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MediCabilis™ 5% CBD ECs315 is available for clinical trial and patient use via the TGA Approved Prescriber (AP) Scheme and Special Access Scheme (SAS). MediCabilis™ 5% CBD ECs315 is not a TGA listed or registered medicine. Information Prepared May 2019, Version 2.0 Dosage and Administration Administration: - MediCabilis™ 5% CBD ECs315 is for oral use only. - Careful supervision and caution is advised when prescribing to new patients, and dependent on the expertise of the prescribing practitioner. Therapeutic effect: - Effects may begin approximately thirty (30) minutes after oral administration. This is based on MediCabilis™ 5% CBD ECs315 Phase 1 trials which have shown it takes approximately 30 minutes for the CBD in MediCabilis™ 5% CBD ECs315 to reach blood circulation. - The effects are expected to last for 3 to 6 hours depending on individuals’ response. - The maximum blood concentrations of CBD are achieved within 1 to 3 hours. Dosage: An optimal dose for particular indications is yet to be established. Titration may be required to establish each patient’s optimal dose. Adults Determining the optimal individualised dose may take some days to weeks, and side effects from either over- or under-dosing may cause temporary problems. The selected dosage should be maintained for a period of two weeks unless adverse effects are significant. Dose reduction may be required in such circumstances. Children There is no data specific for MediCabilis™ 5% CBD ECs315 currently available. MediCabilis™ 5% CBD ECs315 should only be used in children and adolescents below 18 years of age at the discretion of a medical practitioner. Elderly No specific studies using MediCabilis™ 5% CBD ECs315 have been carried out in elderly patients. However cannabis extracts with high CBD and low THC have been shown to be well tolerated in the elderly. Dosage Guidelines For Healthcare Practitioners only MediCabilis™ 5% CBD ECs315 Standardised full spectrum cannabis extract (ECs315) 50mg CBD/mL in a Medium Chain Triglyceride (MCT) for oral administration

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Page 1: Dosage Guidelines · Dosage Guidelines For Healthcare Practitioners only Indication CBD therapeutic dosage rangeˆ MediCabilis 5% CBD ECs315 dose# Epilepsy 300-600 mg/day 6-12 mL/day

MediCabilis™ 5% CBD ECs315 is available for clinical trial and patient use via the TGA Approved Prescriber (AP) Scheme and Special Access Scheme (SAS).

MediCabilis™ 5% CBD ECs315 is not a TGA listed or registered medicine.

Information Prepared May 2019, Version 2.0

Dosage and Administration Administration:

- MediCabilis™ 5% CBD ECs315 is for oral use only.

- Careful supervision and caution is advised when prescribing to new patients, and dependent on the expertise of the prescribing practitioner.

Therapeutic effect:

- Effects may begin approximately thirty (30) minutes after oral administration. This is based on MediCabilis™ 5% CBD ECs315 Phase 1 trials which have shown it takes approximately 30 minutes for the CBD in MediCabilis™ 5% CBD ECs315 to reach blood circulation.

- The effects are expected to last for 3 to 6 hours depending on individuals’ response.

- The maximum blood concentrations of CBD are achieved within 1 to 3 hours.

Dosage:

An optimal dose for particular indications is yet to be established. Titration may be required to establish each patient’s optimal dose.

Adults

Determining the optimal individualised dose may take some days to weeks, and side effects from either over- or under-dosing may cause temporary problems. The selected dosage should be maintained for a period of two weeks unless adverse effects are significant. Dose reduction may be required in such circumstances.

Children

There is no data specific for MediCabilis™ 5% CBD ECs315 currently available. MediCabilis™ 5% CBD ECs315 should only be used in children and adolescents below 18 years of age at the discretion of a medical practitioner.

Elderly

No specific studies using MediCabilis™ 5% CBD ECs315 have been carried out in elderly patients. However cannabis extracts with high CBD and low THC have been shown to be well tolerated in the elderly.

Dosage GuidelinesFor Healthcare Practitioners only

MediCabilis™ 5% CBD ECs315Standardised full spectrum cannabis extract (ECs315)

50mg CBD/mL in a Medium Chain Triglyceride (MCT)

for oral administration

Page 2: Dosage Guidelines · Dosage Guidelines For Healthcare Practitioners only Indication CBD therapeutic dosage rangeˆ MediCabilis 5% CBD ECs315 dose# Epilepsy 300-600 mg/day 6-12 mL/day

Dosage Guidelines For Healthcare Practitioners only

Indication CBD therapeutic dosage rangeˆ MediCabilis 5% CBD ECs315 dose#

Epilepsy 300-600 mg/day 6-12 mL/day

Epilepsy in children 5-10 mg/kg per day (divided into two doses)

Max dose 10 mg/kg per day (divided into two doses)

0.1-0.2 mL/kg per day (divided into two doses)

Max dose 0.2 mL/kg/day

Muscular Sclerosis 25-30 mg/day 0.5-0.6 mL/day

Chemotherapy Induced Nausea and Vomiting (CINV)

5-25 mg/day 0.1-0.5 mL/day

Pain 0.2 - 25 mg/day 0.004-0.5 mL/day

Anxiety 50-300 mg/day 1-6 mL/day

Post-Traumatic Stress Disorder (PTSD)* 300-600 mg/day 6-12 mL/day

Attention deficit hyperactivity disorder (ADHD)

25-100 mg/day 0.5-2 mL/day

Insomnia 25-100 mg/day 0.5-2mL/day

Recommended CBD Dose Range for Specific IndicationsAn optimal dose for particular indications is yet to be established.

The guide below provides a summary of the therapeutic dosage range for the most commonly prescribed indications based on published literature. Individual optimal dosage may vary and is to be determined by the prescribing practitioner.

* max of 600 mg/day. ˆbased on published literature. #Dosage of MediCabilis 5% CBD ECs315 required to achieve the CBD therapeutic dosage range as indicated by literature.

Titration Recommendation:

The following guide provides an example of titration for the first two weeks of treatment. Individual titration is to be determined by the prescribing practitioner and dependent on many factors including individual needs and circumstances. The optimal dose is the lowest dose that achieves the highest benefit.

Titration Period:

A titration period may be required to reach the optimal dose. The number and timing of administration will vary between patients.

Increase the dose every 1 to 2 days until the therapeutic benefic is acheived. Doses should be spread throughout the day and separated by at least 6 hours.

OverdosageThere is no experience of deliberate overdosing with MediCabilis™ 5% CBD ECs315 in patients. In the case of overdose, treatment should be symptomatic and supportive.

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

For Epilepsy, PTSD and Anxiety For ADHD, Insomina and Pain

DaysMorning

DoseEvening

Dose3rd

Dose

Total dose per day of MediCabilis

5% CBD ECs315

Total CBD provided per day

1-2 0.5 mL 0.5 ml X 1 mL 50 mg

3-4 0.75 mL 0.75 mL X 1.5 mL 75 mg

5-6 1 mL 1 mL X 2 mL 100 mg

7-8 1.25 mL 1.25 mL X 2.5 mL 125 mg

9-10 1 mL 1 mL 1 mL 3 mL 150 mg

11-12 1.25 mL 1.25 mL 1.25 mL 3.75 mL 188 mg

13-14 1.5 mL 1.5 mL 1.5 mL 4.5 mL 225 mg

15-16 2 mL 2 mL 2 mL 6 mL 300 mg

DaysMorning

DoseEvening

Dose

Total dose per day of MediCabilis

5% CBD ECs315

Total CBD provided per day

1-2 0.1 mL 0.1 ml 0.2 mL 10 mg

3-4 0.2 mL 0.2 mL 0.4 mL 20 mg

4-5 0.3 mL 0.3 mL 0.6 mL 30 mg

6-7 0.5 mL 0.5 mL 1.0 mL 50 mg

8-9 1 mL 1 mL 2 mL 100 mg

Poison schedule of the medicinePoison schedule: Controlled Drug - Schedule 8

Further informationPlease refer to the MediCabilis™ 5% CBD ECs315 product information for further information or contact Bod Australia on [email protected].

MediCabilis™ is a registered trademark of Bod Australia

Name and address of supplierBod Australia LTD Level1/377 New South Head Road, Double Bay NSW 2028 AUSTRALIA

Tel: 02 9199 5018 Email: [email protected] www.bodaustralia.com

Information Prepared May 2019, Version 2.0 CAN766