EUSPC-ACX-T-092008 (EUSPC 072008 +approved Referral text following EC Decision (Sept 2008) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <ARCOXIA (see Annex 1)> 30 mg film-coated tablets <ARCOXIA (see Annex 1)> 60 mg film-coated tablets <ARCOXIA (see Annex 1)> 90 mg film-coated tablets <ARCOXIA (see Annex 1)> 120 mg film-coated tablets [See
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Hiv & gay men over fifty - leonard alberts md• HE, 63 yo retired gay male schoolteacher. MI at age 46, angioplasty. Smoker, drinker, in allegedly monogamous relationship for 20 years until 2001. Multiple male partners after he discovers Viagra. • On Zocor, Atenolol, HCTZ, Trental. Primary care • Cholesterol fairly well controlled, as is blood • Comes to see me with thrush.
• HIV tested for first time, HIV +, CD4 168, vl • Begun on Viread, Epivir, Sustiva• Major psych problems, exacerbation of depression with Sustiva, switched to Viramune • Rapid development of abnormal LFTs with • Switched to Kaletra, continues on Epivir and Viread. VL <50, CD4 224, but cholesterol rises to 275, and Triglycerides to 312, switched Zocor toLipitor.
• Cholesterol down to 225, but minimal change in • Depression better, but having trouble following low cholesterol diet, and still smoking and drinking • Awakens, after a night of “partying” with negative, MRI: Small Occipital infarct.
• Now stable on Plavix, Kaletra switched to • VL <50, CD4 267.
• Stay tuned• 17 % of people living with HIV > 50 y.o.
– Psych effects of Efavirenz– Hepatotoxicity of Nevirapine – Metabolic effects– ? Advantages of Atazanavir • Aging Immune System• Androgen Deficiency (Hypogonadism)• Cardiovascular Risk Factors – Atherosclerosis– Hypertension– Smoking– Substances ( Including Viagra) • Depression• Wasting/Anorexia/Nutritional Issues • Male gonadal dysfunction• Low testosterone levels/insufficient testosterone secretion• Results from insufficient testosterone secretion• Associated with: – Primary testicular failure1– Hypogonadotropic hypogonadism1– Other combined or individual conditions2 1. Winters SJ. Arch Fam Med. 1999;8:257-263.
2. Tenover JL. Endocrinol Metab Clin North Am. 1998;27:969-987. • Muscle mass ↑• Muscle strength ↑• Fat mass ↓• Bone mass ↑• Libido ↑• Erectile function ↑• Sense of well being ↑↓ = decrease; ↑ = increase Tenover JL. Endocrinol Metab Clin North Am. 1998;27:969-987.
• Regression of secondary sexual characteristics Tenover JL. Endocrinol Metab Clin North Am. 1998;27:969-987.
Initial Tests:• Plasma total testosterone – Measures free plus protein-bound fractions– Morning sample recommended1– <300 ng/dL (10 nmol/L) suggests hypogonadism*2 – Measures non-protein–bound testosterone fractions– Recommended in older patients– <50 pg/mL (173 pmol/L) suggests hypogonadism*3 1. Tenover JL. Endocrinol Metab Clin North Am. 1998;27:969-987.
2. Hypogonadism Task Force. Available at: www.aace.com/clin/guides/hypogonadism.html. Accessed on June 22, 2000.
3. Braunstein JD. In: Greenspan FS, Strewleter GJ, eds. Basic & Clinical Endocrinology. 5th ed. Stamford, Conn: – To ascertain whether cause is primary or secondary – High prolactin levels may suggest presence of Tenover JL. Endocrinol Metab Clin North Am. 1998;27:969-987.
– To ascertain whether cause is primary or secondary – High prolactin levels may suggest presence of Tenover JL. Endocrinol Metab Clin North Am. 1998;27:969-987.
• Restore libido and improve erectile function1-3• Improve lean body mass2,3• Decrease total body fat3• Improve bone density1,2• Improve psychological disposition1-3• Improve energy level3• Improve mood/sense of well being2,3 1. Hypogonadism Task Force. Available at: www.aace.com/clin/guides/hypogonadism.html. Accessed on June 22, 2000.
2. Tenover JL. Endocrinol Metab Clin North Am. 1998;27:969-987.
3. Wang C, Swerdloff RS, Iranmanesh A, et al. JCEM. 2000;85:2839-2853.
• Known or suspected prostate cancer1• Male breast cancer1• Women (patches, gel)2-4 1. Hypogonadism Task Force. AACE clinical practice guidelines for the evaluation and treatment of hypogonadism in adult male patients. Available at: www.aace.com/clin/guides/hypogonadism.html. Accessed on June 22, 2000.
2. Unimed Pharmaceuticals, Inc. AndroGel® (testosterone gel) 1% CIII product information.
3. Testoderm® TTS, Testoderm,® and Testoderm with Adhesive product information. Physicians’ Desk Reference. 54th ed. Montvale, NJ: Medical Economics Co; 2000:515-518.
4. Androderm® product information. Physicians’ Desk Reference. 54th ed. Montvale, NJ: Medical Economics Co; 2000:3170-3172.
• Increased rates of STD Transmission• Increased use of party drugs• Undiagnosed HIV infections • Safe sex “fatigue”• Safe sex vs. “safer” sex• Depression• Barebacking – 541 tests; 18 new cases, 2 chronic cases, 3 false positives – 117 cases in 2000– 282 cases in 2001 (93% male) • Median age 35• Increases in ALL ethnic groups• 79% MSM – 75 % more than one sex partner– 48% HIV +– 36% used alcohol or drugs combined with sexual • 31% clubs• 22% public cruising sites• 14% Internet chat rooms• 11% bathhouses• 5% exchanged sex for money • Syphilis outbreaks also in Seattle, Chicago, San • Concomitant increases in gonorrhea• Factors involved – HAART availability– “AIDS burnout”– Alcohol and drugs– Misperception of risks– Unrecognized HIV infection • 433 HIV+ MSM monitored prospectively with anal pap, colposcopy (high resolution anoscopy), and Bx of any visible lesions; baseline and • 12% AIN-3 at baseline• Prevalence and incidence higher in pts on HAART, despite correcting • Screening to identify and treat AIN should be considered for all HIV+ • 3 cases of invasive anal neoplasia in men over 50 in Ptown • 592 HIV patients in Alabama• Interviewed in private rooms in clinics by trained – sociodemographics – Drug history and current meds– Sexual history (#of partners, type of intercourse, frequency of intercourse, frequency of condom use) • Data divided into MSM, MSW and women• Participants on PI’s were 2X more likely to • 1.6x more likely to inconsistently use • MSM on PI, 4x more likely to never use, • Intentional anal sex without a condom with a man • Any unprotected anal intercourse• Raw sex• San Francisco survey of 554 MSM – 28% African-American, 27%Latino– 79%gay, 21%bisexual– 14% barebacked in past 2 years– Median # of partners 3gay-10bisexual • Greater physical stimulation• Emotionally closer• Do something taboo or racy• Take a major risk; be daring• Don’t like condoms• High on drugs and/or alcohol• Move on with life • GHB and metabolites• Crystal methamphetamine• Ketamine• Cocaine• Ecstasy• Viagra • Abstinence• Oral sex with condoms• Anal sex with condoms• Oral sex with cum• Topping without condom• Bottoming with condom• Sex while high• Not asking status• Bottoming without condom• Taking multiple “loads” – 0.82% (partner +)– 0.27 % (partner unknown) – 0.06 % (partner +)– 0.04% (partner unknown) – 8/123 new cases attributable to oral sex– 7/8 took cum in mouth and had poor dentition • 40% with cum in mouth• 20% with HIV + partners • Near linear reduction of HIV transmission • Serum viral load < 1500 decreases risk of • Maintain STD surveillance• Immunize for Hep A and Hep B• Offer PEP when appropriate• Maintain oral health• Screen for and treat depression• Maintain regular visit schedule• Educate about substances • 49% female• 62 % African-American• 35% Hispanic• 3% white• 2% MSM – 40% unprotected sex despite knowledge of HIV • 25% had a new STD after HIV infection• 50% traded sex for money and/or drugs• 40% used IV drugs prior to HIV Dx• 15% continued IV drugs after Dx • 38 yo male, acute ARS after multiple male • Viral load decreased from > log6 to <200.
– Rebounded to 200,000 after STI; but had several – Viral studies conclusively demonstrate superinfection – Safe sex still a necessity for HIV positive patients • Transmission of resistant virus• Boston Statistics• 20% of acutely infected have some resistance• Chronically infected
Femtosecond Laser Capsulotomy and Manual Continuous Curvilinear Capsulorrhexis Parameters and Their Effects on Intraocular Lens CentrationKinga Kránitz, MD; Agnes Takacs, MD; Kata Miháltz, MD; Illés Kovács, MD, PhD; Michael C. Knorz, MD; Zoltán Z. Nagy, MD, DSCC reation of a precise anterior capsulorrhexis is one of the most important steps of cataract surgery. In recent years, the most co