Product Information for Doctors and Pharmacists

Information for
medical and
pharmaceutical
professionals

version March 2017

Based on the information provided by:
Ministry of Health, Welfare and Sport
Bureau for Medicinal Cannabis
Postbus 16114
2500 BC Den Haag

Adjusted for the application of oil

Download de flyer (PDF)

Medicinal Cannabis Oil

Name of the medication

Cannabis (Cannabis flos)

Cannabis is available in multiple varieties.

Qualitative composition

Cannabis consists of the dried flowers of the female Cannabis sativa L ssp. sativa and ssp. indica plant, grown and processed under standardized conditions to obtain a pharmaceutical grade product. Cannabis contains a number of active substances, including substances that are known as cannabinoids like dronabinol (delta-9-tetrahydrocannabinol, THC) and cannabidiol (CBD). The chemical composition of cannabinoids depends on the cannabis variety. Low temperature CO2 extraction is used to extract the active components from dried cannabis flowers which is subsequently dissolved in almond oil to standardized concentrations.

Pharmaceutical form

Oil obtained from low temperature CO2 extraction.

Clinical information

Therapeutic indications

In the past couple of years, more scientific information has become available regarding the use of cannabis and/or its active components and the effects on symptoms and treatment of illnesses (For more information, go to www.cannabis-med.org.). Medicinal cannabis may only be prescribed by a doctor if the standard treatments and registered medicines do not have the required effect or cause too many side effects. There is sufficient information available to believe that medicinal cannabis can help in cases of:

  • Pain and muscle spasms or cramps associated with multiple sclerosis or spinal cord damage
  • Nausea, loss of appetite, weight loss and debilitation due to cancer or AIDS
  • Nausea and vomiting associated with chemotherapy or radiotherapy used in the treatment of cancer, hepatitis C or HIV infection and AIDS
  • Chronic pain (mainly pain associated with the nervous system, for example that caused by a damaged nerve, phantom pain, facial neuralgia or chronic pain which remains after the recovery from shingles)
  • Gilles de la Tourette syndrome
  • Therapy-resistant glaucoma.

Patients and doctors have also reported positive effects on a range of other conditions, including Crohn’s disease, ulcerative colitis, epilepsy, itching, migraine, rheumatism, rheumatoid arthritis, ADD and brain trauma. These positive effects still need to be confirmed by scientific research. (For more information, go to www.cannabis-med.org.) At present, medicinal cannabis does not cure the disorders mentioned above, but it can relieve the symptoms associated with them. It may also enable other medication to be given at a lower dosage, and reduce their side effects. It is up to doctors to determine whether treatment with medicinal cannabis would benefit a patient, given his or her diagnosis and circumstances. In doing so, they are not limited to the list of conditions given above. A doctor may only prescribe medicinal cannabis if the standard treatments and registered medicines are not having the desired effect or are causing too many side effects.

Contra-indications

Medicinal cannabis should not be prescribed to patients with congenital long QT syndrome or predisposition to psychotic disorders. Medicinal cannabis should be avoided with Brugada- syndrome as this can lead to an abnormal ECG. Caution is warranted with patients diagnosed with other mental health disorders, Cardiac arrhythmia, angina pectoris and ischemic heart disease. There is a higher chance in adolescents (up to 24 years) to develop serious side effects – like psychosis – compared to adults. Therefore, prescription of medicinal cannabis in adolescents should be handled with reservation. In all these cases consult with your doctor or pharmacist prior to use.

Dosage and administration

The required dose of medicinal cannabis oil per day is determined individually. The initial dose should start low and may be gradually increased until sufficient relief of symptoms is achieved. A low dosage often provides sufficient relief, so that psychoactive side effects ‘high’ rarely occur.

Oral:

THC 2,0% (Sativa) oil, THC 2,0% (Indica) oil, CBD 2,0% / THC 1,3% (Sativa) oil and CBD 5,0% / THC 10% (Sativa) oil

Start with 1 drop sublingually 2-3 times a day. If the effect is insufficient, gradually increase the number of drops. Typically, 3-4 drops of oil a day are tolerated well. The dose and effects can vary individually.

CBD 10% (From purified CBD) oil, 10 ml for epilepsy (10% = 100 mg/ml)

Children: Start with 0.2 mg/kg/day in 2 divided doses. The dosage can be gradually increased until the desired effect is reached or to the maximum dose of 25 mg/kg/day in 2 divided doses. The oil is applied under sublingually.

Adults: Start with 0.1 ml per day in 2 divided doses. The dosage can be gradually increased until the desired effect is reached or to 0.5 ml per day in 2 divided doses (if required the dose can be increased in increments of 0.1 ml per 3 days). The oil is applied sublingually.

 

Special warnings and precautions with use

The psychological effects of cannabis can cause fear and confusion in unexperienced users. it is advisable for patients to be in a calm place when using cannabis for the first time and preferably have someone present who can calm the patient if needed.

Prescription of cannabis in cardiac patients (arrhythmia, angina pectoris) should be treated with reservation due to the cardiovascular side effects (primarily tachycardia). A tolerance to cardiac side effects typically occurs within a few days to weeks. The dose may only be increased gradually based on the cardiac effects.

Pregnancy and breastfeeding

The use of medicinal cannabis is not advisable during pregnancy and while breastfeeding. It has been shown that THC can reach the foetus through the umbilical cord. Continuous use of cannabis during pregnancy can affect the foetus. Also, certain components of cannabis – like THC – end up in breast milk.

Driving or operating heavy machinery

The use of cannabis can initially lead to a slower reaction time and decreased ability to concentrate. Once the patient has found the right dose range and a steady state is reached without any signs of sedation it should be possible in most cases to drive and operate heavy machinery.

Side effects

The physical side effects of cannabis can be:

Tiredness, tachycardia, orthostatic hypotension, headache, dizziness, warm or cold hands and feet, red irritated eyes and a dry mouth. These effects usually disappear after a few hours.

Overdose

A high dose can lead to feelings of fear, depression, panic and in rare cases fainting. These effects usually disappear after a few hours. If required, an overdose can be treated with benzodiazepines (diazepam i.v.). Tachycardia can be treated with a betablocker (propranolol i.v.).

Pharmaceutical information

List of excipients

Amygdalae oleum raffinatum PH. EUR. (refined almond oil)

Incompatibility with other pharmaceuticals

None

Expiration

Medicinal cannabis oil can degrade under influence of light and humidity. Medicinal cannabis oil can be stored in the original packaging until the expiration date. The expiration can be found on the package under the ‘niet te gebruiken na’ date.

Storage

The medicinal cannabis oil should be stored in the original packaging in a refrigerator (2-8 °C).

Peculiarities

Cannabis is included in the Dutch Opium Act (list II). Cannabis is seen as a doping agent by the International Olympic Committee (group III).

 

Cannabis is provided under the name Cannabis flos as a pharmaceutical material by:

Bureau voor Medicinale Cannabis, CIBG agency of the Ministry of Health, Welfare and Sport (www.cannabisbureau.nl)