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

scios llc - nesiritide (unii: p7wi8ul647) (nesiritide - unii:p7wi8ul647) - nesiritide 1.5 mg in 5 ml - natrecor (nesiritide) is indicated for the treatment of patients with acutely decompensated heart failure who have dyspnea at rest or with minimal activity. in this population, the use of natrecor reduced pulmonary capillary wedge pressure and improved short term (3 hours) symptoms of dyspnea. natrecor is contraindicated in patients with: - persistent systolic blood pressure <100 mm hg prior to therapy because of an increased risk of symptomatic hypotension [see warnings and precautions (5.1)] - known hypersensitivity to any of its components [see warnings and precautions (5.3)] - cardiogenic shock risk summary there are no data to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes with natrecor use in pregnant women. in animal reproduction studies, intravenous administration of natrecor to pregnant rabbits, during the period of organogenesis at 100 times the maximum recommended human dose (mrhd) did not result in any toxicities to the rabbits or their develo

Canada - English - Health Canada

janssen inc - nesiritide - powder for solution - 1.5mg - nesiritide 1.5mg - miscellaneous vasodilatating agents

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع ادوية شاوي و رشيدات و مسنات - shawi & rushedat drug store - nesiritide (citrate)1.5 mg - (citrate)1.5 mg

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

avera mckennan hospital - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.125 mg

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

ncs healthcare of ky, inc dba vangard labs - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.125 mg - digoxin is indicated for the treatment of mild to moderate heart failure in adults. digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin increases myocardial contractility in pediatric patients with heart failure. digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. digoxin is contraindicated in patients with: - ventricular fibrillation [see warnings and precautions (5.1)] - known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). a hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin. digo

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

precision dose, inc. - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.05 mg in 1 ml

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

precision dose inc. - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.05 mg in 1 ml - digoxin oral solution, usp is indicated for the treatment of mild to moderate heart failure. digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by increased exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. digoxin increases myocardial contractility in pediatric patients with heart failure. digoxin oral solution, usp is indicated for the control of resting ventricular response rate in patients with chronic atrial fibrillation. digoxin should not be used for the treatment of multifocal atrial tachycardia. allergy to digoxin is rare. digoxin is contraindicated in patients with a known hypersensitivity to digoxin or other forms of digitalis. digitalis glycosides, such as digoxin, are contraindicated in ventricula

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

cardinal health - digoxin (unii: 73k4184t59) (digoxin - unii:73k4184t59) - digoxin 0.25 mg - lanoxin is indicated for the treatment of mild to moderate heart failure in adults. lanoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. where possible, lanoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ace) inhibitor. digoxin increases myocardial contractility in pediatric patients with heart failure. lanoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. lanoxin is contraindicated in patients with: lanoxin should be given to a pregnant woman only if clearly needed. it is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. animal reproduction studies have not been conducted with digoxin. there are not enough data from clinical trials to determine

European Union - English - EMA (European Medicines Agency)

biomarin international limited - vosoritide - achondroplasia - drugs for treatment of bone diseases - voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

biomarin pharmaceutical inc. - vosoritide (unii: 7se5582q2p) (vosoritide - unii:7se5582q2p) - voxzogo is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. this indication is approved under accelerated approval based on an improvement in annualized growth velocity [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none risk summary there are no available data on vosoritide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of embryo-fetal toxicity or congenital malformations when pregnant rats and rabbits were administered vosoritide subcutaneously at doses equivalent to 14-times and 200-times, respectively, the exposure at the maximum recommended human dose (mrhd) (see data). the estimated background risk of major birth defects for the indicated population is higher than the general population. the estimated background risk of miscarriage 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 and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in an embryofetal developmental toxicity study in rats, vosoritide was administered at 90, 270, 540 mcg/kg once daily by subcutaneous injection during the period of major organogenesis from gestation day (gd) 6 – 17. there were no effects on maternal animals or on embryofetal development at the highest dose administered (14-times the exposure at the mrhd). in an embryofetal developmental toxicity study in rabbits, vosoritide was administered at 45, 135, 240 mcg/kg once daily by subcutaneous injection during the period of major organogenesis (gd 7 – 19). no effects were observed in maternal animals or on embryofetal development at the highest dose administered (200-times the exposure at the mrhd). in a pre- and postnatal toxicity study in rats, vosoritide was administered at 90, 270, and 540 mcg/kg once daily by subcutaneous injection during the period of major organogenesis and continuing to weaning (gd 6 through postpartum day 20). there were no effects on maternal animals, including maintenance of pregnancy, parturition, or care of offspring, and no effects were noted on offspring growth and development or ability to reproduce at the highest dose (14-times the exposure at the mrhd). risk summary there is no information regarding the presence of vosoritide in human milk, the effects on the breastfed infant, or the effects on milk production. vosoritide is present in rat milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for voxzogo and any potential adverse effects on the breastfed child from voxzogo or from the underlying maternal condition. the safety and effectiveness of voxzogo have been established in pediatric patients for the improvement in linear growth in patients with achondroplasia with open epiphyses. use of voxzogo for this indication is supported by evidence from an adequate and well-controlled study in 121 pediatric patients aged 5 to 15 years with achondroplasia, pharmacokinetic data in pediatric patients aged 4.5 months to 15 years, and additional safety data in pediatric patients aged 4.4 months to <5 years [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the effect of renal impairment on the pharmacokinetics of voxzogo has not been evaluated. no dosage adjustment is needed for patients with egfr ≥ 60 ml/min/1.73 m2 . voxzogo is not recommended for patients with egfr < 60 ml/min/1.73 m2 . this instructions for use contains information for caregivers on how to inject voxzogo. read this instructions for use before you start using voxzogo and each time you get a refill. there may be new information. this information does not take the place of talking to your child's healthcare provider about your child's medical condition and their treatment. before you use voxzogo for the first time, make sure your child's healthcare provider shows you the right way to use it. contact your child's healthcare provider if you or your child have any questions. important information you need to know before injecting voxzogo - wash your hands with soap and water. - do not drop voxzogo or put opened items down on surfaces that are not clean. - voxzogo is available in more than 1 strength. make sure the strength matches your prescription strength. do not open packaging until ready to use. - take the voxzogo vial and prefilled diluent syringe out of the refrigerator and allow them to reach room temperature before mixing. - inspect the vial and supplies for any signs of damage or contamination. do not use if damaged or contaminated. - check the expiration date. the expiration date can be found on the carton, vial and prefilled diluent syringe. do not use if expired. - your child should eat a meal and drink a glass (about 8 to 10 ounces) of fluid (such as water, milk, or juice) within 1 hour before injection. - voxzogo should be given at about the same time every day. - do not mix voxzogo with other medicines. - after mixing the voxzogo, use it right away. do not use the mixed voxzogo if it has been sitting at room temperature for more than 3 hours. throw it away (dispose of) in a sharps container. see step 18 and "how to throw away (dispose of) voxzogo" for more information. - do not reuse any of the supplies. after the injection, throw away (dispose of) the used vial even if there is voxzogo remaining. see step 18 and "how to throw away (dispose of) voxzogo" for more information. how to store voxzogo - store the voxzogo vial and prefilled diluent syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store voxzogo (before mixing) at room temperature between 68°f to 77°f (20°c to 25°c) for 90 days. record the date you started storing voxzogo at room temperature on the carton to keep track of the 90 days. do not return voxzogo to the refrigerator after it has been stored at room temperature. throw voxzogo away if unused within 90 days of storing at room temperature. - do not freeze voxzogo. - store voxzogo out of direct sunlight. keep voxzogo and all other medicines out of the reach of children. supplies needed to inject voxzogo gather all of these supplies on a clean, flat surface before injecting. preparing voxzogo for injection select and prepare injection site giving voxzogo injection how to throw away (dispose of) voxzogo put your used or expired vials, needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the vials, loose needles and syringes in your household trash. if you do not have a fda-cleared sharps disposal container, you may use a household container that: - is made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out, - is upright and stable during use, - is leak-resistant, and - is properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be local or state laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. after the injection - inspect the injection site. if a small amount of bleeding occurs from the injection site, gently press a gauze pad on it for a few seconds or apply a bandage. do not rub the injection site. - monitor for signs of low blood pressure, such as dizziness, tiredness, and nausea. if your child experiences these symptoms you should call your child's healthcare provider, then get your child to lay back with legs raised. for help or more information - call your healthcare provider - call biomarin at 1-800-123-4567 - visit www.voxzogo.com manufactured for: biomarin pharmaceutical inc., novato, ca 94949 rep-5233-c10 this instructions for use has been approved by the u.s. food and drug administration. approved: november 2021