অস্ট্রেলিয়া - ইংরেজি - APVMA (Australian Pesticides and Veterinary Medicines Authority)

animal control technologies (australia) pty ltd - para-aminopropiophenone - bait - para-aminopropiophenone aminoketone active 11.4 g/kg - vertebrate poison

ইস্রায়েল - ইংরেজি - Ministry of Health

lapidot medical import and marketing ltd - lidocaine hydrochloride monohydrate - solution for injection - lidocaine hydrochloride monohydrate 20 mg/ml - lidocaine - local and regional anaesthesia.severe symptomatic ventricular tachycardia or tachy-arrhythmia, if assessed to be life-threatening.

ইউরোপীয় ইউনিয়ন - ইংরেজি - EMA (European Medicines Agency)

zoetis belgium sa - porcine circovirus recombinant virus (cpcv) 1-2, inactivated - immunologicals - pigs (piglets) - active immunisation of pigs over the age of three weeks against porcine circovirus type 2 (pcv2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with pcv2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with post-weaning multisystemic wasting syndrome.

অস্ট্রেলিয়া - ইংরেজি - APVMA (Australian Pesticides and Veterinary Medicines Authority)

animal control technologies (australia) pty ltd - sodium nitrite - bait - sodium nitrite mineral-sodium active 100.0 g/kg - vertebrate poison

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

valeant canada limited - pyridostigmine bromide (unii: kvi301na53) (pyridostigmine - unii:19qm69hh21) - tablet - 30 mg - pyridostigmine bromide is indicated for pretreatment against the lethal effects of soman nerve agent poisoning. pyridostigmine is intended for use in conjunction with protective garments, including a mask. at the first sign of nerve agent poisoning, pyridostigmine should be stopped, and atropine and pralidoxime therapy started immediately. the evidence for the effectiveness of pyridostigmine as pretreatment against soman-induced toxicity was derived from animal studies alone [see nonclinical toxicology (13.2) ]. for military medical use only - mechanical intestinal or urinary obstruction - known hypersensitivity to anticholinesterase agents pregnancy category b pyridostigmine produced no teratogenic effects in rats given up to 30 mg/kg/day and in rabbits given up to 45 mg/kg/day orally during the period of organogenesis. these doses are 3 and 10 times, respectively, the recommended human dose of 90 mg on a mg/m2 basis. in rats, a slight degree of delayed skeletal ossification was seen at 30 mg/kg, a dose wh

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

surgeon general-department of the army (tsg-da) - pyridostigmine bromide (unii: kvi301na53) (pyridostigmine - unii:19qm69hh21) - pyridostigmine bromide is indicated for pretreatment against the lethal effects of soman nerve agent poisoning. pyridostigmine bromide is intended for use in conjunction with protective garments, including a mask. at the first sign of nerve agent poisoning, pyridostigmine bromide should be stopped, and atropine and pralidoxime therapy started immediately. the evidence for the effectiveness of pyridostigmine bromide as pretreatment against soman-induced toxicity was derived from animal studies alone. [see nonclinical toxicology (13.2) .] for military medical use only - mechanical intestinal or urinary obstruction - known hypersensitivity to anticholinesterase agents pregnancy category b pyridostigmine bromide produced no teratogenic effects in rats given up to 30 mg/kg/day and in rabbits given up to 45 mg/kg/day orally during the period of organogenesis. these doses are 3 and 10 times, respectively, the recommended human dose of 90 mg on an mg/m2 basis. in rats, a slight degree of delayed skeletal ossification was seen at 30 mg/kg, a dose which caused maternal toxicity, and a slight increase in the incidence of hydronephrosis was seen at all dose levels (lowest dose tested was 3 mg/kg). in rabbits, a slight increase in the incidence of hydronephrosis was seen at 45 mg/kg, a dose that caused maternal toxicity and increased incidences of blood vessel variations were seen at all doses (lowest dose tested was 5 mg/kg). there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when pyridostigmine bromide is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. clinical studies of pyridostigmine bromide did not contain sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in the elderly (71 to 85 years of age) the elimination half-life, volume of distribution (central and steady state) were comparable with the young (21to 51 years of age). however, the systemic plasma clearance was significantly lower in the elderly compared to the young (6.7 ± 2.2 vs. 9.5 ± 2.7 ml/min/kg). this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. caution should be observed, and dosage be selected carefully, when administering pyridostigmine bromide to patients with impaired renal function. in anephric patients, a 3-fold increase in the elimination half-life and a 75% decrease in systemic clearance were observed. [see clinical pharmacology (12.3).] it may be useful to monitor renal function. no information is available on the pharmacokinetics of pyridostigmine bromide in hepatic impaired patients. although the abuse potential of pyridostigmine bromide has not been specifically assessed, no abuse of, tolerance to, withdrawal from, or drug-seeking behavior was observed in patients who received pyridostigmine bromide in clinical trials. cholinesterase inhibitors are not believed to be associated with drug abuse.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

winthrop u.s, a business of sanofi-aventis u.s. llc - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide is indicated for the treatment of adults with active rheumatoid arthritis (ra). leflunomide is contraindicated in: - pregnant women. leflunomide may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1,5.3)and use in specific populations (8.1)]. - patients with severe hepatic impairment [see warnings and precautions (5.2)]. - patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. known reactions include anaphylaxis [see adverse reactions (6.1)]. - patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pregnancies by calling 1-877-311-8972 or visit http://www.pregnancystudies.org/participate-in-a-study/. risk summary leflunomide is contraindicated for use in pregnant women because of the potential for fetal harm. in animal reproduction studies, oral administration of leflunomide during organogenesis at a dose of 1/10 of, and equivalent to, the maximum recommended human dose (mrhd) based on auc, respectively, in rats and rabbits, caused teratogenicity (rats and rabbits), and embryo-lethality (rats) [see data] . pregnancy exposure registry data are not available at this time to inform the presence or absence of drug-associated risk with the use of leflunomide during pregnancy. the background risk of major birth defects and miscarriage for the indicated populations is unknown. the background risk in the u.s. general population of major birth defects is 2%–4% and of miscarriage is 15%–20% of clinically recognized pregnancies. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, stop treatment with leflunomide, apprise the patient of the potential hazard to a fetus, and perform the accelerated drug elimination procedure to achieve teriflunomide concentrations of less than 0.02 mg/l (0.02 mcg/ml) [see warnings and precautions (5.3)] . clinical considerations fetal/neonatal adverse reactions lowering the plasma concentration of the active metabolite, teriflunomide, by instituting an accelerated drug elimination procedure as soon as pregnancy is detected may decrease the risk to the fetus from leflunomide. the accelerated drug elimination procedure includes verification that the plasma teriflunomide concentration is less than 0.02 mg/l [see warnings and precautions (5.3)and clinical pharmacology (12.3)] . data animal data in an embryo-fetal development study, pregnant rats administered leflunomide during organogenesis from gestation days 7 to 19 at a dose approximately 1/10 of the mrhd (on an auc basis at a maternal oral dose of 15 mg/kg), teratogenic effects, most notably anophthalmia or microphthalmia and internal hydrocephalus, were observed. under these exposure conditions, leflunomide also caused a decrease in the maternal body weight and an increase in embryolethality with a decrease in fetal body weight for surviving fetuses. in an embryo-fetal development study, pregnant rabbits administered leflunomide during organogenesis from gestation days 6 to 18 at a dose approximately equivalent to the mrhd (on an auc basis at a maternal oral dose of 10 mg/kg), a teratogenic finding of fused, dysplastic sternebrae was observed. leflunomide was not teratogenic in rats and rabbits at doses approximately 1/150 and 1/10 of the mrhd, respectively (on an auc basis at maternal oral dose of 1 mg/kg in both rats and rabbits). in a pre and postnatal development study, when female rats were treated with leflunomide at a dose that was approximately 1/100 of the mrhd (on an auc basis at a maternal dose of 1.25 mg/kg) beginning 14 days before mating and continuing until the end of lactation, the offspring exhibited marked (greater than 90%) decreases in postnatal survival. risk summary clinical lactation studies have not been conducted to assess the presence of leflunomide in human milk, the effects of leflunomide on the breastfed child, or the effects of leflunomide on milk production. because of the potential for serious adverse reactions in a breastfed infant from leflunomide, advise a nursing woman to discontinue breastfeeding during treatment with leflunomide. leflunomide may cause fetal harm when administered during pregnancy. advise females of the potential risk to the fetus. advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see use in specific populations (8.1)] . women receiving leflunomide treatment who wish to become pregnant should discontinue leflunomide and undergo an accelerated drug elimination procedure to achieve plasma teriflunomide concentrations of less than 0.02 mg/l (0.02 mcg/ml) [see warnings and precautions (5.3)] . pregnancy testing exclude pregnancy in females of reproductive potential before starting treatment with leflunomide. contraception females advise females of reproductive potential to use effective contraception during treatment with leflunomide and while undergoing a drug elimination procedure until verification that the plasma teriflunomide concentration is less than 0.02 mg/l [see warnings and precautions (5.3)] . the safety and effectiveness of leflunomide in pediatric patients have not been established. the safety and effectiveness of leflunomide in the treatment of polyarticular course juvenile idiopathic arthritis (jia) was evaluated in a single multicenter, double-blind, active-controlled trial in 94 pediatric patients (1:1 randomization) with polyarticular course juvenile idiopathic arthritis (jia) as defined by the american college of rheumatology (acr). in this population, leflunomide treatment was found not to be effective. the safety of leflunomide was studied in 74 patients with polyarticular course jia ranging in age from 3–17 years (47 patients from the active-controlled study and 27 from an open-label safety and pharmacokinetic study). the most common adverse events included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness. less common adverse events included anemia, hypertension, and weight loss. fourteen pediatric patients experienced alt and/or ast elevations, nine between 1.2 and 3-fold the upper limit of normal, and five between 3 and 8-fold the upper limit of normal. of the total number of subjects in controlled clinical trials (trials 1, 2, and 3) of leflunomide, 234 subjects were 65 years and over [see clinical studies (14)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment is needed in patients over 65. dedicated studies of the effect of hepatic impairment on leflunomide pharmacokinetics have not been conducted. given the need to metabolize leflunomide into the active species, the role of the liver in drug elimination/recycling, and the possible risk of increased hepatic toxicity, the use of leflunomide in patients with hepatic impairment is not recommended. dedicated studies of the effect of renal impairment on leflunomide pharmacokinetics have not been conducted. given that the kidney plays an important role in drug elimination, caution should be used when leflunomide is administered to these patients.

অস্ট্রেলিয়া - ইংরেজি - APVMA (Australian Pesticides and Veterinary Medicines Authority)

syngenta australia pty ltd - s-metolachlor; prosulfocarb - emulsifiable concentrate - s-metolachlor anilide/aniline-acetanilides active 120.0 g/l; prosulfocarb carbamate-thiocarbamate active 800.0 g/l - herbicide - barley | wheat - annual ryegrass | barley grass - suppression | brome grass - suppression | canary grass | crassula - suppression | deadnettle - suppression | fumitory - red | fumitory - white | paradoxa grass | phalaris - phalaris spp. | rough poppy - suppression | sand fescue | silvergrass - vulpia spp. | soil surface wild oats | toad rush | wild turnip | wireweed, knotweed or hogweed | yellow burrweed - suppression | annual phalaris | brassica campestris | brassica rapa ssp. sylvestris | brassica rapa var. sylvestris | canary grass | fallopia aviculare | red fumitory | silver grass | stonecrop | surface wild oats | trianthema decandra | trianthema galericulata | white fumitory | zaleya decandra | zaleya galericulata

ইস্রায়েল - ইংরেজি - Ministry of Health

padagis israel agencies ltd, israel - melphalan - tablets - melphalan 2 mg - melphalan - melphalan - for the treatment of : multiple myeloma and advanced ovarian adenocarcinoma

অস্ট্রেলিয়া - ইংরেজি - APVMA (Australian Pesticides and Veterinary Medicines Authority)

kenso corporation (m) sdn. bhd. - prosulfocarb - emulsifiable concentrate - prosulfocarb carbamate-thiocarbamate active 800.0 g/l - herbicide