Prialt
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
23-10-2023
Produktets egenskaber
(SPC)
23-10-2023
Offentlige vurderingsrapport
(PAR)
12-03-2014
Aktiv bestanddel:
ziconotide
Tilgængelig fra:
Esteve Pharmaceuticals GmbH
ATC-kode:
N02BG08
INN (International Name):
ziconotide
Terapeutisk gruppe:
Analgesics
Terapeutisk område:
Injections, Spinal; Pain
Terapeutiske indikationer:
Ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.
Produkt oversigt:
Revision: 30
Autorisation status:
Authorised
Autorisation dato:
2005-02-21
Indlægsseddel
46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRIALT 25 MICROGRAMS/ML SOLUTION FOR INFUSION
Ziconotide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Prialt is and what it is used for
2.
What you need to know before you are given Prialt
3.
How to use Prialt
4.
Possible side effects
5.
How to store Prialt
6.
Contents of the pack and other information
1.
WHAT PRIALT IS AND WHAT IT IS USED FOR
Prialt contains the active substance ziconotide which belongs to a
group of medicines, called
analgesics or ‘painkillers’. Prialt is used for the treatment of
severe, long-term pain in adults who need
a painkiller by intrathecal injection (injection into the space that
surrounds the spinal cord and the
brain).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PRIALT
YOU SHOULD NOT BE GIVEN PRIALT
-
if you are allergic to ziconotide or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are receiving an anticancer medicine into the space around your
spinal cord.
-
if you have a history of suicidal attempt or suicidal ideation with
ziconotide
WARNINGS AND PRECAUTIONS
Patients should undergo a neuropsychiatric evaluation before, after
starting and during intrathecal
ziconotide, and immediately when any depressive signs or symptoms
appear.
Caregivers should contact a physician immediately if the patient
experiences symptoms of potentially
life-threatening adverse event.
Talk to your doctor before you are given Prialt
-
The effects of long-term treatment of Prialt are uncertain at this
time and the possibility of toxic
effects on the spinal cord have not yet been ruled out. In case of a
need for long term treatment,
monitoring may be necessar
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Prialt 25 micrograms/mL solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL solution contains 25 μg ziconotide (as acetate).
Each 20 mL vial contains 500 μg ziconotide (as acetate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion (infusion).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prialt is indicated for the treatment of severe, chronic pain in
adults who require intrathecal (IT)
analgesia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ziconotide should only be undertaken by physicians
experienced in intrathecal (IT)
administration of medicinal products.
Patients should undergo a neuropsychiatric evaluation before, after
starting and during intrathecal
ziconotide and immediately when any depressive signs or symptoms
appear. (See Section 4.3, 4.4, 4.8
and 5.1).
Posology
_Dose initiation _
Dosing of ziconotide should be initiated at
_no more than_
2.4 μg/day and titrated on an individual
patient basis according to analgesic response and adverse reactions.
_Dose titration _
For each dose titration, assess the dosing requirements and adjust the
pump infusion flow rate as
required to achieve the new dosing.
Patients may be titrated in dose increments of ≤ 2.4 μg/day, up to
a maximum dose of 21.6 μg/day.
The minimal interval between dose increases is 24 hours; the
recommended interval, for safety
reasons, is 48 hours or more.
The maximum daily dose is 21.6 µg/day (0.9 µg/h).
The median dose at response is approximately 6.0 μg/day and
approximately 75% of responsive
patients required ≤ 9.6 μg/day in placebo-controlled clinical
trials. However, to limit the occurrence of
3
serious adverse reactions, reports from clinical practice indicate
that responsive patients may require a
smaller daily dose of approximately 3.0 - 4.5 µg/d or lower.
Adjust the dose of intrathecal ziconotide according to the severity of
pain,
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