APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Apr. 2010, p. 2075–2085 Copyright © 2010, American Society for Microbiology. All Rights Reserved. Monitoring the Effects of Chiral Pharmaceuticals on Aquatic Microorganisms by Metabolic Fingerprinting䌤 Emma S. Wharfe, Catherine L. Winder, Roger M. Jarvis, and Royston Goodacre* School of Chemistry and Manchester Interdisciplinary Biocentre, University of Manchester,
Vedafil.co.nzpower, performance, price
Erectile dysfunction Erectile dysfunction is a common condition affecting over 50% of men over the age of 40, at some time1. How many of your patients are hiding in their sheds or workshops, afraid or too embarrassed to discuss their erectile difficulties and not receiving treatment?Men need good tools. So let's get your male patients out of their sheds and workshops and give them the power. Sildenafil is the most common PDE5 inhibitor treatment available2, and with Vedafil®, your patients have a cost effective alternative to help restore their normal sex life Sildenafil use significantly improves erectile function and is well tolerated3.
The efficacy and safety of sildenafil has been established in a large number of clinical trials. In addition to improvements in erectile function, analysis of the data showed that sildenafil treatment also improved the domains of orgasm, satisfaction with intercourse and Vedafil®
• The alternative choice in erectile dysfunction (ED)
• Bioequivalent to Viagra®• Sildenafil citrate is the most common PDE5I treatment • Patient support • Visit www.vedafil.co.nz
Sildenafil citrate 25mg, 50mg and 100mg tablets
Vedafil® is an oral therapy for erectile dysfunction which restores impaired erectile function by increasing blood flow to the penis, resulting in a natural response to sexual stimulation in adult males.
Vedafil® offers your patients a cost effective choice in their ED medication options. While ED treatment options can be expensive, Vedafil® is priced to ensure cost savings to your patient, assisting with any anxiety, stress or worry around the cost of treatment. The Vedafil® Buzz Card loyalty programme provides your patients with a free pack of Vedafil® with every four packs purchased – that's every fifth pack of Vedafil® for free5.
Bioequivalence6 to Viagra®
Single dose fasting bioequivalence study. Mean plasma concentration of sildenafil citrate vs time (N=41)
Viagra® 100mg tablet (Pfizer) Vedafil® 100mg tablet (Mylan)
ation (ng/ml)tr 300 00.00 2.00 4.00 6.00 8.00 10.00 12.00 14.00 16.00 18.00 20.00 22.00 24.00 26.00 Avigra® is an identical formulation to Viagra®. Avigra® was registered as an additional name with Viagra® as the parent product in February 2011. Vedafil® is an approved and registered medicine having been thoroughly evaluated by the required NZ authorities according to international standards.
As part of the registration process, bioequivalence was investigated to compare and evaluate the single-dose oral bioavailability of Vedafil® (sildenafil citrate) 100mg tablets (Mylan Ltd) and Viagra® (sildenafil citrate) 100mg tablets (Pfizer Australia Pty Ltd), as well as to monitor the safety of subjects.
The study was a randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study in healthy human adult male subjects, under fasting conditions. A wash out period of 7 days was maintained between consecutive dosing periods.
Sildenafil citrate 25mg, 50mg and 100mg tablets
Use in adults
The recommended starting dose is 50mg taken approximately one hour before sexual activity. Based on efficacy and toleration, the dose may be increased to 100mg or decreased to 25mg. The maximum recommended dose is 100mg. The maximum recommended dosing frequency is once per day.
When sildenafil is taken with a high fat meal, the rate of absorption is reduced and patients may need to individualise their dosing relative to their food intake based on their own experienced clinical response.
Use in patients with impaired renal or hepatic function, or elderly patients
A 25mg starting dose should be considered in these patient groups. Based on efficacy and toleration, the dose may be increased to 50mg and 100mg.
Use in patients using other medications
Concomitant use of potent CYP 3A4 inhibitors has been associated with increased plasma levels of sildenafil. Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25mg should be considered in these In order to minimise the potential for developing postural hypotension, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at lower doses should be considered.
Refer to the Vedafil® data sheet available at www.medsafe.govt.nz for further information on medications that may be affected by sildenafil or may affect how sildenafil works.
Buzz Card Loyalty Programme
Vedafil® offers your patients additional cost savings with the Buzz Card Loyalty Programme. With every four packs of Vedafil® purchased, we provide the fifth pack free5.
How it works.
The patient completes a Buzz Card application form and posts in to Mylan New Zealand with their four pharmacy purchase receipts.
2. Mylan New Zealand sends a free pack of Vedafil® to the nominated pharmacy for collection by the patient.
Buzz Card application forms can be obtained from www.vedafil.co.nz or from a
pharmacy or doctor. If you would like to request Buzz Cards for your patients, please contact us; [email protected] or Freephone 0800 579 811.
Vedafil® GP Sampling
Mylan New Zealand offers a sampling programme to GP's, enabling your patients to trial Vedafil® prior to purchase.
To join the Vedafil® GP sampling programme, go to the healthcare professional section of www.vedafil.co.nz to send us your request.
Please note that certain criteria apply and must be verified prior to product samples being sent. Establishing a diagnosis and treatment for ED can be an embarrassing and often confusing time for men who are experiencing erectile difficulties, as well as their partners. Vedafil.co.nz offers a variety of information from causes of ED through to what to expect at your doctors visit. Patient resources such as the patient information booklet and Buzz Card can also be downloaded.
Hypersensitivity to any component of the product Men for whom sexual intercourse is inadvisable ED patients with a previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) Severe hepatic impairment Hypotension (<90/50 mmHg) Hypertension (>170/110 mmHg) Recent history of stroke or myocardial infarction Hereditary degenerative retinal disorders Concomitant use with nitric oxide donors, organic nitrates or organic nitrites in any form, including glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates Vedafil® is not indicated for use by women.
Viagra® is a registered trademark of Pfizer Products Inc.
1. Feldman HA et al. J. of Urol. 1994 151:54-61 2. IMS Analyser data May 2014, G04E Erectile Dysfunction Prd, MAT Units 3. Fink H et al. Arch Intern Med. 2002; 162:1349-1360 4. Vedafil® data sheet 5. A valid prescription is required and normal doctor's fees and pharmacy dispensing fees apply 6. Mylan NZ data on file Vedafil (sildenafil citrate) 25 mg, 50 mg, 100 mg Tablets. Medicine Classification: Prescription medicine. Indications: For the treatment of erectile dysfunction in adult males. Contraindications: Hypersensitivity to any component of the tablet; Men for whom sexual intercourse is inadvisable; ED patients with a previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION); severe hepatic impairment; hypotension (<90/50 mmHg); hypertension (>170/110 mmHg); recent history of stroke or myocardial infarction; hereditary degenerative retinal disorders. Concomitant use with nitric oxide donors, organic nitrates or organic nitrites in any form, including glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates. Not indicated for use by women. Precautions: Cardiovascular status including recent onset angina, patients with left ventricular outflow obstruction and patients with multiple system atrophy manifesting as severely impaired autonomic control of blood pressure. Caution in patients with: anatomical deformation of the penis; priapism; bleeding disorders; active peptic ulceration and diabetic retinopathy. Advise caution when driving or operating machinery. Interactions: Caution with CYP3A4 or CYP2C9 inhibitors or inducers and alpha-blockers. Use with other treatments for erectile dysfunction is not recommended. Adverse Effects: Headache, flushing, dyspepsia, nasal congestion, diarrhoea, abnormal/ decreased vision, cardiovascular events. Refer to data sheet for full list of adverse effects. Dosage & Administration: Average dose is 50 mg once daily taken approximately one hour before sexual activity. Vedafil is an unfunded prescription medicine. Your patient will need to pay for this medicine. Before prescribing please refer to the full datasheet, available from www.medsafe.govt.nz. Mylan NZ Ltd., Auckland. DA0114JL-18.
MEN NEED GOOD TOOLS
SAIC/CHCS Doc. TC-4.5-0359 29 Jul 1996 PHR: OUTPATIENT PHARMACY FUNCTIONS Copyright 1996 SAIC License is granted under Contract DAHC94-88-D-0005 and the provisions of DFAR 52.227-7013 (May 1987) to the U.S. Government and third parties under its employ to reproduce this document, in whole or in part, for Government purposes only.