Glossary

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Welcome to the Glossary

Here you will find a list with explanations of the technical terms and abbreviations related to the topic of medical cannabis. With the help of the mouse-over function, you will get a preview of the meaning of underlined words within the page texts. If you click on these, you will be taken to the glossary.

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Quality and
production

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Introduction

01

Our quality promise for products and production

The high quality standards of Fette Pharma's products begin with research and development and also apply to production and logistics. Fette Pharma pays attention to compliance with strict international pharmaceutical standards - both with regard to the selection of raw materials and the manufacturing processes and final quality control.

The group of companies is currently certified according to the worldwide standard ISO 9001 and meets all requirements according to § 13, § 52a, § 67 and § 72 Medicinal Products Act (AMG). This not only meets the high quality standards, but work is also performed in strict compliance with the applicable laws, regulations and quality guidelines.

Highest quality of the RE:CANNIS product line

The RE:CANNIS product range meets, according to legal requirements, the highest controlled quality and safety requirements, from research and development to production and logistics. The cannabis plants are cultivated in Israel according to pharmaceutical standards at medical level - based on more than 16 years of experience. The cannabis varieties from Cannbit - Fette Pharma's Israeli cooperation partner - have unique genetics that have been researched in clinical studies and, thanks to their own studies, are also characterized by extremely high therapeutic accuracy.

Cannbit has been developing innovative production and processing methods in the field of cultivation and processing of medical cannabis for many years. With its decades of know-how, the company is able to produce first-class and stable medical cannabis products in EU-GMP and GDP certified quality.

The exclusive collaboration of Fette Pharma and Cannbit represents proven therapeutic* efficacy:

  • Cannabis varieties with unique genetics, thanks to our own studies with high therapeutic accuracy
  • More than 16 years of experience in genetic research on cannabis
  • > 35 clinical and preclinical studies
  • > 20 published studies on the use of RE:CANNIS
  • Treatment experiences with > 40,000 patients

Dried flowers

Cultivation

Processing

Analysis

Packaging

Re-analysis

Prescription

  • Consistent product quality using cuttings and innovative cultivation technologies
  • Continuous monitoring and breeding under constant conditions
  • Varieties: indica, sativa and hybrid: CBD-dominant, THC-dominant and CBD/THC-balanced
  • Harvesting, removing the flowers from the plants, trimming and drying using innovative technologies
  • Continuous quality assurance system to guarantee consistent quality
  • Complex analysis method for the detection of all cannabinoids, terpenes and pharmacologically active ingredients
  • Issuance of the Certificate of Analysis
  • Packaging under strict quality and safety precautions
  • Testing according to DAB monograph in German GMP laboratory after import
  • Production of the prescription in the pharmacy

Extracts

Cultivation

Extraction

Analysis

Formulation

Packaging

Re-analysis

Prescription

  • Analogous quality standards as for the medical cannabis flowers intended for dispensing
  • CO2 extraction or ethanol extraction*
  • Continuous quality assurance system to guarantee consistent quality
  • Complex analysis method for the detection of all cannabinoids, terpenes and pharmacologically active ingredients
  • Issuance of the Certificate of Analysis
  • Combination of carrier oil and extract
  • Standardization of the concentrations
  • Packaging under strict quality and safety precautions
  • Testing according to DAB monograph in German GMP laboratory after import
  • Production of the prescription in the pharmacy

*Extraction procedure 5 of 6 RE:CANNIS extracts are produced using the CO2 extraction process. This process facilitates the gentle extraction of all pharmaceutically valuable ingredients and is characterized by the fact that the introduction of ethanol as a solvent can be omitted. During extraction with ethanol, the solvent must subsequently be removed in a complicated procedure. CO2 extraction especially ensures the complete absence of solvents in the finished product.

Find out more about this and other topics in our exclusive area.

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References

Status: 2021

  1. Naftali T, Bar-Lev Schleider L, Benjaminov F, et al. Cannabis is associated with clinical remission but not endoscopic remission in ulcerative colitis: a randomized controlled trial. PLOS ONE 2021;16(2):e0246871. https://doi.org/10.1371/journal.pone. e0246871

  2. Naftali T, Bar-Lev Schleider L, Benjaminov F, et al. Medical cannabis for inflammatory bowel disease: real-life experience of mode of consumption and assessment of side-effects. Eur J Gastroenterol Hepatol 2019; 31:1376-13081.DOI:10.1097/MEG.0000000000001565

  3. Naftali T, Bar-Lev Schleider L, Dotan I, et al. Cannabis Induces a Clinical Response in Patients With Crohn’s Disease: A Prospective Placebo-Controlled Study. Clinical Gastroenterology and Hepatology 2013; 11:1276-1280.

  4. Naftali T, Bar-Lev Schleider L, Yablekovitz D, et al. Treatment of Crohn’s Disease with Cannabis: An Observational Study. IMAJ 2011;13:455-458.

  5. Naftali T, Bar-Lev Schleider L, Almog S, et al. Oral CBD-rich cannabis induces clinical but not endoscopic response in patients with Crohn's disease, a randomized controlled trial. Journal of Crohn's and Colitis 2021;15:1799-1806. https://doi.org/10.1093/ecco-jcc/jjab069

  6. Hermush V, Ore L, Stern N, et al. Effects of Full Spectrum Cannabidiol Oil on Behavioral Disturbances in Patients with Dementia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. Submitted to JAMA Psychiatry 2021.

  7. Libzon S, Bar-Lev Schleider L, Saban N, et al. Medical Cannabis for Pediatric Moderate to Severe Complex Motor Disorders. JCN 2018. DOI: 10.1177/0883073818773028

  8. Bar-Lev Schleider L, Mechoulam R, Saban N, et al. Real life Experience of Medical Cannabis Treatment in Autism: Analysis of Safety and Efficacy. Sci. Rep. 2019; 9:200 | DOI:10.1038/s41598-018-37570-y

  9. Barchel D, Stolar O, De-Haan T, et al. Oral Cannabidiol Use in Children With Autism Spectrum Disorder to Treat Related Symptoms and Co-morbidities. Front. Pharmacol 2019. doi: 10.3389/fphar.2018.01521

  10. Aran A, Cassuto H, Lubotzky A, et al. Brief Report: Cannabidiol-Rich Cannabis in Children with Autism Spectrum Disorder and Severe Behavioral Problems—A Retrospective Feasibility Study. J Autism Dev Disord. 2018. https://doi.org/10.1007/s10803-018-3808-2

  11. Tzadok M, Uliel-Siboni S, Linder I, et al. CBD-enriched medical cannabis for intractable pediatric epilepsy: The current Israeli experience. Seizure. 2016; 35:41–44.

  12. Bar-Lev Schleider L, Mechoulam R, Lederman V, et.al Cancer: Prospective Analysis of Safety and Efficacy of Medical Cannabis in Large Unselected Population of Patients with Cancer. European Journal of Internal Medicine 2018;49:37-43.

  13. Abuhasira R, Bar-Lev Schleider L, Mechoulam R. Epidemiological Characteristics, Safety and Efficacy of Medical Cannabis in the Elderly . European Journal of Internal Medicine, 2018;49: 44-50.

  14. Balash Y, Bar-Lev Schleider L, Amos D. Korczyn AD, et al. Medical Cannabis in Parkinson Disease: Real-Life Patients' Experience. Clin Neuropharm 2017;40:268-272.

  15. Thaler A, Shira Arad S, Lihi Bar-Lev Schleider L, et al. Single Center Experience with Medical Cannabis in Gilles de la Tourette Syndrome. Parkinsonism and Related Disorders 2018. https://doi.org/10.1016/j.parkreldis.2018.10.004

  16. Sagy I, Bar-Lev Schleider L , Abu-Shakra M, et al. Safety and Efficacy of Medical Cannabis in Fibromyalgia  J. Clin. Med. 2019, 8, x; doi: FOR PEER REVIEW www.mdpi.com/journal/jcm

  17. Gallily R, Yekhtin Z, Hanuš LO. Overcoming the Bell-Shaped Dose-Response of Cannabidiol by Using Cannabis Extract Enriched in Cannabidiol .Pharmacology & Pharmacy, 2015; 6: 75-85

  18. Gallily R, Yekhtin Z. Avidekel Cannabis extracts and cannabidiol are as efficient as Copaxone in suppressing EAE in SJL/J mice. Inflammopharmacology 2018. https://doi.org/10.1007/s10787-018-0536-3

*Relating to the studies and data Cannbit can access through the acquisition of Tikun Olam Israel.