Австралия - английски - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 0.5 ml - injection, solution - excipient ingredients: - revestive is indicated for the treatment of adult and paediatric patients 2 years of age and above with short bowel syndrome (sbs) who are dependent on parenteral support.,patients should be stable for at least 4 weeks on their parenteral support regimen before initiating teduglutide therapy

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

takeda new zealand limited - teduglutide 5mg; water for injection 0.5 ml - powder for injection with diluent - 5 mg - active: teduglutide 5mg excipient: dibasic sodium phosphate heptahydrate histidine hydrochloric acid mannitol monobasic sodium phosphate monohydrate sodium hydroxide water for injection active: water for injection 0.5 ml - revestive is indicated for the treatment of adult patients with short bowel syndrome (sbs) who are dependent on parenteral support. patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy

Австралия - английски - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - romosozumab, quantity: 105 mg - injection, solution - excipient ingredients: sodium hydroxide; acetate; calcium; water for injections; polysorbate 20; sucrose - evenity is indicated for:,- the treatment of osteoporosis in postmenopausal women at high risk of fracture (see section 5.1 pharmacodynamic properties, clinical trials).,- treatment to increase bone mass in men with osteoporosis at high risk of fracture.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - romosozumab, quantity: 105 mg - injection, solution - excipient ingredients: calcium; polysorbate 20; sucrose; water for injections; sodium hydroxide; acetate - evenity is indicated for:,- the treatment of osteoporosis in postmenopausal women at high risk of fracture (see section 5.1 pharmacodynamic properties, clinical trials).,- treatment to increase bone mass in men with osteoporosis at high risk of fracture.

Израел - английски - Ministry of Health

amgen europe b.v. - romosozumab - solution for injection - romosozumab 90 mg / 1 ml - romosozumab - evenity is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

САЩ - английски - NLM (National Library of Medicine)

owp pharmaceuticals, inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy subvenite is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (pgtc) seizures. - generalized seizures of lennox-gastaut syndrome. monotherapy subvenite is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of subvenite have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. subvenite is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see clinical studies ( 14.2)] . limitations of use treatment of acute manic or mixed episodes is not recommended. effectiveness of subvenite in the acute treatment of mood episodes has not been established. subvenite is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see boxed warning, warnings and precautions ( 5.1, 5.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including subvenite, during pregnancy. encourage women who are taking subvenite during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary data from several prospective pregnancy exposure registries and epidemiological studies of pregnant women have not detected an increased frequency of major congenital malformations or a consistent pattern of malformations among women exposed to lamotrigine compared with the general population (see data) . the majority of subvenite pregnancy exposure data are from women with epilepsy. in animal studies, administration of lamotrigine during pregnancy resulted in developmental toxicity (increased mortality, decreased body weight, increased structural variation, neurobehavioral abnormalities) at doses lower than those administered clinically. lamotrigine decreased fetal folate concentrations in rats, an effect known to be associated with adverse pregnancy outcomes in animals and humans (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. clinical considerations as with other aeds, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. there have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre-pregnancy concentrations after delivery. dose adjustments may be necessary to maintain clinical response. data human data : data from several international pregnancy registries have not shown an increased risk for malformations overall. the international lamotrigine pregnancy registry reported major congenital malformations in 2.2% (95% ci: 1.6%, 3.1%) of 1,558 infants exposed to lamotrigine monotherapy in the first trimester of pregnancy. the naaed pregnancy registry reported major congenital malformations among 2.0% of 1,562 infants exposed to lamotrigine monotherapy in the first trimester. eurap, a large international pregnancy registry focused outside of north america, reported major birth defects in 2.9% (95% ci: 2.3%, 3.7%) of 2,514 exposures to lamotrigine monotherapy in the first trimester. the frequency of major congenital malformations was similar to estimates from the general population. the naaed pregnancy registry observed an increased risk of isolated oral clefts: among 2,200 infants exposed to lamotrigine early in pregnancy, the risk of oral clefts was 3.2 per 1,000 (95% ci: 1.4, 6.3), a 3-fold increased risk versus unexposed healthy controls. this finding has not been observed in other large international pregnancy registries. furthermore, a case-control study based on 21 congenital anomaly registries covering over 10 million births in europe reported an adjusted odds ratio for isolated oral clefts with lamotrigine exposure of 1.45 (95% ci: 0.8, 2.63). several meta-analyses have not reported an increased risk of major congenital malformations following lamotrigine exposure in pregnancy compared with healthy and disease-matched controls. no patterns of specific malformation types were observed. the same meta-analyses evaluated the risk of additional maternal and infant outcomes including fetal death, stillbirth, preterm birth, small for gestational age, and neurodevelopmental delay. although there are no data suggesting an increased risk of these outcomes with lamotrigine monotherapy exposure, differences in outcome definition, ascertainment methods, and comparator groups limit the conclusions that can be drawn. animal data: when lamotrigine was administered to pregnant mice, rats, or rabbits during the period of organogenesis (oral doses of up to 125, 25, and 30 mg/kg, respectively), reduced fetal body weight and increased incidences of fetal skeletal variations were seen in mice and rats at doses that were also maternally toxic. the no-effect doses for embryofetal developmental toxicity in mice, rats, and rabbits (75, 6.25, and 30 mg/kg, respectively) are similar to (mice and rabbits) or less than (rats) the human dose of 400 mg/day on a body surface area (mg/m 2 ) basis. in a study in which pregnant rats were administered lamotrigine (oral doses of 0, 5, or 25 mg/kg) during the period of organogenesis and offspring were evaluated postnatally, neurobehavioral abnormalities were observed in exposed offspring at both doses. the lowest effect dose for developmental neurotoxicity in rats is less than the human dose of 400 mg/day on a mg/m 2 basis. maternal toxicity was observed at the higher dose tested. when pregnant rats were administered lamotrigine (oral doses of 0, 5, 10, or 20 mg/kg) during the latter part of gestation and throughout lactation, increased offspring mortality (including stillbirths) was seen at all doses. the lowest effect dose for pre- and post-natal developmental toxicity in rats is less than the human dose of 400 mg/day on a mg/m 2 basis. maternal toxicity was observed at the 2 highest doses tested. when administered to pregnant rats, lamotrigine decreased fetal folate concentrations at doses greater than or equal to 5 mg/kg/day, which is less than the human dose of 400 mg/day on a mg/m 2 basis. risk summary lamotrigine is present in milk from lactating women taking subvenite ( see data ).  neonates and young infants are at risk for high serum levels because maternal serum and milk levels can rise to high levels postpartum if lamotrigine dosage has been increased during pregnancy but is not reduced after delivery to the pre-pregnancy dosage.  glucuronidation is required for drug clearance.  glucuronidation capacity is immature in the infant and this may also contribute to the level of lamotrigine exposure.  events including rash, apnea, drowsiness, poor sucking, and poor weight gain (requiring hospitalization in some cases) have been reported in infants who have been milk-fed by mothers using lamotrigine; whether or not these events caused by lamotrigine is unknown.  no data are available on the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for subvenite and any potential adverse effects on the breastfed infant from subvenite or from the underlying maternal condition. clinical considerations human milk-fed infants should be closely monitored for adverse events resulting from lamotrigine.  measurement of infant serum levels should be performed to rule out toxicity if concerns arise.  human milk-feeding should be discontinued in infants with lamotrigine toxicity. data data from multiple small studies indicate that lamotrigine plasma levels in nursing infants have been reported to be as high as 50% of maternal plasma concentrations. epilepsy subvenite is indicated as adjunctive therapy in patients aged 2 years and older for partial-onset seizures, the generalized seizures of lennox-gastaut syndrome, and pgtc seizures. safety and efficacy of subvenite used as adjunctive treatment for partial-onset seizures were not demonstrated in a small, randomized, double-blind, placebo-controlled withdrawal trial in very young pediatric patients (aged 1 to 24 months).  subvenite was associated with an increased risk for infectious adverse reactions (subvenite 37%, placebo 5%), and respiratory adverse reactions (subvenite 26%, placebo 5%).  infectious adverse reactions included bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection.  respiratory adverse reactions included nasal congestion, cough, and apnea. bipolar disorder safety and efficacy of subvenite for the maintenance treatment of bipolar disorder were not established in a double-blind, randomized withdrawal, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 years with a current manic/hypomanic, depressed, or mixed mood episode as defined by dsm-iv-tr.  in the randomized phase of the trial, adverse reactions that occurred in at least 5% of patients taking placebo (n = 86) were influenza (subvenite 8%, placebo 2%), oropharyngeal pain (subvenite 8%, placebo 2%), vomiting (subvenite 6%, placebo 2%), upper abdominal pain (subvenite 5%, placebo 1%), and suicidal ideation (subvenite 5%, placebo 0%). juvenile animal data in a juvenile animal study in which lamotrigine (oral doses of 0, 5, 15, or 30 mg/kg) was administered to young rats from postnatal day 7 to 62, decreased viability and growth were seen at the highest dose tested and long-term neurobehavioral abnormalities (decreased locomotor activity, increased reactivity, and learning deficits in animals tested as adults) were observed at the 2 highest doses. the no-effect dose for adverse developmental effects in juvenile animals is less than the human dose of 400 mg/day on a mg/m2 basis. clinical trials of subvenite for epilepsy and bipolar disorder did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients or exhibit a different safety profile than that of younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. experience in patients with hepatic impairment is limited. based on a clinical pharmacology study in 24 subjects with mild, moderate, and severe liver impairment [see clinical pharmacology ( 12.3)] , the following general recommendations can be made. no dosage adjustment is needed in patients with mild liver impairment. initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. escalation and maintenance doses may be adjusted according to clinical response [see dosage and administration ( 2.1)]. lamotrigine is metabolized mainly by glucuronic acid conjugation, with the majority of the metabolites being recovered in the urine. in a small study comparing a single dose of lamotrigine in subjects with varying degrees of renal impairment with healthy volunteers, the plasma half-life of lamotrigine was approximately twice as long in the subjects with chronic renal failure [see clinical pharmacology ( 12.3)]. initial doses of subvenite should be based on patients' aed regimens; reduced maintenance doses may be effective for patients with significant renal impairment. few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine. because there is inadequate experience in this population, subvenite should be used with caution in these patients [see dosage and administration ( 2.1)].

Австралия - английски - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - secukinumab, quantity: 150 mg/ml - injection, solution - excipient ingredients: trehalose dihydrate; water for injections; methionine; nitrogen; polysorbate 80; histidine hydrochloride monohydrate - plaque psoriasis,cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,cosentyx is indicated for the treatment of adult patients with active psoriatic arthritis including axial manifestations of psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (dmard) therapy has been inadequate.,axial spondyloarthritis (axspa) with or without radiographic damage,ankylosing spondylitis (axspa with radiographic damage),cosentyx is indicated for the treatment of adult patients with active ankylosing spondylitis.,non-radiographic axial spondyloarthritis (axspa without radiographic damage),cosentyx is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change, who have had an inadequate response to, or are intolerant to, nsaids.,juvenile idiopathic arthritis (jia),enthesitis-related arthritis (era),cosentyx is indicated for the treatment of active enthesitis-related arthritis in patients 4 years and older who have had an inadequate response or were intolerant to at least one nsaid and at least one dmard.,juvenile psoriatic arthritis (jpsa),cosentyx is indicated for the treatment of active juvenile psoriatic arthritis in patients 2 years and older who have had an inadequate response or were intolerant to at least one nsaid and at least one dmard.,hidradenitis suppurativa (hs),cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

Кения - английски - Pharmacy and Poisons Board

galpha laboratories ltd galpha laboratories ltd - ceftriaxone powder for injection 1gm - injection - ceftriaxone powder for injection 1gm - antiinfectives for systemic use

САЩ - английски - NLM (National Library of Medicine)

remedyrepack inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - adjunctive therapy subvenite is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (pgtc) seizures. - generalized seizures of lennox-gastaut syndrome. monotherapy subvenite is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of subvenite have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. subvenite is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute

Австралия - английски - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - adalimumab, quantity: 80 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.