apply to you.

Children
MultiHance should not be used in children under 2 years of age.

Warnings and precautions
Talk to your doctor before using MultiHance if:

• you suffer from heart problems or high blood pressure
• you have had episodes of epilepsy or a history of brain injury
• you have a cardiac pacemaker or metallic objects such as clips, screws or plates as they may interfere with magnetic resonance imaging equipment
• your kidneys are not functioning properly
• you have recently had or are planning to have a liver transplant soon. The doctor may decide to perform a blood test to assess whether your kidneys are functioning properly before deciding to use MultiHance, especially if you are 65 years of age or older.

Other medicines and MultiHance
No cases of interaction between MultiHance and other medicines have been reported.
Tell your doctor if you are taking or have recently taken any other medicine.

Pregnancy and breastfeeding
Ask your doctor for advice before taking this medicine.

Pregnancy
Tell your doctor if you think you may be pregnant or if you are planning a pregnancy. MultiHance
should not be used during pregnancy unless it is strictly necessary.

Breastfeeding
Tell your doctor if you are breastfeeding or intend to breastfeed. The doctor will assess whether you can
continue breastfeeding or if you should stop breastfeeding for a period of 24 hours after
administration of MultiHance.

Driving and using machines
There is no information regarding the influence of treatment with MultiHance on the ability to
drive or use machines.
Ask your doctor if you can drive or if it is safe to use machines.

Important information about some of the excipients of MultiHance
During storage in the MultiHance solution, small
amounts of benzyl alcohol (a derivative of alcohol) may be released.
Tell your doctor if you are allergic to benzyl alcohol.

3. HOW TO USE MULTIHANCE

MultiHance is administered intravenously, usually in the arm, immediately before the magnetic resonance imaging (MRI) examination. The volume in millilitres that will be administered to you is related to your body weight expressed in kg.
The recommended dose is:
MRI of the liver,0.1 ml/kg of body weight
The administration of MultiHance will be carried out by the medical personnel who will conduct the examination.
It is important to ensure that the intravenous needle is correctly inserted into a vein.
Warnings if you experience pain or burning at the injection site during administration.
It is advisable to remain in hospital for at least one hour after the administration of MultiHance.

Dosage in special patient populations

Subjects with impaired renal function
The use of MultiHance is not recommended in patients with severe kidney problems and in patients who
have recently had or are about to have a liver transplant. However, if use
is strictly required, you should receive only a single dose of MultiHance during
the examination and should not receive a second administration for at least 7 days after the first.

Elderly
No dose adjustment is necessary if you are 65 years of age or older but you may be
subjected to a blood test to assess whether your kidneys are functioning properly.
For any further information on the use of this medicine, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, MultiHance can cause side effects, although not everybody gets them.
Most side effects have been found to be not serious, transient and have resolved spontaneously.
However, serious and life-threatening reactions can occur, which have sometimes resulted in patient death.

Cases of nephrogenic systemic fibrosis (which causes thickening of the skin and can also affect soft tissues and internal organs) have been reported in patients who received MultiHance together with other gadolinium-containing contrast agents.
If you notice any side effect after administration of MultiHance, immediately inform the medical personnel who supervised your examination.
medical personnel who supervised your examination.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, please tell your doctor. You can also report side effects directly through the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MULTIHANCE

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
• Do not freeze.
• MultiHance must be drawn up into the syringe immediately before use.
• Do not use MultiHance if you notice that the container or closure are damaged or the solution has changes in colour or suspended material.
• Do not dispose of any medicine in wastewater or household waste. The hospital pharmacist will take care of the unused or discarded product. This will help protect the environment.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What MultiHance contains

• The active ingredient is Gadobenico Acid as Gadobenate Dimeglumine. 1 mL of injectable solution contains: gadobenico acid 334 mg (0.5 mmol) as gadobenate dimeglumine (529 mg).
• The other component (excipient) is water for injections.

Description of the appearance of MultiHance and contents of the pack
MultiHance is a sterile aqueous solution (clear, colourless or slightly yellow) for
intravenous administration.
MultiHance is dispensed to hospitals in glass vials for single use containing 5 ml, 10 ml, 15
ml or 20 ml of solution.
Multihance is also dispensed as a Kit with administration device: (vial of 15 and 20
mL, automatic injector syringe for magnetic resonance imaging (65 mL syringe (polyethylene/polycarbonate tetraphthalate), 115 mL syringe (polyethylene/polycarbonate tetraphthalate),
connector (PVC/polycarbonate/polypropylene/silicone), 2 spikes (ABS)), 20
G safety catheter.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bracco Imaging S.p.A.- Via Egidio Folli, 50 – 20134 Milan (Italy)

Manufacturer
Patheon Italia S.p.A.2° Trav. SX Via Morolense 5 – 03013 Ferentino (FR) (Italy)
BIPSO GmbH - Robert-Gerwig-Strasse 4 - 78224 Singen (Germany)
Bracco Imaging S.p.A.- Bioindustry Park - Via Ribes, 5 - 10010 Colleretto Giacosa (TO) (Italy)

The following information is intended only for physicians and healthcare professionals.
Method of administration
MultiHance must be drawn up into the syringe immediately before use without dilution.
Any unused product remaining should be discarded and must not be used for
subsequent MR examinations.
To minimise the potential risk of MultiHance extravasation into soft tissues, it is important
to ensure that the intravenous needle or cannula is correctly inserted into a vein.
The product must be administered intravenously as a bolus or by slow injection (10
ml/min), see the table for post-contrast image acquisition.
A bolus of physiological saline solution [Sodium Chloride 9
mg/ml (0.9%)] is recommended following the injection.
Post-contrast image acquisition:

Before administering MultiHance, all patients are recommended to undergo
screening for renal dysfunction, with laboratory tests.
Cases of nephrogenic systemic fibrosis (NSF) have been reported associated with the use of certain gadolinium-containing contrast agents, in patients with severe acute or chronic renal insufficiency (GFR <
30 ml/min/1.73 m ). Patients undergoing liver transplantation are particularly at risk,
because the incidence of acute renal failure is high in this group of patients. Since
NSF may occur after the administration of MultiHance, in patients with severe
renal insufficiency and in patients in the perioperative period of liver transplantation, the use
of the product should be avoided unless the diagnostic information is essential and not obtainable with MR without contrast agent.
If the use of Multihance cannot be avoided, the dose should not exceed 0.05 mmol/kg
of body weight.
Due to the lack of information on repeated administrations, MultiHance injections should not
be repeated without an interval of at least 7 days.
Since renal clearance of gadobenate dimeglumine may be impaired in the elderly, it is considered important to screen
patients aged 65 years and over for renal function.
Haemodialysis immediately after the administration of MultiHance may be useful for removing the
product from the body. There is no evidence to support the use of haemodialysis in the prevention or
treatment of NSF in patients not already undergoing haemodialysis.
MultiHance should not be used during pregnancy unless the clinical condition
in the woman requires the use of gadobenate dimeglumine.
The physician and breastfeeding mother must decide whether to continue or discontinue breastfeeding for
at least 24 hours after the examination.
The traceability adhesive label on the vials should be removed and applied to the patient's documentation, to allow accurate recording of the gadolinium-containing contrast agent
used. The dose used must be recorded.
If electronic documentation is used, the product name, batch number and dose must be entered into the patient's electronic documentation.

MultiHance 529 mg/ml injectable solution in pre-filled syringes

Gadobenate dimeglumine
Read this leaflet carefully before you start to use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you personally. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What MultiHance is and what it is used for
• 2. What you need to know before you are given MultiHance
• 3. How MultiHance is used
• 4. Possible side effects
• 5. How to store MultiHance
• 6. Contents of the pack and other information

1. WHAT IS MULTIHANCE AND WHAT IT IS USED FOR

MultiHance is a contrast agent that contains gadolinium, a metal belonging to the rare earth family that improves the accuracy of liver images during magnetic resonance imaging (MRI) procedures and helps the doctor identify abnormalities in the liver.
This medicine is only for diagnostic use.
The use of MultiHance is approved in children over the age of 2 years.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MULTIHANCE

MultiHance must only be used within hospital facilities or clinical facilities equipped with equipment and medical personnel capable of managing possible allergic reactions.

Accumulation in the body
The action of MultiHance is due to a metal called gadolinium. Studies have shown that small amounts of gadolinium can remain in the body, including the brain. No adverse effects have been observed due to the persistence of gadolinium in the brain.

Do not use MultiHance

• if you are allergic to the active ingredient Gadobenate dimeglumine or to any of the other ingredients of this medicine (listed in section 6)
• if you have had allergic reactions (hypersensitivity reactions) such as rash, itching, hives or difficulty breathing following the administration of Magnetic Resonance contrast agents. Inform your doctor if you think any of the above points may apply to you.

Children
MultiHance should not be used in children under 2 years of age.

Warnings and precautions
Talk to your doctor before using MultiHance if:

• you suffer from heart problems or high blood pressure
• you have had episodes of epilepsy or a history of brain injury
• you have a cardiac pacemaker or metallic objects such as clips, screws or plates as they may interfere with magnetic resonance imaging equipment
• you are allergic (hypersensitive) to benzyl alcohol, as small amounts of benzyl alcohol (a derivative of alcohol) may be released during the storage of MultiHance
• your kidneys are not working properly
• you have recently had or are planning to have a liver transplant. The doctor may decide to have a blood test to assess whether your kidneys are functioning properly before deciding to use MultiHance, especially if you are 65 years of age or older.

Other medicines and MultiHance
No cases of interaction between MultiHance and other medicines have been reported.
Tell your doctor if you are taking or have recently taken any other medicine.

Pregnancy and breastfeeding
Ask your doctor for advice before taking this medicine.

Pregnancy
Tell your doctor if you think you are pregnant or if you are planning a pregnancy. MultiHance should not be used during pregnancy unless strictly necessary.

Breastfeeding
Tell your doctor if you are breastfeeding or intend to breastfeed. The doctor will assess whether you can continue breastfeeding or if you need to stop breastfeeding for a period of 24 hours after the administration of MultiHance.

Driving and using machines
There is no information regarding the influence of treatment with MultiHance on the ability to drive or operate machines.
Ask your doctor if you can drive or if it is safe to use machines.

3. HOW TO USE MULTIHANCE

MultiHance is administered intravenously, usually in the arm, immediately before the magnetic resonance examination. The volume in millilitres that will be administered to you is related to body weight expressed in kg.
The recommended dose is:
magnetic resonance imaging of the liver0.1 ml/kg of body weight
The administration of MultiHance will be performed by the medical personnel who will conduct the examination.
It is important to ensure that the intravenous needle is correctly positioned.
Warnings if you experience pain or burning at the injection site during administration.

It is advisable to remain in hospital for at least one hour after the administration of
MultiHance.
Dosage in special patient populations

Subjects with impaired renal function
The use of MultiHance is not recommended in patients with severe kidney problems and in patients who
have recently had or are about to have a liver transplant. However, if use
is strictly required, you should receive only a single dose of MultiHance during
the examination and should not receive a second administration for at least 7 days from the first.

Elderly
No dose adjustment is necessary if you are 65 years of age or older, but you may be
subjected to a blood test to assess whether your kidneys are functioning properly.
For any further information on the use of this medicine, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, MultiHance can cause side effects, although not everybody gets them.
Most of the side effects have been found to be not serious, transient and have resolved spontaneously.
However, serious reactions can occur which may require urgent medical intervention and have sometimes
caused the patient’s death.

Cases of nephrogenic systemic fibrosis (which causes thickening of the skin and can also
affect soft tissues and internal organs) have been reported in patients who received MultiHance
together with other contrast agents containing gadolinium.
If you notice any side effect after administration of MultiHance, inform immediately the medical
staff who supervised your examination.
personnel medico che ha supervisionato il suo esame.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, please tell your doctor.
You can also report side effects directly through the national reporting system at the address
http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse
By reporting side effects, you can help provide more information on the safety of this medicine .

5. HOW TO STORE MULTIHANCE

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
• Do not freeze.
• MultiHance must be administered immediately after opening.
• Do not use MultiHance if you notice that the container or closure are damaged or the solution has changes in colour or suspended material.
• Do not dispose of any medicine in wastewater or household waste. The hospital pharmacist will take care of unused or expired product. This will help protect the environment.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What MultiHance contains

• The active ingredient is Gadobenico Acid as Gadobenate Dimeglumine. 1 mL of injectable solution contains: gadobenico acid 334 mg (0.5 mmol) as gadobenate dimeglumine (529 mg).
• The other component (excipient) is water for injections.

Description of the appearance of MultiHance and contents of the pack
MultiHance is an aqueous injectable solution (clear, colourless or slightly yellow)
contained in pre-filled syringes.
MultiHance is dispensed in pre-filled single-dose syringes containing 10 ml, 15 ml or 20 ml of
injectable solution.
Multihance is also dispensed in Kits with a delivery device:

• Pre-filled syringe of 15 and 20 mL, 20 mL syringe (polypropylene), 3-way connector (polycarbonate), spike (ABS/polypropylene), 20 G safety catheter.
• Pre-filled syringe of 15 and 20 mL, automatic injector syringe for magnetic resonance (115 mL syringe (polyethylene tetraphthalate/polycarbonate), connector (PVC/polycarbonate/polypropylene/silicone), spike (ABS)), 20 G safety catheter.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bracco Imaging S.p.A.- Via Egidio Folli, 50 – 20134 Milan (Italy)

Manufacturer
Bracco Imaging S.p.A. - Via Ribes 5, Colleretto Giacosa (Ivrea) (TO) (Italy)

The following information is intended only for physicians and healthcare professionals.
Method of administration
MultiHance must be used immediately after opening and must not be diluted.
Any unused product residues must be discarded and are no longer usable for
subsequent MRI scans.
To use the syringe, rotate the plunger rod clockwise so as to screw
its threaded end into the piston and push forward a few millimeters to eliminate any
friction between the piston and the syringe cylinder.
Holding the syringe in a vertical position (with the cap facing upwards) aseptically
remove the cap from the end of the syringe and insert a sterile 5/6 gauge needle or disposable
infusion set with a compatible connector while simultaneously applying pressure and
rotation.
Always keeping the syringe in a vertical position, eliminate air by pushing the plunger until
liquid appears at the end of the needle or the infusion set is completely filled.
Perform the injection after the normal aspiration procedure.
To minimize the potential risk of MultiHance extravasation into soft tissues, it is important
to ensure that the intravenous needle or cannula is correctly inserted into a vein.
The product must be administered intravenously as a bolus or by slow injection (10
ml/min), see the table for post-contrast image acquisition.
The injection should be followed by a flush of Sodium Chloride 9 mg/ml
(0.9%) injectable solution.

Before administering MultiHance, it is recommended that all patients undergo
screening for renal dysfunction, with laboratory tests.
Cases of Nephrogenic Systemic Fibrosis (NSF) have been reported associated with the use of certain contrast agents containing gadolinium, in patients with severe acute or chronic renal insufficiency (GFR <

30 ml/min/1.73 m ). Patients undergoing liver transplantation are particularly at risk,
because the incidence of acute renal failure is high in this group of patients. Since
NSF may occur after the administration of MultiHance, in patients with severe
renal insufficiency and in patients in the perioperative period of liver transplantation, the use of
the product should be avoided unless the diagnostic information is essential and
not obtainable with MRI without contrast medium.
If the use of Multihance cannot be avoided, the dose should not exceed 0.05 mmol/kg of
body weight.
Due to the lack of information on repeated administrations, MultiHance injections should not
be repeated unless the interval between them is at least 7 days.
Since renal clearance of gadobenate dimeglumine may be impaired in the elderly,
it is considered important to screen patients aged 65 years and over for renal function.
Hemodialysis immediately after the administration of MultiHance may be useful to remove the
product from the body. There is no evidence to support the use of hemodialysis in the prevention or
treatment of NSF in patients not already undergoing hemodialysis.
MultiHance should not be used during pregnancy unless the clinical condition
in the woman requires the use of gadobenate dimeglumine.
The physician and breastfeeding mother should decide whether to continue or discontinue
breastfeeding for at least 24 hours after the examination.
The traceability label on the syringes should be removed and applied to the patient's documentation,
to allow accurate recording of the gadolinium-containing contrast agent
used. The dose used must be recorded.
If electronic documentation is used, the product name, batch number and dose must be
entered into the patient's electronic documentation.