Contract
Impianto di proprietà della: | Bracco s.p.a. xxx X. Xxxxx, 00 - 00000 Xxxxxx - Xxxxx | ||||||||||
Prodotto: PROHANCE FLACONI (IE) | Traduzione braille: | ||||||||||
SPECIFICA RIFERIMENTO: | Materiale: Istruzione | Codice Bracco: CL63D02 | Codice Bracco superato: CL63D01 | Vers. e N. Id: IE F1/3009652 | Vers. e N. Id superato: IE F1/0000000 | ||||||
Dimensioni: 148 X 600 mm | Fustella | Eurolaser | CODICE LAETUS | ||||||||
Colori n°: | Black | ||||||||||
1 | |||||||||||
Modifica rispetto la versione precedente: | SAFETY UPDATE IN LINE WITH CDS 2012-13 | ||||||||||
Quality Assurance Packaging Development, Italy | Data Emissione | Data Obsolescenza | Archiviare almeno fino a: | Status | |||||||
CROMinFOTO s.n.c. GRAFICA - FOTOCOMPOSIZIONE Xxx X. Xxxxxxx, 0 - 000 00 - XXXXXX | 10 SET 2014 FCL63D01-PIL-PRO-FLACONI Versione Bracco: 03 | I colori su questa prova sono approssimativi, questa è una stampa a 600 dpi ottenuta con colori a base acqua CMYK. Definizione e colori non | |||||||||
Versione interna: 03 | riflettono il risultato finale della produzione stampata. | ||||||||||
AZIENDA CERTIFICATA UNI EN ISO 9001:2008 | |||||||||||
FRONTE - Font size heading c.19 - Font size subheading c.10 Font size main text c.9 - Font size line-spacing 10
0
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
2
3
ProHance 279.3 mg/ml Solution for injection
4
Gadoteridol
5
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 pharmacist.
6
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
7
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
8
In this leaflet:
1. What ProHance is and what it is used for
9
2. Before you use ProHance
3. How to use ProHance
4. Possible side effects
10
5. How to store ProHance
11
6. Further information
12
1. WHAT PROHANCE IS AND WHAT IT IS USED FOR
13
14
ProHance is a magnetic resonance contrast medium in the form of a solution for injection. It is used for Magnetic Resonance Examinations to provide a better picture of the brain, spine and surrounding tissues in case of lesions involving the blood flow.
15
2. BEFORE YOU USE PROHANCE
Do not use ProHance
16
• if you are allergic (hypersensitive) to Gadoteridol or any of the other ingredients of ProHance (see section 6) or other gadolinium based contrast media.
17
• if you are under 18 years of age
Take special care with ProHance
18
• In some cases ProHance may cause changes in serum iron (the amount of iron in your blood) with no significant effects.
19
• The allergic reactions which have been seen occasionally after the administration of similar products might also happen with ProHance. Therefore emergency measures must be readily available.
20
Tell your doctor if:
- If you have a history of allergy
21
- your kidneys do not work properly
- you have recently had, or soon expect to have, a liver transplant
22
- You have a history of epilepsy or brain lesions
23
Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use ProHance especially if you are 65 years of age or older.
24
Taking other medicines
25
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
26
No drug interactions with ProHance are known.
Pregnancy and breast feeding
27
Ask your doctor for advice before taking any medicine.
Pregnancy
28
You must tell your doctor if you think you are or might become pregnant as ProHance should not be used during pregnancy unless strictly necessary.
Breast-feeding
29
30
Tell your doctor if you are breast-feeding or about to start breast-feeding. Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive ProHance.
Driving and using machines
31
32
There is no information about the effects of ProHance on driving, or using tools or machines. Ask your doctor if you can drive and if it is safe for you to use any tools or machines.
33
3. HOW TO USE PROHANCE
ProHance will be administered to you by a healthcare professional.
34
ProHance is injected into a vein and the dose depends on your weight. The recommended dosage in adults is 0.1-0.3 mmol/kg (0.2-0.6ml/kg).
35
After injection a 5ml normal saline flush will also be given to you. The imaging procedure should be completed within 1 hour after the ProHance injection.
36
Patients with kidney or liver problems
37
38
The use of ProHance is not recommended in patients with severe kidney problems and patients who have recently had, or soon expect to have, a liver transplant. However if use is required you should only receive one dose of ProHance during a scan and you should not receive a second injection for at least 7 days.
Elderly
39
It is not necessary to adjust your dose if you are 65 years of age or older but your doctor may take a blood test to check how well your kidneys are working.
40
Use in children
41
Children under 18 years of age must not use ProHance.
If you are given too much ProHance
42
Cases of overdose have never been reported. Should overdose occur, you should be kept under observation.
43
4. POSSIBLE SIDE EFFECTS
44
Like all medicines, ProHance can cause side effects, although not everybody gets them.
45
46
Most of the side effects that have been reported with ProHance have been mild and not prolonged, without residual effects.
47
If you experience any of the following side effects tell your doctor or nurse immediately.
These are signs of an allergic reaction, which can be serious and may require medical treatment:
48
• wheezing or difficulty breathing
• rash
40
• itching, hives
• swelling of the face, lips, tongue or throat
50
• fainting
51
52
The following information is intended for medical or healthcare professionals only: Prior to administration of ProHance it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests
53
54
55
56
57
58
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR< 30ml/min/1.73 m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with ProHance, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. If it is necessary to use ProHance, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, ProHance injections should not be repeated unless the interval between injections is at least 7 days.
As the renal clearance of gadoteridol may be impaired in the elderly, it is
59
60
(please turn over)
Impianto di proprietà della: | Bracco s.p.a. xxx X. Xxxxx, 00 - 00000 Xxxxxx - Xxxxx | ||||||||||
Prodotto: PROHANCE FLACONI (IE) | Traduzione braille: | ||||||||||
SPECIFICA RIFERIMENTO: | Materiale: Istruzione | Codice Bracco: CL63D02 | Codice Bracco superato: CL63D01 | Vers. e N. Id: IE F1/3009652 | Vers. e N. Id superato: IE F1/0000000 | ||||||
Dimensioni: 148 X 600 mm | Fustella | Eurolaser | CODICE LAETUS | ||||||||
Colori n°: | Black | ||||||||||
1 | |||||||||||
Modifica rispetto la versione precedente: | SAFETY UPDATE IN LINE WITH CDS 2012-13 | ||||||||||
Quality Assurance Packaging Development, Italy | Data Emissione | Data Obsolescenza | Archiviare almeno fino a: | Status | |||||||
CROMinFOTO s.n.c. GRAFICA - FOTOCOMPOSIZIONE Xxx X. Xxxxxxx, 0 - 000 0 0 - XXXXXX | 10 SET 2014 FCL63D01-PIL-PRO-FLACONI Versione Bracco: 03 | I colori su questa prova sono approssimativi, questa è una stampa a 600 dpi ottenuta con colori a base acqua CMYK. Definizione e colori non | |||||||||
Versione interna: 03 | riflettono il risultato finale della produzione stampata. | ||||||||||
AZIENDA CERTIFICATA UNI EN ISO 9001:2008 | |||||||||||
RETRO - Font size heading c.19 - Font size subheading c.10 Font size main text c.9 - Font size line-spacing 10
0
1
Possible side effects
Common: (More than 1 out of 100 persons and less than 1 out of 10 persons)
2
• Feeling sick (nausea)
3
Uncommon:(More than 1 out of 1,000 persons and less than 1 out of 100 persons)
• Headache
• Tingling or numbness of skin
4
• Changes in taste (mainly a metallic taste in the mouth)
• Dizziness
5
• Increased tears
• low blood pressure and heart rate increased
• Vomiting
6
• Dry mouth
• Itching, skin rash, urge to itch
7
• Pain at injection site
• Injection site reaction due to leakage of contrast agent
• Fatigue
8
• Flushing
9
Rare: (More than 1 out of 10,000 persons and less than 1 out of 1,000 persons)
10
• Hypersensitivity reactions (commonly reported symptoms include throat tightness, throat irritation, difficulties in breathing, chest discomfort, feeling hot, difficulties in swallowing, burning sensation, swelling of the throat and low blood pressure)
11
• Anxiety
• Confusion
• Abnormal coordination of movement
12
• Ringing in the ears(tinnitus)
• Changes in heart rhythm
13
• Chest pain
• Abdominal pain
• Fever
14
• Stiff muscles
• Diarrhoea
15
• Fits
• Runny nose
• Spasm of the throat
16
• Shortness of breath
• Cough
17
• Temporary absence of breath
• Wheezing
• Swelling of the tongue
18
• Itching in the mouth
• Inflammation of the gums
19
• Face swelling
Not known (which cannot be estimated with the available data)
20
• Loss of consciousness
• Coma
21
• Respiratory arrest
• Cardiac arrest
• Fluid in the lungs
22
• Kidney failure
23
24
• Vasovagal reaction (Symptoms commonly experienced include nausea, dizziness and excessive sweating. In severe cases, symptoms may include paleness, excessive sweating, slow heartbeat and potentially loss of consciousness. Additional symptoms may be fear or anxiety, restlessness, faintness and excessive salivation)
25
26
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin) and may affect also soft tissue and internal organs) most of which were in patients who received ProHance together with other gadolinium-containing contrast agents.
27
Reporting of side effects
28
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Xxxxxxxxx Xxxxxxx, XXX - Xxxxxx 0;
Tel: x000 0 0000000; Fax: x000 0 0000000.
29
Website: xxx.xxxx.xx;
30
By reporting side effects you can help provide more information on the safety of this medicine.
31
32
5. HOW TO STORE PROHANCE
33
Keep out of reach and sight of children. Keep the container in the outer carton. Do not store above 25°C.
Do not refrigerate or freeze.
34
ProHance should be administered to you immediately after opening. For single use only.
Discard any unused contents.
35
Do not use ProHance after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of the month.
36
Do not use ProHance if you notice solids are visible.
37
38
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
39
6. FURTHER INFORMATION
What ProHance contains
40
• The active substance is Gadoteridol, one ml of solution for injection contains: Gadoteridol 279.3 mg
Quantity of Gadoteridol:
41
- 5 ml contains 1396.5 mg of Gadoteridol.
- 10 ml contains 2793 mg of Gadoteridol.
42
- 15 ml contains 4189.5 mg of Gadoteridol.
- 20 ml contains 5586 mg of Gadoteridol.
43
• The other ingredients are calteridol calcium, hydrochloric acid, sodium hydroxide, tromethamine, water for injection.
44
What ProHance looks like and contents of the pack
ProHance is clear colourless to pale yellow sterile solution for injection.
45
ProHance is available in 5, 10, 15, 20ml vials with grey rubber stoppers and aluminium seals. Not all pack sizes may be marketed.
46
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
47
Bracco International B.V, Strawinskylaan 3051, 1077 ZX Amsterdam, The Netherlands.
48
Manufacturers:
BIPSO GmbH, Xxxxxx-Xxxxxx-Xxxxxxx 0, 00000 Xxxxxx, Xxxxxxx
40
and FAMAR ITALIA S.P.A., Xxx Xxxxxxxxxx 00, 00000 Xxxxxxxxx (XX), Xxxxx.
50
Date of package leaflet updating: Sept 2014.
51
52
(continuation of information intended for medical and healthcare professionals only)
particularly important to screen patients aged 65 years and older for renal dysfunction.
53
54
Haemodialysis shortly after ProHance administration may be useful at removing ProHance from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
55
ProHance should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteridol.
56
Continuing or discontinuing breast-feeding for a period of 24 hours after administration of ProHance, should be at the discretion of the doctor and lactating mother.
57
58
The peel-off tracking label on the vial should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
59
60
CL63D02-IE F1/0000000