Prialt

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Prialt
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Prialt
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • ANALGESICS
  • Żona terapewtika:
  • Injections, Spinal, Pain
  • Indikazzjonijiet terapewtiċi:
  • Ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.,
  • Sommarju tal-prodott:
  • Revision: 23

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Authorised
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/000551
  • Data ta 'l-awtorizzazzjoni:
  • 20-02-2005
  • Kodiċi EMEA:
  • EMEA/H/C/000551
  • L-aħħar aġġornament:
  • 23-05-2019

Rapport ta 'Valutazzjoni Pubblika

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

EMA/80652/2014

EMEA/H/C/00551

EPAR summary for the public

Prialt

ziconotide

This is a summary of the European public assessment report (EPAR) for Prialt. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Prialt.

What is Prialt?

Prialt is a solution for infusion that contains the active substance ziconotide.

What is Prialt used for?

Prialt is used to treat 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).

Because the number of patients who have long-term pain that requires painkillers to be injected

directly into the spine is low, the disease is considered ‘rare’, and Prialt was designated an ‘orphan

medicine’ (a medicine used in rare diseases) on 9 July 2001.

The medicine can only be obtained with a prescription.

How is Prialt used?

Treatment with Prialt should only be carried out by a doctor who has experience in the intrathecal

dosing of medicines.

Prialt must be given as a very slow continuous infusion through an intrathecal catheter (a tube inserted

into the spinal canal) using an infusion pump capable of delivering an accurate amount of the

medicine. Prialt may need to be diluted before use, especially with the lower doses needed at the start

of treatment. The starting dose of Prialt is 2.4 micrograms per day. The dose should be gradually

increased, preferably every two days or more, to obtain the best balance between pain relief and

Prialt

Page 2/3

possible side effects. The dose must not be increased more than once in any 24 hour period. Most

patients need doses lower than 9.6 micrograms per day. The maximum dose is 21.6 micrograms per

day.

How does Prialt work?

The active substance in Prialt, ziconotide, is a copy of a natural substance called omega-conopeptide,

which is found in the venom of a type of sea snail. Ziconotide acts by blocking special pores called

calcium channels on the surface of the nerve cells that transmit the pain signals. By blocking the flow

of calcium into the nerve cells, ziconotide interferes with the transmission of pain signals within the

spine. This helps to bring relief from pain.

How has Prialt been studied?

Prialt has been compared with placebo (a dummy treatment) in 589 patients with severe long-term

pain in three main studies. Two of the studies were short-term, lasting five or six days: one in pain due

to cancer or AIDS, and one in pain due to other causes such as nerve damage. The third study looked

at the use of the medicine over three weeks. In all of the studies, the main measure of effectiveness

was the change in the Visual Analog Scale of Pain Intensity (VASPI). This is a score given by the

patients of their pain on a scale from 0 mm (no pain) to 100 mm (maximum pain).

What benefit has Prialt shown during the studies?

Prialt was more effective than placebo in the first two studies. Before treatment, patients with cancer

or AIDS pain had an average VASPI score of 74 mm, and those with other types of pain had a score of

80 mm. After treatment, the scores in patients receiving Prialt decreased to 35 and 54 mm,

respectively, while scores in patients receiving placebo were 61 and 72 mm.

In the third study, there was a trend for Prialt to be more effective than placebo, with the VASPI score

changing from 81 mm before treatment to 68 mm in patients receiving Prialt and to 74 mm in patients

receiving placebo.

What is the risk associated with Prialt?

The most common side effects with Prialt (seen in more than 1 patient in 10) are confusion, dizziness,

nystagmus (uncontrolled eye movement), impaired memory (forgetfulness), headache, somnolence

(sleepiness), blurred vision, nausea (feeling sick), vomiting, abnormal gait (difficulty walking) and

asthenia (weakness).

Prialt must not be used in patients at the same time as intrathecal chemotherapy (medicines to treat

cancer that are injected into the spinal canal). For the full list of all side effects and restrictions with

Prialt, see the package leaflet.

Why has Prialt been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Prialt provides an

alternative to other intrathecal painkillers, such as opioids. It decided that Prialt’s benefits are greater

than its risks and recommended that it be given marketing authorisation.

Prialt was originally authorised under ‘exceptional circumstances’, because, as the disease is rare,

limited information was available at the time of approval. As the company had supplied the additional

information requested, the ‘exceptional circumstances’ ended on 17 January 2014.

Prialt

Page 3/3

What information is still awaited for Prialt?

The company that makes Prialt is carrying out a study looking at the long-term use of the medicine,

looking in particular at the possibility of development of tolerance to treatment (when doses of a

medicine that used to be effective become less effective over time).

What measures are being taken to ensure the safe and effective use of

Prialt?

A risk management plan has been developed to ensure that Prialt is used as safely as possible. Based

on this plan, safety information has been included in the summary of product characteristics and the

package leaflet for Prialt, including the appropriate precautions to be followed by healthcare

professionals and patients.

Other information about Prialt

The European Commission granted a marketing authorisation valid throughout the European Union for

Prialt on 21 February 2005.

The full EPAR for Prialt can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with Prialt, read

the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Prialt can be found on

the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation

This summary was last updated in 02-2014.

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B.

PACKAGE LEAFLET

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

What Prialt is and what it is used for

What you need to know before you are given Prialt

How to use Prialt

Possible side effects

How to store Prialt

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

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 tenderness in the area around the tube without signs of infection, you should

seek advice from your doctor as soon as possible as tenderness may be an early sign of

infection.

If you are receiving Prialt via a pump worn outside your body and any part of the infusion

tubing becomes disconnected, you must contact your doctor or nurse immediately.

If you have any of the following symptoms: high temperature, headache, stiff neck, tiredness,

confusion, feeling sick, vomiting or occasional fits, these may be signs of meningitis. You must

tell your doctor immediately if you experience any of the above symptoms.

If you notice any adverse change in your thinking, mood or memory, please tell your doctor.

If you are receiving chemotherapy please tell your doctor.

You may have an increased level of an enzyme called creatine kinase in your blood and

although this does not usually cause any symptoms or problems, your doctor is likely to monitor

its level. In addition, you may also occasionally experience muscular problems. If such is the

case, you should immediately notify your doctor, as he/she may decide to halt your Prialt

treatment.

You should tell your doctor immediately if you experience any of the following symptoms after

receiving your treatment; sudden wheeziness, difficulty in breathing, pain in the chest, swelling

of eyelids, face or lips, rash or itching (especially affecting the whole body). These may be signs

of a severe allergic reaction.

In patients that suffer from severe long term pain, there is a higher likelihood of suicide and

attempted suicide than in the general population. Prialt may also cause or worsen depression in

people that are already susceptible. If you are experiencing depression or have a history of

depression please inform your healthcare professional before you are commenced on Prialt. If

after starting Prialt you experience a worsening of your depression or have any other symptoms

affecting your mood, please inform your healthcare professional.

You may experience drowsiness or may not be fully aware of your surroundings whilst

receiving treatment. If this happens, you should immediately notify your doctor, as he/she may

decide to halt your Prialt treatment.

Children and adolescents

Prialt is not recommended for use in children and adolescents.

Other medicines and Prialt

Tell your doctor if you are taking, have recently taken or might take any other medicines (for example,

baclofen used to treat muscle spasticity, clonidine used to treat high blood pressure, bupivacaine used

for local anaesthesia, morphine used for pain, propofol used for general anaesthesia, or any medicine

which is administered by intrathecal injection (injection into the space that surrounds the spinal cord

and the brain)). You may feel drowsy if you are given Prialt with certain other medicines used to treat

pain.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask

your doctor for advice before taking this medicine.

Prialt is not recommended during pregnancy and in women of childbearing potential not using

contraception.

Driving and using machines

The use of Prialt has been reported to cause confusion and drowsiness. Ask your doctor for advice

before you drive or operate machinery.

This medicinal product contains less than 1 mmol sodium (23 mg) per maximum recommended

intrathecal dose (21.6 μg/day)

,

i.e. essentially ‘sodium- free’.

3.

How to use Prialt

Your treatment with Prialt will be managed by a doctor who has experience of giving medicines into

the space around the spinal cord, and in the use of internal and external infusion pumps.

The recommended starting dose is no more than 2.4 micrograms per day. Your doctor will adjust the

dose of Prialt according to the severity of your pain by adding no more than 2.4 micrograms/day. The

maximum dose is 21.6 micrograms/day. At the start of your treatment your doctor may increase your

dose every 1 to 2 days or more. If needed, the dose may be decreased or injection stopped if the side

effects are too great.

Prialt is given as a very slow continuous injection into the space surrounding the spinal cord

(intrathecal use). The medicine will be administered continuously from a pump either implanted into

your abdominal wall or placed externally in a belt pouch. Your doctor will discuss with you the kind

of pump that will be most suitable for you and when you need to have your pump refilled.

If you feel that you are still in too much pain while receiving Prialt, or that the side effects are too

great, talk to your doctor.

Before giving you Prialt, your doctor might decide to slowly stop giving you opiates (other types of

medicinal product which are used to treat pain) into your spinal cord and instead replace with

alternative pain medicinal products.

If you receive more Prialt than you should

If you receive more Prialt than your doctor intended, you may feel unwell with signs such as

confusion, problems with speech, word finding difficulties, excessive shaking, light-headedness,

excessive sleepiness, feeling or being sick. If this happens, consult your doctor or hospital

immediately.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

You must tell your doctor immediately if you notice these serious side effects as you may require

urgent medical treatment.

Meningitis (may affect up to 1 in 100 people) – is inflammation of the coverings of the brain and

spinal cord usually caused by an infection. Symptoms of meningitis are headache, stiff neck,

dislike of bright lights, fever, vomiting, confusion and drowsiness.

Convulsions (may affect up to 1 in 100 people) – convulsions (fits) are when a person's body

shakes rapidly and uncontrollably. During a convulsion, the person's muscles contract and relax

repeatedly and the person may lose consciousness.

Suicidal thoughts or suicide attempt (may affect up to 1 in 100 people).

Rhabdomyolysis (may affect up to 1 in 100 people) – is breakdown of muscle fibres that can lead

to kidney damage. Symptoms of rhabdomyolysis are abnormal urine colour (brown coloured),

reduced urine production, muscle weakness, muscle aching and muscle tenderness.

Coma (may affect up to 1 in 100 people) – a state of unconsciousness with difficulty responding

or waking up.

Anaphylactic reaction (it is not known how many people this affects) – is a severe allergic

reaction, the signs of which are sudden wheeziness, difficulty in breathing, pain in the chest,

swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

Other side effects

Very common

may affect more than 1 user in 10)

Confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or

impairment of memory (forgetfulness), vomiting, nausea, general weakness and drowsiness.

Common (may affect 1 to 10 users in 100)

Decreased appetite, anxiety or worsened anxiety, hallucinations, inability to fall or stay asleep,

agitation, disorientation, depression or worsened depression, nervousness, mood swings, mental status

changes (thinking abnormal, confusion), paranoia, irritability, worsened confusion, difficulty with

learning, memory or thinking, reflexes absent or impaired, problems expressing or understanding

words, slurred speech, difficulty with speech or loss of ability to speak, sluggishness, balance or

coordination impaired, burning sensation, increased abnormal sensation, reduced level of

consciousness (unresponsive or almost unconscious), sedation, difficulty in concentrating, problems

with the sense of smell, odd or no sense of taste, shaking, pins and needles, double vision, visual

disturbance, intolerance to light, tinnitus (ringing in the ears), dizziness or spinning sensation, light-

headedness or dizziness when standing, low blood pressure, shortness of breath, dry mouth, abdominal

pain, worsened nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms,

muscle cramp, muscle or joint pain, difficult or painful urination, difficulty starting or controlling

urination, feeling jittery, falling, pain or pain exacerbated, fatigue, feeling cold, swelling of the face,

legs or feet, chest pain, blood chemistry changes, mental impairment and weight decreased.

Uncommon (may affect 1 to 10 users in 1000)

Infection of the blood stream, delirium (feeling of mental confusion), psychotic disorder (abnormal

thinking and perceptions), thought disorders, abnormal dreams, incoherence (inability to make sense),

loss of consciousness, stupor (unresponsive/difficult to arouse), stroke, encephalopathy (brain

disorder), aggressiveness, abnormal heart rhythm, difficulty breathing, indigestion, rash, muscle

inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal heart trace

measurements (ECG), raised body temperature, difficulty walking.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.

By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Prialt

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 and carton after EXP. The

expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Chemical and physical in use stability has been demonstrated for 60 days at 37°C.

From a microbiological point of view, if the product is diluted it should be transferred to the infusion

pump immediately. If not used immediately, in-use storage times and conditions prior to use are the

responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C, unless dilution

has taken place in controlled and validated aseptic conditions.

Do not use this medicine if you notice any discolouration or cloudiness or if particulate matter is

observed.

6.

Contents of the pack and other information

What Prialt contains

The active substance is ziconotide.

One ml solution contains 25 micrograms ziconotide (as acetate).

Each 20 ml vial contains 500 micrograms ziconotide (as acetate).

The other ingredients are methionine, sodium chloride, water for injections, hydrochloric acid

and sodium hydroxide.

What Prialt looks like and contents of the pack

Prialt is a solution for infusion (infusion). The solution is clear and colourless. Prialt is supplied in

packs containing a single vial of 20 ml.

Marketing Authorisation Holder

RIEMSER Pharma GmbH

An der Wiek 7

17493 Greifswald-Insel Riems

Germany

Manufacturer

RIEMSER Pharma GmbH

Bahnhofstr. 44b

17489 Greifswald

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Duitsland/Allemagne/Deutschland)

Lietuva

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Vokietija)

България

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Германия)

Luxembourg/Luxemburg

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Allemagne/Deutschland)

Česká republika

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Německo)

Magyarország

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Németország)

Danmark

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Tyskland)

Malta

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Il-Ġermanja/Germany)

Deutschland

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

Nederland

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Duitsland)

Eesti

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Saksamaa)

Norge

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Tyskland)

Ελλάδα

RIEMSER Pharma GmbH

Τηλ: +49 (0)30 338427-0

info@RIEMSER.com

(Γερμανία)

Österreich

AGEA Pharma GmbH

Tel: +43 (0)1 336 01 41

office@ageapharma.com

España

BCN Farma

Tel: +34 (0)932 684 208

info@bcnfarma.com

Polska

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Niemcy)

France

KEOCYT

Tél: +33 (0)1 42 31 07 10

contact@keocyt.com

Portugal

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Alemanha)

Hrvatska

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Njemačka)

România

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Germania)

Ireland

Intrapharm Laboratories Ltd

Tel: + 44 (0)1628 771800

medinfo@intrapharmlabs.com

(United Kingdom)

Slovenija

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Nemčija)

Ísland

RIEMSER Pharma GmbH

Sími: +49 (0)30 338427-0

info@RIEMSER.com

(Þýskaland)

Slovenská republika

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Nemecko)

Italia

Euromed S.R.L.

Tel: +39 (0)081 241 5204

moreinfo@euromed.it

Suomi/Finland

RIEMSER Pharma GmbH

Puh/Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Saksa/Tyskland)

Κύπρος

RIEMSER Pharma GmbH

Τηλ: +49 (0)30 338427-0

info@RIEMSER.com

(Γερμανία)

Sverige

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Tyskland)

Latvija

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Vācija)

United Kingdom

Intrapharm Laboratories Ltd

Tel: + 44 (0)1628 771800

medinfo@intrapharmlabs.com

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

------------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for use and handling

Prialt is supplied as a clear, colourless solution in single use vials. It should be inspected visually for

particulate matter and discolouration prior to administration. The solution should not be used if

discoloured or cloudy or if particulate matter is observed.

For single use only. Any unused medicinal product or waste material should be disposed of in

accordance with local requirements.

If dilution is required, Prialt must be diluted aseptically with preservative-free sodium chloride

9 mg/ml (0.9%) solution for injection before use. The concentration of the solution used in the

infusion pump must be no lower than 5 μg/ml ziconotide in an external pump and 25 μg/ml in an

internal pump.

Strict aseptic procedures must be used during the preparation and handling of the solution for infusion

and refilling of the pump. The patient and health-care providers must be familiar with the handling of

the external or internal infusion system and be aware of the need to guard against infection.

Specific instructions for using the pumps must be obtained from the manufacturer.

Prialt has been shown to be chemically and physically compatible with the implantable Synchromed

pump and the external CADD-Micro pump at the concentration levels indicated above. Chemical and

physical in-use stability has been demonstrated for 14 days at 37ºC in the Synchromed pump when the

pump has not previously been exposed to the medicinal product. The initial fill must therefore be

replaced after 14 days.

Prialt was stable for 60 days at 37°C in the Synchromed pump previously exposed to the medicinal

product. Stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.

The technical data are given only for information and should not limit health-care providers’ choice.

CE marked pumps equivalent to the Synchromed and CADD-Micro pump should be used to deliver

ziconotide.

Pumps previously used to deliver other medicinal products must be washed out three times with

sodium chloride 9 mg/ml (0.9%) solution for injection (preservative-free) before being filled with

ziconotide. The introduction of air into the pump reservoir or cartridge should be minimized, as

oxygen can degrade ziconotide.

Prior to initiation of therapy, an internal pump must be rinsed three times with 2 ml of the solution at

25 μg/ml. The concentration of Prialt in a naïve pump may be reduced due to adsorption onto the

surfaces of the device, and/or dilution by the residual space of the device. Because of this, after the

first use of Prialt, the reservoir should be emptied and refilled after 14 days. Subsequently the pump

should be emptied and refilled every 60 days.

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

What Prialt is and what it is used for

What you need to know before you are given Prialt

How to use Prialt

Possible side effects

How to store Prialt

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

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 tenderness in the area around the tube without signs of infection, you should

seek advice from your doctor as soon as possible as tenderness may be an early sign of

infection.

If you are receiving Prialt via a pump worn outside your body and any part of the infusion

tubing becomes disconnected, you must contact your doctor or nurse immediately.

If you have any of the following symptoms: high temperature, headache, stiff neck, tiredness,

confusion, feeling sick, vomiting or occasional fits, these may be signs of meningitis. You must

tell your doctor immediately if you experience any of the above symptoms.

If you notice any adverse change in your thinking, mood or memory, please tell your doctor.

If you are receiving chemotherapy please tell your doctor.

You may have an increased level of an enzyme called creatine kinase in your blood and

although this does not usually cause any symptoms or problems, your doctor is likely to monitor

its level. In addition, you may also occasionally experience muscular problems. If such is the

case, you should immediately notify your doctor, as he/she may decide to halt your Prialt

treatment.

You should tell your doctor immediately if you experience any of the following symptoms after

receiving your treatment; sudden wheeziness, difficulty in breathing, pain in the chest, swelling

of eyelids, face or lips, rash or itching (especially affecting the whole body). These may be signs

of a severe allergic reaction.

In patients that suffer from severe long term pain, there is a higher likelihood of suicide and

attempted suicide than in the general population. Prialt may also cause or worsen depression in

people that are already susceptible. If you are experiencing depression or have a history of

depression please inform your healthcare professional before you are commenced on Prialt. If

after starting Prialt you experience a worsening of your depression or have any other symptoms

affecting your mood, please inform your healthcare professional.

You may experience drowsiness or may not be fully aware of your surroundings whilst

receiving treatment. If this happens, you should immediately notify your doctor, as he/she may

decide to halt your Prialt treatment.

Children and adolescents

Prialt is not recommended for use in children and adolescents.

Other medicines and Prialt

Tell your doctor if you are taking, have recently taken or might take any other medicines (for example,

baclofen used to treat muscle spasticity, clonidine used to treat high blood pressure, bupivacaine used

for local anaesthesia, morphine used for pain, propofol used for general anaesthesia or any medicine

which is administered by intrathecal injection (injection into the space that surrounds the spinal cord

and the brain)). You may feel drowsy if you are given Prialt with certain other medicines used to treat

pain.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask

your doctor for advice before taking this medicine.

Prialt is not recommended during pregnancy and in women of childbearing potential not using

contraception.

Driving and using machines

The use of Prialt has been reported to cause confusion and drowsiness. Ask your doctor for advice

before you drive or operate machinery.

This medicinal product contains less than 1 mmol sodium (23 mg) per maximum recommended

intrathecal dose (21.6 μg/day)

,

i.e. essentially ‘sodium- free’.

3.

How to use Prialt

Your treatment with Prialt will be managed by a doctor who has experience of giving medicines into

the space around the spinal cord, and in the use of internal and external infusion pumps.

The recommended starting dose is no more than 2.4 micrograms per day. Your doctor will adjust the

dose of Prialt according to the severity of your pain by adding no more than 2.4 micrograms/day. The

maximum dose is 21.6 micrograms/day. At the start of your treatment your doctor may increase your

dose every 1 to 2 days or more. If needed, the dose may be decreased or injection stopped if the side

effects are too great.

Prialt is given as a very slow continuous injection into the space surrounding the spinal cord

(intrathecal use). The medicine will be administered continuously from a pump either implanted into

your abdominal wall or placed externally in a belt pouch. Your doctor will discuss with you the kind

of pump that will be most suitable for you and when you need to have your pump refilled.

If you feel that you are still in too much pain while receiving Prialt, or that the side effects are too

great, talk to your doctor.

Before giving you Prialt, your doctor might decide to slowly stop giving you opiates (other types of

medicinal product which are used to treat pain) into your spinal cord and instead replace with

alternative pain medicinal products.

If you receive more Prialt than you should

If you receive more Prialt than your doctor intended, you may feel unwell with signs such as

confusion, problems with speech, word finding difficulties, excessive shaking, light-headedness,

excessive sleepiness, feeling or being sick. If this happens, consult your doctor or hospital

immediately.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

You must tell your doctor immediately if you notice these serious side effects as you may require

urgent medical treatment.

Meningitis (may affect up to 1 in 100 people) – is inflammation of the coverings of the brain and

spinal cord usually caused by an infection. Symptoms of meningitis are headache, stiff neck,

dislike of bright lights, fever, vomiting, confusion and drowsiness.

Convulsions (may affect up to 1 in 100 people) – convulsions (fits) are when a person's body

shakes rapidly and uncontrollably. During a convulsion, the person's muscles contract and relax

repeatedly and the person may lose consciousness.

Suicidal thoughts or suicide attempt (may affect up to 1 in 100 people).

Rhabdomyolysis (may affect up to 1 in 100 people) – is breakdown of muscle fibres that can lead

to kidney damage. Symptoms of rhabdomyolysis are abnormal urine colour (brown coloured),

reduced urine production, muscle weakness, muscle aching and muscle tenderness.

Coma (may affect up to 1 in 100 people) – a state of unconsciousness with difficulty responding

or waking up.

Anaphylactic reaction (it is not known how many people this affects) – is a severe allergic

reaction, the signs of which are sudden wheeziness, difficulty in breathing, pain in the chest,

swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

Other side effects

Very common

may affect more than 1 user in 10)

Confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or

impairment of memory (forgetfulness), vomiting, nausea, general weakness and drowsiness.

Common (may affect 1 to 10 users in 100)

Decreased appetite, anxiety or worsened anxiety, hallucinations, inability to fall or stay asleep,

agitation, disorientation, depression or worsened depression, nervousness, mood swings, mental status

changes (thinking abnormal, confusion), paranoia, irritability, worsened confusion, difficulty with

learning, memory or thinking, reflexes absent or impaired, problems expressing or understanding

words, slurred speech, difficulty with speech or loss of ability to speak, sluggishness, balance or

coordination impaired, burning sensation, increased abnormal sensation, reduced level of

consciousness (unresponsive or almost unconscious), sedation, difficulty in concentrating, problems

with the sense of smell, odd or no sense of taste, shaking, pins and needles, double vision, visual

disturbance, intolerance to light, tinnitus (ringing in the ears), dizziness or spinning sensation, light-

headedness or dizziness when standing, low blood pressure, shortness of breath, dry mouth, abdominal

pain, worsened nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms,

muscle cramp, muscle or joint pain, difficult or painful urination, difficulty starting or controlling

urination, feeling jittery, falling, pain or pain exacerbated, fatigue, feeling cold, swelling of the face,

legs or feet, chest pain, blood chemistry changes, mental impairment and weight decreased.

Uncommon (may affect 1 to 10 users in 1000)

Infection of the blood stream, delirium (feeling of mental confusion), psychotic disorder (abnormal

thinking and perceptions), thought disorders, abnormal dreams, incoherence (inability to make sense),

loss of consciousness, stupor (unresponsive/difficult to arouse), stroke, encephalopathy (brain

disorder), aggressiveness, abnormal heart rhythm, difficulty breathing, indigestion, rash, muscle

inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal heart trace

measurements (ECG), raised body temperature, difficulty walking.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.

By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Prialt

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 and carton after EXP. The

expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Chemical and physical in use stability has been demonstrated for 60 days at 37°C.

From a microbiological point of view, if the product is diluted it should be transferred to the infusion

pump immediately. If not used immediately, in-use storage times and conditions prior to use are the

responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C, unless dilution

has taken place in controlled and validated aseptic conditions.

Do not use this medicine if you notice any discolouration or cloudiness or if particulate matter is

observed.

6.

Contents of the pack and other information

What Prialt contains

The active substance is ziconotide.

One ml solution contains 100 micrograms ziconotide (as acetate).

Each 1 ml vial contains 100 micrograms; each 2 ml vial contains 200 micrograms; each 5 ml

vial contains 500 micrograms.

The other ingredients (excipients) are methionine, sodium chloride, water for injections,

hydrochloric acid and sodium hydroxide.

What Prialt looks like and contents of the pack

Prialt is a solution for infusion (infusion). The solution is clear and colourless. Prialt is supplied in

packs containing a single vial of either 1 ml, 2 ml or 5 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

RIEMSER Pharma GmbH

An der Wiek 7

17493 Greifswald-Insel Riems

Germany

Manufacturer:

RIEMSER Pharma GmbH

Bahnhofstr. 44b

17489 Greifswald

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Duitsland/Allemagne/Deutschland)

Lietuva

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Vokietija)

България

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Германия)

Luxembourg/Luxemburg

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Allemagne/Deutschland)

Česká republika

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Německo)

Magyarország

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Németország)

Danmark

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Tyskland)

Malta

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Il-Ġermanja/Germany)

Deutschland

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

Nederland

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Duitsland)

Eesti

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Saksamaa)

Norge

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Tyskland)

Ελλάδα

RIEMSER Pharma GmbH

Τηλ: +49 (0)30 338427-0

info@RIEMSER.com

(Γερμανία)

Österreich

AGEA Pharma GmbH

Tel: +43 (0)1 336 01 41

office@ageapharma.com

España

BCN Farma

Tel: +34 (0)932 684 208

info@bcnfarma.com

Polska

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Niemcy)

France

KEOCYT

Tél: +33 (0)1 42 31 07 10

contact@keocyt.com

Portugal

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Alemanha)

Hrvatska

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Njemačka)

România

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Germania)

Ireland

Intrapharm Laboratories Ltd

Tel: + 44 (0)1628 771800

medinfo@intrapharmlabs.com

(United Kingdom)

Slovenija

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Nemčija)

Ísland

RIEMSER Pharma GmbH

Sími: +49 (0)30 338427-0

info@RIEMSER.com

(Þýskaland)

Slovenská republika

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Nemecko)

Italia

Euromed S.R.L.

Tel: +39 (0)081 241 5204

moreinfo@euromed.it

Suomi/Finland

RIEMSER Pharma GmbH

Puh/Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Saksa/Tyskland)

Κύπρος

RIEMSER Pharma GmbH

Τηλ: +49 (0)30 338427-0

info@RIEMSER.com

(Γερμανία)

Sverige

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Tyskland)

Latvija

RIEMSER Pharma GmbH

Tel: +49 (0)30 338427-0

info@RIEMSER.com

(Vācija)

United Kingdom

Intrapharm Laboratories Ltd

Tel: + 44 (0)1628 771800

medinfo@intrapharmlabs.com

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

------------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for use and handling

Prialt is supplied as a clear, colourless solution in single use vials. It should be inspected visually for

particulate matter and discolouration prior to administration. The solution should not be used if

discoloured or cloudy or if particulate matter is observed.

For single use only. Any unused medicinal product or waste material should be disposed of in

accordance with local requirements.

If dilution is required, Prialt must be diluted aseptically with preservative-free sodium chloride

9 mg/ml (0.9%) solution for injection before use. The concentration of the solution used in the

infusion pump must be no lower than 5 μg/ml ziconotide in an external pump and 25 μg/ml in an

internal pump.

Strict aseptic procedures must be used during the preparation and handling of the solution for infusion

and refilling of the pump. The patient and health-care providers must be familiar with the handling of

the external or internal infusion system and be aware of the need to guard against infection.

Specific instructions for using the pumps must be obtained from the manufacturer.

Prialt has been shown to be chemically and physically compatible with the implantable Synchromed

pump and the external CADD-Micro pump at the concentration levels indicated above. Chemical and

physical in-use stability has been demonstrated for 14 days at 37ºC in the Synchromed pump when the

pump has not previously been exposed to the medicinal product. The initial fill must therefore be

replaced after 14 days.

Prialt was stable for 60 days at 37°C in the Synchromed pump previously exposed to the medicinal

product. Stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.

The technical data are given only for information and should not limit health-care providers’ choice.

CE marked pumps equivalent to the Synchromed and CADD-Micro pump should be used to deliver

ziconotide.

Pumps previously used to deliver other medicinal products must be washed out three times with

sodium chloride 9 mg/ml (0.9%) solution for injection (preservative-free) before being filled with

ziconotide. The introduction of air into the pump reservoir or cartridge should be minimized, as

oxygen can degrade ziconotide.

Prior to initiation of therapy, an internal pump must be rinsed three times with 2 ml of the solution at

25 μg/ml. The concentration of Prialt in a naïve pump may be reduced due to adsorption onto the

surfaces of the device, and/or dilution by the residual space of the device. Because of this, after the

first use of Prialt, the reservoir should be emptied and refilled after 14 days. Subsequently the pump

should be emptied and refilled every 60 days.