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in view of its observed benefits. The following matters need to be further investigated via post-marketing surveillance: (1) the occurrence of hepatic function disorder, hypertension, cardiovascular events (including venous thromboembolic events), hemorrhagic events, pneumothorax, thyroid function abnormal, gastrointestinal perforations and gastrointestinal fistula, proteinuria and nephrotic syndrome, wound healing delayed, infections, posterior reversible encephalopathy syndrome, and interstitial (...) lung disease and (2) further safety information on the product in the patients with hepatic impairment and patients with soft tissue sarcoma of tumor types not evaluated in clinical studies. As a result of its regulatory review, the Pharmaceuticals and Medical Devices Agency has concluded that the product may be approved for the following indications and dosage and administration, with the following conditions for approval. [Indications] Soft tissue sarcoma [Dosage and administration] The usual
with authorised orphan medicinal products because there is no authorised orphan medicinal product for a condition related to the proposed indication. New active Substance status The applicant requested the active substance afatinib contained in the above medicinal product to be considered as a new active substance in itself, as the applicant claims that it is not a constituent of a product previously authorised within the Union. Licensing status Giotrif has been given a Marketing Authorisation in the USA (...) in the clinical management of early stage NSCLC by establishing comprehensive, multi-modality treatment regimens; however, the prognosis for advanced disease has not improved substantially. With an overall 5-year survival rate of 9% to 13%, the treatment of NSCLC remains a highly unmet medical need. According to the European Society for Medical Oncology (ESMO) guidelines, first-line treatment with a tyrosine kinase inhibitor (TKI), erlotinib or gefitinib, should be prescribed to patients with tumours bearing
maximum tolerated dose NSCLC non-small cell lung cancer NOAEL no observed adverse effect level OATP Organic anion-transporting polypeptide ORR objective response rate OS overall survival OVAT One Variable At a Time PK pharmacokinetics PFS progression free survival PR partial response RECIST response evaluation criteria in solid tumours RPES Posterior reversible encephalopathy syndrome SAE serious adverse event SD stable disease SJS Stevens-Johnson-Syndrome TEN Toxic epidermal necrolysis TG (...) Pursuant to Article 7 (EC) No 1901/2006, the application included an EMA Decision CW/1/2011 on the granting of a class waiver. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing the possible similarity with authorised orphan medicinal products because there is no authorised orphan medicinal product for a condition related
antifungal shampoos are based on expert opinion in clinical guidance Evidence-based Danish guidelines for the treatment of Malassezia-related skin diseases [ ], Fungal skin and nail infections: diagnosis and laboratory investigation [ ], Antifungal agents for common outpatient paediatric infections [ ], and Pityriasis versicolor [ ]; expert opinion in a dermatology textbook [ ]; and a review article [ ]. Ketoconazole shampoo or selenium sulphide shampoo as an alternative are widely recommended (...) antifungal treatment before considering oral antifungal treatment is based on the expert opinion of previous external reviewers of this CKS topic. Oral antifungal treatment The recommendations on oral antifungal treatment are based on clinical guidance Evidence-based Danish guidelines for the treatment of Malassezia-related skin diseases [ ] and Fungal skin and nail infections: diagnosis and laboratory investigation [ ], expert opinion in a dermatology textbook [ ], a review article
in the NDA, both with possible concomitant allergic phenomena. Both of these cases had confounding factors. In one of these cases, Stevens-Johnson syndrome with reported, along with increased serum ALT, AST and builirubin in a patient taking mirabegron 100 mg and an acetaminophen-containing herbal medication. The risk benefit analysis is, in my opinion, satisfactory for NDA approval. The data provided in the Sponsor’s submissions support adequate directions for use, including the data to describe (...) with renal impairment were compared pharmacokinetically to healthy control volunteers who were matched for sex, age and weight. Following single dose administration of 100 mg mirabegron in volunteers with mild renal impairment (estimated glomerular filtration rate [eGFR] 60 to 89 mL/min/1.73 m2 as estimated using the Modification of Diet in Renal Disease [MDRD] equation), mean mirabegron C max and AUC inf were increased by 6% and 31% relative to volunteers with normal renal function. In volunteers
Tavaborole in Difficult-to-Treat Onychomycosis Cases: A Post-hoc Assessment of Phase III Subjects. Toenail onychomycosis is a chronic fungal infection that often requires prolonged treatment in order to effectively manage pathogenic organisms and obtain a clear nail. Traditionally, certain clinical features of onychomycosis, including the presence of substantial lateral disease, focal fungal masses, yellow/brown streaks, and extensive nail involvement (ie, >50%), indicate a poor treatment (...) application of either tavaborole 5% solution or vehicle. Our post-hoc analysis identified 84 difficult-to-treat cases (tavaborole 5%; n=60; vehicle, n=24) in subjects with toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes. No subjects identified as difficult-to-treat and treated with vehicle achieved a complete cure, while 6 subjects treated with tavaborole 5% attained a completely clear nail and negative mycology. Similarly, 7 subjects treated with tavaborole 5% solution
Topical Tavaborole in the Treatment of Onychomycosis Complicated by Dermatophytoma: A Post-hoc Assessment of Phase II Subjects. Dermatophytoma is a little-known, difficult to treat fungal infection that complicates onychomycosis. First described by Roberts and Evans in the late 1990's, dermatophytoma presents as a dense concentration of fungal hyphae within or under the nail plate and is generally white or yellow/brown in color, and linear (streaks) or round (patches) in shape; primary (...) into the use of topical tavaborole for dermatophytoma, a condition previously thought to respond only to oral or combination therapy.
) (sandpapered nails, trachyonychia) ( cheveux incoiffable , pili trianguli et canaliculi, spun-glass hair) (woolly hair nevus) Conditions of the subcutaneous fat [ ] See also: Conditions of the are those affecting the layer of that lies between the and underlying . (Lawrence syndrome, Lawrence–Seip syndrome) (Dercum's disease) (alpha1-protease deficiency panniculitis, alpha1-proteinase deficiency panniculitis) (acquired partial lipodystrophy, cephalothoracic lipodystrophy, progressive lipodystrophy) (benign (...) deficiency) (hypodontia with nail dysgenesis, Witkop syndrome) (Treacher Collins–Franceschetti syndrome) (Bourneville disease, epiloia) (adult progeria) (craniocarpotarsal syndrome, distal arthrogryposis type 2, Freeman–Sheldon syndrome, Windmill–Vane–Hand syndrome) (4p- syndrome) (steroid sulfatase deficiency, X-linked recessive ichthyosis) (Cockayne syndrome complex) Infection-related [ ] See also: and Infection-related cutaneous conditions may be caused by , , , , or . Bacterium-related [ ] See also
and a significant risk factor for chronic kidney disease for people with diabetes (Scottish Intercollegiate Guidelines Network [SIGN], 2010). It may also be a risk factor for retinopathy in type 1 diabetes. Smoking cessation reduces these risks and may optimize conditions for wound healing (SIGN, 2010).20 REGISTERED NURSES’ ASSOCIATION OF ONTARIO RECOMMENDATIONS Assessment and Management of Foot Ulcers for People with Diabetes, Second Edition Glycemic Control (Level of Evidence = Ib) Improved glycemic control (...) and depth of wound bed . Ia – IV ? 1 . 2 Assess bed of foot ulcer(s) for exudate, odour, condition of peri-ulcer skin and pain . IV ? 1 . 3 Assess affected limb(s) for vascular supply and facilitate appropriate diagnostic testing, as indicated . III – IV ? 1 . 4 Assess foot ulcer(s) for infection G using clinical assessment techniques, based on signs and symptoms, and facilitate appropriate diagnostic testing, if indicated . Ia ? 1 . 5 Assess affected limb(s) for sensory, autonomic and motor changes
this blog longer than seven years, because that’s the last time I wrote about Ms. Tinkham. Basically, Ms. Tinkham was diagnosed with breast cancer. Unfortunately, she was also inspired by Oprah and her promotion of The Secret to . It , though. It was of , whom you might remember as the man responsible for the “pH Miracle Living” quackery, where acid was The One True Cause of All Disease, particularly but also and , and who is now in . Tinkham was fortunate in that she did fairly well for three years (...) program said, “We don’t take positions on the opinions of our guests. Rather, we offer a platform for guests to share their first-person stories in an effort to inform the audience and put a human face on topics relevant to them.” When McCarthy’s views have been discussed on the air, statements from the Centers for Disease Control and Prevention and the American Academy of Pediatrics saying that there’s no scientific evidence of a vaccine-autism link have been read. Overall, Oprah had a malign
the disconnect between how we view ourselves and how those whose misinformation we combat view us. Earlier this week, I wrote about the , the 17-year-old boy who four years ago developed transverse myelitis. The disease initially rendered him quadriplegic and landed him in the hospital for a month and a half. Prior to his illness, Colton was a highly active 13-year-old who enjoyed motocross and a variety of other sports. By all reports, he was happy, healthy, and on his way to a fantastic life. After his (...) is not a mistake. Michael J. Dochniak (MJD) Panacea writes, Researching a promising idea is not a mistake. MJD says, Orac has taught MJD that proving a negative is medically unethical, therefore, I’ve used common-sense teachings to induce exclusionary measures that may affect the disease/disorder incidence thereafter. In simplicity, stop what you’re doing and see what happens. I like Orac, although, once a decade. Panacea MJD: If that’s what you think Orac taught you, then you didn’t understand him
of HCV infection in children, the diagnostic workup, monitoring and treatment of disease, and provides an update on future treatment options and areas of research. Key Words: chronic hepatitis, infectious hepatitis, interferon therapy, pediatric liver disease (JPGN 2012;54: 838–855) H epatitis C virus (HCV) is an RNA virus that affects>180 million individuals worldwide with a high propensity for chronic infection (www.who.int/immunization/topics/hepatitis). The overall prevalence of hepatitis C (...) of disclosure. What people with whom the HCV-infected child interacts should be told about the infection? What are the legal rights of the child and caregivers in regard to disclosure? The child with CHC is frequently stigmatized; how should this issue be addressed? Can the child with CHC play sports without disclosing the HCV status? Although children with CHC generally have a mild course of liver disease during childhood, there is still concern for cirrhosis, liver trans- plantation, and cancer
Distinct Patterns and Aetiology of Chromonychia. Abnormal colouring of the nails may be a sign of underlying systemic or local disorders. This study investigated the prevalence and causes of chromonychia as a whole, as well as of each subtype. Among 163 patients with chromonychia, trauma was the pathogenesis in up to 20.9% (34/163) of cases. The most common subtype was melanonychia (54.0%; 88/163), followed by leukonychia (23.9%), red (8.6%), green (6.7%), yellow (4.9%) and blue (1.8%) nails (...) . Nail matrix naevus (33.3%; 29/88) was the most common cause of melanonychia, while skin diseases (41.0%; 16/39), such as psoriasis (75%, 12/16) and alopecia areata (18.8%; 3/16), in addition to systemic diseases (33.3%; 13/39) including anaemia (38.5%, 5/13) and chronic renal failure (15.4%; 2/13) were the dominant causes of leukonychia. As chromonychia may be the first or only sign of an underlying disorder, it should alert physicians and patients to the need for a prompt and thorough evaluation.
23, 2018 Sponsor: Gema Biotech S.A. Collaborator: QUID Quality in Drugs and Devices Latin American Consulting SRL Information provided by (Responsible Party): Gema Biotech S.A. Study Details Study Description Go to Brief Summary: The purpose of this study is to asses the long term efficacy, safety and immunogenicity of ENERCEPTAN® in combination with Methotrexate for the treatment of patients with rheumatoid arthritis up to 104 weeks Condition or disease Intervention/treatment Phase Rheumatoid (...) or current serious medical conditions which had appeared during the study GEMENE001 that, in the opinion of the investigator, constitute a contraindication for the study treatment, as: Administration of vaccines: Subjects who have received a live attenuated vaccine within 3 months prior to the selection Visit (for example, varicella-zoster, oral polio, rabies, yellow fever vaccines.) Subjects who have received the BCG vaccine within the GEMENE001 study Presence of : a. At the time of the inclusion i
, suggesting neoplasia of malignant behavior, besides to presenting the yellownailsyndrome. Dermatological examination presented erythematous-infiltrated plaques in the occipital region. Also, the patient presented tegumentary lesions on the scalp and lumbar region from which the histopathological examination was carried out, which evidenced yeasts cells. The drug of choice for therapy was Liposomal Amphotericin-B. At the end of the antifungal treatment, liver enzyme dosages were normalized (...) Disseminated paracoccidioidomycosis prediagnosticated as neoplasm: An important challenge in diagnosis using rt-PCR This paper presents a case of disseminated paracoccidioidomycosis in a 62-year-old male patient, who lives in Belo Horizonte, MG, Brazil. The patient was hospitalized with icteric syndrome of cholestatic pattern and weight loss, with loss 30 kg in 5 months. The imaging of the abdomen showed lesion of infiltrative pattern, affecting gallbladder and intrahepatic bile ducts
the proximal fold Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) Infection involving lunula e.g., genetic naildisorders, primentary disorders Severe plantar (moccasin) tinea pedis Psoriasis of the skin and/or nails, lichen planus, or other medical conditions known to induce nail changes Onychogryphosis Trauma from ill-fitting shoes, running, or overly-aggressive nail care Previous toenail surgery Uncontrolled diabetes mellitus Peripheral (...) , 2018 See Sponsor: Erchonia Corporation Information provided by (Responsible Party): Erchonia Corporation Study Details Study Description Go to Brief Summary: The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis. Condition or disease Intervention/treatment Phase Onychomycosis of Toenail Device: Erchonia LunulaLaser Not Applicable Detailed Description: Nail onychomycosis, or fungus
to the unconscious but exposed patient? ..Maurice. AS OF JANUARY 6 2019 VOLUME 93 WILL BE CLOSE FOR FURTHER COMMENTS. GO TO FOR MAKING COMMENTS. posted by Maurice Bernstein, M.D. @ 175 Comments: At , said... Good Afternoon: Patient Modesty in Healthcare There’s an illness that’s moving like wildfire through our medical community. This illness effects everyone from the CEO down through the rank and file workers. We’ve seen illnesses like this before and they are very very strong however, there is a cure (...) for it. We have an antibiotic strong enough to kill it in its tracks but because the virus has spread so quickly throughout the medical community, the only way it will be effectively stopped, is if the entire medical community not just here and there to get inoculated. The illness is bad. Currently, the virus is showing up more everyday within the hallowed walls of our medical institutions. It rears its ugly head more often when dealing with male patients than female patients but it happens to both
pharmaceutical “research” (choke) and how the public and physicians have been hoodwinked into believing that dangerous drugs/devices are the solution for just about every ill, and that for the most part these drugs are safe, or, at least better than the “disease” they are supposedly managing (never curing of course, for it is foundational to profit that people remain ill). We’ve seen that the makemsick industry is founded on the principle of poisoning as a path to “health,” and it is a vicious monopoly (...) of a building is rotten and said building is full of mold/rot/vermin (most makemsick minions) then it must be burned to the ground and built from scratch. A new medical model would involve real healing based on non poisonous methods. No, one can't do one's own kidney dialysis but looking at the broader picture much kidney disease is caused by allopathic drugs, so, one has to really look at the root causes of illness in the later 20th and now the 21st centuries. You stated previously that we should do our