USA - engelska - NLM (National Library of Medicine)

butler animal health supply, llc dba covetrus north america - polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i) - this product is indicated for the treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to organisms susceptible to one or more of the antibiotics contained in the ointment. laboratory tests should be conducted including in vitro culturing and susceptibility tests on samples collected prior to treatment.

USA - engelska - NLM (National Library of Medicine)

akorn - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i) - neomycin 3.5 mg in 1 g - neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment. usp is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis. neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment, usp is contraindicated in individuals who have shown hypersensitivity to any of its components.

USA - engelska - NLM (National Library of Medicine)

akorn - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - neomycin 3.5 mg in 1 g - neomycin and polymyxin b sulfates, bacitracin zinc, and hydrocortisone ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see clinical pharmacology: microbiology ). the particular anti-infective drugs in this product

Australien - engelska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

akorn animal health inc - xylazine hydrochloride - parenteral liquid/solution/suspension - xylazine hydrochloride thiazole active 100.0 mg/ml - central nervous system

Australien - engelska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

akorn animal health inc - tolazoline as tolazoline hydrochloride - parenteral liquid/solution/suspension - tolazoline as tolazoline hydrochloride imidazole active 100.0 mg/ml - antidotes

Nya Zeeland - engelska - Ministry for Primary Industries

akorn animal health nz ltd - butorphanol tartrate - butorphanol tartrate 10 g/litre - sedative

USA - engelska - NLM (National Library of Medicine)

henry schein inc. - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i) - neomycin 3.5 mg in 1 g - neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment. usp is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis. neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment, usp is contraindicated in individuals who have shown hypersensitivity to any of its components.

USA - engelska - NLM (National Library of Medicine)

henry schein inc. - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - neomycin 3.5 mg in 1 g - neomycin and polymyxin b sulfates, bacitracin zinc, and hydrocortisone ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see clinical pharmacology: microbiology ). the particular anti-infective drugs in this produ

USA - engelska - NLM (National Library of Medicine)

akorn - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg in 20 ml - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)], heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. mycophenolate mofetil for injection is contraindicated in patients who are allergic to polysorbate 80 (tween). pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary use of mycophenolate mofetil (mmf) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see human data] . oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients) [see animal data]. consider alternative immunosuppressants with less potential for embryofetal toxicity. risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman. the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. 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 a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following mmf exposure. animal data in animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. oral administration of mmf to pregnant rats from gestational day 7 to day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. oral administration of mmf to pregnant rabbits from gestational day 7 to day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. risk summary there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child [see data] . studies in rats treated with mmf have shown mycophenolic acid (mpa) to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition. data limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34 to 40 weeks gestation, and breastfed for up to 14 months. no adverse events were reported. females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. pregnancy planning for patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. risks and benefits of mycophenolate mofetil should be discussed with the patient. pregnancy testing to prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting mycophenolate mofetil. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. contraception female patients females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see table 9 for acceptable contraception methods). patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence. patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see drug interactions (7.2)]. - intrauterine devices (iuds) - tubal sterilization - patient's partner vasectomy - oral contraceptive pill - transdermal patch - vaginal ring - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom - injection - implant - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom male patients genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, s exually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolate mofetil and for at least 90 days after cessation of treatment [see use in specific populations (8.1), nonclinical toxicology (13.1), patient counseling information (17.9)] . safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogeneic kidney, heart or liver transplant. kidney transplant use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)]. heart transplant and liver transplant use of mycophenolate mofetil in pediatric heart transplant and liver transplant patients is supported by adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [see dosage and administration (2.3, 2.4), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)]. clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between geriatric and younger patients. in general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies. [see adverse reactions (6.1), drug interactions (7)]. patients with kidney transplant no dose adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see clinical pharmacology (12.3)]. in kidney transplant patients with severe chronic impairment of the graft (gfr < 25 ml/min/1.73 m2 ), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided. patients with heart and liver transplant no data are available for heart or liver transplant patients with severe chronic renal impairment. mycophenolate mofetil may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks. patients with kidney transplant no dose adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. however, it is not known whether dose adjustments are needed for hepatic disease with other etiologies [see clinical pharmacology (12.3)]. patients with heart transplant no data are available for heart transplant patients with severe hepatic parenchymal disease.

Kanada - engelska - Health Canada

akorn animal health inc - xylazine (xylazine hydrochloride) - solution - 100mg - xylazine (xylazine hydrochloride) 100mg - horses