Short film about legalizing cannabis
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Medical/Therapeutic Uses
Characteristics for Medical Cannabis Finished Products
1. Maximum quantitative composition in plant (−)-trans-Δ9-tetrahydrocannabinol (THC) derived from Cannabis sativa L varieties, to apply solely and restrictively.
Content in Δ9-tetrahydrocannabinol (THC) which is per case documented by the applicant in agreement with the recommended dosage.
2. Pharmaceutical forms
Forms intended for [oral/oromucosal/buccal/sublingual/nasal/rectal] use/administration.
3. Pharmacological properties -Clinical particulars
THC is the main psychoactive ingredient of [Medical Cannabis Finished Product] and acts on the endocannabinoid system receptors (CB1, CB2), as well as on certain other receptors.
3.1 Single dose administration
After a single administration of cannabis: euphoria, relaxation, hypoactivity, drowsiness, hilarity and laughter, analgesia, appetite stimulation, vasodilation (redness of the conjunctiva), hypotension (mainly postural), dizziness, tachycardia, dry mouth and decrease of intraocular pressure were observed.
Cognitive and sensorimotor dysfunction (reduced alertness, impaired balance and coordination of movements, alterations in time perception, poor concentration, attention and memory impairments, impaired orientation in space and time), panic attacks and psychotic reactions are also recorded.
3.2 Chronic administration
After chronic administration, cannabis may lead to cannabis use disorder characterized by the development of tolerance to cannabis, withdrawal syndrome (characterized by anger, anxiety, restlessness, irritability, depression, sleep disturbances, odd dreams, decreased appetite and weight loss, indifference), craving for cannabis, lack of motivation and neglect of important activities of daily living.
During chronic administration, tolerance to certain side effects may develop.
4. Medical/Therapeutic Uses
• Prevention and treatment of nausea and/or vomiting due to the administration of antineoplastic drugs.
• Neuropathic pain, cancer pain, persisting for more than three months, not responding to other treatment regimens or interventions or when regimens available for pain treatment are not well tolerated or are contraindicated for the particular patient.
• Spasticity and pain in patients with Multiple Sclerosis.
5.Maximum dosage and method of administration
Prescription of [Medical Cannabis Finished Product] should be considered in cases where the use of already approved and established drugs has been proven non-feasible and/or non-tolerated and/or non-effective for the particular patient. For safety reasons it is recommended to use the minimum effective dose, for the shortest possible time.
Dosage will be determined per case depending on the pharmaceutical form, the route of administration and the desired therapeutic effect.
5.1 Special populations
Children and adolescents: Administration of [Medical Cannabis Finished Product] is contraindicated in children and adolescents.
Elderly: [Medical Cannabis Finished Product] must be administered with caution in elderly patients.
Hepatic/Renal impairment: [Medical Cannabis Finished Product] must be administered with caution in patients with renal/hepatic impairment.
Preventive screening of hepatic/renal function before and periodic screening during administration of [Medical Cannabis Finished Product] is advised.
6. Contraindications
Administration in children/adolescents.
Administration in pregnant and lactating patients and in patients who planning for pregnancy.
Allergy or intolerance to the active substance or to any of the excipients listed.
7. Special warnings and precautions for use
[Medical Cannabis Finished Product] must be administered with caution in patients with psychosis, severe personality disorders and/or emotional disorders and in patients with positive family history of psychosis. In case of a psychotic reaction after taking [Medical Cannabis Finished Product], treatment must be immediately discontinued, and the patient's doctor must be informed.
Epilepsy: [Medical Cannabis Finished Product] must be administered with caution in epileptic patients.
Elderly: [Medical Cannabis Finished Product] must be administered with caution in senior patients.
Hepatic/Renal impairment: [Medical Cannabis Finished Product] must be administered with caution in patients with renal/hepatic conditions.
Preventive screening of hepatic/renal function before and periodic screening during administration of [Medical Cannabis Finished Product] is advised.
[Medical Cannabis Finished Product] must be administered with caution in patients with a history of drug use disorders, as they are more prone to product abuse.
8.Interactions with medicinal products and other forms of interaction
Given the suppressive action of cannabis on the Central Nervous System (CNS), co-administration with other sedative drugs must be carried out with extreme caution.
Alcohol consumption during treatment with [Medical Cannabis Finished Product] is prohibited.
As cannabinoids are metabolized mainly through CYP3A4 and CYP2C9 cytochromes, there is a possibility of interaction with other drugs that use the same metabolic pathways.
9.Use during pregnancy and lactation/fertility
Use of [Medical Cannabis Finished Product] is contraindicated during pregnancy and lactation. There are no sufficient data concerning possible effects on fertility.
[Medical Cannabis Finished Product] is contraindicated in patients who plan on having children.
Use of appropriate contraception is advised during treatment and for 3 months after cessation of treatment.
10. Effects on ability to drive and use machines
Taking into account the effects of [Medical Cannabis Finished Product] on the CNS (dizziness, drowsiness etc.), driving vehicles and using machines as well as any other activity that requires alertness should be avoided during treatment.
It is prohibited to drive and use machines for at least seven days after dose fixation of [Medical Cannabis Finished Product] and for as long as side effects from the CNS are observed. [Medical Cannabis Finished Product] administration in professional drivers is prohibited.
11.Undesirable effects
Metabolism and nutrition disorders
Nervous system disorders
- Dizziness
- Impaired alertness
- Impaired balance and coordination of movements (risk of frequent falls), muscle weakness
- Impaired orientation in space and time, a sense that time is running slower
- Attention and memory impairment
- Speech disorders, dysarthria
- Suppression
- Numbness
- Muscle cramps
- Glared vision
- Mental confusion
- Blurred vision
- Headache
Psychiatric disorders
- Psychotic reaction, induction or aggravation of psychosis of schizophrenia or of bipolar disorder (particularly in patients with predisposition)
- Panic attacks
- Euphoria or dysphoria
- Lack of motivation and neglect of important activities of daily living
- Anxiety
- Suicidal ideation/suicide attempts (especially in men)
- Confusion
- Depersonalization
- Hallucinations
- Delusional ideas/paranoia
- Depression
- Addiction
Cardiac disorders
- Tachycardia with single use administration (development of resistance resistance in chronic administration)
- Arrhythmias (ventricular extrasystoles, palpitations, atrial fibrillation)
- Increased cardiac output and increased myocardial oxygen demand
Vascular disorders
- Vasodilation
- Redness of the conjunctiva
- Increased blood flow in the brain with acute administration and decreased with chronic use
- Postural hypotension
- Hypertension (supine)
Gastrointestinal
- Dry mouth
- Reduced intestinal motility
- Abdominal pain
- Pancreatitis
- Nausea
- Vomiting
- Diarrhea
Hepatobiliary disorders
General disorders
The effects of [Medical Cannabis Finished Product] vary widely among patients. Also, adverse reactions may be more intense in the elderly, in patients with impaired health and in those taking other medications.
It should be noted that certain effects of the [Medical Cannabis Finished Product] depend on the dosage and present paradoxical differentiation between smaller and larger doses. For example, while small doses help reduce nausea, large doses may deteriorate nausea.
12.Overdose (symptoms, emergency procedures, antidotes, management).
There is no literature on deaths caused exclusively by cannabis overdose. However, high THC levels can lead to severe accidents due to psychotic agitation or simultaneous use of other psychoactive substances.
12.1 Toxicity treatment
There is no specific antidote for toxicity caused by [Medical Cannabis Finished Product] overdose. Treating toxicity is symptomatic with in-hospital follow-up and monitoring of cardiac and respiratory functions. In cases of psychotic reactions, appropriate treatment should be used.
The [Medical Cannabis Finished Product] must be kept in a safe place, out of reach of children.
Source: National Organization for Medicines (EOF) Stop & C hat
VK Medical Cannabis have the experience in preparing business plans and application packages for state licenses in the medical cannabis industry.
Specifically, VK Medical Cannabis provides:
- Expert advice on regularity, policy, licensing issues,
- Land search and evaluation,
- Support, preparation and submission of the applications and all the requirements throughout the authorization process,
- Necessary updates during authorization process,
- Guidance on any changes – amendments needed to the applications submitted,
- Investment deployment,
- All mediation services with government and local authorities.
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