Prialt 100 micrograms/ml solution for infusion

Prialt belongs to a group of medicines, called analgesics or ?painkillers?. Prialt is used for the treatment of long-term pain when your existing treatment is not effective or causes severe side effects.

Do not use Prialt

• If you are allergic (hypersensitive) to ziconotide or any of the other ingredients of Prialt.
• If you are receiving an anticancer medicine into the space around your spinal cord.

Take special care with 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 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.

• Severe allergic reactions have not been seen in clinical studies so far, however it is not yet possible to say for certain that a severe allergic reaction will not happen when you are given Prialt. 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).
• 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.
• 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.
• Not recommended for use in children and adolescents.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines (for example, baclofen, clonidine, bupivacaine or propofol), including medicines obtained without a prescription. 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, think you may be pregnant, or are breast-feeding ask your doctor for advice before taking any medicine.

Prialt should not be used during pregnancy or breast-feeding unless clearly necessary.

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.

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.

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

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 in dose increments of ? 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.

If you feel that you are still in too much pain while taking 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 use 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.

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

The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)

Very common:
Confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or impairment of memory (forgetfulness), difficulty walking, vomiting, nausea, general weakness and drowsiness.

Common:
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 pain sensitivity, 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, lightheadedness 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, fever, blood chemistry changes, mental impairment and weight decreased.

Uncommon

Infection of the blood stream, meningitis, delirium (feeling of mental confusion), psychotic disorder (abnormal thinking and perceptions), suicidal thought or attempt, thought disorders, abnormal dreams, incoherence (inability to make sense), loss of consciousness, coma, stupor (unresponsive/difficult to arouse), convulsions (fits), stroke, encephalopathy (brain disorder), abnormal heart rhythm, difficulty breathing, indigestion,rash, muscle breakdown (rhabdomyolysis), muscle inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal heart trace measurements (ECG), raised body temperature.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Prialt after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store unopened vial in 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.

What Prialt contains

• The active substance is ziconotide.
• One ml solution contains 100 micrograms ziconotide (as acetate).
• One vial of 1 ml contains 100 micrograms; one vial of 2 ml contains 200 micrograms; one vial of 5 ml contains 500 micrograms.
• 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. 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 and Manufacturer

Marketing Authorisation Holder:
Eisai Ltd.
Mosquito Way
Hatfield
Herts
AL10 9SN
United Kingdom

Manufacturer:
Eisai Manufacturing Limited
Mosquito Way
Hatfield
Herts
AL10 9SN
United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Eisai Europe Ltd. TélTel 32 0 2 735 45 34 LuxembourgLuxemburg Eisai Europe Ltd. TélTel 32 0 2 735 45 34 BelgiqueBelgien

Magyarország Eisai GesmbH Tel. 36 1 230 43 20 Eisai Ltd. Te. 44 208 600 1400

eská republika Eisai GesmbH organizaní sloka Tel 420 242 485 839 Malta Associated Drug Company Ltd Tel 356 0 227 780 00

Danmark NordicInfu Care Tlf 46 08 601 24 40 Sverige Nederland Eisai Europe Ltd. Tel 32 0 2 735 45 34 BelgiëBelgique

Deutschland Eisai GmbH Tel 49 0 69 66 58 50 Norge NordicInfu Care Tlf 46 08 601 24 40 Sverige

Österreich Eisai GesmbH Tel 43 0 1 535 1980-0 Eesti Eisai Ltd. Tel 44 208 600 1400 Ühendkuningriik

Arriani Pharmaceuticals S.A. 30 210 668 3000 Polska Eisai Ltd. Tel. 44 208 600 1400 Wielka Brytania

España Eisai Farmacéutica, S.A. Tel 34 91 455 94 55 Portugal Eisai Farmacêutica, Unipessoal Lda Tel 351 214 875 540

France Eisai SAS Tél 33 1 47 67 00 05 România Eisai Ltd. Tel 44 208 600 1400 Marea Britanie

Ireland Eisai Ltd. Tel 44 208 600 1400 United Kingdom Slovenija Eisai Ltd. Tel 44 208 600 1400 Velika Britanija

Ísland NordicInfu Care Sími 46 08 601 24 40 Svíjóð Slovenská republika Eisai GesmbH organizaní sloka Tel 420 242 485 839 eská republika

Italia Eisai S.r.l. Tel 39 02 5181401 SuomiFinland NordicInfu Care PuhTel 46 08 601 24 40 RuotsiSverige

Arriani Pharmaceuticals S.A. 30 210 668 3000 Sverige NordicInfu Care Tel 46 08 601 24 40

United Kingdom Eisai Ltd. Tel 0208 600 1400 Latvija Eisai Ltd. Tel 44 208 600 1400 Lielbritnija

Lietuva

Eisai Ltd.
Tel. + 44 208 600 1400
(Jungtin- Karalyst-)

This leaflet was last approved in {MM/YYY}.

This medicine has been authorised under ?Exceptional Circumstances?. This means that because of the rarity of the disease it has been impossible to get complete information on this medicine. The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.

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The following information is intended for medical or 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 solution should be discarded according to local regulations.

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 ?g/ml ziconotide in an external pump and 25 ?g/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.

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.

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