États-Unis - anglais - NLM (National Library of Medicine)

eusa pharma (uk) ltd - siltuximab (unii: t4h8fma7im) (siltuximab - unii:t4h8fma7im) - sylvant is indicated for the treatment of patients with multicentric castleman's disease (mcd) who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative. limitations of use sylvant was not studied in patients with mcd who are hiv positive or hhv-8 positive because sylvant did not bind to virally produced il-6 in a nonclinical study. severe hypersensitivity reaction to siltuximab or any of the excipients in sylvant [see warnings and precautions (5.3)] . hypersensitivity reactions, including anaphylactic reaction, hypersensitivity, and drug hypersensitivity have been reported in patients treated with siltuximab. risk-summary in an animal reproduction study, intravenous administration of a human antibody to il-6 to pregnant monkeys from the onset of organogenesis through delivery caused functional impairment in pregnant animals and in the offspring. siltuximab and the human antibody to il-6 crossed the placenta in monkeys ( see data ). the limited available information on sylvant use during pregnancy is not sufficient to inform a drug-associated risk of major birth defects or miscarriage. infants born to pregnant women treated with sylvant may be at increased risk of infection (see clinical considerations). advise pregnant women of the potential risk to a fetus. the estimated background risk for the indicated population is 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 is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. clinical considerations fetal/neonatal adverse reactions monoclonal antibodies are transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. infants born to pregnant women treated with sylvant may be at increased risk of infection. consider the risks and benefits of administering live or live-attenuated vaccines to infants exposed to sylvant in utero [see warnings and precautions (5.2)] . data animal data in an embryo-fetal development study in cynomolgus monkeys, pregnant animals received intravenous doses of siltuximab of 9.2 or 46 mg/kg/week during gestation days (gd) 20 to 118, which includes the period of organogenesis. fetuses were evaluated on gd 140, approximately 25 days prior to the natural birth. exposures at the low and high dose after the 25 th administration were approximately 3 and 7 times, respectively, the human exposure based on auc in patients with mcd at the recommended dose of 11 mg/kg every three weeks. no maternal or fetal structural abnormalities were observed. however, siltuximab crossed the placenta at both doses and when measured on gd 140, fetal serum concentrations of siltuximab were similar to maternal concentrations. in a combined embryofetal and pre- and post-natal development study in cynomolgus monkeys, pregnant animals received intravenous doses of 10 or 50 mg/kg/week of a human antibody to il-6 from gd 20 to natural delivery (gd 167). the offspring were evaluated up to 7 months after birth for developmental effects. no maternal or infant structural abnormalities were observed; however, globulin levels were decreased in pregnant animals (gd 34 through lactation day 30) and in the offspring (lactation days 30-120) at both doses. risk summary there are no data on the presence of siltuximab in human milk, the effects on the breastfed child, or the effects on milk production. however, low levels of the human antibody to il-6 was present in the milk of lactating cynomolgus monkeys. when a drug is present in animal milk, it is likely that the drug will be present in human milk. because of the potential for serious adverse reactions in the breastfed child including gastrointestinal perforations, advise patients that breastfeeding is not recommended during treatment with sylvant, and for 3 months after the last dose. contraception females sylvant may cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with sylvant and for 3 months after the last dose. the safety and efficacy of sylvant have not been established in pediatric patients. of the patients treated with sylvant monotherapy in clinical studies 127 (35%) were 65 years and older. no overall differences in safety profile were observed between these patients and younger patients, and other reported clinical experience has not identified differences in the safety profile between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. clinical studies did not include sufficient numbers of patients aged 65 years and older to determine the effect of age on efficacy in mcd population. based on a population pharmacokinetic analysis using data from clinical trials in patients, no significant difference in siltuximab clearance was observed in patients with pre-existing renal impairment (creatinine clearance (clcr) ≥ 15 ml/min) compared to patients with baseline normal renal function (clcr ≥ 90 ml/min). no initial dosage adjustment is necessary for patients with clcr ≥ 15 ml/min. the potential effect of end stage renal disease on siltuximab pharmacokinetics cannot be determined [see clinical pharmacology (12.3)]. based on a population pharmacokinetic analysis using data from clinical trials in patients, no significant difference in siltuximab clearance was observed in patients with pre-existing mild to moderate hepatic impairment (child-pugh class a and b, respectively) compared to patients with baseline normal hepatic function. no initial dosage adjustment is necessary for patients with mild to moderate hepatic impairment. patients with baseline severe hepatic impairment (child-pugh class c) were not included in clinical trials [see clinical pharmacology (12.3)].

Malaisie - anglais - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

range pharma sdn. bhd. - tiamulin hydrogen fumarate -

Canada - anglais - Health Canada

sterimax inc - levetiracetam - solution - 100mg - levetiracetam 100mg

États-Unis - anglais - NLM (National Library of Medicine)

smiths medical asd, inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine 1 mg in 1 ml - lidocaine hydrochloride and epinephrine injection, usp is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. epinephrine is used as a hemostatic agent. it is also used in treating mucosal conge

États-Unis - anglais - NLM (National Library of Medicine)

smiths medical asd, inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine 1 mg in 1 ml - epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. epinephrine is used as a hemostatic agent. it is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. epinephrine injection can be utilized to prolong the action of anesthetics used in local and regional anesthesia. epinephrine is co

États-Unis - anglais - NLM (National Library of Medicine)

smiths medical asd, inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine 1 mg in 1 ml - epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. epinephrine is used as a hemostatic agent. it is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. epinephrine injection can be utilized to prolong the action of anesthetics used in local and regional anesthesia. epinephrine is co

États-Unis - anglais - NLM (National Library of Medicine)

smiths medical asd, inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine 1 mg in 1 ml - bupivacaine spinal is indicated for the production of subarachnoid block (spinal anesthesia). standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia. bupivacaine spinal (bupivacaine in dextrose injection, usp) is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type. the following conditions preclude the use of spinal anesthesia: 1.severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output. 2.local infection at the site of proposed lumbar puncture. 3.septicemia. lidocaine hydrochloride injection, usp is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural bl

États-Unis - anglais - NLM (National Library of Medicine)

bimeda, inc. - spectinomycin sulfate (unii: bz0h4tlf9x) (spectinomycin - unii:93aki1u6qf) - indications and usage spectogard sterile solution is indicated for the treatment of bovine respiratory disease (pneumonia) associated with mannheimia haemolytica, pasteurella multocida, and histophilus somni. contraindications as with all drugs, the use of spectogard sterile solution is contraindicated in animals previously found to be hypersensitive to the drug.

États-Unis - anglais - NLM (National Library of Medicine)

sanofi pasteur inc. - tuberculin purified protein derivative (unii: i7l8fkn87j) (tuberculin purified protein derivative - unii:i7l8fkn87j) - tuberculin purified protein derivative 5 [iu] in 0.1 ml - tubersol tuberculin purified protein derivative (mantoux), is indicated to aid diagnosis of tuberculosis infection (tb) in persons at increased risk of developing active disease. the centers for disease control and prevention (cdc) have published guidelines regarding populations that would benefit from tuberculin skin testing (tst). current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm. previous bcg vaccination is not a contraindication to tuberculin testing. the skin-test results of bcg vaccinated persons can be used to support or exclude the diagnosis of tb infection. however, an fda-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with bcg. (8) allergy to any component of tubersol or an anaphylactic or other allergic reaction to a previous test of tuberculin ppd is a contraindication to the use of tubersol. (see description and how supplied.) tubersol should not be administered to: - persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock, or ulcerations) to a previous tst, - persons with documented active tuberculosis or a clear history of treatment for tb infection or disease, (9) - persons with extensive burns or eczema.

États-Unis - anglais - NLM (National Library of Medicine)

a-s medication solutions - tuberculin purified protein derivative (unii: i7l8fkn87j) (tuberculin purified protein derivative - unii:i7l8fkn87j) - tuberculin purified protein derivative 5 [iu] in 0.1 ml - tubersol tuberculin purified protein derivative (mantoux), is indicated to aid diagnosis of tuberculosis infection (tb) in persons at increased risk of developing active disease. the centers for disease control and prevention (cdc) have published guidelines regarding populations that would benefit from tuberculin skin testing (tst). current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm. previous bcg vaccination is not a contraindication to tuberculin testing. the skin-test results of bcg vaccinated persons can be used to support or exclude the diagnosis of tb infection. however, an fda-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with bcg. (8) allergy to any component of tubersol or an anaphylactic or other allergic reaction to a previous test of tuberculin ppd is a contraindication to the use of tubersol. (see description and how supplied.) tubersol should not