№ lp_1_2_00693
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This document is a guideline for the NHS Pharmacy First Scotland service, outlining conditions under which registered pharmacists can supply trimethoprim tablets for the treatment of acute uncomplicated urinary tract infections (UTIs) in non-pregnant females aged 16 years and older.
Note:
Year
Organization / Institution:
NHS Scotland
Author:
Dr Laura Ryan, Dr John McAnaw, Mr Jim Miller
Target Audience:
Qualified health professionals within NHS Scotland
Changes History:
Eligibility age extended, new conditions added, clarifications made
Clinical Situation:
Acute uncomplicated urinary tract infection (UTI) in non-pregnant females aged 16 years and over.
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2024
Region / City:
Wales
Topic:
Healthcare, Pharmacy, Urinary Tract Infection
Document Type:
Patient Group Directions (PGD)
Organisation:
Welsh Medicines Advice Service, NHS Wales
Author:
Dianne Burnett, Louise Allen, Emlyn Pritchard, Adam Mackridge, Richard Coulthard
Target Audience:
Healthcare professionals, community pharmacists
Validity Period:
From 03 June 2024 to 02 June 2027
Approval Date:
22 April 2024
Ratification Date:
09 May 2024
Review Date:
08 February 2027
Expiry Date:
02 June 2027
Version:
1.0
Change History:
Version 1.0 developed on 22 December 2023
Clinical Condition:
Acute, uncomplicated lower urinary tract infection
Treatment:
Nitrofurantoin, Trimethoprim
Applicable Group:
Non-pregnant females or transgender males (16-64 years)
Authorising Organisation:
Local Health Board
Staff Requirements:
Registered pharmacists, authorised by name
Retention Period:
8 years for adults, 25 years for children
Local Inquiries:
[insert local details]
Note:
Year
Document type:
Product Information
Organ / institution:
European Medicines Agency
Target audience:
Healthcare professionals, patients
Year:
2014
Region / city:
Australia
Topic:
Pharmaceutical product submission
Document type:
Application for listing
Organization / institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target audience:
Health professionals, regulatory authorities
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
1 April 2014
Year:
2022
Region / City:
Australia
Topic:
Oncology / Hematology
Document Type:
Submission Report
Organ / Institution:
Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Celgene Pty Limited
Target Audience:
Healthcare professionals, regulatory authorities
Validity Period:
Ongoing
Approval Date:
8 April 2022
Amendment Date:
Not specified
Year:
2017
Region / city:
Australia
Topic:
Treatment of moderate to severe plaque psoriasis
Document type:
Resubmission for PBS listing
Authority:
Therapeutic Goods Administration (TGA)
Author:
Celgene Pty Ltd
Target audience:
Healthcare professionals, dermatologists, general physicians
Period of validity:
Ongoing
Approval date:
2017
Date of amendments:
2017
Year:
2026
Region / City:
Europe
Subject:
Product Information
Document Type:
Summary of Product Characteristics
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:
2025
Region / City:
England
Topic:
Emergency contraception
Document type:
Patient Group Direction (PGD)
Organization / Institution:
NHS England
Author:
Dr Cindy Farmer, Michelle Jenkins, Vicky Garner, Gail Rowley, Julia Hogan, Kate Devonport, Chetna Parmar, Helen Donovan, Carmel Lloyd, Clare Livingstone, Kirsty Armstrong, Dipti Patel, Emma Anderson, Dr Kathy French, Dr Sarah Pillai, Alison Crompton, Andrea Smith, Lisa Knight, Bola Sotubo, Tracy Rogers, Sandra Wolper, Jo Jenkins
Target audience:
Pharmacists, Pharmacy Technicians
Effective period:
June 2025 - February 2026
Approval date:
November 2022
Review date:
September 2025
Expiry date:
February 28, 2026
Year:
2023
Region / city:
Europe
Theme:
Pharmaceutical, HIV Treatment
Document Type:
Summary of Product Characteristics
Organization / Institution:
European Medicines Agency (EMA)
Author:
European Medicines Agency
Target audience:
Healthcare professionals, doctors
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2025
Author:
Bahá’u’lláh
Religious Tradition:
Bahá’í Faith
Genre:
Sacred scripture
Form:
Tablets and devotional texts
Primary Themes:
Revelation, divine love, steadfastness, martyrdom, spiritual transformation
Named Individuals:
Muḥammad-‘Alí
Liturgical Element:
Tablet of visitation
Language Style:
Devotional and exhortatory prose
Intended Audience:
Believers and followers of the Cause of God
Historical Context:
Successive divine dispensations and fulfillment of prophetic promises
Name of the medicinal product:
Miraba-S Tablets
Active substances:
Mirabegron (Extended-Release) 25 mg; Solifenacin succinate 5 mg
Pharmaceutical form:
Film coated tablet
Description:
Yellow coloured, round, biconvex, film coated tablet
Therapeutic indications:
Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Posology:
One tablet daily; may increase to two tablets daily after 4 to 8 weeks based on efficacy and tolerability
Dose adjustments:
Maximum once daily in severe renal impairment (CLcr 15–29 mL/min or eGFR 15–29 mL/min/1.73 m2) or moderate hepatic impairment (Child-Pugh Class B); not recommended in ESRD or severe hepatic impairment
Method of administration:
Swallowed whole with water, with or without food; not chewed, divided, or crushed
Contraindications:
Hypersensitivity to mirabegron, solifenacin succinate, or any excipients
Special warnings and precautions:
Risk of increased blood pressure, urinary retention, angioedema, and interactions with CYP2D6 substrates
Drug interactions:
CYP2D6 substrates (e.g., metoprolol, desipramine, thioridazine, flecainide, propafenone); digoxin; warfarin
Fertility:
No human data available; no treatment-related effects observed in animals
Pregnancy:
No adequate studies in pregnant women
Lactation:
No information on presence in human milk or effects on breastfed child
Effects on ability to drive and use machines:
Mirabegron has negligible influence; solifenacin may cause blurred vision, somnolence, and fatigue
Undesirable effects:
Dry mouth, urinary tract infection, constipation, tachycardia, hypertension, urinary retention, angioedema
Reporting of suspected adverse reactions:
Healthcare professionals advised to report adverse reactions
Year:
2021
Region / City:
Global
Topic:
Medicine/Pharmaceuticals
Document Type:
Pharmaceutical Product Information
Organization:
N/A
Author:
N/A
Target Audience:
Healthcare Professionals
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2025
Region / City:
England
Topic:
Emergency contraception, NHS Pharmacy Contraception Service
Document Type:
Patient Group Direction
Organization / Institution:
NHS England
Author:
Dr Cindy Farmer, Michelle Jenkins, Vicky Garner, Gail Rowley, Julia Hogan, Kate Devonport, Chetna Parmar, Helen Donovan, Carmel Lloyd, Clare Livingstone, Kirsty Armstrong, Dipti Patel, Emma Anderson, Dr Kathy French, Dr Sarah Pillai, Alison Crompton, Andrea Smith, Lisa Knight, Bola Sotubo, Tracy Rogers, Sandra Wolper, Jo Jenkins
Target Audience:
Community Pharmacists, Pharmacy Technicians
Effective Date:
29 October 2025
Review Date:
September 2028
Expiry Date:
28 February 2029
Approval Date:
November 2022
Document Status:
Draft
Document Version:
1.0
Change History:
Version 1.0 approved on 20 June 2025
Clinical Condition:
Unprotected sexual intercourse, contraceptive failure
Criteria for Inclusion:
Emergency contraception within 96 hours post-UPS, vomiting after EC
Criteria for Exclusion:
Age under 16, pregnancy, recent childbirth or miscarriage
Cautions:
Fraser guidelines for underage assessments, safeguarding protocols
Context:
A PGD outlining the conditions and procedures for emergency contraception administration by authorized pharmacists and technicians in NHS pharmacies in England.
Year:
2026
Region / City:
Australia
Topic:
Pharmaceutical Application
Document Type:
Authority Submission
Organization / Institution:
TEVA Pharma Australia Pty Ltd
Author:
Not specified
Target Audience:
Health care professionals, including dental medical practitioners, nurse practitioners, optometrists, midwives
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2022
Region / city:
European Union
Topic:
Pharmaceutical Product Information
Document Type:
Product Summary
Organization / Institution:
European Medicines Agency
Author:
Not specified
Target Audience:
Healthcare professionals
Period of validity:
Not specified
Approval Date:
Not specified
Date of modifications:
2022
Organization:
Digestive Disease Associates of Rockland, PC
Address:
974 Route 45, Pomona NY 10970
Contact Phone:
845-354-3700
Website:
www.ddar.com
Country:
United States
City / Region:
Pomona, New York
Document Type:
Medical preparation instructions
Medical Procedure:
Colonoscopy
Medication Referenced:
Osmo-Prep tablets
Subject:
Patient preparation protocol before colonoscopy
Target Audience:
Patients scheduled for colonoscopy
Preparation Period:
Five days before procedure through day of procedure
Dietary Instructions:
Low fiber diet followed by clear liquid diet
Medication Management:
Guidance for blood thinners, diabetes medications, anti-inflammatory drugs, supplements, and GLP-1 medications
Sedation Requirement:
Intravenous sedation administered during procedure
Transportation Requirement:
Responsible adult escort required after procedure
Estimated Visit Duration:
At least four hours
Additional Clinical Notes:
Pregnancy test requirement for women under 50 and instructions regarding hydration and bowel cleansing
Year:
2025
Region / city:
England
Topic:
Immunization
Document type:
Patient Group Direction (PGD)
Organization / institution:
UK Health Security Agency (UKHSA)
Author:
Suki Hunjunt, Professor Shamez Ladhani, David Green
Target audience:
Healthcare professionals involved in immunization
Period of validity:
From 5 January 2026 to 5 January 2029
Approval date:
5 January 2026
Amendment date:
2 June 2025, 16 December 2025
Description:
A document detailing the administration guidelines for the pneumococcal polysaccharide conjugate vaccine (PCV13, PCV15) for children under 2 years old in the UK.
Year:
2025
Region / city:
England
Topic:
Influenza immunisation
Document type:
Patient Group Direction (PGD)
Organisation:
UK Health Security Agency (UKHSA)
Author:
Christina Wilson, Jamie Lopez-Bernal, Greta Hayward
Target audience:
Healthcare practitioners, NHS organisations
Period of validity:
From 1 September 2025 to 1 April 2026
Approval date:
3 July 2025
Revision history:
Updated annually, latest update 9 July 2025
Reference no:
HPV (GBMSM) PGD
Version no:
v5.0
Valid from:
1 September 2025
Review date:
1 April 2028
Expiry date:
1 September 2028
Author:
Suki Hunjunt, Sharif Ismail, David Green
Region / city:
England
Target audience:
Healthcare practitioners administering HPV vaccine to GBMSM
Type of document:
Patient Group Direction
Organisation:
UK Health Security Agency (UKHSA)
Date of approval:
17 July 2025
Date of modifications:
16 July 2025
Context:
A formal Patient Group Direction for the administration of HPV vaccine to GBMSM, detailing legal, clinical, and procedural requirements for healthcare practitioners in England.
Reference no:
Hib/MenC PGD
Version no:
v6.0
Valid from:
1 July 2025
Expiry date:
30 April 2026
Authorising organisations:
UK Health Security Agency (UKHSA)
Target audience:
Registered healthcare practitioners
Responsible body:
UKHSA
Note:
Amendment history
v1.0 and v2.0:
See previous versions of this PGD template for details (19 January 2016 to 23 April 2018)
v3.0:
PHE Hib/MenC PGD amended to: include vaccination of individuals for the prevention of secondary cases of meningococcal group C disease (24 April 2018)
v4.0:
PHE Hib/MenC PGD amended to: remove reference to individuals with an underlying medical condition (5 March 2020)
v5.0:
UKHSA Hib/MenC PGD amended to: include minor rewording of standard text, layout and formatting changes (4 May 2022)
v6.0:
UKHSA Hib/MenC PGD amended to: include minor rewording, updated references, and changes to the childhood immunisation schedule (2 June 2025)
Developed by:
Christina Wilson (Lead Pharmacist), Professor Shamez Ladhani (Paediatric Infectious Diseases Consultant), David Green (Nurse Consultant for Immunisation Programmes)
Peer-reviewed by:
UKHSA Immunisations PGD Expert Panel
Date approved:
2 June 2025