PRIALT 100 MICROGRAMMI/ML Infusion solution

Зміст інструкції

1. Prialt 25 micrograms/mL solution for infusion
   1. What is Prialt 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. Package contents and other information
2. Prialt 100 micrograms/mL solution for infusion
   1. What is Prialt and what is it 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

Prialt 25 micrograms/mL solution for infusion

Ziconotide

Read 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 questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, ask your doctor. See section 4.

Contents of 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 is Prialt and what it is used for

Prialt contains the active substance ziconotide, which belongs to a category of medicines called
“analgesics” or “pain relievers”. Prialt is used for the treatment of severe chronic pain, in
adults who require a pain reliever for intrathecal injection (injection into the space surrounding
the spinal cord and brain).

2. What you need to know before you are given Prialt

Prialt must not be given to you

• if you are allergic to ziconotide or any of the other ingredients of this medicine (listed in section 6).
• if you are given an anti-cancer medicine into the space surrounding the spinal cord.
• if you have a history of suicide attempt or suicidal thoughts with ziconotide.

Warnings and precautions
Patients must undergo a neuropsychiatric evaluation before, after the start and during
treatment with intrathecal ziconotide, and immediately upon the appearance of signs or symptoms of depression.
Those who care for patients must contact a doctor immediately if the patient
presents symptoms of potentially fatal adverse events.
Talk to your doctor before you are given Prialt

• The effects of long-term treatment with Prialt are currently uncertain and the possibility of toxic effects on the spinal cord has not yet been ruled out. With prolonged treatment, it may be necessary to keep you under observation (at the doctor's discretion).
• If you receive Prialt through an external pump, it is important to check every day for signs of infection at the catheter insertion site.
• If you notice signs of infection around the catheter, such as redness, swelling, pain or leakage of fluid (exudate), you should immediately contact your doctor for the necessary care.
• If you experience irritation in the area around the catheter without signs of infection, contact your doctor as soon as possible as this may be an early sign of infection.
• If you receive Prialt through an external pump and any part of the infusion device detaches, contact your doctor or nurse immediately.
• If you experience any of the following symptoms: high fever, headache, stiff neck, fatigue, confusion, nausea, vomiting or occasional seizures, this may be a sign of meningitis. If you experience any of these symptoms, contact your doctor immediately.
• If you notice any changes in your thoughts, mood or memory, contact your doctor.
• If you are undergoing chemotherapy (for the treatment of cancer), inform your doctor.
• An increase in the level of an enzyme called creatine kinase in the blood may occur and, although this usually does not cause symptoms or problems, your doctor will likely monitor this level. Muscle problems may also occur occasionally. In this case, you should inform your doctor immediately, who may decide to stop treatment with Prialt.
• You should immediately inform your doctor if any of the following symptoms occur after treatment administration: sudden wheezing, difficulty breathing, chest pain, swelling of the eyelids, face or lips, rash or itching (especially if it affects the whole body). These may be signs of a serious allergic reaction.
• Patients suffering from chronic severe pain are more likely to experience suicide and suicide attempts than the general population. Prialt can also cause or worsen depression in people already predisposed. If you experience depression or have suffered from depression in the past, inform your healthcare provider before starting treatment with Prialt. If your depression worsens after starting to take Prialt, or if you experience other symptoms affecting your mood, inform your healthcare provider.
• You may experience drowsiness or a lack of awareness of your surroundings during treatment administration. If this occurs, you should immediately inform your doctor, who may decide to stop treatment with Prialt.

Children and adolescents
The use of Prialt is not recommended in children and adolescents.

Other medicines and Prialt
Tell your doctor if you are taking, have recently taken or might take any other
medicines (e.g. baclofen, used for the treatment of muscle spasticity, clonidine, used for
treatment of high blood pressure, bupivacaine, used for local anesthesia, morphine, used for
pain, propofol, used for general anesthesia, or any other medicine administered with
intrathecal injection (injection into the space surrounding the spinal cord and brain)). If you are
given Prialt together with other medicines for pain, drowsiness may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Prialt is not recommended during pregnancy and in women of childbearing potential who are not using
contraceptive measures.

Driving and using machines
It has been reported that the use of Prialt causes confusion and drowsiness. Ask your doctor
before driving vehicles or using machines.

Prialt contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per each maximum intrathecal dose
recommended (21.6 micrograms per day), i.e. it is essentially “sodium-free”.

3. How to use Prialt

Your treatment with Prialt will be managed by a doctor experienced in administering medications
in the space around the spinal cord and in the use of infusion pumps, both internal and external.
The recommended starting dose should not exceed2.4 micrograms per day. The doctor may
very slowly adjust the dosage of Prialt based on the severity of your pain, adding no more
than 2.4 micrograms/day. The maximum dose is 21.6 micrograms/day. At the beginning of treatment, the
doctor may increase your dose every 1-2 or more days. If necessary, the dose can be
decreased or administration can be stopped if the side effects are too strong.
Prialt is administered in the form of a very slow continuous injection into the space around the
spinal cord (intrathecal use). The medication must be administered continuously
through a pump that will be implanted in the abdominal wall, or fixed externally in a
pocket on a belt. The doctor will discuss with you the type of pump most suitable for your needs, and the
method of refilling the pump.
Pain relief may be achieved gradually by very
slowly increasing the dosage of Prialt. If you still experience a lot of pain while receiving Prialt, or if the side effects
are too strong, contact your doctor.
Before giving you Prialt, the doctor may decide to slowly discontinue the
administration of opioids (other types of medications used to treat pain) in the
spinal cord and replace them with other pain medications.

If you receive more Prialt than you should
If you receive more Prialt than your doctor has prescribed, you may feel unwell and experience
symptoms such as confusion, difficulty speaking, tremor, a feeling of emptiness in your head, excessive drowsiness,
nausea or vomiting. In these cases, contact your doctor immediately or go to hospital.
If you have any doubts about the use of this medicine, contact your doctor.

4. Possible side effects

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

Serious side effects
Tell your doctor immediately if you notice any of these serious side effects, as urgent medical treatment may be needed.

• Meningitis (may affect up to 1 in 100 people): this is an inflammation of the membranes covering the brain and spinal cord, usually caused by an infection. Symptoms of meningitis are headache, stiff neck, dislike of bright light, fever, vomiting, confusion and drowsiness.
• Convulsions (may affect up to 1 in 100 people): convulsions (fits) manifest with rapid and uncontrollable tremors of the body. During a convulsion, muscles contract and relax repeatedly and the person may lose consciousness.
• Suicidal thoughts or attempts (may affect up to 1 in 100 people).
• Rhabdomyolysis (may affect up to 1 in 100 people): this is the breakdown of muscle fibres, which can cause kidney damage. Symptoms of rhabdomyolysis are alteration of the colour of the

urine (brown colour), reduced urine production, weakness, pain and sensitivity of the
muscles.

• Coma (may affect up to 1 in 100 people): a state of unconsciousness with difficulty reacting or waking up.
• Anaphylactic reaction (frequency cannot be estimated from available data): this is a severe allergic reaction, the signs of which are sudden wheezing, difficulty breathing, chest pain, swelling of the eyelids, face or lips, rash or itching (especially if it affects the whole body).

Other side effects
Very common (may affect more than 1 in 10 people)
Confusion, dizziness, blurred vision, headache, rapid eye movements, loss or impairment
of memory (amnesia), vomiting, nausea, general weakness and drowsiness.

Common (may affect up to 1 in 10 people)
Decreased appetite, anxiety or worsening of anxiety, hallucinations, difficulty falling
or staying asleep, agitation, disorientation, depression or worsening of depression, nervousness,
mood swings, changes in mental state (abnormal thoughts, confusion), paranoia, irritability,
worsening of confused states, difficulty in learning, memory and thinking,
absent or altered reflexes, problems expressing or understanding words, slurred speech,
difficulty or loss of ability to speak, sluggishness, altered sense of balance or
motor coordination, burning sensation, increased abnormal sensation, decreased
level of consciousness (unresponsive or nearly unconscious), sedation, difficulty concentrating,
problems with smell, problems with taste, tremors, pins and needles sensation, double vision, visual disturbances, light sensitivity, tinnitus (ringing in the ears), dizziness or vertigo, feeling of emptiness in the
head when standing up, hypotension, difficulty breathing, dry mouth, abdominal pain,
worsening of nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms,
muscle cramps, muscle pain or joint pain, difficulty or pain when urinating
(passing urine), difficulty starting or controlling urination, nervous tension, falls, pain or
worsening of pain, fatigue, feeling cold, swelling of the face, legs or feet, chest pain, changes in laboratory values, mental deficit and weight loss.

Uncommon (may affect up to 1 in 100 people)
Blood infection, delirium (feeling of mental confusion), psychotic disorder (abnormal thoughts or
perceptions), thought disorders, nightmares, confused state, loss of consciousness, stupor
(lack of reactivity/difficulty reacting), stroke, encephalopathy (brain disease), aggression,
irregular heartbeat, difficulty breathing, indigestion, rash, muscle inflammation, back pain, muscle spasms, neck pain, acute renal failure, abnormal heart tracing (ECG), increased body temperature, difficulty walking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system
described in Annex 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 the packaging after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store the vials in the outer packaging to protect the medicine from light.
Chemical and physical stability has been demonstrated during use for 60 days at a temperature of 37 ° C.
From a microbiological point of view, in case of dilution of the medicine, this must be transferred
immediately into the infusion pump. In the event that the medicine is not used
immediately, the storage times during use and the conditions before use are
the responsibility of the user and normally should not exceed 24 hours at a temperature of
2 °C – 8 ° C, unless the dilution has been carried out under controlled and
validated aseptic conditions.
Do not use this medicine if you notice a change in color or turbidity, or if you observe the presence of
visible particles.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how
to dispose of medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Prialt contains

• The active ingredient is ziconotide.
• One mL of solution contains 25 micrograms of ziconotide (as acetate).
• Each 20 mL vial contains 500 micrograms of ziconotide (as acetate).
• The other components are methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.

Description of the appearance of Prialt and contents of the pack
Prialt is a solution for infusion (infusion). The solution is clear and colourless. Prialt is presented in
packs containing a single vial containing 20 mL of medicinal product.

Marketing Authorisation Holder:
Esteve Pharmaceuticals GmbH
Hohenzollerndamm 150-151
14199 Berlin
Germany

Manufacturer:
HWI pharma services GmbH
Straßburger Straße 77
77767 Appenweier
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Esteve Pharmaceuticals GmbH
Tél/Tel: +49 (0)30 338427-0
[email protected]
(Duitsland/Allemagne/Deutschland)

Lietuva
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Vokietija)

България
Esteve Pharmaceuticals GmbH
Teл.: +49 (0)30 338427-0
[email protected]
(Германия)

Luxembourg/Luxemburg
Esteve Pharmaceuticals GmbH
Tél/Tel: +49 (0)30 338427-0
[email protected]
(Allemagne/Deutschland)

Česká republika
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Německo)

Magyarország
Esteve Pharmaceuticals GmbH
Tel.: +49 (0)30 338427-0
[email protected]
(Németország)

Danmark
Esteve Pharmaceuticals GmbH
Tlf: +49 (0)30 338427-0
[email protected]
(Tyskland)

Malta
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Il-Ġermanja/Germany)

Deutschland
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]

Nederland
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Duitsland)

Eesti
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Saksamaa)

Norge
Esteve Pharmaceuticals GmbH
Tlf: +49 (0)30 338427-0
[email protected]
(Tyskland)

Ελλάδα
Esteve Pharmaceuticals GmbH
Τηλ: +49 (0)30 338427-0
[email protected]
(Γερμανία)

Österreich
AGEA Pharma GmbH
Tel: +43 (0)1 336 01 41
[email protected]

España
Esteve Pharmaceuticals, S.A.
Tel: +34 93 446 60 00

Polska
IMED POLAND Sp. z o.o.
Tel.: +48 (0)22 663 43 03
[email protected]

France
ESTEVE PHARMACEUTICALS S.A.S
Tél: +33 (0)1 42 31 07 10
[email protected]

Portugal
Esteve Pharmaceuticals, S.A.
Tel: +34 93 446 60 00
(Espanha)

Hrvatska
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Njemačka)

România
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germania)

Slovenija
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Nemčija)

Ísland
Esteve Pharmaceuticals GmbH
Sími: +49 (0)30 338427-0
[email protected]
(Þýskaland)

Ireland
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Slovenská republika
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Nemecko)

Italia
Esteve Pharmaceuticals S.r.l.
[email protected]

Suomi/Finland
Esteve Pharmaceuticals GmbH
Puh/Tel: +49 (0)30 338427-0
[email protected]
(Saksa/Tyskland)

Κύπρος
Esteve Pharmaceuticals GmbH
Τηλ: +49 (0)30 338427-0
[email protected]
(Γερμανία)

Sverige
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Tyskland)

Latvija
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Vācija)

United Kingdom (Northern Ireland)
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/. Furthermore, links to other websites on rare diseases and
related therapeutic treatments are provided.
------------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:

Instructions for use and handling
Prialt is a clear and colourless solution in single-dose vials. Before administration,
it must be visually inspected for particulate matter and colour change. The solution
should not be used if the colour has changed or if it appears cloudy or if particulate
matter is visible.
For single use only. Unused medicinal product and waste materials derived from this medicinal product must
be disposed of in accordance with local regulations.
If dilution is necessary, Prialt must be aseptically diluted with a
sodium chloride 9 mg/mL (0.9%) solution for injection without preservatives before use. The
concentration of the solution used in the infusion pump must not be less than
5 μg/mL of ziconotide for an external pump and 25 μg/mL for an internal pump.
Strict aseptic procedures must be observed during the preparation and handling of the infusion solution and for loading
the pump. The patient and healthcare professionals
must have experience with the external or internal infusion system and must be aware of the
need to protect against infections.
Specific instructions for using the pumps must be obtained from the pump manufacturer.
Prialt has been shown to be chemically and physically compatible with the implantable
Synchromed pump and the external CADD-Micro pump with the concentration levels indicated above. It
has been demonstrated to be chemically and physically stable for use for 14 days at a temperature of 37 ºC in
the Synchromed pump if it has not been previously exposed to the medicinal product. After 14 days
the pump needs to be refilled.
Prialt remained stable for 60 days at 37 °C in the Synchromed pump previously exposed to the
medicinal product. The product has been shown to be stable for 21 days at room temperature in the
CADD-Micro pump.
Technical data are provided for informational purposes only and should not limit the choice of
healthcare professionals. CE-marked pumps equivalent to the Synchromed and CADD-Micro pumps must be used to administer Prialt.
Pumps previously used to administer other medicinal products must be flushed three times with
a sodium chloride 9 mg/mL (0.9%) solution for injection (without preservatives) before
introducing Prialt. The introduction of air into the reservoir or cartridge of the pump must be
minimised, as air can degrade ziconotide.
Before starting therapy, an internal pump must be flushed three times with 2 mL of Prialt at a
concentration of 25 μg/mL. The concentration of Prialt in a pump that has never been used may be
reduced due to adsorption on the surfaces of the device, and/or dilution by the
residual volume of the device. For this reason, after the first use of Prialt, the reservoir must be
emptied and refilled after 14 days. Subsequently, the pump must be emptied and
recharged every 60 days.

Prialt 100 micrograms/mL solution for infusion

Ziconotide

Read 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 questions, ask your doctor.
• If any side effects occur, including any not listed in this leaflet, tell your doctor. See section 4.

Contents of 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 is Prialt and what is it used for

Prialt contains the active substance ziconotide, which belongs to a category of medicines called
“analgesics” or “pain relievers”. Prialt is used for the treatment of severe chronic pain, in
adults who require a pain reliever for intrathecal injection (injection into the space surrounding
the spinal cord and brain).

2. What you need to know before you are given Prialt

Prialt must not be given to you

• if you are allergic to ziconotide or any of the other ingredients of this medicine (listed in section 6).
• if you are given an anti-cancer medicine into the space surrounding the spinal cord.
• if you have a history of suicide attempt or suicidal thoughts with ziconotide.

Warnings and precautions
Patients must undergo a neuropsychiatric evaluation before, after the start and during
treatment with intrathecal ziconotide, and immediately upon the appearance of signs or symptoms of depression.
Those who care for patients should contact a doctor immediately if the patient
presents symptoms of potentially life-threatening adverse events.
Talk to your doctor before you are given Prialt

• The effects of long-term treatment with Prialt are currently uncertain and the possibility of toxic effects on the spinal cord has not yet been ruled out. With prolonged treatment, it may be necessary to keep you under observation (at the doctor's discretion).
• If you receive Prialt through an external pump, it is important to check every day for signs of infection at the catheter entry point.
• If you notice signs of infection around the catheter, such as redness of the skin, swelling, pain or leakage of fluid (exudate), you should contact your doctor immediately for the necessary care.
• If you experience irritation in the area around the catheter without signs of infection, contact your doctor as soon as possible as this may be an early sign of infection.
• If you receive Prialt through an external pump and any part of the infusion device detaches, contact your doctor or nurse immediately.
• If you experience any of the following symptoms: high fever, headache, stiff neck, fatigue, confusion, nausea, vomiting, or occasional seizures, this may be a sign of meningitis. If you experience any of these symptoms, contact your doctor immediately.
• If you notice any changes in your thoughts, mood, or memory, contact your doctor.
• If you are undergoing chemotherapy (for the treatment of cancer), inform your doctor.
• An increase in the level of an enzyme called creatine kinase in the blood may occur, and although this usually does not cause symptoms or problems, your doctor is likely to monitor this level. Muscle problems may also occur occasionally. In such a case, you should inform your doctor immediately, who may decide to stop treatment with Prialt.
• You should immediately inform your doctor if any of the following symptoms appear after the administration of treatment: sudden wheezing, difficulty breathing, chest pain, swelling of the eyelids, face or lips, rash or itching (especially if it affects the whole body). These may be signs of a serious allergic reaction.
• Patients suffering from chronic severe pain are more likely to commit suicide and attempt suicide than the general population. Prialt can also cause or worsen depression in people who are already predisposed. If you feel depressed or have suffered from depression in the past, inform your healthcare provider before starting treatment with Prialt. If your depression worsens after starting to take Prialt, or if you experience other symptoms affecting your mood, inform your healthcare provider.
• You may experience drowsiness or a lack of full awareness of your surroundings during treatment administration. If this occurs, you should inform your doctor immediately, who may decide to stop treatment with Prialt.

Children and adolescents
The use of Prialt is not recommended in children and adolescents.

Other medicines and Prialt
Tell your doctor if you are taking, have recently taken or might take any other
medicines (e.g. baclofen, used for the treatment of muscle spasticity, clonidine, used for
the treatment of high blood pressure, bupivacaine, used for local anesthesia, morphine, used for
pain, propofol, used for general anesthesia, or any other medicine administered with
intrathecal injection (injection into the space surrounding the spinal cord and brain)). If you are
given Prialt together with other medicines for pain, drowsiness may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Prialt is not recommended during pregnancy and in women of childbearing potential who are not using
contraceptive measures.

Driving and using machines
It has been reported that the use of Prialt causes confusion and drowsiness. Ask your doctor
before driving vehicles or using machines.

Prialt contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum intrathecal dose
recommended (21.6 micrograms per day), i.e. it is essentially “sodium-free”.

3. How to use Prialt

Your treatment with Prialt will be managed by a doctor experienced in administering medications
around the spinal cord and in using infusion pumps, both internal and external.
The recommended starting dose should not exceed2.4 micrograms per day. The doctor may
very slowly adjust the Prialt dosage based on the severity of your pain, adding no more
than 2.4 micrograms/day. The maximum dose is 21.6 micrograms/day. At the beginning of treatment, the
doctor may increase your dose every 1-2 or more days. If necessary, the dose can be
decreased or administration can be stopped if the side effects are too severe.
Prialt is administered as a very slow continuous injection into the space around the
spinal cord (intrathecal use). The medication must be administered continuously
through a pump that will be implanted in the abdominal wall, or fixed externally in a
pocket on a belt. The doctor will discuss with you the type of pump most suitable for your needs, and the
method of refilling the pump.
Pain relief may be achieved gradually by very
slowly increasing the Prialt dosage. If you still experience a lot of pain while receiving Prialt, or if the side effects
are too severe, contact your doctor.
Before starting you on Prialt, your doctor may decide to slowly discontinue the
administration of opioids (other types of medications used to treat pain) in the
spinal cord and replace them with other pain medications.

If you receive more Prialt than you should
If you receive more Prialt than your doctor has prescribed, you may feel unwell and experience
symptoms such as confusion, difficulty speaking, tremor, a feeling of emptiness in your head, excessive drowsiness,
nausea or vomiting. In these cases, contact your doctor immediately or go to hospital.
If you have any questions about 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
Tell your doctor immediately if you notice any of these serious side effects, as urgent medical treatment may be needed.

• Meningitis (may affect up to 1 in 100 people): this is an inflammation of the membranes surrounding the brain and spinal cord, usually caused by an infection. Symptoms of meningitis are headache, stiff neck, sensitivity to bright light, fever, vomiting, confusion and drowsiness.
• Convulsions (may affect up to 1 in 100 people): convulsions (fits) manifest with rapid and uncontrollable tremors of the body. During a convulsion, muscles contract and relax repeatedly and the person may lose consciousness.
• Suicidal thoughts or attempts (may affect up to 1 in 100 people).
• Rhabdomyolysis (may affect up to 1 in 100 people): this is the breakdown of muscle fibres, which can cause kidney damage. Symptoms of rhabdomyolysis are changes in the colour of the

urine (brown colour), reduced urine production, weakness, pain and sensitivity of the
muscles.

• Coma (may affect up to 1 in 100 people): a state of unconsciousness with difficulty reacting or waking up.
• Anaphylactic reaction (frequency cannot be estimated based on available data): this is a severe allergic reaction, the signs of which are sudden wheezing, difficulty breathing, chest pain, swelling of the eyelids, face or lips, rash or itching (especially if it affects the whole body).

Other side effects
Very common (may affect more than 1 in 10 people)
Confusion, dizziness, blurred vision, headache, rapid eye movements, loss or impairment of
memory (amnesia), vomiting, nausea, general weakness and drowsiness.

Common (may affect up to 1 in 10 people)
Decreased appetite, anxiety or worsening of anxiety, hallucinations, difficulty falling
asleep or staying asleep, agitation, disorientation, depression or worsening of depression, nervousness,
mood swings, changes in mental state (abnormal thoughts, confusion), paranoia, irritability,
worsening of confused states, difficulty in learning, memory and thinking,
absence or altered reflexes, problems expressing or understanding words, slurred speech,
difficulty or loss of ability to speak, sluggishness, altered sense of balance or
motor coordination, burning sensation, increased abnormal sensation, decreased
level of consciousness (unresponsive or almost unconscious), sedation, difficulty concentrating,
problems with smell, problems with taste, tremors, pins and needles sensation, double vision, visual disturbances, light sensitivity, tinnitus (ringing in the ears), dizziness or vertigo, feeling of emptiness in the
head when standing up, low blood pressure, difficulty breathing, dry mouth, abdominal pain,
worsening of nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms,
muscle cramps, muscle or joint pain, difficulty or pain when urinating
(urinating), difficulty starting or controlling urination, nervous tension, falls, pain or
worsening of pain, fatigue, feeling cold, swelling of the face, legs or feet, chest pain, changes in laboratory values, mental deficit and weight loss.

Uncommon (may affect up to 1 in 100 people)
Blood infection, delirium (feeling of mental confusion), psychotic disorder (abnormal thoughts or
perceptions), thought disorders, nightmares, confused state, loss of consciousness, stupor
(lack of reactivity/difficulty reacting), stroke, encephalopathy (brain disease), aggressiveness,
irregular heartbeat, difficulty breathing, indigestion, rash, muscle inflammation, back pain, muscle spasms, neck pain, acute renal failure, abnormal heart tracing (ECG), increased body temperature, difficulty walking.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system indicated in Annex 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 on the package after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store the vials in the outer packaging to protect the medicine from light.
Chemical and physical stability has been demonstrated during use for 60 days at a temperature of 37 ° C.
From a microbiological point of view, in case of dilution of the medicine, this must be transferred
immediately into the infusion pump. In the event that the medicine is not used
immediately, the storage times during use and the conditions before use are
the responsibility of the user and normally should not exceed 24 hours at a temperature of
2 ° C – 8 ° C, unless the dilution has been carried out under controlled and
validated aseptic conditions.
Do not use this medicine if you notice a change in colour or turbidity, or if you observe the presence of
visible particles.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Prialt contains

• The active substance is ziconotide.
• 1 mL of solution contains 100 micrograms of ziconotide (acetate).
• Each 1 mL vial contains 100 micrograms of ziconotide; each 2 mL vial contains 200 micrograms of ziconotide; each 5 mL vial contains 500 micrograms of ziconotide.
• The other components are methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.

Description of Prialt and contents of the pack
Prialt is a solution for infusion (infusion). The solution is clear and colourless. Prialt is presented in
packs containing a single vial containing 1 mL, 2 mL or 5 mL of medicinal product. It is possible
that not all pack sizes are marketed.

Marketing Authorisation Holder:
Esteve Pharmaceuticals GmbH
Hohenzollerndamm 150-151
14199 Berlin
Germany

Manufacturer:
HWI pharma services GmbH
Straßburger Straße 77
77767 Appenweier
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Lietuva
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

България
Esteve Pharmaceuticals GmbH
Тел.: +49 (0)30 338427-0
[email protected]
(Germany)

België/Belgique/Belgien
Esteve Pharmaceuticals GmbH
Tél/Tel: +49 (0)30 338427-0
[email protected]
(Germany/Allemagne/Deutschland)

Luxembourg/Luxemburg
Esteve Pharmaceuticals GmbH
Tél/Tel: +49 (0)30 338427-0
[email protected]
(Germany/Deutschland)

Česká republika
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Magyarország
Esteve Pharmaceuticals GmbH
Tel.: +49 (0)30 338427-0
[email protected]
(Germany)

Danmark
Esteve Pharmaceuticals GmbH
Tlf: +49 (0)30 338427-0
[email protected]
(Germany)

Malta
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Deutschland
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]

Nederland
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Eesti
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Norge
Esteve Pharmaceuticals GmbH
Tlf: +49 (0)30 338427-0
[email protected]
(Germany)

Ελλάδα
Esteve Pharmaceuticals GmbH
Τηλ: +49 (0)30 338427-0
[email protected]
(Germany)

Österreich
AGEA Pharma GmbH
Tel: +43 (0)1 336 01 41
[email protected]

España
Esteve Pharmaceuticals, S.A.
Tel: +34 93 446 60 00

Polska
IMED POLAND Sp. z o.o.
Tel.: +48 (0)22 663 43 03
[email protected]

France
ESTEVE PHARMACEUTICALS S.A.S
Tél: +33 (0)1 42 31 07 10
[email protected]

Portugal
Esteve Pharmaceuticals, S.A.
Tel: +34 93 446 60 00
(Spain)

Hrvatska
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

România
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Ireland
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Slovenija
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Ísland
Esteve Pharmaceuticals GmbH
Sími: +49 (0)30 338427-0
[email protected]
(Germany)

Slovenská republika
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Italia
Esteve Pharmaceuticals S.r.l.
[email protected]

Suomi/Finland
Esteve Pharmaceuticals GmbH
Puh/Tel: +49 (0)30 338427-0
[email protected]
(Germany/Tyskland)

Κύπρος
Esteve Pharmaceuticals GmbH
Τηλ: +49 (0)30 338427-0
[email protected]
(Germany)

Sverige
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Latvija
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

United Kingdom (Northern Ireland)
Esteve Pharmaceuticals GmbH
Tel: +49 (0)30 338427-0
[email protected]
(Germany)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/. In addition, links to other websites on rare diseases and related
therapeutic treatments are provided.
------------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals:
Instructions for use and handling
Prialt is a clear and colourless solution in single-dose vials. Before administration,
it must be visually inspected for particulate matter and colour change. The solution
should not be used if the colour has changed or if it appears cloudy or if particulate
matter is visible.
For single use only. Unused medicinal product and waste materials derived from such medicinal product must
be disposed of in accordance with local regulations.
If dilution is necessary, Prialt must be aseptically diluted with a
sodium chloride 9 mg/mL (0.9%) solution for injection without preservatives before use. The
concentration of the solution used in the infusion pump must not be less than
5 μg/mL of ziconotide for an external pump and 25 μg/mL for an internal pump.
Strict aseptic procedures must be followed during the preparation and handling of the infusion solution and for
loading the pump. Patients and healthcare professionals must have experience with the external or internal
infusion system and must be aware of the need to protect against infections.
Specific instructions for using the pumps must be obtained from the pump manufacturer.
Prialt has been shown to be chemically and physically compatible with the implantable
Synchromed pump and the external CADD-Micro pump with the concentration levels indicated above. Chemical
and physical stability has been demonstrated for use for 14 days at a temperature of 37 ºC in the
Synchromed pump if it has not been previously exposed to the medicinal product. After 14 days
the pump must be reloaded.
Prialt remained stable for 60 days at 37 °C in the Synchromed pump previously exposed to the
medicinal product. The product has been shown to be stable for 21 days at room temperature in the
CADD-Micro pump.
Technical data is provided for informational purposes only and should not limit the choice of
healthcare professionals. Pumps with CE marking equivalent to the Synchromed and CADD-Micro pumps must
be used to administer Prialt.
Pumps previously used to administer other medicinal products must be washed three times with a
sodium chloride 9 mg/mL (0.9%) solution for injection (without preservatives) before
introducing Prialt. The introduction of air into the reservoir or cartridge of the pump must be
minimised, as air can degrade ziconotide.
Before starting therapy, an internal pump must be washed three times with 2 mL of Prialt at a
concentration of 25 μg/mL. The concentration of Prialt in a pump that has never been used may be
reduced due to absorption on the surfaces of the device and/or dilution by the
residual space of the device. For this reason, after the first use of Prialt, the reservoir must be
emptied and refilled after 14 days. Subsequently, the pump must be emptied and
reloaded every 60 days.