الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

volu-sol - isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302), alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

evaxo international inc - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - first aid antiseptic uses  first aid to help prevent the risk of infection in minor cuts, scrapes, and burns.

الولايات المتحدة - الإنجليزية - 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

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

مستودع البتراء للمواد الطبية - petra drug store - mesalazine 1 g - 1 g

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

مستودع البتراء للمواد الطبية - petra drug store - mesalazine 500 mg - 500 mg