New standard in Vaginitis treatment

VAGINAL INFECTIONS Worldwide problem Affect 75% of women at least once in their lives Recur in at least 40 % of these women. Not easily treated Productivity and quality of life is highly affected No satisfactory single product previously available Ref: Scott, E.: The Management of Candida Infections. Practitioner, 1990; 234: 232-236 2

General Symptoms of Vaginitis Vaginal and vulvar itching Increase in vaginal discharge, change in color and consistency Unpleasant odour Pain on urination / coitus 3

Three Major Types of Vaginal Infections Candidal vulvo-vaginitis 4

Three Major Types of Vaginal Infections Trichomonal Vaginitis 5

Three Major Types of Vaginal Infections Bacterial Vaginosis 6

CANDIDAL VULVO-VAGINITIS Clinical findings: Itching White,“Cottage cheese-like” discharge Cause: Candida ssp. Standard Treatment: Miconazole nitrate 7

CANDIDAL VULVO-VAGINITIS Local preparations are preferred Pessaries, creams Vaginal tablets may cause irritation of the vaginal mucosa ! *Isoconazole *Nystatine *Fluconazole *Clotrimazole *Miconazole Ref: Sexually Transmitted Diseases, Treatment Guideline, 2006 8

TRICHOMONAL VAGINITIS Clinical findings: Profuse discharge yellow-green or brown Unpleasant odour Strawberry cervix Dyspareunia Cause: Trichomonas vaginalis Standard Treatment: Metronidazole 9

Alternative Treatments Ornidazole Tinidazole Treatment of the Partner: (Metronidazole 2 g single dose) 10

BACTERIAL VAGINOSIS Metronidazole Clinical Findings: Causes: Profuse, white/gray discharge Fishy smell Itching Dysuria 50% asymptomatic Causes: G. vaginalis, anaerobes Standard Treatment: Metronidazole 11

Differential Diagnosis Fishy smell on 10% KOH application pH > 4.5 “Clue” cells “Clue” cell 12

Alternative Treatments (Systemic or Local) Ornidazole Tinidazole Clindamycin 13

Basis of laboratory diagnosis Bacterial vaginosis Vulvovaginal candidiasis Trichomoniasis Vaginal pH (normal = <4.5) Elevated (>4.5) Normal Microscopic examination of wet-mount and KOH preparations of vaginal discharge "Clue cells" (vaginal epithelial cells coated with coccobacilli) Few lactobacilli Mobiluncus species Pseudohyphae, budding yeast cells Motile trichomonads "Whiff" test (normal = no odor) Positive Negative Can be positive Additional tests Amsel's criteria (three of four criteria must be met). Criteria of Nugent for Gram stain. KOH microscopy Gram stain Culture DNA probe tests: sensitivity 90%, specificity 99.8% Culture: sensitivity 98% , specificity 100% 14

Taifa Leo, April 26, 2006

New standard in Vaginitis treatment

QUESTION: Is there an efficient single medication for vaginitis and mixed infections ? 17

Product Rationale - 1 40-50 % of patients with candidal vaginitis may have coexisting bacterial vaginosis and/or trichomoniasis mixed infections mixed infections require more than one medication 18

MIXED VAGINITIS 40-50 % of Patients have CVV together with BV or TV 19

Product Rationale - 2 Diagnosis is usually made on the basis of clinical findings Microbiological tests take some time to obtain or may not be available at all 20

Diagnosis of Vaginal Infections 90% of physicians never measure pH or check odour 21

Limitations of Direct Microscopy Availability of a quality microscope Training of the observer Mixed pathogens Poor reproducibility 22

Trichomonas vaginalis Vaginal cultures for detection of require up to 5 days of incubation 23

Bacterial vaginosis Amsel Criteria: abnormal vaginal discharge, amine odour, pH >4.5, clue cells on microscopy. Nugent Criteria: Specialized Gram stain evaluation for BV is frequently not available. Routine cultures are not useful for diagnosis because more than 50 % of women are asymptomatic. 24

Candidiasis culture positivity does not mean candidiasis. Yeast is part of normal vaginal flora culture positivity does not mean candidiasis. 25

Product Rationale - 3 Metronidazole may cause development of vaginal candidiasis Metronidazole should be combined with an antifungal (e.g. miconazole) 26

Product Rationale - 4 Combining two standard treatments greatly increases patient compliance Higher compliance à Higher Cure Rates à Economical treatment 27

Product Rationale - 5 Local treatment is preferred to oral therapy Systemic therapy does not increase cure rates does not eliminate candidal reservoirs in the bowel may cause systemic side effects more expensive 28

QUESTION: Is there an efficient single medication for vaginitis and mixed infections ? 29

NEO-PENOTRAN® FORTE VAGINAL PESSARY Yes ! NEO-PENOTRAN® FORTE VAGINAL PESSARY 30

NEO-PENOTRAN® FORTE VAGINAL PESSARY Metronidazole 750 mg Miconazole nitrate 200 mg 31

Indication: Bacterial vaginosis Trichomonal vaginitis antifungal antibacterial Bacterial vaginosis Trichomonal vaginitis Vaginal candidiasis Mixed infections antiprotozoal

POSOLOGY Special ovule shape (Spade form) providing large contact area with vaginal mucosa (2.5 grams) – guarantees complete release of all active ingredients. 7 Pessaries / box (1 for 7 days). 7 Disposable Finger stalls for ease of application. 34

Why Do Doctors Choose NeoPenotran®Forte Why Do Doctors Choose NeoPenotran®Forte? They have the availablity of treating mixed vaginal infections with only ‘1’ ovule !!! Other benefits… Unique combination Ovula formulation Excellent patient compliance Broad spectrum with a single product (BV, TV, VC, MixIn.) Economic treatment No need for laboratory testing Impressive track and safety record worldwide 7 day therapy duration 35 35

Patient Safety is important to us! Pharmacovigilance (Patient Safety) is important to Bayer. We are committed to the National and International obligations for Pharmacovigilance Any suspected Adverse Drug Reaction (sADR) to a Bayer medicine should be reported to: Suggested presenter’s notes: As Bayer, we are committed to patient safety. If you have any reports to our medicines, you can contact us directly using these contact details. Pharmacovigilance Department Phone: +254 20 8600000 Emergency phone: +254 705 837 298 (outside working hours) E-mail: pharmacovigilance.middleafrica@bayer.com proSMS: Report to "22937" Pharmacovigilance• July 2013

Pharmacovigilance• July 2013 Medical Enquiries proSMS Any medical enquiries? Please contact: Medical Affairs Department Phone: +254 20 8600000 E-mail: medical.middleafrica@bayer.com Suggested presenter’s notes: If you have any medical related enquiries, do write to us on these details… You can also sms to us using the number “22937” (which spells “BAYER”) and we will promptly respond to your enquiry. This is a free sms service provided by Bayer. In order to use this, you need to subscribe using this form and we will have you connected at the earliest… etc Pharmacovigilance• July 2013

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