Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - prialt

Document Subject

Generated Narrative: MedicinalProductDefinition mp23c171402ffd8448c1d943b191514c66

identifier: http://ema.europa.eu/identifier/EU/1/04/302/004 – 20 mL solution for infusion

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Prialt 25 micrograms/mL solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-23c171402ffd8448c1d943b191514c66

identifier: http://ema.europa.eu/identifier/EU/1/04/302/004 – 20 mL solution for infusion

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - prialt

Attesters

What is in this leaflet

1. What Prialt is and what it is used for
2. What you need to know before you are given Prialt
3. How to use Prialt
4. Possible side effects
5. How to store Prialt
6. Contents of the pack and other information

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).

You should not be given Prialt

• if you are allergic to ziconotide or any of the other ingredients of this medicine (listed in section 6).
• if you are receiving an anticancer medicine into the space around your spinal cord.
• if you have a history of suicidal attempt or suicidal ideation with ziconotide

Warnings and precautions Patients should undergo a neuropsychiatric evaluation before, after starting and during intrathecal ziconotide, and immediately when any depressive signs or symptoms appear. Caregivers should contact a physician immediately if the patient experiences symptoms of potentially life-threatening adverse event.

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.

Prialt contains sodium This medicine contains less than 1 mmol sodium (23 mg) per maximum recommended intrathecal dose (21.6 micrograms per day), that is to say essentially sodium-free .

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 at no more than 2.4 micrograms per day. Your doctor may adjust the dose of Prialt very slowly 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.

Pain relief may be achieved through a stepwise process by adjusting the dose of Prialt very slowly. 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.

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 (frequency cannot be estimated from the available data) 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 in 10 people) 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 up to 1 in 10 people) 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 up to 1 in 100 people) 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.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 Esteve Pharmaceuticals GmbH Hohenzollerndamm 150-14199 Berlin Germany

Manufacturer HWI pharma services GmbH Stra burger Stra e 77767 Appenweier Germany

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

Belgi /Belgique/Belgien Esteve Pharmaceuticals GmbH T l/Tel: +49 (0)30 338427-0 info.germany@esteve.com (Duitsland/Allemagne/Deutschland)

Lietuva Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Vokietija)

Esteve Pharmaceuticals GmbH Te .: +49 (0)30 338427-0 info.germany@esteve.com ( )

Luxembourg/Luxemburg Esteve Pharmaceuticals GmbH T l/Tel: +49 (0)30 338427-0 info.germany@esteve.com (Allemagne/Deutschland)

esk republika Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (N mecko)

Magyarorsz g Esteve Pharmaceuticals GmbH Tel.: +49 (0)30 338427-0 info.germany@esteve.com (N metorsz g)

Danmark Esteve Pharmaceuticals GmbH Tlf: +49 (0)30 338427-0 info.germany@esteve.com (Tyskland)

Malta Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Il- ermanja/Germany)

Deutschland Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com

Nederland Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Duitsland)

Eesti Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Saksamaa)

Norge Esteve Pharmaceuticals GmbH Tlf: +49 (0)30 338427-0 info.germany@esteve.com (Tyskland)

Esteve Pharmaceuticals GmbH : +49 (0)30 338427-0 info.germany@esteve.com ( )

sterreich AGEA Pharma GmbH Tel: +43 (0)1 336 01 office@ageapharma.com

Espa a Esteve Pharmaceuticals, S.A. Tel: +34 93 446 60 Polska IMED POLAND Sp. z o.o. Tel.: +48 (0)22 663 43 imed@imed.com.pl

France ESTEVE PHARMACEUTICALS S.A.S T l: +33 (0)1 42 31 07 contact-france@esteve.com Portugal Esteve Pharmaceuticals, S.A. Tel: +34 93 446 60 (Espanha)

Hrvatska Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Njema ka)

Rom nia
Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Germania)

Ireland Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Germany)
Slovenija Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Nem ija)

sland Esteve Pharmaceuticals GmbH S mi: +49 (0)30 338427-0 info.germany@esteve.com ( skaland)

Slovensk republika Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Nemecko) Italia Esteve Pharmaceuticals S.r.l. info.italy@esteve.com Suomi/Finland Esteve Pharmaceuticals GmbH Puh/Tel: +49 (0)30 338427-0 info.germany@esteve.com (Saksa/Tyskland)

Esteve Pharmaceuticals GmbH : +49 (0)30 338427-0 info.germany@esteve.com ( )

Sverige Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Tyskland) Latvija Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (V cija)

United Kingdom (Northern Ireland) Esteve Pharmaceuticals GmbH Tel: +49 (0)30 338427-0 info.germany@esteve.com (Germany)

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: