Prialt

Italy
Brand name Prialt
Form solution for infusion
Active substance / Dosage
ZICONOTIDE
Prescription type Restricted prescription – hospital or equivalent facility use only
ATC code
N02BG08
Registration number 037310
Manufacturer Esteve Pharmaceuticals GmbH
Prialt solution for infusion

Table of Contents

Package leaflet: Information for the patient

Prialt 25 micrograms/mL solution for infusion

Ziconotide
Please read this leaflet carefully before this medicine is administered to you 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 you experience any side effects, including those 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 being administered 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 class of medicines called
"analgesics" or "painkillers". Prialt is used for the treatment of severe chronic pain in
adults who require a painkiller administered by intrathecal injection (injection into the space surrounding the spinal cord and brain).

2. What you should know before being administered Prialt

Prialt must not be administered to you

  • if you are allergic to ziconotide or to any of the other ingredients of this medicine (listed in section 6).
  • if you are being administered an anticancer medicine into the space surrounding the spinal cord.
  • if you have a history of suicide attempts or suicidal ideation with ziconotide.

Warnings and precautions
Patients must undergo a neuropsychiatric assessment before, after initiation of, and during treatment with intrathecal ziconotide, and immediately upon the onset of signs or symptoms of depression.
Caregivers should contact a doctor immediately if the patient develops symptoms of potentially life-threatening adverse events.
Talk to your doctor before being administered Prialt

  • The long-term effects of 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, monitoring may be required (at the doctor’s discretion).
  • If you receive Prialt via an external pump, it is important to check daily for signs of infection at the catheter insertion site.
  • If you notice signs of infection around the catheter, such as redness of the skin, swelling, pain, or fluid leakage (exudate), you must contact your doctor immediately for appropriate treatment.
  • If you experience irritation around the catheter site without signs of infection, contact your doctor as soon as possible, as this may be an early sign of infection.
  • If you receive Prialt via an external pump and any part of the infusion device becomes disconnected, 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 could be a sign of meningitis. If you develop any of these symptoms, seek immediate medical attention.
  • If you notice any changes in your thoughts, mood, or memory, consult your doctor.
  • If you are undergoing chemotherapy (for cancer treatment), inform your doctor.
  • There may be an increase in the level of an enzyme called creatine kinase in the blood; although this usually does not cause symptoms or problems, your doctor will likely monitor this level. Muscle-related problems may also occasionally occur. If this happens, inform your doctor immediately, who may decide to discontinue treatment with Prialt.
  • You must inform your doctor immediately 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 widespread). These may be signs of a severe allergic reaction.
  • In patients suffering from severe chronic pain, the risk of suicide and suicide attempts is higher than in the general population. Prialt may also cause or worsen depression in individuals already predisposed. If you experience depression or have previously suffered from depression, inform your healthcare provider before starting treatment with Prialt. If your depression worsens after starting Prialt, or if you develop other mood-related symptoms, inform your healthcare provider.
  • You may experience drowsiness or reduced awareness of your surroundings during treatment administration. If this occurs, inform your doctor immediately, who may decide to discontinue treatment with Prialt.

Children and adolescents
The use of Prialt is not recommended in children and adolescents.
Other medicines and Prialt
Inform your doctor if you are taking, have recently taken, or might take any other medicines (e.g., baclofen, used to treat muscle spasticity; clonidine, used to treat high blood pressure; bupivacaine, used for local anesthesia; morphine, used for pain; propofol, used for general anesthesia; or any other medicine administered via intrathecal injection (injection into the space surrounding the spinal cord and brain)). If Prialt is administered together with other pain medicines, drowsiness may occur.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor 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
Use of Prialt has been reported to cause confusion and drowsiness. Consult your doctor before driving or operating machinery.
Prialt contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum recommended intrathecal dose (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 medicines into the space around the spinal cord and in the use of both internal and external infusion pumps.
The recommended starting dose must not exceed 2.4 micrograms per day. Your doctor may adjust the dose of Prialt very slowly according to the severity of your pain, increasing it by no more than 2.4 micrograms/day. The maximum dose is 21.6 micrograms/day. At the beginning of treatment, your doctor may increase your dose every 1–2 days or more. If necessary, the dose may be reduced or administration may be stopped if side effects are too severe.
Prialt is administered as a continuous, very slow injection into the space around the spinal cord (intrathecal use). The medicine must be administered continuously through a pump that will either be implanted in the abdominal wall or attached externally in a pouch on a belt. Your doctor will discuss with you the type of pump most suitable for your needs and how the pump will be refilled.
Pain relief may be achieved gradually by very slowly increasing the dose of Prialt. If you still experience significant pain while receiving Prialt, or if side effects are too severe, consult your doctor.
Before starting you on Prialt, your doctor may decide to gradually discontinue the administration of opioids (other types of medicines used to treat pain) into the spinal cord and replace them with other pain medicines.
If you receive more Prialt than you should
If you receive more Prialt than prescribed by your doctor, you may feel unwell and experience symptoms such as confusion, speech difficulties, tremor, a feeling of emptiness in the head, excessive drowsiness, nausea, or vomiting. In such cases, contact your doctor immediately or go to hospital.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Contact your doctor immediately if you notice any of these serious side effects, as urgent medical treatment may be required.

  • Meningitis (may affect up to 1 in 100 people): inflammation of the membranes covering the brain and spinal cord, usually caused by infection. Symptoms of meningitis include headache, neck stiffness, sensitivity to bright light, fever, vomiting, confusion, and drowsiness.

  • Seizures (may affect up to 1 in 100 people): seizures (fits) characterized by rapid, uncontrollable body shaking. During a seizure, muscles contract and relax repeatedly, and the person may lose consciousness.

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

  • Rhabdomyolysis (may affect up to 1 in 100 people): breakdown of muscle fibres, which may lead to kidney damage. Symptoms of rhabdomyolysis include discoloured urine (brown colour), reduced urine output, weakness, muscle pain, and tenderness.

  • Coma (may affect up to 1 in 100 people): a state of unconsciousness with difficulty in responding or waking up.

  • Anaphylactic reaction (frequency cannot be estimated from available data): a severe allergic reaction, with symptoms such as sudden wheezing, breathing difficulties, chest pain, swelling of the eyelids, face or lips, skin rash or itching (especially if affecting 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 deficit of memory (amnesia), vomiting, nausea, general weakness, and drowsiness.
Common (may affect up to 1 in 10 people)
Loss of appetite, anxiety or worsening of anxiety, hallucinations, difficulty falling or staying asleep, agitation, disorientation, depression or worsening of depression, nervousness, mood swings, mental state changes (abnormal thoughts, confusion), paranoia, irritability, worsening of confusion, difficulty with learning, memory, and thinking, absence of or altered reflexes, problems speaking or understanding words, slurred speech, difficulty or loss of ability to speak, lethargy, altered sense of balance or motor coordination, burning sensation, increased abnormal sensation, decreased level of consciousness (unresponsive or nearly unconscious), sedation, difficulty concentrating, smell disturbances, taste disturbances, tremors, pins and needles sensation, double vision, visual disturbances, light intolerance, tinnitus (ringing in the ears), dizziness or vertigo, empty sensation in the head when upright, hypotension, breathing difficulties, dry mouth, abdominal pain, worsening of nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms, muscle cramps, muscle or joint pain, difficulty or pain during urination, 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, laboratory test abnormalities, mental impairment, 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, confusional state, loss of consciousness, stupor (lack of reactivity/difficulty in responding), stroke, encephalopathy (brain disease), aggression, abnormal heart rhythm, breathing difficulties, indigestion, skin rash, muscle inflammation, back pain, muscle spasms, neck pain, acute kidney failure, abnormal electrocardiogram (ECG), increased body temperature, difficulty walking.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects helps 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 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 vials in the outer packaging to protect the medicine from light.
Chemical and physical in-use stability has been demonstrated for 60 days at 37 °C.
From a microbiological point of view, following dilution of the medicine, it should be immediately
transferred into the infusion pump. If the medicine is not used immediately, the storage times during
use and the conditions prior to use are the responsibility of the user and normally should not exceed
24 hours at 2 °C – 8 °C, unless the dilution was carried out under controlled and validated aseptic
conditions.
Do not use this medicine if you notice any change in colour or turbidity, or if you see visible particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Prialt contains

  • The active substance 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 ingredients 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. The solution is clear and colourless. Prialt is available in packs containing a single vial with 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

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

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

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

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

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

Ελλάδα Österreich
Esteve Pharmaceuticals GmbH AGEA Pharma GmbH
Τηλ: +49 (0)30 338427-0 Tel: +43 (0)1 336 01 41
[email protected] [email protected]
(Γερμανία)

España Polska
Esteve Pharmaceuticals, S.A. IMED POLAND Sp. z o.o.
Tel: +34 93 446 60 00 Tel.: +48 (0)22 663 43 03
[email protected]

France Portugal
ESTEVE PHARMACEUTICALS S.A.S Esteve Pharmaceuticals, S.A.
Tél: +33 (0)1 42 31 07 10 Tel: +34 93 446 60 00
[email protected] (Espanha)

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

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

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

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

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

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

The following information is intended for healthcare professionals only:

Instructions for use and handling
Prialt is a clear, colourless solution in single-use vials. Before administration, it should be inspected visually for suspended particles and discoloration. The solution must not be used if discoloured, cloudy, or if particulate matter is visible.
For single use only. Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

If dilution is required, Prialt must be aseptically diluted before use with sodium chloride 9 mg/mL (0.9%) solution for injection, free of preservatives. 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 preparation and handling of the infusion solution and when filling the pump. The patient and healthcare professionals must be experienced with either external or internal infusion systems and must be aware of the need to take precautions against infection.

Specific instructions for pump use 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 at the concentration levels indicated above. Chemical and physical stability has been demonstrated for 14 days at 37°C in the Synchromed pump, provided the pump has not been previously exposed to the drug. After 14 days, the pump must be refilled.

Prialt has remained stable for 60 days at 37°C in the Synchromed pump previously exposed to the drug. Product stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.

Technical data are provided for informational purposes only and should not restrict healthcare professionals' choice of equipment. To administer Prialt, CE-marked pumps equivalent to the Synchromed and CADD-Micro pumps must be used.

Pumps previously used for other medications must be flushed three times with sodium chloride 9 mg/mL (0.9%) solution for injection (without preservatives) before introducing Prialt. Introduction of air into the pump reservoir or cartridge must be minimized, as air may 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 previously unused pump may be reduced due to absorption onto device surfaces and/or dilution by residual volume in the device. Therefore, after the first use of Prialt, the reservoir must be emptied and refilled after 14 days. Subsequently, the pump must be emptied and refilled every 60 days.

Patient information leaflet

Prialt 100 micrograms/mL solution for infusion

Ziconotide
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult your doctor.
  • If you experience any side effects, including those not listed in this leaflet, consult 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 administered 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 chronic pain in adults who require an intrathecal injection analgesic (an injection into the space surrounding the spinal cord and brain).

2. What you should know before you are given Prialt

Prialt must not be administered to you

  • if you are allergic to ziconotide or to any of the other ingredients of this medicine (listed in section 6).
  • if you are being administered an anticancer medicine into the space surrounding the spinal cord.
  • if you have a history of suicide attempts or suicidal ideation with ziconotide.

Warnings and precautions
Patients must undergo a neuropsychiatric assessment before treatment, after starting treatment, and during treatment with intrathecal ziconotide, and immediately if signs or symptoms of depression occur.
Caregivers must contact a doctor immediately if the patient experiences 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, monitoring may be required (according to the physician's judgment).
  • If you receive Prialt via an external pump, it is important to check daily for signs of infection at the catheter insertion site.
  • If you notice signs of infection around the catheter, such as redness of the skin, swelling, pain, or fluid leakage (exudate), you must contact your doctor immediately for appropriate treatment.
  • If you experience irritation around the catheter site without signs of infection, contact your doctor as soon as possible, as this may be an early sign of infection.
  • If you receive Prialt via an external pump and any part of the infusion device becomes disconnected, 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 could be a sign of meningitis. If you develop 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 cancer treatment), 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. Occasionally, muscle-related problems may also occur. In such cases, you must inform your doctor immediately, who may decide to discontinue treatment with Prialt.
  • You must inform your doctor immediately 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 widespread). These may be signs of a severe allergic reaction.
  • In patients with severe chronic pain, the risk of suicide and suicide attempts is higher than in the general population. Prialt may also cause or worsen depression in individuals already predisposed. If you experience depression or have had depression in the past, inform your healthcare provider before starting treatment with Prialt. If your depression worsens after starting Prialt, or if you develop other mood-related symptoms, inform your healthcare provider.
  • You may experience drowsiness or reduced awareness of your surroundings during treatment administration. If this occurs, you must inform your doctor immediately, who may decide to discontinue treatment with Prialt.

Children and adolescents
The use of Prialt is not recommended in children and adolescents.
Other medicines and Prialt
Inform your doctor if you are taking, have recently taken, or might take any other medicines (e.g., baclofen, used to treat muscle spasticity; clonidine, used to treat high blood pressure; bupivacaine, used for local anesthesia; morphine, used for pain; propofol, used for general anesthesia; or any other medicine administered via intrathecal injection (injection into the space surrounding the spinal cord and brain)). If Prialt is administered together with other pain medicines, drowsiness may occur.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Prialt is not recommended during pregnancy or in women of childbearing potential who are not using contraceptive measures.
Driving and using machines
Use of Prialt has been reported to cause confusion and drowsiness. Consult your doctor before driving or operating machinery.
Prialt contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum recommended intrathecal dose (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 medicines into the space around the spinal cord and in the use of both internal and external infusion pumps.
The recommended starting dose must not exceed 2.4 micrograms per day. Your doctor may very slowly adjust your Prialt dosage according to the severity of your pain by increasing it by no more than 2.4 micrograms/day. The maximum dose is 21.6 micrograms/day. At the beginning of treatment, your doctor may increase your dose every 1–2 days or more. If necessary, the dose may be reduced or administration may be stopped if side effects are too severe.
Prialt is administered as a continuous, very slow injection into the space around the spinal cord (intrathecal use). The medicine must be administered continuously through a pump implanted in the abdominal wall or attached externally in a pouch on a belt. Your doctor will discuss with you the type of pump most suitable for your needs and how the pump will be refilled.
Pain relief may be achieved gradually by very slowly increasing the dose of Prialt. If you still experience significant pain while receiving Prialt, or if side effects are too severe, contact your doctor.
Before starting you on Prialt, your doctor may decide to slowly discontinue opioids (other types of pain medicines) administered into the spinal cord and replace them with other pain medications.
If you receive more Prialt than prescribed
If you receive more Prialt than your doctor has prescribed, you may feel unwell and experience symptoms such as confusion, speech difficulties, tremor, a feeling of emptiness in the head, excessive drowsiness, nausea, or vomiting. In such cases, contact your doctor immediately or go to hospital.
If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Contact your doctor immediately if you notice any of these serious side effects, as urgent medical treatment may be required.

  • Meningitis (may affect up to 1 in 100 people): inflammation of the membranes covering the brain and spinal cord, usually caused by infection. Symptoms of meningitis include headache, neck stiffness, sensitivity to bright light, fever, vomiting, confusion, and drowsiness.

  • Seizures (may affect up to 1 in 100 people): seizures (fits) characterized by rapid, uncontrollable body shaking. During a seizure, muscles contract and relax repeatedly, and the person may lose consciousness.

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

  • Rhabdomyolysis (may affect up to 1 in 100 people): breakdown of muscle fibers, which can lead to kidney damage. Symptoms of rhabdomyolysis include dark-colored urine (brown), reduced urine output, weakness, muscle pain, and muscle tenderness.

  • Coma (may affect up to 1 in 100 people): a state of unconsciousness with difficulty responding or waking up.

  • Anaphylactic reaction (frequency cannot be estimated from available data): a severe allergic reaction, with signs including sudden wheezing, breathing difficulties, chest pain, swelling of the eyelids, face, or lips, skin rash, or itching (especially if widespread).

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)
Loss of appetite, anxiety or worsening of anxiety, hallucinations, difficulty falling or staying asleep, restlessness, disorientation, depression or worsening of depression, nervousness, mood swings, mental status changes (abnormal thoughts, confusion), paranoia, irritability, worsening of confusion, difficulties in learning, memory, and thinking, absence or altered reflexes, problems with speaking or understanding words, slurred speech, difficulty or loss of ability to speak, lethargy, altered sense of balance or motor coordination, burning sensation, increased abnormal sensation, decreased level of consciousness (unresponsive or nearly unconscious), sedation, difficulty concentrating, smell disorders, taste disorders, tremors, pins and needles sensation, double vision, visual disturbances, light intolerance, tinnitus (ringing in the ears), dizziness or vertigo, feeling of emptiness in the head when upright, hypotension, breathing difficulties, dry mouth, abdominal pain, worsening of nausea, diarrhea, constipation, sweating, itching, muscle weakness, muscle spasms, muscle cramps, muscle or joint pain, difficulty or pain during urination, difficulty starting or controlling urination, nervous tension, falls, pain or increased pain, fatigue, feeling cold, swelling of the face, legs, or feet, chest pain, laboratory test abnormalities, mental impairment, 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, abnormal heart rhythm, breathing difficulties, indigestion, skin rash, muscle inflammation, back pain, muscle spasms, neck pain, acute kidney failure, abnormal electrocardiogram (ECG), increased body temperature, difficulty walking.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects 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 stated on the label and the 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 vials in the outer packaging to protect the medicine from light.
Chemical and physical in-use stability has been demonstrated for 60 days at 37 °C.
From a microbiological point of view, following dilution of the medicine, it should be transferred
immediately into the infusion pump. If the medicine is not used immediately, the in-use storage times and
conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at
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 any change in colour or cloudiness, or if you see visible particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. This will help protect the environment.

6. Package contents 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.

The following information is intended exclusively for healthcare professionals:

Instructions for use and handling
Prialt is a clear, colourless solution in single-use vials. Before administration, it should be inspected visually for suspended particles and discoloration. The solution must not be used if discolored, cloudy, or if visible particles are present.
For single use only. Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.
If dilution is required, Prialt must be aseptically diluted before use with 9 mg/mL (0.9%) sodium chloride solution for injection, free of preservatives. 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 preparation and handling of the infusion solution and when filling the pump. Patients and healthcare providers must be experienced with either the external or internal infusion system and must be aware of the need to take precautions against infection.
Specific instructions for pump use 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 at the concentrations indicated above. Chemical and physical stability has been demonstrated for 14 days at 37°C in the Synchromed pump, provided the pump has not been previously exposed to the drug. After 14 days, the pump must be refilled.
Prialt has remained stable for 60 days at 37°C in the Synchromed pump previously exposed to the drug. Product stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.
Technical data are provided for informational purposes only and should not limit healthcare professionals' choice. To administer Prialt, CE-marked pumps equivalent to the Synchromed and CADD-Micro pumps must be used.
Pumps previously used for other medicinal products must be flushed three times with 9 mg/mL (0.9%) sodium chloride solution for injection (without preservatives) before introducing Prialt. Introduction of air into the pump reservoir or cartridge must be minimized, as air may 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 previously unused pump may decrease due to adsorption onto device surfaces and/or dilution by residual volume in the device. Therefore, after the first use of Prialt, the reservoir must be emptied and refilled after 14 days. Subsequently, the pump must be emptied and refilled every 60 days.