KANOBIL® HIV

Category of the product: Product from cannabis for medical use
Type of ATC Product: §▲KANOBIL® HIV is dispensed on prescription in duplicate upon recommendation of medical doctor.
▲ triangle – absolute prohibition on driving a motor vehicle or handling machines.
§ – narcotic drug
Product Name: KANOBIL® HIV
Generics: tetrahydrocannabinol (THC), cannabidiol (CBD)
Dose:

Oil solution for oral administration

(2,5 mg tetrahydrocannabinol  (THC) and

1 mg cannabidiol  (CBD))/ 1 ml

(300 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
KANOBIL® HIV
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. 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 without consulting your doctor.

KANOBIL® HIV is for oral use. Shake the bottle before use. Use the plastic graduated oral syringe for pulling out a dose of the oil solution which is equal to the dose in accordance to the scheme given by your doctor.

Carefully press to release the content of the oral dosing syringe in the mouth and slowly swallow.

Depending on the condition for which this medicine is taken, your doctor will recommend the daily dose of KANOBIL® HIV according to the following schemes:

Adults

The therapy with KANOBIL® HIV includes:

A period of titration and a maintenance period, complying with the dosing scheme:

The period of titration usually lasts for 2 weeks and includes:

-Evaluation of the severity of the patient’s symptoms, before starting and during the therapy, by using VAS value scale for the appetite and the feeling of fullness regarding the food intake;

-The amount of the energy intake – evaluated as a number of calories or number of meals taken per day.

-Gradual increase of the dose until achieving the desired effect: increasing the weight and stopping the loss of weight with as small number of side effects as possible.

-When the desired effect is reached with the titration, the dose shouldn’t be further increased regardless of whether the dose reached is the maintenance dose or not.

-If during the titration moderate adverse events 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 which is in the frames of the maximal recommended daily dose and is well tolerable is the Maintenance dose.

-The maximal daily dose of THC is 37,5mg/day.

Upon a recommendation of a doctor, the dose can be decreased or increased.

PERIOD OF TITRATION

DAILY DOSE
(the period
between
2 p.m. and 6p.m.
in the afternoon)
quantity of the oil solution (ml)		 EVENING DOSE
(before sleeping)
quantity of the oil solution (ml)		 Total daily quantity

of oil solution (ml)

 Total daily dose
THC/ CBD (mg)
Day 1 / 1ml 1ml 2,5mg/1mg
Day 2 1ml 1ml 2ml 5mg/2mg
Day 3 1ml 2ml 3ml 7,5mg/3mg
Day 4 2ml 2ml 4ml 10mg/4mg
Day 5 2ml 3ml 5ml 12,5mg/5mg
Day 6 3ml 3ml 6ml 15mg/6mg
Day 7 3ml 4ml 7ml 17,5mg/7mg
Day 8 3ml 5ml 8ml 20mg/8mg
Day 9 4ml 5ml 9ml 22,5mg/9mg
Day 10 4ml 6ml 10ml 25mg/10mg
Day 11 5ml 6ml 11ml 27,5mg/11mg
Day 12 5ml 7ml 12ml 30mg/12mg
Day 13 6ml 7ml 13ml 32,5mg/13mg
Day 14 6ml 8ml 14ml  32,5mg/13mg
Day 15 6ml 9ml 15ml  37,5mg/15mg

MAINTENANCE DOSE
Day 15- 6ml 9ml 15ml- 37,5mg/15mg

Children

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

Category:

COMPOSITION

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

 

THERAPEUTIC INDICATIONS

KANOBIL® HIV can be used in adult patients as add-on therapy to the regular therapy for:

HIV infections – to improve symptoms of:

-Weight loss and impaired appetite, when there is intolerance to megestrol acetate or the therapy with megestrol acetate does not give the expected results.

 

CONTRAINDICATIONS

Do not take KANOBIL® HIV if:

-if you are allergic to cannabinoids or any of the excipients of this medicine;
-if you or anyone directly related to you has any mental health problems such as schizophrenia, psychosis or other significant psychiatric disorder. This does not include depression due to your primary condition;
-if you are pregnant or breast-feeding.
Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using KANOBIL® HIV.

 

PACKAGING

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