50 micrograms / ml, 0.5 mg / ml and 2 mg / ml Solution for injection / infusion
Baclofen
What Lionova is and what it is used for
Lionova is given as an injection into the spinal canal directly into the spinal fluid ( intrathecal injection ) and reduces severe muscle cramps (spasticity).
Lionova is used to treat severe, prolonged muscle spasm (spasticity) that occurs in various diseases, such as:
- brain or spinal cord injuries or diseases
- multiple sclerosis , which is a progressive (progressive) nerve disease in the brain and spinal cord with physical and mental symptoms.
Lionova is used for adults and children aged 4 years and up. It is used when other medicines taken orally (by mouth), including baclofen, have failed or caused unacceptable side effects .
The baclofen contained in Lionova may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before using Lionova
Do not use Lionova
- If you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6).
- If you have epilepsy that can not be treated.
- Via a route of administration other than the spinal canal.
Warnings and cautions
Talk to your doctor, pharmacist or nurse before using Lionova:
- If you have an infection .
- If you have had a head injury. In patients with spasticity due to head injury, intrathecal treatment with Lionova should not be initiated until the symptoms of spasticity are stable and can be safely assessed.
- If you have had autonomic dysreflexia: a reaction to overstimulation of the nervous system that rapidly leads to severely elevated blood pressure .
- If you have reduced circulation of the fluid in the brain and spinal cord as a result of an obstruction, e.g. caused by inflammation or damage.
- If you have epilepsy that can be treated.
- If you have had a stomach or intestinal ulcer.
- If you have an overactive sphincter ( sphincter ) of the urinary bladder.
- If you have acute or chronic conditions of confusion.
- If you have psychotic illness or schizophrenia (mental illness).
- If you have Parkinson’s disease .
- If you have impaired kidney function or a liver disease.
- If you have insufficient blood circulation in the brain ( cerebrovascular insufficiency ).
- If you have heart or breathing problems.
- Monitoring of cardiovascular and respiratory functions is necessary during the initial test phase, especially if you have heart or respiratory problems.
- If you have diabetes
- If you are going to have an operation.
Contact your doctor immediately if you notice any of these symptoms during treatment with Lionova:
- If you get pain in the back, neck and buttocks (may be a symptom of a type of spinal deformity called scoliosis).
Contact your doctor immediately if you think Lionova is not working as well as usual. It is important to check that there are no problems with the infusion pump.
You will be closely monitored in an environment with complete equipment and personnel during the screening phase and during the period in which the correct dose is determined immediately after implantation of the infusion pump. You will be assessed regularly for the dose you need, for any side effects or signs of infection . The function of the administration system (pump and associated equipment) will also be checked.
Treatment with Lionova must not be stopped abruptly due to the risk of discontinuation of effects. Make sure you do not forget to visit the hospital to replenish the infusion pump reservoir.
Children and young people
Lionova is not recommended for children under 4 years. Children must have a sufficiently large body to accommodate the implanted infusion pump. There are limited clinical data in children under 4 years of age.
Older
Some patients over 65 years of age have been treated with intrathecal baclofen during clinical trials without specific problems. However, experience with baclofen tablets shows that this patient group may be more susceptible to side effects . Elderly patients should therefore be closely monitored for the occurrence of side effects.
Other drugs and Lionova
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking any of the following medicines as they may affect or be affected by Leonova:
- Other drugs to treat conditions with muscle spasms. If possible, your doctor will slowly discontinue other medicines that treat muscle spasms.
- Drugs to treat depression.
- Drugs to treat high blood pressure .
- Levodopa , carbidopa: medicines to treat Parkinson’s disease .
- Strong painkillers, e.g. morphine.
- Drugs that have a dampening effect on the central nervous system , e.g. sleep-inducing drugs.
- Other drugs that are administered in the spine.
- Administration of other drugs in the spine is not recommended during treatment with Lionova.
Concomitant use of anesthetics may increase the risk of heart failure and seizures.
Lionova with alcohol
Do not drink alcohol during treatment with Lionova as it may lead to an unwanted increase or unpredictable change in the effect of the medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited experience with the use of intrathecal baclofen during pregnancy or lactation. Leonova should not be used during pregnancy or breastfeeding unless the expected benefit to the mother outweighs the potential risk to the baby.
Breast-feeding
Lenovo passes into breast milk, but low levels are expected after intrathecal administration. Leonova can thus be used during breastfeeding.
Driving and using machines
During treatment with Lionova, the ability to drive or use machines may be impaired.
Some people may feel drowsy, have dizziness, eye problems, difficulty controlling movement, or have hallucinations when treated with Leonova. If this applies to you, do not drive or do anything that requires increased attention (such as the use of tools or machines) until these effects have disappeared. Before driving or using machines, consult your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lionova contains sodium
50 micrograms / ml = 0.05 mg baclofen in a 1 ml ampoule contains less than 1 mmol sodium (23 mg) per dose , ie essentially ‘sodium-free’.
0.5 mg / ml = 10 mg baclofen in a 20 ml ampoule contains 180 mg of sodium chloride corresponding to 70.81 mg of sodium (the main ingredient in table salt / table salt) per dose . This corresponds to 3.5% of the maximum recommended daily intake of sodium for adults.
2 mg/ml = 10 mg baclofen in a 5 ml ampoule contains 45 mg of sodium chloride corresponding to 17.70 mg of sodium (the main ingredient in table salt/table salt)
per dos. This corresponds to 0.9% of the maximum recommended daily sodium intake for adults.
How to be given Lionova
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Only your doctor can change your dose.
Leonova should only be given by a specially trained doctor.
The recommended dose is:
Dose one varies depending on the condition of each person. Your doctor will determine your dose after testing how you respond to this medicine.
First, your doctor will give you a single dose of Lionova to see if the medicine is right for you. During this period, your heart and lung function will be closely monitored. If your symptoms improve, a special pump that allows Lionova to be continuously inserted (implanted) into the chest or abdominal wall. Your doctor will give you all the information you need to use the infusion pump and dosing information. Make sure you understand everything.
Your dose depends on how you respond to the medicine. You start with a low dose that is gradually increased over a few days with the doctor’s supervision until you get the right dose.
You are more likely to get side effects if the starting dose is too high or the dose is increased too fast. To avoid these effects, which can be serious, the medicine in the pump mustn’t run out. Make sure you do not forget your hospital visits.
You must visit the doctor to refill the infusion pump, otherwise, the cramps may return as you will not receive a sufficiently high dose of Leonova. As a result, your muscle cramps may worsen.
If your muscle elasticity does not improve or if you start having cramps again, either gradually or suddenly, contact your doctor immediately.
If treatment with Lionova is stopped
It is very important that you, and those who care for you, can recognize the signs of the release of Leonova. These can come on suddenly or slowly as a result of the pump not working properly due to problems with the battery, catheter, or alarm.
Signs of release are:
- Increased spasticity, too high muscle tension ( muscle tone ).
- Difficulty with muscle movements.
- Increased heart rate or heart rate .
- Itching , tingling, burning or numbness ( paresthesia ) in the hands or feet.
- Palpitation.
- Anxiety.
- High body temperature.
- Low blood pressure .
- Changed mental state e.g. agitation, confusion, hallucinations, abnormal thoughts and deviant behavior, seizures.
- Persistent painful erection in the penis (priapism).
If you notice any of the above signs, contact a doctor immediately. These signs can be followed by more serious side effects if you do not receive treatment immediately.
Method of administration
Leonova should only be given in the spinal canal ( intrathecal use).
Usage time
Determined by the doctor.
During long-term treatment, some patients find Lionova less effective. Your doctor may recommend temporary treatment interruptions to counteract this.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These occur more often at the beginning of treatment during the hospital stay, but can also occur later. For many of these side effects, there is also a link to the specific medical condition you are being treated for.
Side effects can occur with the following frequencies:
Very common side effects are (can occur in more than 1 in 10):
- Drowsiness
- Reduced muscle tension.
Common side effects are (may affect up to 1 in 10):
- Drowsiness, dizziness, feeling of instability.
- Pain, fever, chills.
- Abnormal sensation, e.g. knitting.
- Problems with vision with blurred vision or double vision.
- Slurred speech.
- Numbness, weakness
- Respiratory problems (impaired respiratory function, shortness of breath, slow breathing), pneumonia (aspiration pneumonia).
- Insomnia.
- Confusion, disorientation, anxiety, restlessness, depression.
- Low blood pressure .
- Constipation, diarrhea
- Dry mouth , decreased appetite, severe salivation.
- Rash, itching .
- Tissue swelling of the face, hands or feet.
- Urinary incontinence (urine leakage).
- Increased muscle tension, muscle weakness.
- Sexual problems, e.g. impotence .
The following side effects are more common in patients with cerebral spasticity:
Seizures, headaches, nausea, vomiting, and difficulty urinating.
Less common side effects are (may affect up to 1 in 100):
- Feeling unusually cold.
- Involuntary eye movements ( nystagmus ).
- Difficulty controlling movements ( ataxia ).
- Impaired memory.
- Mood disorders, feelings of elation ( euphoria ), persecution mania ( paranoia ), hallucinations, suicidal thoughts and attempts.
- Intestinal obstruction, difficulty swallowing, lack of taste, dehydration.
- High blood pressure , slow heartbeat.
- Blood clot formation in a vein ( venous thrombosis ).
- Redness or pale skin, heavy sweating.
- Hair loss.
Rare side effects are (may affect up to 1 in 1000 people):
- Life-threatening withdrawal symptoms due to failed drug administration.
Has been reported (occurs in an unknown number of users):
- Increased curvature of the spine laterally (scoliosis).
- Difficulty getting or maintaining an erection ( erectile dysfunction ).
For a description of the signs of discontinuation, see “If treatment with Lionova is stopped”.
For a description of signs of overdose, see “If you are given too much Leonova”.
There have been reports of problems with the infusion pump and the administration system, e.g. infection, inflammation of the membranes of the brain and spinal cord ( meningitis ), or inflammation at the tip of the administration system.
How to store Lionova
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton and ampoule after EXP. The expiration date is the last day of the specified month.
After the first opening: the product should be used immediately.
Because the drug is restricted to hospital use, the hospital discards drugs that are no longer used.
Contents of the pack and other information
Content declaration
- The active substance is baclofen
- The other ingredients are sodium chloride and water for injections
What the medicine looks like and contents of the pack
Appearance
Lionova is a clear, colorless solution for injection / infusion, pH 5.0 to 7.0.
Pack sizes
Leonova 50 micrograms/ml is supplied in cartons containing 5 glass ampoules of 1 ml each.
Lionova 0.5 mg / ml is available in cartons containing 1 20 ml glass ampoule .
Leonova 2 mg/ml in a carton containing 1 glass vial of 5 ml and 5 glass ampoule s of 5 ml each.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark
Ti llverkare
Bioindustry LIMSpA, Via De Ambrosius 2, 15067 Novi Ligure (AL), Italy
or
Orifarm Generics A / S, Energivej 15, 5260 Odense S, Denmark
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Sweden, Norway: Leonova