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Champions League Draw Live Posted: 19 Dec 2008 05:17 AM CST Here is the draw for the next round of the Champions League 16 clubs go to the next round, the winners are drawn against the runners up and cannot be drawn against their own leagues:- Chelsea V Juventus Villarreal V Panathanikos Sporting Lisbon V Bayern Munich Athletico Madrid V FC Porto Olympic Lyonnais V Barcelona Real Madrid V Liverpool Arsenal V Roma Internazionale V Man Utd Related Posts Fergie - I Would Not Sell Real Madrid A Virus Liverpool Fans - Paying the Price for Racist Spaniards

Fergie - I Would Not Sell Real Madrid A Virus Posted: 19 Dec 2008 05:01 AM CST Sir Alex Ferguson, finally speaks out after Real Madrid talk of a “Gentlemans agreement” regarding Ronaldo Man United manager Sir Alex Ferguson furiously hit out at Real Madrid in Japan after learning that the La Liga club had told Spanish media that there is an agreement to sign Cristiano Ronaldo next summer. “You don’t think we’d get into a contract with that mob, do you?” said Ferguson, “I wouldn’t sell them a virus. So that’s a “No”. There is no agreement between the clubs.” United will play Liga de Quito from Ecuador in Sunday’s final in the FIFA Club World Cup in Tokyo. Fergie continued his rant: “I said to (chief executive) David Gill when we sold Heinze that you can bet the Cristiano thing will start up. It did and it will happen again in January. “We have to ignore it because we can’t keep worrying about them. We need to concentrate on our own form. “There can be anger in this situation and we can get annoyed. But there’s no point. We know their game. It won’t affect us” With the draw for the Champions League due later today, Fergie and Utd have other things on their mind, especially as Real could play them next round.. Related Posts Cristiano Ronaldo not too fond of Manchester, almost joined Arsenal. Cristiano Ronaldo unsurprisingly claims Ballon d’Or Rooney apologises for diving, no word from C-Ron. Ronaldo adds to inifinte supply of worldwide of adoration Champions League Draw Live

Britain’s Got An Extra Pop Factor And Then Some 2 + 1 Posted: 19 Dec 2008 04:37 AM CST Peter Kay brings a follow up show based on his reality TV character Geraldine McQueen Good TV or a waste of talent.  The jury is out on this show with the first show flopping after the break. Back on TV tonight with a follow-up show, Peter Kay shows what has happened to Geraldine since she won Britains Got The Pop Factor.. Although some points are funny, the mock-reality TV gag is so like the real thing, it becomes almost unfunny, still with a Christmas single out (although number one seems to be a no no) and the chance of getting some extra sales this will be a good advert for Kay. We hope that Peter Kay will drop Geraldine like Simon Cowell would in X Factor and return to some classic comedy like Phoenix Nights. Tonight, Channel 4 9pm. Related Posts Mid Week Charts Show Hallelujah To Top The Christmas Charts The Musical Grinch Who Stole Christmas Just What Did Alexandra Win On The X-Factor? Britney Won’t be Giving a Masterclass Britney Spears on X Factor this Saturday

The IT Crowd - One To Watch Tonight Posted: 19 Dec 2008 04:23 AM CST Fiendface - Jen introduces the guys to social networking Jen introduces Roy and Moss to a new social networking website, and then finds out why some friendships are best left in the past, some would call Web 1.0. Great comedy series that is getting funnier, with 600k people signing up to Facebook every day, many people will find this episode the one that gets them hooked. Channel 4 10pm Tonight. Related Posts Merlin Runs Up £46,000 For A Party Jamie Oliver to Stop Swearing on TV One to Watch Tonight - Country House Rescue Facebook and Marmite… Relationship Status: Love or Hate Teacher Found Guilty of Spending Too Much Time on Facebook

Shopkeeper’s Jokes Must Stop or he faces Prosecution Posted: 19 Dec 2008 01:00 AM CST A shopkeeper in south Wales has been told to stop putting jokes on promotional leaflets for his store or he faces prosecution. For 10 years, Bob Singh as been adding jokes to the Landmark store’s adverts. One day police came by his store to advise him to stop doing this. He said: “We’ve been doing this for years and I’ve never had a problem until now. “I get the jokes off the internet. They don’t target any person or gender and there’s no bad language. “I couldn’t believe it when three police officers turned up and said someone had contacted them about the leaflet because they didn’t like it.” Mr Singh put a sign in the front window saying: “We would like to apologise to anyone who may have been offended by the contents of our Christmas leaflet. In future we will try to be more politically correct.” Related Posts No Related Post

The Musical Grinch Who Stole Christmas Posted: 18 Dec 2008 09:36 AM CST It’s all Simon Cowell’s fault that Christmas has died And now, a special comment from our Senior Christmas Number One Correspondant, Ewan Spence. The Musical Grinch Who Stole Christmas(with thanks to Keith Olbermann) The race to Christmas number one in the UK has been devalued by Simon Cowell When I was young, this was the time of year that had you on the edge of your seats. This was the last few days before Christmas, but you had something to distract you from your presents. You had something that was more important. You had to decide who you wanted to be at the top of the charts and claim the Christmas number one. In those days, those heady days of Paul McCartney, Jona Lewie, Mud, Slade, Roy Wood with Wizzard, we even forgave Shaking Stevens and Elton John. Christmas was a fair and honourable race that everyone in the country all partook in. Even those who failed in the race, those that many say should have been the rightful winners, were duly rewarded with inclusion on the many Christmas compilation albums and ensuing royalties that let them buy a bottle of wine every year. That was the pact. The covenant. They did the cliches, the sleigh bells, the children’s choirs – we bought into that view, we bought the singles, and everyone knew that Christmas was special. Until reality TV arrived. There has been no faster way to devalue the spirit of Christmas than this crass, media driven sledgehammer. After three solid months of free advertising on every single media outlet, the national press, the radio and commercial television, the minds of the watchers have been conditioned to accept the winner as being bigger than The Beatles. The effect lasts about a week, but that’s enough for our Grinch to steal the Christmas Number One. And our Grinch, Simon Cowell, has had this since 2003. The year before the warning signs were there, as Girls Aloud and One True voice were created to battle each other for this spot, excluding everyone else from the race. We hoped it would be a one-off. We were wrong. 2003 was to prove the epilogue to a tradition that has run from a time before Noddy Holder’s "It’s Christmas" boomed out across the nation. The Darkness, a last gamble glam group from Lowestoft knew the rules, and penned "It’s Christmas Time, Don’t Let The Bells End." In a cruel twist, it reached number two, joining the greatest song of all time, A Fairytale of New York in the bin marked "Should have been." And to stick the knife in further, the number one was "Mad World" Never a truer song title has been sung The winner of the X-factor has been all but guaranteed the Christmas Number One. It doesn’t matter what they sing, who sings it, or whether they will feature on Now That’s What I call Christmas in ten years time. Do songs called That’s My Goal, A Moment Like This and When You Believe do not speak of family, of friends, or a deeper relationship with the world and the human condition. They said pop will eat itself. If that’s the case, then Mr Cowell has a Michelin Star atop his Christmas Tree. His chosen track this year is a cover of Leonard Cohen’s Hallelujah, and everyone outside of Sony BMG and Syco are hoping that a download only cover of this song, now eligible for the charts, from Jeff Buckley can put a stop to this madness of capitalism from the music industry. I fear that this will not be enough and our Grinch will laugh all the way to the bank having stolen what was once precious to an entire nation. (with thanks to Keith Olbermann and Seesmic). Related Posts Mid Week Charts Show Hallelujah To Top The Christmas Charts Just What Did Alexandra Win On The X-Factor? Britain’s Got An Extra Pop Factor And Then Some 2 + 1 X Factor - And The Winner Is.. Britney Won’t be Giving a Masterclass

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HIV/AIDS Update- New 75 mg Prezista tablet and corresponding pediatric dosing information approved

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

On December 18, 2008 FDA approved new pediatric dosing recommendations for a new 75 mg Prezista (darunavir) tablet formulation for patients from 6 to less than 18 years of age.

Section 1 Indications and Usage, Section 2 Dosage and Administration, and Section 3 Dosage Forms and Strenghts were modified to reflect the changes.

Dosing recommendations are provided based on the pharmacokinetic, activity and safety data from study TMC114-C212 in children 6- <18 years of age. A description of study TMC114-C212 including the pharmacokinetic, safety and activity results, and rationale for dose selection for children were included in Section 6 Adverse Reactions, Section 8 Use in Specific Populations, Section 12 Clinical Pharmacology and Section 14 Clinical Studies as shown below.

1 Indications and Usage

1.2 Pediatric Patients.
PREZISTA, co-administered with ritonavir (PREZISTA/rtv), and with other antiretroviral agents, is indicated for the treatment of HIV infection in pediatric patients 6 years of age and older [see Use in Specific Populations (8.4)].

This indication is based on 24-week analyses of plasma HIV RNA levels and CD4+ cell counts from an open-label Phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age.

2 Dosage and Administration

2.2 Pediatric Patients (age 6 to < 18 years)
Do not use once daily dosing in pediatric patients.

Healthcare professionals should pay special attention to accurate dose selection of PREZISTA, transcription of the medication order, dispensing information and dosing instruction to minimize risk for medication errors, overdose, and underdose.

Prescribers should select the appropriate dose of PREZISTA/rtv for each individual child based on body weight (kg) and should not exceed the recommended dose for treatment-experienced adults.

Before prescribing PREZISTA, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of PREZISTA tablets may not be appropriate.

The recommended dose of PREZISTA/rtv for pediatric patients (6 to < 18 years of age and weighing at least 44 lbs (20 kg)) is based on body weight (see Table 1) and should not exceed the recommended treatment-experienced adult dose (PREZISTA/rtv 600/100 mg b.i.d.). PREZISTA tablets should be taken with ritonavir twice daily and with food.

Table 1: Recommended Dose for Pediatric Patients (6 to < 18 years of age) for Prezista Tablets with ritonavir

Body Weight		Dose
(kg)	(lbs)
> 20 kg – < 30 kg	> 44 lbs – < 66 lbs	375 mg PREZISTA/50 mg ritonavir twice daily
> 30 kg – < 40 kg	> 66 lbs – < 88 lbs	450 mg PREZISTA/60 mg ritonavir twice daily
> 40 kg	> 88 lbs	600 mg PREZISTA/100 mg ritonavir twice daily

The safety and efficacy of PREZISTA/rtv in pediatric patients 3 to < 6 years of age have not been established.

PREZISTA/rtv should not be used in pediatric patients below 3 years of age [see Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2)].

3 Dosage Forms and Strengths

3.1 PREZISTA 75 mg Tablets
PREZISTA (darunavir) 75 mg tablets are supplied as white, caplet-shaped, film-coated tablets containing darunavir ethanolate equivalent to 75 mg of darunavir per tablet. Each tablet is debossed with “75” on one side and “TMC” on the other side.

6 Adverse Reactions

6.6 Clinical Trials Experience: Treatment-Experienced Pediatric Patients
PREZISTA/rtv has been studied in 80 antiretroviral treatment-experienced HIV-1-infected pediatric subjects 6 to < 18 years of age and weighing at least 44 lbs (20 kg) in combination with other antiretroviral agents [see Use in Specific Populations (8.4) and Clinical Studies (14.4)].

Frequency, type, and severity of ADRs in pediatric subjects were comparable to those observed in adults. ADRs to PREZISTA/rtv (all grades, ≥ 3%), excluding laboratory abnormalities reported as ADRs, were vomiting (13%), diarrhea (11%), abdominal pain (10%), headache (9%), rash (5%), nausea (4%) and fatigue (3%).

Grade 3 or 4 laboratory abnormalities were ALT increased (Grade 3: 3%; Grade 4: 1%), AST increased (Grade 3: 1%, Grade 4: 0%), pancreatic amylase increased (Grade 3: 4%, Grade 4: 1%), pancreatic lipase increased (Grade 3: 1%, Grade 4: 0%), total cholesterol increased (Grade 3: 1%), and LDL increased (Grade 3: 3%).

8 Use in Specific Populations

8.4 Pediatric Use
PREZISTA/rtv should not be used in pediatric patients below 3 years of age because of toxicity and mortality observed in juvenile rats dosed with darunavir (from 20 mg/kg to 1000 mg/kg) up to days 23 to 26 of age [see Warnings and Precautions (5.11), Use in Specific Populations (8.1), Clinical Pharmacology (12.3) and Nonclinical Toxicology (13.2)].

The pharmacokinetics, safety, tolerability, and efficacy of PREZISTA/rtv in pediatric patients 3 to < 6 years of age have not been established.

PREZISTA/rtv once daily should not be used in pediatric patients.

The safety, pharmacokinetic profile, and virologic and immunologic responses of PREZISTA/rtv were evaluated in treatment-experienced HIV-1-infected pediatric subjects 6 to < 18 years of age and weighing at least 44 lbs (20 kg) [see Adverse Reactions (6.6), Clinical Pharmacology (12.3) and Clinical Studies (14.4)]. Frequency, type, and severity of adverse drug reactions in pediatric subjects were comparable to those observed in adults [see Adverse Reactions (6.6)]. Please see Dosage and Administration (2.2) for dosing recommendations for pediatric subjects 6 to < 18 years of age and weighing at least 44 lbs (20 kg).

12.3 Pharmacokinetics

Pediatric Patients
The pharmacokinetics of darunavir in combination with ritonavir in 74 antiretroviral treatment-experienced HIV-1-infected pediatric subjects 6 to < 18 years of age and weighing at least 44 lbs (20 kg) showed that the administered weight-based dosages resulted in darunavir exposure comparable to that in treatment-experienced adults receiving PREZISTA/rtv 600/100 mg twice daily [see Dosage and Administration (2.2)].

Table 9: Population Pharmacokinetic Estimates of Darunavir Exposure (Study TMC114-C212) Following Administration of Doses in Table 1

Parameter Median (Range)	PREZISTA/rtv twice daily N = 74
AUC24h (ng∙h/mL)	127340 (67054-230720)
C0h (ng/mL)	3888 (1836-7821)
N = number of subjects with data. *AUC24h is calculated as AUC12h*2

14 CLINICAL STUDIES

Pediatric Patients:
The pharmacokinetic profile, safety and antiviral activity of PREZISTA/rtv was evaluated in a randomized, open-label, multicenter study. This study enrolled treatment-experienced pediatric subjects between the ages of 6 and < 18 years and weighing at least 44 lbs (20 kg). Patients were stratified according to their weight (≥ 20 - < 30 kg, ≥ 30 - < 40 kg, ≥ 40 kg) and received PREZISTA/rtv plus background therapy consisting of at least two non-protease inhibitor antiretroviral drugs. Eighty patients were randomized and received at least one dose of PREZISTA/rtv. Pediatric subjects who were at risk of discontinuing therapy due to intolerance of ritonavir oral solution (e.g., taste aversion) were allowed to switch to the capsule formulation. Of the 44 pediatric subjects taking ritonavir oral solution, 23 subjects switched to the 100 mg capsule formulation and exceeded the weight-based ritonavir dose without changes in observed safety.

The 80 randomized pediatric subjects had a median age of 14 (range 6 - < 18 years), and were 71% male, 54% Caucasian, 30% Black, 9% Hispanic and 8% other. The mean baseline plasma HIV-1 RNA was 4.64 log10 copies/mL, and the median baseline CD4+ cell count was 330 cells/mm3 (range: 6 to 1505 cells/mm3). Overall, 38% of pediatric subjects had baseline plasma HIV-1 RNA ³ 100,000 copies/mL. Most pediatric subjects (79%) had previous use of at least one NNRTI and 96% of pediatric subjects had previously used at least one PI.

Seventy-seven pediatric subjects (96%) completed the 24 week period. Of the patients who discontinued, one patient discontinued treatment due to an adverse event. An additional 2 patients discontinued for other reasons, one patient due to compliance and another patient due to relocation.

The proportion of pediatric subjects with HIV-1 RNA < 400 copies/mL and < 50 copies/mL was 64% and 50%, respectively. The mean CD4+ cell count increase from baseline was 117 cells/mm3.

The dose selection was based on the following:

• Similar darunavir plasma exposures in children compared to adults
• Similar virologic response rates and safety profile in children compared to adults

The complete revised labeling will be posted soon on the FDA web site at Drugs@FDA.

Prezista is a Protease Inhibitor, manufactured by Tibotec Inc.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration 

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Spotting an Arrhythmia

Heart Health December 19, 2008
Do You Have an Abnormal Heart Rhythm? Know What to Look For Not everyone's heart beats the same way. But for some people, a different kind of heartbeat could be the sign of a problem. Whether the heart is beating too fast or too slow, an arrhythmia can often be a warning light for several conditions, or signal an increased risk of cardiac arrest. While many types of arrhythmia can be treated with lifestyle changes or medication, some require more serious intervention. The most serious abnormal heart rhythms could require a pacemaker or implantable defibrillator. Connect: Being diagnosed with an arrhythmia can be scary and may seem overwhelming. It may help to share your experience with others who are going through the same thing at Heart Health message board. Heart Healthy News Light Drinking Poses No Heart Risk for Women Vitamin D Vital for the Heart Heavy Traffic Can Be Heartbreaking Rapid Response Teams Don't Cut Hospital Heart Attacks, Death Rates Another Study Warns of Risk from Cardiac Surgery Drug Watch Your Cholesterol Anyone who is concerned about their heart should be concerned about their cholesterol. Check out the Cholesterol Health Corner for all the answers! Preparing for Your Weight-Loss Procedure It is important to be fully prepared before having weight-loss surgery. Find out what questions you should be asking your doctor. NeverSayDiet Community Challenge Sign up for the six-week Community Challenge and get daily exercise and nutrition assignments from a personal trainer and a nutritionist so you can make your New Year's resolution a reality this year. ADVERTISEMENT	NEWSLETTERS Click to sign up in one click! Diet & Fitness: Diets, workouts and weight loss secrets Arthritis: The latest information on arthritis and treatments Women's Wellness: Need-to-know information for your health and wellness More free newsletters>>> VIDEOS Is your house making you sick? The facts about uterine fibroids Secrets to a great memory ADVERTISEMENT
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48 Hours E-mail Alert

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Breaking News Fri., December 19, 2008

Breaking News from ABCNEWS.com:

White House to Give Automakers $17.4B in Short-Term Loans [8:45 a.m. ET]

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