Írország - angol - HPRA (Health Products Regulatory Authority)

horizon pharma ireland limited - interferon gamma - solution for injection - international unit - interferons

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - erythromycin, quantity: 250 mg - capsule, enteric - excipient ingredients: povidone; monobasic potassium phosphate; lactose monohydrate; gelatin; carbon black; sunset yellow fcf; shellac; indigo carmine; purified water; cellacefate; erythrosine; diethyl phthalate - mayne pharma erythromycin is indicated in children and adults for the treatment of the following conditions: upper respiratory tract infections of mild to moderate degree caused by streptococcus pyogenes (group a beta haemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae). lower respiratory tract infections of mild to moderate severity caused by streptococcus pyogenes (group a beta hemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae), acute and chronic bronchitis, pneumonia. sinusitis caused by streptococcus pneumoniae, streptococcus pyogenes. otitis media due to streptococcus pneumoniae, streptococcus pyogenes. respiratory tract infections due to mycoplasma pneumonia (eaton's agent). skin, and skin structure infections of mild to moderate severity caused by streptococcus pyogenes and staphylococcus aureus (resistant staphylococci may emerge during treatment). bordetella pertussis: erythromycin produces early elimination of the causative organism from the nasopharynx although the clinical course of the disease is not altered; therapeutic doses should be continued for at least 10 days. diphtheria: as an adjunct to antitoxin infections due to corynebacterium diphtheriae, to prevent establishment of carriers and to eradicate the organism in carriers. erythrasma: in the treatment of infections due to corynebacterium minutissimum. infections due to listera monocytogenes. non-gonococcal urethritis: chlamydia trachomatis and ureaplasma urealyticum have been shown to be sensitive to erythromycin and clinical studies have demonstrated its efficacy in urethritis due to these organisms. a minimum of 10 days therapy appears to be required. chlamydia trachomatis infection (excluding non-gonococcal urethritis): erythromycin has been shown to be effective in the treatment of trachoma or inclusion-body conjunctivitis and pneumonia in infants caused by chlamydia trachomatis. campylobacter fetus (subspecies) jejuni: infections due to this organism when antibiotic therapy is indicated. primary syphilis caused by treponema pallidum: erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. in the treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the followup after therapy. legionnaires' disease caused by legionella pneumophila: although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires' disease. prevention of initial attacks of rheumatic fever: penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of group a beta - haemolytic streptococcal infections of the upper respiratory tract e.g. tonsillitis or pharyngitis). erythromycin is indicated for the treatment of penicillin allergic patients. a therapeutic dose should be administered for 10 days. prevention of recurrent attacks of rheumatic fever: penicillin or sulphonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. in patients who are allergic to penicillin and sulphonamides, oral erythromycin is recommended by the american heart association in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever). prevention of bacterial endocarditis: although no controlled clinical efficacy trials have been conducted, oral erythromycin has been suggested by the american heart association and the american dental association in a regimen for prophylaxis against bacterial endocarditis in patients sensitive to penicillin who have congenital heart disease, or rheumatic or other acquired valvular heart disease when they undergo dental or surgical procedures of the upper respiratory tract. erythromycin is not suitable prior to genitourinary or gastrointestinal tract surgery.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - desflurane, quantity: 1 g/g - inhalation, conventional - excipient ingredients: - indications: suprane is indicated as an inhalation agent for maintenance of anaesthesia. suprane is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events.

Írország - angol - HPRA (Health Products Regulatory Authority)

zambon s.p.a. - colistin mesilate sodium - powder for nebuliser solution - 1 million international unit - polymixins

Ausztrália - angol - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - manganese as disodium manganese edta; copper as copper disodium edta; selenium as sodium selenite; zinc as zinc disodium edta - parenteral liquid/solution/suspension - manganese as disodium manganese edta chelating agent active 10.0 g/l; copper as copper disodium edta mineral-copper active 10.0 g/l; selenium as sodium selenite mineral-selenium active 3.0 g/l; zinc as zinc disodium edta mineral-zinc active 40.0 g/l - nutrition & metabolism

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - erythromycin, quantity: 250 mg - capsule, enteric - excipient ingredients: gelatin; povidone; cellacefate; lactose monohydrate; monobasic potassium phosphate; diethyl phthalate; erythrosine; indigo carmine; carbon black; purified water; shellac; sunset yellow fcf - indications as at 22 may 2003: eryc is indicated in children and adults for the treatment of the following conditions: upper respiratory tract infections of mild to moderate degree caused by streptococcus pyogenes (group a beta haemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae). lower respiratory tract infections of mild to moderate severity caused by streptococcus pyogenes (group a beta hemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae), acute and chronic bronchitis, pneumonia. sinusitis caused by streptococcus pneumoniae, streptococcus pyogenes. otitis media due to streptococcus pneumoniae, streptococcus pyogenes. respiratory tract infections due to mycoplasma pneumonia (eaton's agent). skin, and skin structure infections of mild to moderate severity caused by streptococcus pyogenes and staphylococcus aureus (resistant staphylococci may emerge during treatment). bordetella pertussis: erythromycin produces early elimination of the causative organism from the nasopharynx although the clinical course of the disease is not altered; therapeutic doses should be continued for at least 10 days. diphtheria: as an adjunct to antitoxin infections due to corynebacterium diphtheriae, to prevent establishment of carriers and to eradicate the organism in carriers. erythrasma: in the treatment of infections due to corynebacterium minutissimum. non-gonococcal urethritis: chlamydia trachomatis and ureaplasma urealyticum have been shown to be sensitive to erythromycin and clinical studies have demonstrated its efficacy in urethritis due to these organisms. a minimum of 10 days therapy appears to be required. chlamydia trachomatis infection (excluding non-gonococcal urethritis): erythromycin has been shown to be effective in the treatment of trachoma or inclusion-body conjunctivitis and pneumonia in infants caused by chlamydia trachomatis. campylobacter fetus (subspecies) jejuni: infections due to this organism when antibiotic therapy is indicated. primary syphilis caused by treponema pallidum: erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. in the treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the followup after therapy. legionnaires' disease caused by legionella pneumophila: although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires' disease. prevention of initial attacks of rheumatic fever: penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of group a beta - haemolytic streptococcal infections of the upper respiratory tract e.g. tonsillitis or pharyngitis). erythromycin is indicated for the treatment of penicillin allergic patients. a therapeutic dose should be administered for 10 days. prevention of recurrent attacks of rheumatic fever: penicillin or sulphonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. in patients who are allergic to penicillin and sulphonamides, oral erythromycin is recommended by the american heart association in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever). prevention of bacterial endocarditis: although no controlled clinical efficacy trials have been conducted, oral erythromycin has been suggested by the american heart association and the american dental association in a regimen for prophylaxis against bacterial endocarditis in patients sensitive to penicillin who have congenital heart disease, or rheumatic or other acquired valvular heart disease when they undergo dental or surgical procedures of the upper respiratory tract. erythromycin is n ot suitable prior to genitourinary or gastrointestinal tract surgery.

Egyesült Államok - angol - NLM (National Library of Medicine)

rising pharmaceuticals, inc - protriptyline hydrochloride (unii: 44665v00o8) (protriptyline - unii:4ndu154t12) - protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. its activating properties make it particularly suitable for withdrawn and anergic patients. protriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. it should not be given concomitantly with a monoamine oxidase inhibiting compound. hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. when it is desired to substitute protriptyline for a monoamine oxidase inhibitor, a minimum of 14 days should be allowed to elapse after the latter is discontinued. protriptyline should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. protriptyline is contraindicated in patients taking cisapride because of the possibility of adverse cardiac interaction

Egyesült Államok - angol - NLM (National Library of Medicine)

remedyrepack inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibility testing should be done. if resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see  clinical pharmacology (12.4) and the clarithromycin prescribing information, microbiology section ]. omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults. omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with gerd for up to 4 weeks in patients 2 years of age and older. pediatric patients 2 years of age to adults omeprazole delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) of ee due to acid-mediated gerd that has been diagnosed by endoscopy in patients 2 years of age and older. the efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with ee has not been established. if a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. if there is recurrence of ee or gerd symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered. omeprazole delayed-release capsules are indicated for the maintenance healing of ee due to acid-mediated gerd in patients 2 years of age and older. controlled studies do not extend beyond 12 months. omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults. - omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [ see warnings and precautions (5.2), adverse reactions (6)] . - proton pump inhibitors (ppis), including omeprazole delayed-release capsules, are contraindicated in patients receiving rilpivirine-containing products [see drug interactions (7)]. - for information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole delayed-release capsules, refer to the contraindications section of their package inserts. risk summary there are no adequate and well-controlled studies with omeprazole in pregnant women. available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person). changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age [see data]. the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to h 2 -receptor antagonists or other controls. a population-based retrospective cohort epidemiological study from the swedish medical birth registry, covering approximately 99% of pregnancies, from 1995 to 99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. the number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low apgar score, or hospitalization was similar to the number observed in this population. the number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. a population-based retrospective cohort study covering all live births in denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitor. the overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester. a retrospective cohort study reported on 689 pregnant women exposed to either h 2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. the overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an h 2 -blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively. a small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% with first trimester exposures). the reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease-paired controls. rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups. several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia. animal data omeprazole reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at doses up to 69.1 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) during organogenesis did not disclose any evidence for a teratogenic potential of omeprazole. in rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions. in rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138 mg/kg/day (about 3.4 to 34 times an oral human doses of 40 mg on a body surface area basis), administered prior to mating through the lactation period. esomeprazole the data described below was generated from studies using esomeprazole, an enantiomer of omeprazole. the animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole. no effects on embryo-fetal development were observed in reproduction studies with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) or in rabbits at oral doses up to 86 mg/kg/day (about 42 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis) administered during organogenesis. a pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with esomeprazole magnesium at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). neonatal/early postnatal (birth to weaning) survival was decreased at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). body weight and body weight gain were reduced and neurobehavioral or general developmental delays in the immediate post-weaning timeframe were evident at doses equal to or greater than 69 mg/kg/day (about 17 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). in addition, decreased femur length, width and thickness of cortical bone, decreased thickness of the tibial growth plate and minimal to mild bone marrow hypocellularity were noted at doses equal to or greater than 14 mg/kg/day (about 3.4 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). physeal dysplasia in the femur was observed in offspring of rats treated with oral doses of esomeprazole magnesium at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). effects on maternal bone were observed in pregnant and lactating rats in the pre- and postnatal toxicity study when esomeprazole magnesium was administered at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). when rats were dosed from gestational day 7 through weaning on postnatal day 21, a statistically significant decrease in maternal femur weight of up to 14% (as compared to placebo treatment) was observed at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). a pre- and postnatal development study in rats with esomeprazole strontium (using equimolar doses compared to esomeprazole magnesium study) produced similar results in dams and pups as described above. a follow up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with esomeprazole magnesium at oral doses of 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) where esomeprazole administration was from either gestational day 7 or gestational day 16 until parturition. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age. risk summary limited data suggest omeprazole may be present in human milk. there are no clinical data on the effects of omeprazole on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omeprazole and any potential adverse effects on the breastfed infant from omeprazole or from the underlying maternal condition. the safety and effectiveness of omeprazole have been established in pediatric patients 2 to 16 years for the treatment of symptomatic gerd, treatment of ee due to acid-mediated gerd, and maintenance of healing of ee due to acid-mediated gerd. use of omeprazole in this age group is supported by adequate and well-controlled studies in adults and uncontrolled safety, efficacy and pharmacokinetic studies performed in pediatric and adolescent patients [see clinical pharmacology (12.3), clinical studies (14.8)]. in the pediatric population, adverse reactions of the respiratory system were frequently reported in the entire (2 to 16 years) age group. accidental injuries were frequently reported in the 2 to 16 year age group [see adverse reactions (6.1)]. the safety and effectiveness of omeprazole have not been established in:  - patients less than 1 year of age for: treatment of symptomatic gerd maintenance of healing of ee due to acid-mediated gerd       - treatment of symptomatic gerd - maintenance of healing of ee due to acid-mediated gerd       - pediatric patients for: treatment of active duodenal ulcer h. pylori eradication to reduce the risk of duodenal ulcer recurrence treatment of active benign gastric ulcer pathological hypersecretory conditions - treatment of active duodenal ulcer - h. pylori eradication to reduce the risk of duodenal ulcer recurrence - treatment of active benign gastric ulcer - pathological hypersecretory conditions juvenile animal data esomeprazole, an enantiomer of omeprazole, was shown to decrease body weight, body weight gain, femur weight, femur length, and overall growth at oral doses about 34 to 68 times a daily human dose of 40 mg esomeprazole or 40 mg omeprazole based on body surface area in a juvenile rat toxicity study. the animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole. a 28-day toxicity study with a 14-day recovery phase was conducted in juvenile rats with  esomeprazole magnesium at doses of 70 to 280 mg/kg/day (about 17 to 68 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). an increase in the number of deaths at the high dose of 280 mg/kg/day was observed when juvenile rats were administered esomeprazole magnesium from postnatal day 7 through postnatal day 35. in addition, doses equal to or greater than 140 mg/kg/day (about 34 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis), produced treatment-related decreases in body weight (approximately 14%) and body weight gain, decreases in femur weight and femur length, and affected overall growth. comparable findings described above have also been observed in this study with another esomeprazole salt, esomeprazole strontium, at equimolar doses of esomeprazole. omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the u.s. and europe. there were no differences in safety and effectiveness between the elderly and younger subjects. other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. pharmacokinetic studies have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. the plasma clearance of omeprazole was 250 ml/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers. however, no dosage adjustment is necessary in the elderly [see clinical pharmacology (12.3)] . in patients with hepatic impairment (child-pugh class a, b, or c) exposure to omeprazole substantially increased compared to healthy subjects. dosage reduction of omeprazole to 10 mg once daily is recommended for patients with hepatic impairment for maintenance of healing of ee [see dosage and administration (2.1), clinical pharmacology (12.3)] . in studies of healthy subjects, asians had approximately a four-fold higher exposure than caucasians. dosage reduction of omeprazole to 10 mg once daily is recommended for asian patients for maintenance of healing of ee [see dosage and administration (2.1) , clinical pharmacology (12.5)] . omeprazole delayed-release capsules, usp (oh mep' ra zole) omeprazole delayed-release capsules taking omeprazole delayed-release capsules with applesauce: 1. place 1 tablespoon of applesauce into a clean container. 2. carefully open the capsule and sprinkle the pellets onto the applesauce. mix the pellets with the applesauce. 3. swallow the applesauce and pellet mixture right away. do not chew or crush the pellets. do not store the applesauce and pellet mixture for later use.

Egyesült Államok - angol - NLM (National Library of Medicine)

rising pharma holdings, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - attention deficit disorders, narcolepsy attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. special diagnostic considerations specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal eeg. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. drug treatment is not indicated for all children with this syndrome. stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is generally necessary. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. methylphenidate hydrochloride chewable tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the drug. methylphenidate hydrochloride is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result). methylphenidate hydrochloride should not be used in children under six years, since safety and efficacy in this age group have not been established. methylphenidate hydrochloride chewable tablets contain methylphenidate, a schedule ii controlled substance. methylphenidate hydrochloride chewable tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warningsand precautions). methylphenidate hydrochloride chewable tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including methylphenidate hydrochloride chewable tablets, can result in overdose and death (see overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence methylphenidate hydrochloride chewable tablets may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including methylphenidate hydrochloride chewable tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hydrochloride chewable tablets may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Izrael - angol - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - voriconazole - powder for concentrate for solution for infusion - voriconazole 200 mg/vial - voriconazole - vortimal is a broad spectrum, triazole antifungal agent and is indicated as follows:- treatment of invasive aspergillosis.- treatment of candidaemia in non-neutropenic patients.- treatment of fluconazole-resistant serious invasive candida infections (including c. krusei).- treatment of serious fungal infections caused by scedosporium spp. and fusarium spp.vortimal should be administered primarily to immunocompromised patients with progressive, possibly life-threatening infections.prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients