№ files_lp_3_process_9_32061
File format: docx
Character count: 157832
File size: 229 KB
This document provides detailed product information for CIALIS, including dosage instructions, contraindications, and therapeutic indications for the treatment of erectile dysfunction in adult males.
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
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.
Note:
Year
Document type:
Product Information
Organ / institution:
European Medicines Agency
Target audience:
Healthcare professionals, patients
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:
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
Active ingredient:
Rivaroxaban
Form:
Film-coated tablet
Dosage:
15 mg, 20 mg
Indication:
Treatment and prevention of deep vein thrombosis and pulmonary embolism
Pharmaceutical form:
Film-coated tablet
Therapeutic indications:
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), prevention of recurrent DVT and PE
Dosage instructions:
15 mg twice daily for the first three weeks, followed by 20 mg once daily
Special populations:
Renal impairment
Side effects:
See section 4.8 for adverse reactions
Contraindications:
See section 4.3 for contraindications
Storage conditions:
Store below 30°C
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
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.
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
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