Kenya - English - Pharmacy and Poisons Board

106.0 eid 50 of live newcastle disease virus… - injection - 106.0 eid50 of live newcastle disease virus… - other veterinary immunologicals: other live

Ireland - English - HPRA (Health Products Regulatory Authority)

reckitt benckiser ireland ltd - sodium alginate; sodium bicarbonate; calcium carbonate - chewable tablet - 250 mg/106.5 mg/187.50 milligram(s) - other drugs for peptic ulcer and gastro-oesophageal reflux disease (gord); alginic acid

United States - English - NLM (National Library of Medicine)

zydus lifesciences limited - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablet is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablet is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin.  in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablet is indicated to reduce the rate of mi and stroke. clopidogrel bisulfate is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracran

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use: sotalol hydrochloride tablets have not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. sotalol hydrochloride tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of afib/afl) in patients with highly symptomatic afib/afl who are currently in sinus rhythm. limitation of use: because sotalol hydrochloride tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol hydrochloride tablets. sotalol hydrochloride tablets are contraindicated in patients with: - sinus bradycardia, sick sinus syndrome, second and third degree av block, unless a functioning pacemaker is present - congenital or acquired long qt syndromes - cardiogenic shock or decompensated heart failure - serum potassium <4 meq/l - bronchial asthma or related bronchospastic conditions - hypersensitivity to sotalol for the treatment of afib/afl, sotalol hydrochloride tablets are also contraindicated in patients with: - baseline qt interval >450 msec risk summary both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate (see clinical considerations). in animal reproduction studies in rats, early resorptions were increased at 15 times the maximum recommended human dose (mrhd). in rabbits an increase in fetal death was observed at 2 times the mrhd administered as a single dose. sotalol did not reveal any teratogenic potential in rats or rabbits at 15 and 2 times the mrhd respectively (see data). all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the united states (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 the incidence of vt is increased and may be more symptomatic during pregnancy. most tachycardia episodes are initiated by ectopic beats and the occurrence of arrhythmia episodes may, therefore, increase during pregnancy. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions sotalol has been shown to cross the placenta and is found in amniotic fluid. from published observational studies, the potential fetal adverse effects of sotalol use during pregnancy are growth restriction, transient fetal bradycardia, hyperbilirubinemia, hypoglycemia, uterine contractions, and possible intrauterine death. sotalol may have a greater effect on qt prolongation in the immature heart than in the adult heart, and therefore, conveys an increased risk of serious fetal arrhythmia and/or possible intrauterine death. monitor the newborn for symptoms of beta blockade. labor or delivery generally, risk of arrhythmias increases during the labor and delivery process; therefore, considering the proarrhythmia potential of the drug, patients treated with sotalol should be monitored continuously during labor and delivery. data animal data reproduction studies in rats and rabbits administered sotalol during organogenesis at 15 times and 2 times the mrhd as mg/m2 , respectively, did not reveal any teratogenic potential associated with sotalol. in pregnant rats, sotalol doses administered during organogenesis at approximately 15 times the mrhd as mg/m2 , increased the number of early resorptions, while no increase in early resorptions was noted at 2 times the mrhd as mg/m2 . in reproductive studies in rabbits, a sotalol dose (160 mg/kg/day) at 5 times the mrhd as mg/m2 produced a slight increase in fetal death, and maternal toxicity. however, one study from published data reported an increase in fetal deaths in rabbits receiving a single dose (50 mg/kg) at 2 times the mrhd as mg/m2 on gestation day 14. risk summary limited available data from published literature report that sotalol is present in human milk. the estimated daily infant dose of sotalol received from breastmilk is 0.8-3.4 mg/kg, estimated at 22 to 25.5% of the maternal weight-adjusted dosage of sotalol hydrochloride (see data ). the amount of the drug in breast milk is similar to the neonatal therapeutic dosage. therefore, there is potential for bradycardia and other symptoms of beta blockade such as dry mouth, skin or eyes, diarrhea or constipation in the breastfed infant. there is no information regarding the effects of sotalol on milk production. because of the potential serious adverse reactions to the breastfed child and the high level of sotalol in breast milk, advise women not to breastfeed while on treatment with sotalol hydrochloride. data sotalol is present in human milk in high levels. a prospective study evaluated 20 paired samples of breast milk and maternal blood from 5 mothers who elected to breastfeed. breast milk samples had a mean sotalol concentration of 10.5 mcg/ml (± 1.1 mcg/ml; range: 4.8 to 20.2 mcg/ml) compared to a simultaneous mean maternal plasma concentration of 2.3 mcg/ml (± 0.3 mcg/ml; range: 0.8 to 5.0 mcg/ml). the mean milk plasma ratio was 5.4:1 (range: 2.2 to 8.8). the estimated daily infant dose was 0.8-3.4 mg/kg, estimated at 22 to 25.5% of the maternal weight-adjusted dosage of sotalol. this is similar to recommended therapeutic dose in neonates. none of the mothers reported any adverse reactions in the breastfed infant. infertility based on the published literature, beta blockers (including sotalol) may cause erectile dysfunction. the safety and effectiveness of sotalol in children have not been established. however, the class iii electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (qtc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see dosage and administration (2.4) and clinical pharmacology (12.2)] . associated side effects of sotalol use in pediatric patients are those typical of a beta-blocking agent, and lead to discontinuation of the drug in 3 to 6% of patients. as in adults, the class iii antiarrhythmic action of sotalol in pediatric patients is associated with a significant proarrhythmic potential for adverse effects. in pediatric patients, the incidence of proarrhythmic side effects of sotalol varies from 0 to 22%; however, sotalol-induced torsade de pointes tachycardias are observed less frequently in the pediatric population. proarrhythmic effects of sotalol in pediatric patients included increased ventricular ectopy and exacerbation of bradycardia, the latter predominantly in patients with sinus node dysfunction following surgery for congenital cardiac defects. bradycardia may require emergency pacemaker implantation. close in-patient monitoring is recommended for several days. sotalol is mainly eliminated via the kidneys. adjust dosing intervals based on creatinine clearance [see dosage and administration (2.5)] .

United States - English - NLM (National Library of Medicine)

antigen laboratories, inc. - opilio crab (unii: pqd7zso3du) (opilio crab - unii:pqd7zso3du) - opilio crab 0.05 g in 1 ml - allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. confirmation is determined by skin testing. diagnostic use of allergenic extracts usually begins with direct skin testing. this product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing. do not administer in the presence of diseases characterized by bleeding diathesis. individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying disease, possibly due to routine immunization. patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease.

United States - English - NLM (National Library of Medicine)

akorn - isoflurane (unii: cys9akd70p) (isoflurane - unii:cys9akd70p) - isoflurane 1 ml in 1 ml - isoflurane, usp is used for induction and maintenance of general anesthesia in horses and dogs. isoflurane, usp is contraindicated in horses and dogs with known sensitivity to isoflurane or to other halogenated agents.

United States - English - NLM (National Library of Medicine)

kadmon pharmaceuticals, llc - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribasphere (ribavirin, usp) in combination with peginterferon alfa-2a is indicated for the treatment of patients 5 years of age and older with chronic hepatitis c (chc) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. the following points should be considered when initiating ribasphere combination therapy with peginterferon alfa-2a: ribasphere (ribavirin, usp) is contraindicated in: ribasphere and peginterferon alfa-2a combination therapy is contraindicated in patients with: teratogenic effects pregnancy: category x [see contraindications (4)] . ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted. the incidence and severity of teratogenic effects increased with escalation of the drug dose. survival of fetuses and offspring was reduced [see contraindications (4) an

United States - English - NLM (National Library of Medicine)

a-s medication solutions - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see adverse reactions (6) and description (11)] . risk summary data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. however, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data human data epidemiologic

United States - English - NLM (National Library of Medicine)

orchid healthcare (a division of orchid chemicals & pharmaceuticals ltd.) - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii-r or dsm-iv category of major depressive disorder (see clinical trials ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessne

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - dexamethasone 4 mg in 1 ml - - intravenous or intramuscular administration. when oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: endocrine disorders. primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is