Category of the product: Product from cannabis for medical use
Type of ATC Product:§▲KANOBIL® MS is dispensed on prescription in duplicate upon recommendation of medical doctor, specialist in neurology.
▲ triangle – absolute prohibition on driving a motor vehicle or handling machines.
§ – narcotic drug
Product Name: KANOBIL® MS cannabis oil extract for medical use
Generics: tetrahydrocannabinol (THC), cannabidiol (CBD)
Oil solution for oral administration
(2 mg tetrahydrocannabinol (THC) and
1 mg cannabidiol (CBD))/ 1 ml
(240 mg tetrahydrocannabinol (THC) and
120 mg cannabidiol (CBD))120 ml
The text is not intended for self-medication!
Text is intended for informative purposes of healthcare workers.
NAME OF PRODUCT
tetrahydrocannabinol (THC), cannabidiol (CBD)
POSOLOGY AND METHOD OF ADMINISTRATION
Stick strictly to the recommendations from your doctor. The therapy has to be recommended and monitored by a doctor, specialist in neurology. Your doctor will tell you how many doses per day you should take and when. You must not change the doses or discontinue the treatment regime without consulting your doctor.
KANOBIL® MS is for oral administration. Shake the bottle before use. Use the plastic oral dosing syringe for drawing a dose of the oil solution which is equal to the dose given in the recommendation by your doctor.
Carefully press to release the content of the oral dosing syringe in the mouth and swallow.
You can take KANOBIL® MS with or without food. However, taking KANOBIL® MS with food can affect the amount your body takes in. You should try, as far as possible, to take KANOBIL MS the same way in relation to food each time, so you get the same effect each time.
Depending on the condition for which this medicine is taken, your doctor will determine the daily dose of KANOBIL® MS according to the following tables:
The therapy with KANOBIL® MS includes:
Period of Titration and Maintenance period, complying with the dosing scheme.
The period of titration last several weeks, usually 3-4 weeks and includes:
- Evaluation of the severity of symptoms in patient, prior to the beginning and during the treatment, by measurement of the NRS values (NRS – numerical rating scale for measuring the intensity of the symptoms: 0= no symptoms, 10-most severe symptoms)
- Gradual increase of the dose until achieving the desired effect: reducing muscle spasms (stiffness) with less possible adverse events.
- Dose increase should be stopped when the desired effect is reached with the titration, regardless of whether the applied dose is the maintenance dose or not.
- If during the titration moderate side effects occur (usually a feeling of dizziness), the dose should be decreased, in particular, a daily dose per day gradually (in reverse order from increasing).
- If any severe side effects occur during the titration, the therapy should be discontinued.
- The dose reached during the titration that is within recommended maximal daily dose limits, that is well tolerable and enables reaching decrease of the NRS values, is the MAINTENANCE DOSE.
- The maximal daily dose of THC is 30mg/day
- Upon a recommendation of a doctor, the dose can be decreased or increased.
PERIOD OF TITRATION
| MORNING DOSE
(the period between waking up and
12 o’clock in the afternoon) quantity of oil solution (ml)
(the period between 4 p.m. and before going to bed)
quantity of oil solution (ml)
|The total daily quantity of oil solution (ml)||Total daily dose THC/CBD (mg)|
|Day 1||/||1 ml||1 ml||2mg/1mg|
|Day 2||/||1 ml||1 ml||2mg/1mg|
|Day 3||/||2 ml||2 ml||4mg/2mg|
|Day 4||/||2 ml||2 ml||4mg/2mg|
|Day 5||1 ml||2 ml||3 ml||6mg/3mg|
|Day 6||1 ml||3 ml||4 ml||8mg/4mg|
|Day 7||1 ml||4 ml||5 ml||10mg/5mg|
|Day 8||2 ml||4 ml||6 ml||12mg/6mg|
|Day 9||2 ml||5 ml||7 ml||14mg/7mg|
|Day 10||2 ml||5 ml||8 ml||16mg/8mg|
|Day 11||3 ml||6 ml||9 ml||18mg/9mg|
|Day 12||4 ml||6 ml||10 ml||20mg/10mg|
|Day 13||4 ml||7 ml||11 ml||22mg/11mg|
|Day 14||5 ml||7 ml||12 ml||24mg/12mg|
|Day 15||5 ml||8 ml||13 ml||26mg/13mg|
|Day 16||6 ml||8 ml||14 ml||28mg/14mg|
|Day 17||6 ml||9 ml||15 ml||30mg/15mg|
During the therapy course, at every 4, 8 and 12 weeks, a laboratory control has to be performed for haematological, hepatic and renal analyses in order to monitor the occurrence of side effects and tolerance to them. In case of variations that surpass the benefit/risk ratio and when there is no improvement of the clinical status, discontinuation of therapy should be considered.
KANOBIL® MS is not recommended for use in children and adolescents aged below 18, due to lack of safety and efficacy information.
|(2 mg tetrahydrocannabinol (THC) and 1 mg cannabidiol (CBD))/ 1 ml
(240 mg tetrahydrocannabinol (THC) and 120 mg cannabidiol (CBD))120 ml
|KANOBIL® MS is used in adult patients as symptomatic adjuvant therapy to the standard therapy in multiple sclerosis (MS) to improve symptoms related to muscle stiffness. This is also called “spasticity”.
Spasticity means there is an increase in 'muscle tone' which makes the muscles feel more stiff or rigid. This means it is more difficult than normal to move the muscle. KANOBIL® MS is used when other medicines have not helped your muscle stiffness.
Only a doctor, specialist neurologist can start your treatment with KANOBIL® MS.
Before you start using KANOBIL® MS, your specialist doctor will do an assessment. This is to see how bad your muscle stiffness is. They will look at how well other treatments have worked.
|Do not take KANOBIL® MS if:
-if you are hypersensitive to cannabinoids or to any of the excipients;
-if you or anyone from your family has any issues related to the mental health, like schizophrenia, psychoses or other sever psychiatric conditions; this does not include the depression which results from your primary condition;
-if you are pregnant or breastfeeding.
Do not take KANOBIL® MS if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking KANOBIL® MS.
|A box with a glass bottle containing 120 ml of the oil solution (equal to 120 doses) and a plastic graduated dosing syringe.
Prescription in two copies with the mark “copy” on the second copy and with the ordinal number from the evidence book of prescribed medicines containing narcotics and psychotropic substances.