Prialt 500micrograms5ml solution for infusion vials

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Ziconotide acetate

Disponível em:

Intrapharm Laboratories Ltd

Código ATC:

N02BG08

DCI (Denominação Comum Internacional):

Ziconotide acetate

Dosagem:

100microgram/1ml

Forma farmacêutica:

Solution for infusion

Via de administração:

Intrathecal

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: ; GTIN: 5036519000335

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRIALT 100 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.
WARNINGS AND PRECAUTIONS
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 necessary (as decided by your doctor).
-
If you are receiving Prialt via a pump worn outside your body, it is
important you check once
daily for any signs of infection at the point where the tube enters
your body.
-
If you observe any signs of infection around the tube, such as skin
redness, swelling, pain or
discharge, you must tell your doctor immediately and seek treatment
for the infection.
-
If you develop any t

Características técnicas

OBJECT 1
PRIALT SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 07-Mar-2017 | Eisai Ltd
1. Name of the medicinal product
Prialt 100 micrograms/ml solution for infusion
2. Qualitative and quantitative composition
One ml solution contains 100 μg ziconotide (as acetate).
Each 1 ml vial contains 100 μg ziconotide (as acetate).
Each 5 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
Ziconotide 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.
Posology
_Adults (including the elderly ≥ 65 years of age)_
Dosing of ziconotide should be initiated at 2.4 μg/day and titrated
on an individual patient basis according
to the patient's analgesic response and adverse reactions. Patients
should 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. If necessary the dose can be
decreased by any amount (including stopping the infusion) for the
management of adverse reactions.
Approximately 75% of patients who respond satisfactorily to treatment
require a dose of ≤ 9.6 μg/day.
_Renal impairment_
Studies have not been conducted in patients with impaired renal
function. Caution should be exercised
when ziconotide is administered to patients with impaired renal
function.
_Hepatic impairment_
Studies have not been conducted in patients with impaired hepatic
function. Caution should be exercised
when ziconotide is administered to patients with impaired hepatic
function.
_Paediatric population_
The safety and efficacy of ziconotide in children age