KANOBIL® CANC

Category of the product: Product from cannabis for medical use
Type of ATC Product: §KANOBIL® CANC   is dispensed on prescription in duplicate upon recommendation of medical doctor, specialist in oncology or haematology.
triangle – absolute prohibition on driving a motor vehicle or handling machines.
§
narcotic drug
Product Name: KANOBIL® CANC cannabis oil extract for medical use
Generics: tetrahydrocannabinol (THC), cannabidiol (CBD)
Dose:
Oil solution for oral administration
(2,5 mg tetrahydrocannabinol (THC) and
2,5 mg cannabidiol (CBD))/ 1 ml
(300 mg tetrahydrocannabinol (THC) and
300 mg cannabidiol (CBD))120 ml
(600 mg tetrahydrocannabinol (THC) and
600 mg cannabidiol (CBD))240ml

The text is not intended for self-medication!
Text is intended for informative purposes of healthcare workers.


NAME OF PRODUCT
KANOBIL® CANC
tetrahydrocannabinol (THC), cannabidiol (CBD)
ATC N02BG10


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 oncology or haematology. 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® CANC 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® CANC with or without food. However, taking KANOBIL® CANC with food can affect the amount your body takes in. You should try, as far as possible, to take KANOBIL® CANC 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® CANC according to the following tables:

Adults

The therapy with KANOBIL® CANC includes:
A period of titration and a maintenance period, complying with the following dosage tables:

I.    DOSAGE IN PATIENTS WITH MALIGNANT DISEASES
Decrease of pain
The therapy includes: a titration period and maintenance period.

Prior to the beginning of the therapy, the symptoms in the patient have to be evaluated by application of the NRS values (NRS – numerical rating scale for measuring the intensity of the symptoms: 0= no symptoms, 10-most severe symptoms)

TITRATION PERIOD
Due to the specific condition, the titration phase has to last no longer than 10-14 days.
The dosage is expressed through the concentration of THC of 2.5 mg in 1 ml (which means that simultaneously there is 2.5 mg CBD in 1 ml)
Every increase in the dose is 3 x 2,5 mg/day.

STARTING DOSE
Take 3 ml of the oil solution divided into 3 equal daily doses.

Day/No. Dosage Total daily dose THC/CBD/(mg)  The total daily quantity of oil solution (ml)
Day 1 3 × 2,5 mg 7,5 mg 3 mL
Day 2 3 × 2,5 mg 7,5 mg 3 mL
Day 3 3 × 2,5 mg 7,5 mg 3 mL

If well tolerated, the starting dose should be repeated during a period of the next 3 days, which are then followed by an increase of the dose I – by adding 3 x 2,5 mg/day, total of 3×5,0 mg /day. If moderate adverse events occur during the starting dose, the starting dose should be repeated during the next 5-6 days because there is a possibility that the effects will withdraw. In case of severe adverse events, the therapy should be discontinued.

THE NEXT DOSE – Increase the dose I – 3 x 5 mg/day
Take 6 ml of the oil solution, divided into three equal daily doses.

Day/No. Dosage Total daily dose THC/CBD/(mg)  The total daily quantity of oil solution (ml)
Day 1 3 × 5 mg 15 mg 6 ml
Day 2 3 × 5 mg 15 mg 6 ml
Day 3 3 × 5 mg 15 mg 6 ml

If during the Increase of the dose I any adverse events which are moderate occur, the dose has to be repeated during the next 5 days because there is a possibility that the effects will withdraw. In case of severe adverse events, the therapy should be discontinued or the dose should be decreased for one level lower. If the Increase of the dose I is well tolerated, after 3 days follows:

Increase the dose II – 3 x 7,5 mg/day
Take 9 ml of the oil solution, divided into three equal daily doses.

Day/No. Dosage Total daily dose THC/CBD/(mg)  The total daily quantity of oil solution (ml)
Day 1 3 × 7,5 mg 22,5 mg 9 ml
Day 2 3 × 7,5 mg 22,5 mg 9 ml
Day 3 3 × 7,5 mg 22,5 mg 9 ml

If the Increase of the dose II is well tolerated, after 3 days follows:
Increase the dose III – 3 x 10 mg/day
Take 12 ml of the oil solution, divided into three equal daily doses.

Day/No. Dosage Total daily dose THC/CBD/(mg)  The total daily quantity of oil solution (ml)
Day 1 3 × 10 mg 30 mg 12 ml
Day 2 3 × 10 mg 30 mg 12 ml
Day 3 3 × 10 mg 30 mg 12 ml

If the Increase of the dose III, after 3 days follows:
Increase the dose IV – 3 x 12,5 mg/day
Take 15 ml of the oil solution, divided into three equal daily doses.

Day/No. Dosage Total daily dose THC/CBD/(mg)  The total daily quantity of oil solution (ml)
Day 1 3 × 12,5 mg 37,5 mg 15 ml
Day 2 3 × 12,5 mg 37,5 mg 15 ml
Day 3 3 × 12,5 mg 37,5 mg 15 ml

This titration regime, through the gradual increase of the daily dose for 3 x 2,5 mg/day, or the possible decrease if the adverse events are very stressed, enables reaching the highest dose which is tolerable without any stressed adverse events.
The dose which is reached during the titration, which is the frames of the recommended maximal daily dose that is well tolerable and which enables reaching decrease of the NRS values, is the MAINTENANCE DOSE.

MAINTENANCE PERIOD

MAINTENANCE DOSE – 3 x 12,5 mg/day

Take 15 ml of the oil solution divided into 3 equal daily doses.

Day/No. Dosage Total daily dose THC/CBD/(mg) The total daily quantity of oil solution (ml)
15 – 3 × 12,5 mg 37,5 mg 15 mL

During the therapy regime, the NRS value has to be repeated every 1-2 weeks.
If the decrease of the NRS value is <25% in respect of the condition before the therapy commencement, then the dose should be increased for 3 x 2,5 mg, like in the titration phase. If this is not possible (i.e. the recommended maximum daily dose is surpassed) or the increase of the dose (up to the maximum recommended) does not produce a decrease of the NRS value for ≥25%, i.e. the value is <25% in respect of the condition in the very beginning – the therapy should be discontinued.

MAXIMUM DAILY DOSE OF THC/CBD

Day/No. Dosage Total daily dose THC/CBD/(mg) The total daily quantity of oil solution (ml)
15 – 3 × 12,5 mg 37,5 mg 15 mL

If during the first 2 weeks, any highest tolerable dose (≤37,5 mg/day) does not produce a decrease of the NRS for ≥25%, the therapy should be discontinued.

II.    DOSAGE IN PATIENTS WITH MALIGNANT DISEASES
Nausea and vomiting during chemotherapy

The therapy is recommended in patients who are experiencing acute or prolonged symptoms after they were administered, intravenously or orally, 5-HT3 antagonists prior to the chemotherapy and orally administered during 2 days after the chemotherapy in combination with intravenous administration of dexamethasone before and oral administration 2 days after the chemotherapy,

BEFORE THE CHEMOTHERAPY
The dosage is expressed through the concentration of THC of 2,5 mg in 1 ml (which means that there is simultaneously 2,5 mg CBD in 1 ml).

Time Dosage Total daily dose THC/CBD/(mg) The total daily quantity of oil solution (ml)
2 hours before the chemotherapy is started 1 х 2,5 mg 2,5 mg 1 ml

If during a period of 45 minutes from the administration of the Starting dose severe adverse events occur, the therapy should be discontinued.

NEXT DOSE I:

Time Dosage Total daily dose THC/CBD/(mg) The total daily quantity of oil solution (ml)
45 min. after the Starting dose, if no severe adverse events occur. 1 х 2,5 mg 2,5 mg 1 ml

If during a period of 45 minutes from the administration of the NEXT DOSE I severe adverse events occur, the therapy should be discontinued.

NEXT DOSE II:

Time Dosage Total daily dose THC/CBD/(mg) The total daily quantity of oil solution (ml)
45 min. after the NEXT DOSE I,
1,5 hours after the Starting dose and about 30 min. before the start onset of the chemotherapy, if no severe adverse events occur.
1 х 2,5 mg 2,5 mg 1 ml

TOTAL BEFORE CHEMOTHERAPY:
During a period of 1,5 hours before the chemotherapy, the following doses are administered 3 ml (3 x 2,5 mg) or in total (7,5 mg THC + 7,5 mg CBD).

AFTER THE CHEMOTHERAPY

RECOMMEDNED DOSES

Time Dosage /
Day
Total dose THC/CBD (mg) The total quantity of oil solution (ml)
If the treatment preceding the chemotherapy has not caused severe adverse events, the treatment should be continued for 4 days after the chemotherapy. 6 х 2,5 mg 15 mg 6 ml

RECOMMENDED DOSES
Time Dosage /

Time Dosage /
Day
Total dose THC/CBD (mg) The total quantity of oil solution (ml)
If the symptoms of nausea and vomiting are moderate, the dose can be decreased 4 x 2,5 mg 10 mg 4 ml


Children

KANOBIL® CANC is not recommended for use in children and adolescents aged below 18, which is recommended due to a lack of information on safety and efficacy.

Category:

Description

COMPOSITION

(2,5 mg tetrahydrocannabinol  (THC) and 2,5 mg cannabidiol  (CBD))/ 1 ml(300 mg tetrahydrocannabinol  (THC) and  300 mg cannabidiol  (CBD))120 ml

(600 mg tetrahydrocannabinol  (THC) and 600 mg cannabidiol  (CBD))240ml

THERAPEUTIC INDICATIONS

KANOBIL® CANC can be administered in adult patients as symptomatic adjuvant therapy to regular therapy in cases of:
Malignant diseases – for improvement of the symptoms of:
-Pain;
-Chemotherapy-induced nausea and vomiting in patients in whom the standard therapy with other anti-nausea medicinal products (such as 5-HT3 agonists) does not produce the expected results.

CONTRAINDICATIONS

Do not take KANOBIL® CANC 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® CANC if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking KANOBIL® CANC.


PACKAGING

A box with a glass bottle containing 120 ml of the oil solution (equal to 120 doses) and a plastic graduated dosing syringe.
A box with a glass bottle containing 240 ml of the oil solution (equal to 240 doses) and a plastic graduated dosing syringe.