25 micrograms / ml solution for infusion
ziconotide
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 to treat severe, chronic pain in adults who need painkillers by intrathecal injection ( injection into the space around the spinal cord and brain).
What You Need To Know Before You Get Prialt
You should not receive Prialt
- if you are allergic to ziconotide or any of the other ingredients of this medicine (listed in section 6).
- if you are being treated with any cancer medicine that is being inserted into the space around the spinal cord.
Warnings and cautions
Talk to your doctor before receiving Prialt.
- The effects of long-term treatment with Prialt are currently uncertain and the risk of toxic effects on the spinal cord has not yet been ruled out. If you need long-term treatment, monitoring may be necessary (according to your doctor’s decision).
- If you receive Prialt through a pump worn on the outside of the body, you must check once a day for any signs of infection where the tubing enters the body.
- If you see any signs of infection around the tube, such as reddening of the skin, swelling, pain, or where, you must immediately inform your doctor and seek treatment for infection.
- If you feel soreness around the tube but you have no signs of infection, you should still consult your doctor as soon as possible, as soreness can be an early sign of infection.
- If you get Prialt through a pump carried on the outside of your body and any part of the infusion line comes loose, you must contact your doctor or nurse immediately.
- If you get any of the following symptoms: high fever, headache, neck stiffness, fatigue, confusion, nausea, vomiting, or occasional cramps, it may be a sign of meningitis. You must tell your doctor immediately if you get any of these symptoms.
- If you notice any adverse effects on your thoughts, mood, or memory, tell your doctor.
- If you are receiving chemotherapy (“chemotherapy”), tell your doctor.
- You may have an increased level of an enzyme called creatine kinase in your blood. This usually does not cause any symptoms or problems, but your doctor will likely check the level. In addition, you may sometimes have muscle problems. If this is the case, you should tell your doctor immediately, as he/she may decide to stop your treatment with Prialt.
- You should tell your doctor immediately if you get any of the following symptoms after treatment: sudden wheezing, difficulty breathing, chest pain, swelling of the eyelids, face or lips, rash or itching (especially if this affects the whole body). This can be a sign of a serious side effect.
- In patients suffering from severe, prolonged pain, there is a higher probability of suicide and suicide attempts than in the general population. Prialt can also cause or worsen depression in people who are already sensitive. If you have depression or have ever had depression, tell your doctor before taking Prialt. If, after starting Prialt, you experience a worsening of your depression or if you experience other symptoms that affect your mood, tell your doctor.
- You may become drowsy or may not be fully aware of your surroundings while receiving treatment. If this happens, tell your doctor immediately, as he/she may decide to stop your treatment with Prialt.
Children and young people
Prialt is not recommended for use in children and adolescents.
Other drugs and Prialt
Tell your doctor if you are taking, have recently taken, or might take any other medicines (eg baclofen for muscle spasticity, clonidine for high blood pressure, bupivacaine for local anesthesia, morphine for pain, propofol for anesthesia, or anything else). medicines given by intrathecal injection [injection into the space surrounding the spinal cord and brain] You may feel drowsy if you are given Prialt with some other painkillers.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Prialt is not recommended during pregnancy or in women of childbearing potential not using contraception.
Driving and using machines
It has been reported that Prialt may cause confusion and drowsiness. Consult a doctor or pharmacist before driving or using machines.
This medicine contains less than 1 mmol sodium (23 mg) per maximum recommended intrathecal dose (21.6 micrograms/day), ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Prialt
Your Prialt treatment will be handled by a doctor who has experience in administering medicine into the space around the spinal cord and in using implanted and external infusion pumps.
The recommended starting dose is as low as 2.4 micrograms a day. Your doctor will adjust the Prialt dose depending on the severity of your pain by adding a maximum of 2.4 micrograms/day. The maximum dose is 21.6 micrograms/day. At the beginning of treatment, your doctor may gradually increase the dose one by one, at least 1-2 days apart. If the side effects become too bothersome, you can, if necessary, reduce the dose one or stop the injection completely.
Prialt is given as a very slow, continuous injection into the space around the spinal cord ( intrathecal use). The drug is delivered continuously from a pump that is either implanted in the abdominal wall or externally placed in a belt bag. Your doctor will discuss with you which type of pump is best for you and when you need to top up your pump.
Talk to your doctor if you feel that the pain is still too severe or if the side effects are too severe.
Before your doctor gives you Prialt, he/she may decide to slowly stop giving you opiates (other types of medicines used to treat pain) into your spinal cord and replace them with other painkillers instead.
If you take more Prialt than you should
If you get more Prialt than your doctor planned, you may experience the following discomfort: confusion, speech problems, difficulty finding words, severe tremors, dizziness, excessive sleepiness, nausea, or vomiting. In this case, contact your doctor or hospital immediately.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
You must tell your doctor immediately if you notice these serious side effects as you may need urgent medical attention.
- Meningitis (may affect up to 1 in 100 people) – inflammation of the membranes that cover the brain and spinal cord and is most often caused by an infection. Symptoms of meningitis include headache, stiff neck, sensitivity to bright light, fever, vomiting, confusion, and drowsiness.
- Convulsions (may affect up to 1 in 100 people) – convulsions (seizures) are when a person’s body shakes quickly and without control. During a seizure, the person’s muscles contract and relax repeatedly and the person may become unconscious.
- Suicidal ideation or suicide attempt (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 are the abnormal color of the urine (brown), reduced urine production, muscle weakness, muscle aches, and sore muscles.
- Coma (may affect up to 1 in 100 people) – a state of unconsciousness when it is difficult to react or wake up.
- Anaphylactic reaction (it is not known how many people are affected) – is a serious side effect, where the symptoms are sudden shortness of breath, difficulty breathing, chest pain, swollen eyelids, lips, and swollen face, rash or itching (especially affects the whole body).
Other side effects ar
Very common (may affect more than 1 user in 10)
Confusion, dizziness, blurred vision, headache, rapid eye movement back and forth, loss or deterioration of memory (forgetfulness), vomiting, nausea, general weakness, and drowsiness.
Common (may affect up to 1 to 10 users)
Decreased appetite, anxiety or aggravated anxiety, hallucinations, inability to fall asleep or sleep, anxiety, disorientation, depression or aggravated depression, nervousness, mood swings, altered mental status (abnormal thoughts, confusion), paranoia , irritability, aggravated confusion, learning, memory – or difficulty thinking, lost or impaired reflexes, difficulty expressing or understanding words, slurred speech, difficulty speaking or loss of speech, inertia, impaired balance or coordination, burning sensation, increased abnormal sensation, decreased level of consciousness (does not react or is almost unconscious), sedative effect, difficulty concentrating, problems with the sense of smell, abnormal or non-existent sense of taste, tremors, ant crawls, double vision, visual disturbances, photosensitivity,tinnitus (ringing in the ears), dizziness or “carousel feeling”, dizziness when standing, low blood pressure , shortness of breath, dry mouth , abdominal pain, aggravated nausea, diarrhea, constipation, sweating, itching , muscle weakness, muscle spasms, muscle cramps, muscle or joint pain, when urinating, difficulty getting started or controlling urination, feeling nervous, falls, pain or aggravated pain, fatigue, feeling cold, swelling of the face, legs or feet, chest pain, changes in blood chemistry, impaired mental function and weight loss.
Uncommon (may affect up to 1 in 100 people)
Infection in the blood, delirium (feeling of mental confusion), psychotic disorder (abnormal thoughts and abnormal perception), thought disorders, abnormal dreams, the incoherence (lack of context), loss of consciousness, stupor (no reaction / difficulty to evoke), stroke, encephalopathy (brain disease), aggression, abnormal heart rhythm, difficulty breathing, indigestion, rash, muscle inflammation, back pain, muscle twitching, neck pain, acute kidney failure, abnormal ECG (recording of heart activity), elevated body temperature, gait difficulties.
How to store Prialt
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Keep the vial in the outer carton. Sensitive to light.
Chemical and physical in-use stability has been demonstrated for 60 days at 37 ° C.
For microbiological reasons, the product, if diluted, must be transferred immediately to the infusion pump. If the solution is not used immediately, the storage time and circumstances before use are the responsibility of the user. The storage time should not normally exceed 24 hours at 2–8 ºC unless dilution has taken place under controlled and validated aseptic conditions.
Do not use this medicine if you notice any discoloration or turbidity or if you see particles.
Contents of the pack and other information
Content declaration
- The active substance is ziconotide.
- One ml of solution contains 25 micrograms of ziconotide (in the form of acetate).
- One 20 ml vial contains 500 micrograms of ziconotide (in the form of acetate).
- The other ingredients are methionine, sodium chloride, water for injections, hydrochloric acid, and sodium hydroxide.
What the medicine looks like and the contents of the pack
Prialt is a solution for infusion ( infusion ). The solution is clear and colorless. Each pack of Prialt contains only one 20 ml vial.
Marketing Authorisation Holder
RIEMER Pharma GmbH
A der Wiek 7
17493 Greifswald-Insel Riems
Germany
Manufacturer
Eisai Manufacturing Limited
Mosquito Way
Hatfield
Herts
AL10 9SN
UK
Contact the representative of the marketing authorization holder to find out more about this medicine:
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