№ lp_1_11393
File format: docx
Character count: 18990
File size: 240 KB
This PGD outlines the provision of docusate sodium 100 mg capsules by pharmacists under the Common Ailments Service in accordance with NHS Wales guidelines, detailing authorisation and usage requirements.
Year:
2025
Region / City:
[insert local health board name]
Topic:
Community Pharmacy, Common Ailments Service, Docusate Sodium
Document Type:
Patient Group Direction (PGD)
Organization / Institution:
Welsh Medicines Advice Service
Author:
Dianne Burnett
Target Audience:
Pharmacists working within the Common Ailments Service of the Clinical Community Pharmacy Service
Period of Validity:
01 November 2025 - 31 October 2028
Approval Date:
29 August 2025
Review Date:
31 July 2028
Expiration Date:
31 October 2028
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / City:
[insert local health board name]
Topic:
Clinical Guidelines for Antibiotics
Document Type:
Patient Group Directions (PGD)
Organ / Institution:
Welsh Medicines Advice Service
Author:
Jennifer Ellis, Dianne Burnett
Target Audience:
Community pharmacists, healthcare providers in Wales
Effective Period:
From 03 June 2025 to 02 June 2028
Approval Date:
21 February 2025
Amendments Date:
18 January 2025
Year:
2023
Region / city:
Wales
Topic:
Healthcare, Pharmaceutical Services, Urinary Tract Infections
Document Type:
Consultation Document
Organization / Institution:
AWTTC (All Wales Therapeutic and Toxicology Centre)
Author:
Alwyn Fortune
Target Audience:
Healthcare professionals, pharmacists, public health authorities
Effective Period:
Until consultation closing date
Approval Date:
Not provided
Amendment Date:
Not provided
Year:
Not specified
Region / City:
Australia
Subject:
Avian health and diseases
Document Type:
Guide / Reference document
Institution:
Not specified
Author:
Dr Harry Cooper
Target Audience:
Bird owners, avian veterinarians
Parasite Types:
External mites, red mites, other mites, air sac mites, worms
Disease Types:
Enteritis, coccidia, chronic respiratory disease, nutritional deficiencies, short tail disease, trichomoniasis
Treatment Methods:
Insecticides, antibiotics, nutritional supplements, iodine, environmental control
Application Period:
Not specified
Publication Notes:
Recommendations are based on Australian conditions
Year:
2024
Region / City:
Australia
Document Type:
Regulatory submission for PBS listing
Organization:
Biogen Australia Pty Ltd
Drug Name:
Omaveloxolone (Skyclarys®)
Indication:
Friedreich’s ataxia in adults and adolescents aged 16 years and older
Dosage Form:
Capsule 50 mg, oral administration
Regulatory Status:
Orphan drug status granted by TGA, EMA and FDA approvals
Submission Date:
26 June 2024
PBAC Meeting:
March 2025
Population:
Patients aged 16 years and older with Friedreich’s ataxia
Treatment Phase:
Initial and continuing treatment
Prescriber Type:
Dental, Medical Practitioners, Nurse Practitioners, Optometrists
Restriction Type:
Authority Required (telephone/online PBS Authorities system)
Clinical Criteria:
Genetic confirmation of FXN mutation, presence of clinical symptoms, management under a specialist or consultation with specialized unit if needed
Treatment Criteria:
Must be given with best supportive care, hemodynamically stable in case of cardiac history
Administrative Advice:
Queries directed to Services Australia, prescribing information available online
Year:
2026
Region / City:
European Union
Subject:
Pharmaceutical product information
Document type:
Summary of Product Characteristics
Organization / Institution:
European Medicines Agency (EMA)
Author:
European Medicines Agency
Target Audience:
Healthcare professionals
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
2026
Region / City:
Europe
Topic:
Medicine Information
Document Type:
Pharmaceutical Product Information
Organization / Institution:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Healthcare professionals
Period of Validity:
Ongoing
Approval Date:
2026
Date of Changes:
2026
Year:
2019
Region / city:
Saint-Cloud Cedex, France
Topic:
Medicine information
Document type:
Prescribing Information
Organization / institution:
Ethypharm
Author:
Not specified
Target audience:
Healthcare professionals
Effective period:
Not specified
Approval date:
December 2019
Amendment date:
Not specified
Contraindications:
Hypersensitivity to diltiazem, sick sinus syndrome, severe bradycardia, and others
Warnings and precautions:
Monitor patients with reduced left ventricular function, bradycardia, and others
Interactions:
Dantrolene, Ivabradine, and others
Side effects:
Peripheral oedema, atrioventricular block, dizziness, and others
Product License Number:
PL 06934/0195
Marketing Authorization Number:
PL 06934/0195
Legal Category:
POM
Description:
Information document regarding Angitil capsules for managing angina pectoris and hypertension, including dosage, contraindications, interactions, and side effects.
Authors:
N. Salinas; P. Mendoza; L. Corvo; C. Miquel; Y. Beldengrün; J. Miras; C. González; J. Esquena
Presenting author:
J. Esquena
Affiliations:
Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Barcelona, Spain; Networking Research Center on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Barcelona, Spain; Department of Chemical Engineering and Analytical Chemistry, University of Barcelona, Spain
Funding:
FP7-PEOPLE-2013-ITN project (Grant 606713, BIBAFOODS project); CTQ2017-84998-P
Type of document:
Scientific conference paper / research abstract
Field:
Colloid and interface science; biomaterials; food and drug delivery systems
Materials:
Sodium alginate; sodium carboxymethyl cellulose (NaCMC); bovine serum albumin (BSA); Ca2+; Fe3+
Methodology:
Preparation of aqueous two-phase systems (ATPS); formation and characterization of water-in-water emulsions; ionic gelation; freeze-drying
Subject:
Formation, stabilization and encapsulation of water-in-water emulsions within polyelectrolyte capsules
References cited:
Nguyen et al. (2013); Esquena (2016); Nicolai and Murray (2017); Beldengrün et al. (2018); Dickinson (2019)
Medicine:
Pirfenidone 267 mg capsule
Brand name:
Esbriet®
Manufacturer:
Roche Products Pty Ltd
Quantity:
270 capsules
Maximum quantity:
1
Number of repeats:
5
Program:
Section 100 – Highly Specialised Drugs Program
Schedule:
General Schedule (Code GE)
Condition:
Idiopathic pulmonary fibrosis
Treatment phases:
Initial treatment; Continuing treatment; Initial PBS-subsidised treatment (grandfather patient)
Restriction level:
Restricted benefit – Authority Required
Authority method:
In Writing; Telephone; Emergency; Electronic; Streamlined
Prescriber requirement:
Respiratory physician or specialist physician experienced in idiopathic pulmonary fibrosis
Population criteria:
Patients aged 40 years or older
Clinical criteria (initial):
Confirmed diagnosis of idiopathic pulmonary fibrosis supported by HRCT with or without surgical lung biopsy; FVC ≥ 50%; DLCO ≥ 30%
Clinical criteria (continuing):
Prior PBS-subsidised treatment with pirfenidone
Administrative authority:
Department of Human Services, Australia
Application requirement:
Completed authority prescription form and IPF Initial PBS authority application form with supporting diagnostic documentation
Geographical reference:
Hobart, TAS 7001, Australia
Doxycycline 100mg Capsules Initial Supply for Tularemia Patient Group Direction (PGD), Version 6.00a
Publications reference number:
PRN01582
Reference:
Doxycycline 100mg capsules PGD initial supply tularemia
Version number:
6.00a
Valid from:
1 October 2024
Review date:
1 March 2027
Expiry date:
30 September 2027
Developed by:
UK Health Security Agency (UKHSA)
Legal framework:
Human Medicines Regulations 2012 (HMR2012), Schedule 16 Part 2
Type of document:
Patient Group Direction (PGD)
Medicinal product:
Doxycycline 100mg capsules
Indication:
Initial supply following known or suspected deliberate release of tularemia
Eligible population:
Adults and children aged 12 years and over not showing symptoms compatible with tularemia infection
Exclusion criteria:
Under 12 years, no valid consent, known severe hepatic impairment, taking enzyme inducing antiepileptics
Authorising organisations:
NHS organisations and commissioners in accordance with HMR2012
Record retention requirement:
25 years after PGD expiry
Change history latest update:
Correction of typo and mail hyperlink to [email protected]
Note:
on 4 November 2024
Developed by (named professional):
Kiran Attridge, Senior Medical Adviser
Name of the medicinal product:
Cefi-Q 200 mg Capsules
Active substance:
Cefixime (as Cefixime Trihydrate) 200 mg per capsule
Excipients:
Lactose crystalline (monohydrate) 10 mg per capsule
Pharmaceutical form:
Hard gelatin capsule, size 2, pink cap and white body, printed “Maxpan” and “200”, containing light yellow granular powder
Therapeutic indications:
Upper and lower respiratory tract infections, otitis media, sinusitis, urinary tract infections, uncomplicated gonorrhea caused by susceptible microorganisms
Target population:
Adults and pediatric patients 6 months of age or older
Dosage (adults):
200–400 mg daily; recommended dose 400 mg daily; single 400 mg dose for uncomplicated gonorrhea
Dosage (pediatric):
8 mg/kg/day as single or divided doses
Special populations:
Patients with renal impairment including those on hemodialysis or peritoneal dialysis
Route of administration:
Oral
Treatment duration:
At least 10 days for infections due to Streptococcus pyogenes
Dosage forms available:
Capsules, chewable tablets, oral suspension
Suspension strengths:
100 mg/5 mL, 200 mg/5 mL, 500 mg/5 mL
Reconstitution instructions:
Specific water volumes provided for 100 mL, 75 mL, 50 mL, 37.5 mL, 25 mL, and 20 mL bottle sizes
Medicinal Product:
Hydrocortisone granules in capsules 0.5 mg, 1 mg, 2 mg, 5 mg (Alkindi®)
Sponsor:
Chiesi Australia
Regulatory Status:
Registered in the ARTG by the TGA on 18 August 2020
Orphan Drug Status:
Granted by the TGA
Submission Type:
Category 3 submission
Requested Listing:
Authority Required (STREAMLINED), General Schedule (Code GE)
Indication:
Replacement therapy of adrenal insufficiency
Population Criteria:
Patients diagnosed and initiated on treatment at 6 years of age or less; or patients 6 years of age or older with difficulty swallowing hydrocortisone tablets resulting in poor treatment compliance
Comparator:
Hydrocortisone 4 mg and 20 mg tablets (Hydrocortisone Mylan 4®, Hysone 4®, Hydrocortisone Mylan 20®, Hysone 20®)
Legislative Framework:
Section 101(3B) of the National Health Act 1953
Clinical Studies:
Infacort 001; Infacort 003; Infacort 004
Hearing:
No sponsor hearing conducted
Consumer Input:
Comments received from individuals, health care professionals and organisations via the PBS website
Economic Analysis:
Not presented
Exempt Distribution of Carbon14 Urea Capsules for In Vivo Diagnostic Use in Humans, Effective 1/2/98
Year:
1998
Agency:
U.S. Nuclear Regulatory Commission
Document Type:
Federal Regulation / Rule
Subject:
Radioactive Drugs, Licensing Exemptions
RATS ID:
19977
Effective Date:
1/2/1998
CFR Sections:
30.21, 32.21, 32.21a
Usage Restrictions:
In vivo diagnostic use for humans only; not for research involving human subjects; not for incorporation into food, beverages, cosmetics, or other drugs
License Requirements:
Specific license required for commercial distribution, manufacture, or research use
Labeling Requirements:
Must indicate radioisotope, physical/chemical form, activity, and usage restrictions
Name of medicinal product:
FORTALINE® PLUS Omega 3 fatty acids – vitamin E
Strength:
500 mg marine lipid concentrate (18% EPA, 12% DHA) – 10 mg vitamin E
Pharmaceutical form:
Soft capsule
Composition:
Marine lipid concentrate (fish oil) and α-tocopheryl acetate (vitamin E)
Active substances:
Omega-3 fatty acids (EPA, DHA), Vitamin E
Technology:
EnteriCare™ Anti-Reflux Technology
ATC code:
C10AX06; A11HA03
Pharmacotherapeutic group:
Other lipid modifying agents; Other plain vitamins
Route of administration:
Oral use
Recommended dosage (adults):
One to two capsules per day
Recommended dosage (pregnant and lactating women):
Two to three capsules per day
Recommended dosage (children able to swallow capsules):
One capsule per day
Therapeutic indications:
Dietary supplementation with omega-3 fatty acids for nutritional balance and physiological support
Contraindications:
Hypersensitivity to ingredients; concomitant use with aspirin or anticoagulants such as warfarin; patients at high risk of bleeding
Adverse reactions:
Gastrointestinal disorders, nausea, dyspepsia, rash, bruising, belching, diarrhoea, heartburn, bad breath
Pharmacological components:
Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), Vitamin E
Target populations:
Adults, pregnant and lactating women, children able to swallow capsules
Document type:
Medicinal product summary of characteristics
Field:
Pharmacology / dietary supplementation