ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:
Solutie antistress!
Construieste poduri :)
Prinde pisica neagra :)
FDA Approves XYZAL(R) Oral Solution For The Relief Of Seasonal And Year Round Allergies And Chronic Idiopathic Urticaria
UCB (Euronext: UCB) and sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) approved a New Drug
Application (NDA) for XYZAL(R) (levocetirizine dihydrochloride) 0.5 mg/mL
oral solution, a prescription antihistamine indicated for the relief of
symptoms associated with indoor and outdoor allergies, as well as the
treatment of chronic idiopathic urticaria. XYZAL(R) tablets received FDA
approval on May 25, 2007 and both formulations are now approved for use in
adults and children 6 years and older.
"The oral solution of XYZAL(R) provides a welcome alternative for those
patients who have difficulty swallowing or who prefer liquid medication,"
said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine
at the University of Tennessee Health Science Center in Memphis, Tennessee.
"Both the oral solution and tablets offer patients powerful and
long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine
significantly reduced the symptoms of sneezing, itchy nose, runny nose, and
itchy eyes. Studies in chronic idiopathic urticaria patients showed
levocetirizine significantly reduced the severity of itching and the number
and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement to
launch and co-market XYZAL(R) in the U.S. UCB and sanofi-aventis have a
long history in the allergy treatment arena and are committed to advancing
treatment for allergy sufferers and helping meet unmet medical needs for
patients with chronic allergy symptoms.
About Allergic Conditions
Many people suffer from the symptoms associated with common allergic
conditions. The immune system of allergy sufferers over-reacts to something
in the environment, leading to symptoms that affect their respiratory
system, eyes, or skin. Estimates from the American Academy of Allergy,
Asthma & Immunology (AAAAI) suggest that indoor and outdoor allergies
affect as many as 40 million people in the United States.
Seasonal allergic rhinitis (SAR), commonly referred to as "hay fever"
or "outdoor allergies," is the most common form of allergic rhinitis. By
definition, SAR includes allergies to seasonal pollens like grass, trees,
and weeds, as well as mold. Perennial Allergic Rhinitis (PAR) is sometimes
referred to as "year round" or "indoor allergies" and is characterized by
allergic symptoms that last longer than four weeks. House dust mites,
animal dander, and mold most commonly trigger PAR. Chronic Idiopathic
Urticaria (CIU) is most commonly known as "chronic hives of unknown origin"
and is defined as the occurrence of daily, or almost daily, wheals and
itching for at least six weeks with no obvious causes.
About XYZAL(R)
Indications and Important Safety Information
XYZAL(R) is indicated for the relief of symptoms associated with
allergic rhinitis (seasonal and perennial) and the treatment of
uncomplicated skin manifestations of chronic idiopathic urticaria in adults
and children 6 years of age and older.
The use of XYZAL(R) is contraindicated in: patients with a known
hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to
cetirizine (observed reactions range from urticaria to anaphylaxis);
patients with end-stage renal impairment at less than 10 mL/min creatinine
clearance or patients undergoing hemodialysis; and pediatric patients aged
6 to 11 years with impaired renal function.
Patients should be cautioned against engaging in hazardous occupations
requiring complete mental alertness and motor coordination, such as
operating machinery or driving a motor vehicle, after ingestion of
XYZAL(R). Concurrent use of XYZAL(R) with alcohol or other central nervous
system (CNS) depressants should be avoided because additional reductions in
alertness and additional impairment of CNS performance may occur.
In clinical trials, the most common adverse reactions in > or = 2% of
adult and adolescent patients (12 years of age and older) taking XYZAL 2.5
mg, XYZAL(R) 5 mg, or placebo were somnolence (5%, 6%, 2%), nasopharyngitis
(6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis
(2%, 1%, 1%), respectively.
In clinical trials 4 to 6 weeks in duration, the most common adverse
reactions in > or = 2% of pediatric patients (6-12 years of age) taking
XYZAL(R) 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs
FDA a aprobat XYZAL (R), soluþie oralã pentru scutire de sezon ºi anul alergii ºi urticaria idiopaticã cronicã - FDA Approves XYZAL(R) Oral Solution For The Relief Of Seasonal And Year Round Allergies And Chronic Idiopathic Urticaria - articole medicale engleza - startsanatate