Pin up bet
The safety profile of voriconazole in parents is based on an integrated based on security data of more than 2000 subjects (even 1603 adult patients in therapeutic studies) and implicit 270 adult patients in pin up bet prevention studies. The mirror is a heterogeneous population consisting of patients with hematological malignancies, hiv-infected patients with esophageal candidiasis and refractory fungal diseases, patients without neutropenia with candidemia or aspergillosis, and healthy volunteers.
The most commonly reported adverse reactions were blurred vision, fever, rash, vomiting, nausea, diarrhea, migraine, peripheral edema, abnormal liver tests, respiratory distress, and abdominal exercise.
Table below since many studies were open-ended, listing all causal side effects and their frequency categories in 1873 adults from pooled therapeutic (1603) and preventive (270) studies by genre of organ systems.
adverse effects reported in subjects receiving voriconazole:
> 1/10
> 1/100 to > 1/1000 to > 1/10k to Frequency unknown
(Cannot be estimated from the available data)
Infections and infestations
Sinusitis
Pseudomembranous colitis
Agranulocytosis1, pancytopenia, thrombocytopenia2, leukopenia, anemia
Bone marrow failure, lymphadenopathy, eosinophilia
Disseminated intravascular coagulation
Convulsions, syncope, tremor, hypertension3, paresthesia, drowsiness, dizziness
Grey matter edema, encephalopathy4, extrapyramidal disorder5, peripheral neuropathy, ataxia , hypoesthesia, dysgeusia
Hepatic encephalopathy, guillain-barré syndrome, nystagmus
visual impairment6
Optic nerve disorder7, disc edema optic nerve8, oculogiric crisis, diplopia, scleritis, blepharitis
Ventricular fibrillation, ventricular extrasystole, ventricular tachycardia, prolongation of the qt interval on the electrocardiogram, supraventricular tachycardia
Thrombophlebitis, lymphangitis
Respirator distress9
Diarrhea, vomiting, abdominal pain, nausea
Cheilitis, dyspepsia, constipation, gingivitis
Peritonitis , pancreatitis, tongue edema, duodenitis, gastroenteritis, glossitis
Hepatobiliary disorders
Abnormal liver function tests
Jaundice , cholestatic jaundice, hepatitis10
Exfoliative dermatitis, alopecia, maculopapular rash, pruritus, erythema
Stevens-johnson syndrome, phototoxicity, purpura, urticaria, allergic dermatitis , rash papular, rash macular, eczema ephelids*, lentigo*
Chest pain, pin up casino facial swelling11, asthenia, chills
Injection point reaction, influenza-like illness
the level of blood urea is increased, the level of cholesterol in the subcortex is increased
- Hrr detected after registration
1 includes febrile neutropenia and neutropenia.
2 includes immune thrombocytopenic purpura.
3 includes occipital stiffness and tetany.
4 including hypoxic chemical encephalopathy and metabolic encephalopathy.
5 including akathisia and parkinsonism.
7 long-term optic neuritis has been reported post-marketing.
9 includes dyspnoea and dyspnea on exertion.
10 includes drug-induced liver injury, toxic hepatitis, hepatocellular dent and hepatotoxicity.
11 includes periorbital edema, lip marginal edema, and mouth swelling.
Altered taste perception
Based on pooled data from three bioequivalence studies using oral suspension powder, treatment-related taste perversion was reported in 12-16%) of the subjects.
Visual disorders
In clinical trials, eye disorders incl. Blurred vision, photophobia, chloropsia, chromatopsia, color blindness, cyanopsia, blurred vision, halo vision, night blindness, oscillopsia, photopsia, scintillation scotoma, decreased vigilance, visual brightness, visual field defect, vitreous future flies and xanthopsia) with voriconazole e) were quite common. These visual disturbances were transient and entirely reversible, while the vast majority of the lesions spontaneously resolved within 60 years - but no clinically significant long-term visual effects were documented.There was evidence of attenuation with further doses of voriconazole. Visual impairment was generally mild, rarely led to discontinuation of therapy, and was not always associated with long-term effects. Visual disturbances are associated with very high plasma concentrations and/or doses.
Mechanism of action unknown, although the site of action is likely to be in the retina. , Voriconazole caused a decrease in the amplitude of the electroretinogram (erg) wave. The erg measures electrical currents in the retina. Erg changes did not progress after 29 days of therapy and were tightly reversible when voriconazole was discontinued.
Dermatological reactions were frequently observed in patients receiving voriconazole in clinical studies, but there were significant additional problems in such patients. Infirmities and received several concomitant medications. Most of the rashes were simple and moderate in severity. Patients have developed serious skin reactions including stevens-johnson syndrome (uncommon), toxic epidermal necrolysis (very rare, and erythema multiforme (rare) while taking pinap.
If a patient develops a rash pinup should be carefully monitored and discontinued if lesions progress.Photosensitivity reactions, including ephelid, lentigo and actinic keratosis, have been reported, especially with long-term therapy.The clinical program of voriconazole was 18.0% (319/1768) in parents and 25.8% (73/283) in infants treated with voriconazole for combined therapeutic and prophylactic use abnormal liver function tests are associated with the highest plasma concentrations and/or doses most abnormal liver function tests either resolved during therapy without dose change or after dose adjustment including discontinuation of therapy conditions includes cases of jaundice, hepatitis and pe anaphylactoid-type reactions, even hot flashes, fever, sweating, tachycardia, chest tightness, shortness of breath, syncope, nausea, pain and rash occurred. Symptoms were immediate from the start of the infusion.
In an open, comparative, multicentre study comparing voriconazole and itraconazole as primary prevention in parents and children receiving allogeneic hsct without prior proven or probable ifi, permanent discontinuation voriconazole use due to aes was reported in 39.3% of patients compared with 39.6% of itraconazole group patients. Lateral hepatic aes during treatment resulted in complete discontinuation of study medication in 50 subjects (21.4%) treated with voriconazole and in 18 subjects (7.1%) treated with itraconazole.
The safety of voriconazole has been investigated. In 288 children aged 2 to It is important to talk about suspected adverse reactions after the registration of the desired drug is completed. This allows ongoing monitoring of the benefit/risk ratio of the medicinal product. .Gov.Uk/yellowcard
Ireland
Healthcare professionals are asked to report any suspected adverse effects via pharmacovigilance hpra, earlsfort terrace, hdi - dublin 2; tel.: 353 1 6764971; fax: 353 1 6762517 website: www.Hpra.Ie; email: [email protected]
Security profile summary
The pinup security profile focuses on an integrated security data bank of more than two thousand subjects (even 1655 patients in therapeutic trials and 279 in prevention trials). The mirror is a heterogeneous population consisting of us with hematologic malignancies, hiv-infected patients with esophageal candidiasis and refractory fungal diseases, non-neutropenic patients with candidemia or aspergillosis, and healthy volunteers. Seven hundred five (705) patients had been treated with pinup for more than 12 weeks, while 164 patients had received pinup for more than six months.
The most common adverse reactions were visual disturbances, fever, rash, vomiting, nausea , diarrhea, migraine, peripheral edema, abnormal liver function tests, respiratory distress, and abdominal exercise.
The severity of side effects was usually almost innocent to moderate. No clinically significant differences were documented when analyzing protection data by age, race, or sex.
List of side effects in the table
In the table below: since many of the studies were open-label, all causal side effects are listed by category of internal organs and frequency.
Frequency categories are expressed in steps: often (>1/10 ); often from one/100 to one/1000 to one/10000 to In each frequency group, unwanted effects are suggested in an organized order of "aging" severity.
Unwanted effects, which reported in subjects treated with pinup:
System organ class
Adverse drug responses
Infections and infestations
Gastroenteritis, sinusitis, gingivitis
Pseudomembranous colitis, lymphangitis, peritonitis
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Squamous cell carcinoma*
Disturbances of related blood and lymphatic systems
Agranulocytosis, pancytopenia, thrombocytopenia, anemia
Dic, bone marrow failure, leukopenia, lymphadenopathy, eosinophilia
Immune side disorders
hypersensitivity
Anaphylactoid reaction
Endocrine disorders
Adrenal insufficiency hypothyroidism
hyperthyroidism
Metabolic and nutritional disorders
Peripheral edema
Hypoglycemia , hypokalemia, hyponatremia
Mental disorders
Depression, hallucinations, ti-anxiety, insomnia, agitation, confusion
Disorders nervous system
Headache
Convulsions, tremor, paresthesia, hypertension, drowsiness, fainting, dizziness
Grey matter edema , encephalopathy, extrapyramidal disorders, peripheral neuropathy, ataxia, hypoesthesia, dysgeusia, nystagmus
Hepatic encephalopathy, guillain-barré syndrome
Eye diseases
Retinal hemorrhage
Oculogiric crisis, optic nerve injury, papilledema, scleritis, blepharitis, diplopia
Optical atrophy, corneal opacity
Ear and labyrinth diseases
Hypoacusis, vertigo, tinnitus
visual heart disorders
Supraventricular arrhythmia, tachycardia, bradycardia
Ventricular fibrillation, ventricular extrasystole, supraventricular tachycardia, ventricular tachycardia
torsades of the "pirouette" type, complete atrioventricular block, leg block bundle of his, junctional rhythm
Vascular disorders
Hypotension, phlebitisThrombophlebitis
Respiratory, thoracic and mediastinal disorders
Respiratory distress
Acute respiratory distress syndrome, pulmonary edema
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, diarrhea
Dyspepsia, constipation, cheilitis
Pancreatitis, duodenitis, glossitis , swelling of the tongue
Hepato-biliary disorders
Abnormal liver function tests (including ast, alt, alkaline phosphatase, gamma-glutamyl transpeptidase [ggt], lactate dehydrogenase [ldh], bilirubin)
Jaundice, cholestatic jaundice, hepatitis
Liver failure, hepatoma gallia, cholecystitis, cholelithiasis
Disturbances from the side of the epidermis and subcutaneous tissue
Rash
Exfoliative dermatitis, maculo-papular rash, pruritus, alopecia, erythema
Rare
Pseudoporphyria, fixed drug rash
Dermal lupus erythematosus*
Musculoskeletal and connective tissue disorders
Back pain
Arthritis
Unknown
Periostitis*
Renal and urinary disorders
Acute renal failure, hematuria
Renal necrosis tubules, proteinuria, nephritis
General disorders and disorders in the injection zone
Very often
Pyrexia
chest pain, swelling of the face, asthenia, flu similar illness, chills
Reaction in the area of injection
Examinations
Often
Increase in the level of creatinine in the blood *Adverse events identified during post-registration use
Description of selected adverse reactions
Impaired vision
in clinical trials pinup visual impairments have been very popular. In therapeutic studies, visual disturbances associated with pinup treatment have been fairly common.In studies such as short-term, never long-term treatment, approximately 21% of subjects experienced altered/enhanced visual perception, blurred vision, altered color vision, or photophobia. These visual disturbances were transient and entirely reversible, but most of them resolved spontaneously within 60 times - but no clinically significant long-term visual effects were documented. There was evidence of attenuation with repeated doses of pinup. Visual disturbances were usually non-severe, rarely led to discontinuation of treatment, and were not synonymous with long-term effects. Visual disturbances are associated with very high plasma concentrations and/or doses.
Mechanism of action unknown, although the site of action usually remains in the retina. In a healthy volunteer review examining the effects of pinup on retinal function , pinup caused a decrease in the amplitude of the electroretinogram wave (erg). The erg measures electrical currents in the retina. Erg changes did not progress after 29 days of therapy and were tightly reversible after pinup was discontinued.
There were post-marketing reports of long-term adverse reactions in the lateral side of the eyes.
Dermatological reactions
Dermatologic reactions were common in patients treated with pinup in clinical studies, however, these patients had significant additional problems and consultants received several concomitant medications. Most of the rashes were mild to moderate in severity. Patients rarely developed serious skin reactions, including stevens-johnson syndrome, toxic epidermal necrolysis, and erythema multiforme during pinup treatment. Lesions progress. Photosensitivity reactions have been reported, especially during prolonged therapy.
There have been reports of squamous cell skin cancer in patients treated with pinup for an extended period of time; mechanism unknown.
Liver function tests
The overall incidence of clinically significant transaminase abnormalities in the pinup clinical program was 13.5% (258/1918). ) Of subjects processed by pinup. Liver function abnormalities are associated with very high plasma concentrations and/or doses. Most liver function abnormalities either resolved during therapy without dose changes or after dose adjustments, including discontinuation of therapy. Pinup has rarely been associated with serious hepatotoxicity in patients with other important comorbidities. This includes cases of jaundice and unique cases of hepatitis and liver failure contributing to death.
Infusion-related reactions
During infusion of the intravenous form of pinup, healthy volunteers have experienced anaphylactoid-type reactions including hot flashes, fever, sweating, tachycardia, chest tightness, dyspnoea, syncope, nausea, itching, and rash. Symptoms appeared on the day the infusion was started.
Prophylaxis
In an open, comparative, multicentre study comparing pinup and itraconazole as primary prevention in adults and offspring of allogeneic hsct recipients without previously proven or probable invasive mycoses (ifi), definitive pinup cessation through aes was reported in 39.3% of subjects compared to 39.6% of itraconazole group subjects. Third-liver aes during therapy led to permanent discontinuation of study medication in 50 subjects (21.4%) treated with pinup and 18 subjects (7.1%) treated with itraconazole.
Pediatric population
The safety of pinup has been studied in 285 infants aged 2 to Reports of suspected adverse reactions
Reports of suspected side effects after the clearance of the drug, the drug is beneficial. This makes it possible to continuously monitor the benefit/risk ratio of the medicinal product. Medical professionals are asked to reason about any suspected side effects through the yellow card scheme, website: www.Mhra.Gov.Uk/yellowcard.
