№ lp_1_01032
File format: docx
Character count: 2475
File size: 484 KB
Clarifies the purpose of medication prescribed for adults under the Disability Services Act 2006 and its distinction from chemical restraint.
Year:
2006
Region / City:
Australia
Topic:
Medication management, disability services
Document Type:
Legal / Regulatory
Organization:
Disability Services
Author:
Not specified
Target Audience:
Healthcare providers, professionals in disability services
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
Australia
Subject:
Chronic migraine, medicinal product submission
Document type:
Submission for PBS listing
Organization:
Novartis Pharmaceuticals Australia Pty. Limited
Author:
Not specified
Target audience:
Health professionals, pharmaceutical regulatory bodies
Period of validity:
Not specified
Date of approval:
2 July 2018
Date of amendments:
November 2023
Year:
2024
Regulatory authority:
Therapeutic Goods Administration (TGA)
Medicine:
MACITENTAN 10 mg with TADALAFIL 40 mg (Opsynvi®)
Indication:
Pulmonary arterial hypertension (PAH), WHO Group 1, functional class II and III
Therapy type:
Dual or triple combination therapy
Dosage form:
Tablet, fixed dose combination (FDC)
Prescriber type:
Medical practitioners
Restriction type:
Authority Required (Written, Complex Authority Required)
Clinical criteria:
Treatment as dual therapy (MAC+TAD) or triple therapy with prostanoid
Population:
Adult patients with stable PAH on separate doses of macitentan and tadalafil
Previous considerations:
PBAC recommendations for macitentan and tadalafil since 2011–2014
Approval date:
16 September 2024
Source documents:
TGA registration, PBAC meeting minutes, ACM minutes August 2024, FDA, EMA, CDA references
Note:
Year
Subject:
High Dose Antipsychotic Monitoring
Document Type:
Medical Form
Institution:
Oxford Health
Target Audience:
Healthcare professionals
Year:
2024
Region / city:
United Kingdom
Subject:
Radiological Protection, Transport of Radioactive Materials
Document Type:
Technical Assessment Guide
Organization:
Office for Nuclear Regulation (ONR)
Author:
Inspector - Nuclear Safety
Target Audience:
ONR safety inspectors
Validity Period:
October 2024 - October 2029
Approval Date:
October 2024
Revision Date:
Not applicable
Document Reference:
NS-TAST-GD-100
Record Reference:
2020/281169
Issue:
2.1
Purpose:
Guidance for assessing shielding designs and dose rates of transport packages for radioactive materials.
Scope:
Focuses on shielding and dose rate assessments in accordance with IAEA regulations for transport safety.
Related Legislation:
IAEA SSR-6 (2018), UK regulations for radioactive materials transport
Note:
Contextual Description
Year:
Not specified
Region / City:
Not specified
Topic:
Infliximab dose escalation in Crohn’s disease treatment
Document type:
Medical request letter
Institution / Organization:
Not specified
Author:
Not specified
Target audience:
Insurance company
Period of validity:
Not specified
Approval date:
Not specified
Date of modifications:
Not specified
Note:
Year
Topic:
Lung disease, steroid treatment
Document type:
Information sheet
Organization / institution:
Sheffield Teaching Hospitals NHS Foundation Trust
Author:
Respiratory and endocrinology teams
Target audience:
People with lung disease on high dose inhaled steroids
Year:
2023
Region / city:
Canberra, Australia
Topic:
Obstetrics, Pre-eclampsia, Pregnancy Care
Document type:
Guideline
Organization / institution:
Canberra Health Services
Author:
Society of Obstetric Medicine Australia and New Zealand (SOMANZ)
Target audience:
Medical Officers, Registered Nurses, Registered Midwives, Students, Pharmacists
Period of validity:
Not specified
Approval date:
2023
Date of amendments:
Not specified
Year:
2022
Region / City:
Australia
Subject:
Pharmacology, Pharmaceutical Benefits Scheme (PBS)
Document Type:
Submission
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Not specified
Target Audience:
Medical practitioners, healthcare professionals
Period of validity:
Not specified
Approval Date:
3 June 2022
Date of Changes:
Not specified
Contextual Description:
A regulatory submission detailing the request for listing of dupilumab in new forms for treating severe atopic dermatitis and uncontrolled severe asthma in pediatric patients under the PBS.
Note:
Year
Background:
The submission requested a General Schedule Authority Required (Telephone/Online) listing of a new form of adrenaline (epinephrine) acid tartrate 150 micrograms/0.15 mL autoinjector (AI) (Jext® Junior (Jr)) and 300 micrograms/0.3 mL AI (Jext®) under the same circumstances as the currently listed adrenaline (epinephrine) 150 microgram/0.3 mL AI (EpiPen® Jr and Anapen® Jr 150) and 300 microgram/0.3 mL AI (EpiPen® and Anapen® 300).
Year:
Not specified
Region / city:
Not specified
Theme:
Clinical Trials, Dose Escalation
Document type:
Protocol
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Clinical researchers, Principal Investigators
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2022
Region / City:
Australia
Topic:
Medicinal Product Submission
Document Type:
Submission for Pharmaceutical Listing
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Healthcare professionals, policy makers
Period of Validity:
Not specified
Approval Date:
10 August 2022
Date of Changes:
Not specified
Year:
2021
Region / City:
Australia
Topic:
Atopic dermatitis treatment, medication submission
Document Type:
Submission report
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Sanofi-Aventis
Target Audience:
Medical professionals, regulatory authorities
Action Period:
Ongoing treatment evaluation
Approval Date:
17 August 2021
Modification Date:
Not specified
Background:
Dupilumab registration history
Clinical Claim:
Dupilumab has superior efficacy compared to standard care for children with severe atopic dermatitis
Episodicity:
Chronic
Severity:
Severe
Condition:
Atopic dermatitis
PBS Indication:
Chronic severe atopic dermatitis
Prescriber Type:
Medical practitioners, dermatologists, clinical immunologists
Treatment Phase:
Initial, continuing
Population Criteria:
Children aged 6 to 11 years, specific weight ranges
Comparator:
Placebo
Outcomes:
EASI-75, IGA 0 or 1 at Week 16, improvement in itch score
Dosing:
Tiered by body weight
Cost:
$1,754.28–$3,380.91
Price:
Published price for maximum quantity
Form:
Pre-filled syringe
Medical Information:
Dupilumab 300 mg/2 mL, 200 mg/1.14 mL
Note:
Comparator
Standard of care (Placebo)
Source:
PBAC submission
Year:
2016
Region / city:
United Kingdom
Topic:
Medical imaging, Radiation dose reduction
Document Type:
Guidelines
Organization / institution:
Royal College of Radiologists, British Association of Urological Surgeons
Author:
Dr. John Maguire, Nicola Spence, Dr. Karen Gray
Target Audience:
Radiologists, CT radiographers
Effective Period:
Ongoing
Approval Date:
28 January 2016
Last Reviewed:
8 April 2018
Year:
not specified
Country:
United Kingdom
Medication:
Zopiclone
Therapeutic class:
Hypnotic
Indication:
Insomnia
Licensed use duration:
Up to 4 weeks
Adult licensed dose:
7.5 mg at bedtime
Elderly licensed dose:
3.75–7.5 mg at bedtime
Off-licence use:
Yes
Primary topic:
Dose reduction and withdrawal
Withdrawal risks:
Physical and psychological withdrawal symptoms
Target population:
Adult patients using zopiclone long term
Recommended tapering pace:
No faster than one change per week
Dose forms:
3.75 mg tablets, 7.5 mg tablets
Reference bodies:
All Wales Medicines Strategy Group; NICE
Document components:
Clinical guidance; tapering schedule; patient reduction record
Note:
Year
Topic:
Medication Administration
Document Type:
Guidelines
Target Audience:
Staff in care homes
Year:
2023
Region / City:
United States
Topic:
Environmental Protection, Water Quality, Stormwater Management
Document Type:
Technical Clarification
Organization / Institution:
NPDES
Author:
N/A
Target Audience:
Permit holders, construction industry professionals, environmental regulators
Validity Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2024
Note:
Region / City
Topic:
Buffer Modeling, IBIS AMI, Ts4file
Document Type:
Technical Specification
Organization / Institution:
Intel Corporation
Author:
Michael Mirmak
Target Audience:
Engineers, IBIS users
Approval Date:
February 21, 2024
Year:
2004
Region / City:
USA
Subject:
Education
Document Type:
Guideline
Organization:
U.S. Department of Education
Author:
Not specified
Target Audience:
Educators, Special Education Teachers
Period of Validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2008
Study Type:
Expert consensus
Study Size (N):
N/A
Inclusion Criteria:
N/A
Exclusion Criteria:
N/A
Endpoints:
N/A
Study Limitations and Adverse Events:
Most databases have fewer patients with diameter in 5.0–5.5 cm size.
Conclusions:
Surgical treatment recommended at 5.5 cm diameter for ascending and 6.5 cm for descending aorta to prevent complications. For Marfan’s syndrome or a BAV, 15% of dissections occur at ascending aorta diameter of 5.0 cm. Dividing the ascending aorta maximal cross-sectional area by pt height and using threshold of 10 recommended for indication of operation. At high experience facilities, it has been suggested for asymptomatic pts (with connective tissue disorders, chronic aortic dissection with increased growth rate) to use <5 cm for ascending and <6 cm for descending aorta and thoracoabdominal aorta as criteria. No evidence that asymptomatic aneurysms <5.5 cm benefit from repair.
Authors:
Svensson LG, et al.
Institution:
N/A
Target Audience:
Medical professionals, clinicians
Period of Validity:
N/A
Approval Date:
N/A
Revision Date:
N/A
Year:
2023
Region / City:
United States
Subject:
Importation Process, CBP Forms
Document Type:
Government Regulation / Response
Organization:
U.S. Customs and Border Protection (CBP)
Author:
U.S. Customs and Border Protection (CBP)
Target Audience:
Importers, Customs Brokers
Validity Period:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified