Australië - Engels - Department of Health (Therapeutic Goods Administration)

cerner corporation pty ltd - 58842 - pharmaceutical information system application software - an application , routine, and/or algorithm intended for use as or in an information system to receive, collect, store, manage,assist in analysis of, display, output and distribute data within or between healthcare facilities, to assist with therapeutic pharmaceutical prescription and management

Verenigde Staten - Engels - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - tisagenlecleucel (unii: q6c9whr03o) (tisagenlecleucel - unii:q6c9whr03o) - tisagenlecleucel 2000000 - kymriah is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: patients up to 25 years of age with b-cell precursor acute lymphoblastic leukemia (all) that is refractory or in second or later relapse. adult patients with relapsed or refractory (r/r) large b-cell lymphoma after two or more lines of systemic therapy including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high grade b-cell lymphoma and dlbcl arising from follicular lymphoma. limitation of use: kymriah is not indicated for treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory (r/r) follicular lymphoma (fl) after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and duration of response [see clinical studies (14.3)] . 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 with kymriah use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with kymriah to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if kymriah has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including b-cell lymphocytopenia. therefore, kymriah is not recommended for women who are pregnant, and pregnancy after kymriah administration should be discussed with the treating physician. report pregnancies to novartis pharmaceuticals corporation at 1-888-669-6682.  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. risk summary there is no information regarding the presence of kymriah in human milk, the effect on the breastfed infant, and the effects on milk production. a risk to the breastfed infant cannot be excluded. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kymriah and any potential adverse effects on the breastfed infant from kymriah or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually-active females of reproductive potential should have a pregnancy test prior to starting treatment with kymriah. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with kymriah. infertility there are no data on the effect of kymriah on male and female fertility. the safety and efficacy of kymriah have been established in pediatric patients with r/r b-cell all. use of kymriah is supported by a single-arm trial [see clinical studies (14.1)] that included 61 pediatric patients with r/r b-cell precursor all in the following age groups: 40 children (ages 2 years to less than 12 years) and 21 adolescents (ages 12 years to less than 17 years). no differences in efficacy or safety were observed between the different age subgroups or in comparison to the young adults in the trial. the safety and efficacy of kymriah in pediatric patients with r/r dlbcl and r/r fl have not been established. the safety and effectiveness of kymriah have not been established in geriatric patients with r/r b-cell all. clinical studies of kymriah did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Verenigde Staten - Engels - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1.0 ml - extavia is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. extavia is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. risk summary although there have been no well-controlled studies in pregnant women, available data, which include prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of interferon beta-1b to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see animal data ). 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 the majority of the observational studies reporting on pregnancies exposed to interferon beta-1b did not identify an association between the use of interferon beta-1b during pregnancy and an increased risk of major birth defects. animal data when interferon beta-1b (doses ranging from 0.028 to 0.42 mg/kg/day) was administered to pregnant rhesus monkeys throughout the period of organogenesis (gestation days 20 to 70), a dose-related increase in the incidence of abortion was observed. the low-effect dose is approximately 3 times the recommended human dose of 0.25 mg on a body surface area (mg/m2 ) basis. a no-effect dose for embryo-fetal developmental toxicity in rhesus monkeys was not established. risk summary there are no data on the presence of interferon beta-1b in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for extavia and any potential adverse effects on the breastfed child from extavia or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of interferon beta-1b did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. extavia (interferon beta-1b) patient instructions for use if your doctor decides that you or a caregiver may be able to give your injections of extavia at home, your doctor or nurse should instruct you on the right way to prepare and inject extavia. to lower your risk of infection, it is important that you follow the technique that your doctor or nurse discussed with you to prepare and inject extavia.  do not try to inject extavia yourself until you have been shown by your doctor or nurse the right way to prepare and give the injections. it is important for you to read, understand, and follow these instructions. call your doctor if you or your caregiver has any questions about the right way to prepare or inject extavia. important safety information - the rubber cap on the diluent pre-filled syringe is made of natural rubber latex. tell your doctor if you are allergic to rubber or latex. - do not leave the blister pack containing extavia where others might tamper with it. - keep the blister pack containing extavia out of the reach of children. - do not open the blister pack or take out any of the items until right before you are ready to use them. - do not use extavia if the seal on the vial is broken. if the seal is broken, the product may not be safe for you to use. - do not use extavia after the expiration date shown on the blister pack label or box (figure 1). if it has expired, return the entire pack to the pharmacy. figure 1 - do not use any of the items in the blister pack more than one time. see the section at the end of this leaflet, “dispose of used syringes, needles, and vials.” throw away any open and unused medicine. gather your supplies. you will need the following supplies to get ready to give your injection of extavia: - a blister pack containing the following items (figure 2) a vial of extavia a pre-filled syringe of diluent (0.54% sodium chloride solution) a vial adapter with a 27-gauge needle attached (in its own container) two (2) alcohol wipes - a vial of extavia - a pre-filled syringe of diluent (0.54% sodium chloride solution) - a vial adapter with a 27-gauge needle attached (in its own container) - two (2) alcohol wipes figure 2 - a dry cotton ball and gauze - a sharps disposal container (figure 3). see the section “dispose of used syringes, needles, and vials.” figure 3 prepare for self-injection - wash your hands well with soap and water. - open the blister pack by peeling off the label and take out all the items. make sure the blister pack containing the vial adapter is sealed. check to make sure the rubber cap on the diluent syringe is firmly attached. - turn the blister pack over, and place the vial in the well (vial holder) and place the pre-filled syringe in the u-shaped trough (figure 4). figure 4 mix extavia 4.       remove the extavia vial from the well and take the cap off the vial (figure 5). figure 5 5.       place the vial back in the vial holder. 6.       use an alcohol wipe to clean the top of the vial (figure 6). wipe in one direction only. figure 6 7.       leave the alcohol wipe on top of the vial until step 9 below. 8.       peel the label off the container with the vial adapter in it, but do not remove the vial adapter. the vial adapter is sterile, so do not touch it. 9.       remove the alcohol wipe from the top of the vial. pick up the container that holds the vial adapter. turn over the container keeping the vial adaptor inside. put the adapter on top of the vial. push down on the adapter until it pierces the rubber top of the vial and snaps in place (figure 7). lift the container off the vial adapter. figure 7 10.       remove the rubber cap from the pre-filled syringe using a twist and pull motion (figure 8). throw away the rubber cap. figure 8 11.       remove the vial from the vial holder by grasping the vial. do not touch any part of the vial adapter. be careful not to pull the vial adapter off the top of the vial. 12.       connect the pre-filled syringe of diluent to the vial adapter by turning clockwise and tighten carefully (figure 9). figure 9 13.       slowly push the plunger of the pre-filled syringe all the way in. this will push all of the liquid from the syringe into the vial (figure 10). continue to hold the plunger while you mix extavia with the liquid from the syringe. if you do not hold the plunger in, it may return to its original position after you let go. figure 10 14.       gently swirl the vial to completely dissolve the white powder (extavia). do not shake. shaking and even gentle mixing can cause foaming of the medicine. if there is foam, let the vial sit until the foam settles. 15.       after the powder dissolves, look closely at the solution in the vial. do not use the solution if it is not clear or colorless, or if it contains particles. the injection should be given right away after you mix extavia and let any foam in the solution settle. if you must wait for any reason before giving yourself the injection, you may refrigerate the medicine after you mix it. but you should use it within three hours. 16.       with your thumb still pushing the plunger, turn the syringe and vial, so that the vial is on top (figure 11). 17.       slowly pull the plunger back to withdraw the entire contents of the vial into the syringe. figure 11 18.       turn the syringe so that the needle end is pointing up. remove any air bubbles by tapping the outside of the syringe with your fingers (figure 12). slowly push the plunger to the 1 ml mark on the syringe or to the mark that matches the amount of extavia prescribed by your doctor. if too much solution is pushed back into the vial, return to step 16. figure 12 19.       remove the vial adapter and the vial from the syringe by twisting the vial adapter (figure 13). figure 13 choose an injection site - extavia is injected under the skin and into the fat layer between the skin and the muscles (subcutaneous tissue). the best areas for injection are where the skin is loose and soft and away from the joints, nerves, and bones. do not use the area near your navel (belly button) or waistline. if you are very thin, use only the thigh or outer surface of the arm for injection. - choose a different site each time you give yourself an injection. figure 14 shows different areas for giving injections. do not inject in the same area for two injections in a row. keep a record of your injections to help make sure you change (rotate) your injection sites. if there are any sites that are difficult for you to reach, you can ask someone who has been trained to give the injection to you. figure 14 - do not inject extavia in a site where the skin is red, bruised, infected, or scabbed, has broken open, or has lumps, bumps, or pain. tell your doctor if you find skin conditions like the ones mentioned here or any other unusual looking areas where you have been given injections. injecting extavia 20.       using a circular motion, clean the injection site with an alcohol wipe, starting at the injection site and moving outward (figure 15). let the skin area air dry. figure 15 21.       remove the cap from the needle (figure 16). figure 16 22.       gently pinch the skin around the site with your thumb and forefinger of the other hand (figure 17). insert the needle straight up and down into your skin at a 90˚ angle with a quick, dart-like motion. figure 17 23.       once the needle is in your skin, slowly pull back on the plunger. if blood appears in the syringe, it means that you have entered a blood vessel. do not inject extavia. withdraw the needle. throw away the syringe and needle in your puncture-proof container. do not use the same syringe or any of the other supplies that you used for this injection. repeat the above steps to prepare your dose using a new blister pack. choose and clean a new injection site. 24.       if no blood appears in the syringe, slowly push the plunger all the way in until the syringe is empty (figure 18). remove the needle from the skin; then place a dry cotton ball or gauze pad over the injection site. gently massage the injection site for a few minutes with the dry cotton ball or gauze pad. throw away the syringe in your puncture-proof disposal container. figure 18 dispose of used syringes, needles, and vials   - to prevent needle-stick injury and spread of infection, do not try to re-cap the needle. - place used needles, syringes, and vials in a closeable, puncture-resistant container. you may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). do not use glass or clear plastic containers. ask your doctor for instructions on the right way to throw away (dispose of) the container. there may be state and local laws about how you should throw away used needles and syringes. - do not throw used needles, syringes, or vials in your household trash or recycle. - throw away any unused medicine. do not save any unused extavia for a future dose. - keep the disposal container, needles, syringes, and vials of extavia out of the reach of children. manufactured by: novartis pharmaceuticals corporation east hanover, nj 07936 u.s. license no. 1244 this instructions for use has been approved by the u.s. food and drug administration.           revised: november 2021 © novartis t2021-147

Verenigde Staten - Engels - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine 150 mg - trileptal is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. trileptal is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see warnings and precautions (5.2, 5.3) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as trileptal, during pregnancy. encourage women who are taking trileptal during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of trileptal in pregnant women; however, trileptal is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. data on a limited number of pregnancies from pregnancy registries suggest that trileptal monotherapy use is associated with congenital malformations (e.g., craniofacial defects, such as oral clefts, and cardiac malformations, such as ventricular septal defects). increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (mhd) during pregnancy at doses similar to the maximum recommended human dose (mrhd). 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. clinical considerations an increase in seizure frequency may occur during pregnancy because of altered levels of the active metabolite of oxcarbazepine. monitor patients carefully during pregnancy and through the postpartum period [see warnings and precautions (5.10)] . data human data data from published registries have reported craniofacial defects, such as oral clefts and cardiac malformations, such as ventricular septal defects in children with prenatal oxcarbazepine exposure. animal data when pregnant rats were given oxcarbazepine (0, 30, 300, or 1000 mg/kg/day) orally throughout the period of organogenesis, increased incidences of fetal malformations (craniofacial, cardiovascular, and skeletal) and variations were observed at the intermediate and high doses (approximately 1.2 and 4 times, respectively, the mrhd on a mg/m2 basis). increased embryofetal death and decreased fetal body weights were seen at the high dose. doses ≥300 mg/kg/day were also maternally toxic (decreased body weight gain, clinical signs), but there is no evidence to suggest that teratogenicity was secondary to the maternal effects. in a study in which pregnant rabbits were orally administered mhd (0, 20, 100, or 200 mg/kg/day) during organogenesis, embryofetal mortality was increased at the highest dose (1.5 times the mrhd on a mg/m2 basis). this dose produced only minimal maternal toxicity. in a study in which female rats were dosed orally with oxcarbazepine (0, 25, 50, or 150 mg/kg/day) during the latter part of gestation and throughout the lactation period, a persistent reduction in body weights and altered behavior (decreased activity) were observed in offspring exposed to the highest dose (less than the mrhd on a mg/m2 basis). oral administration of mhd (0, 25, 75, or 250 mg/kg/day) to rats during gestation and lactation resulted in a persistent reduction in offspring weights at the highest dose (equivalent to the mrhd on a mg/m2 basis). risk summary oxcarbazepine and its active metabolite (mhd) are present in human milk after trileptal administration. the effects of oxcarbazepine and its active metabolite (mhd) on the breastfed infant or on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trileptal and any potential adverse effects on the breastfed infant from trileptal or from the underlying maternal condition. contraception use of trileptal with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with decreased plasma concentrations of these hormones and may result in a failure of the therapeutic effect of the oral contraceptive drug. advise women of reproductive potential taking trileptal who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see drug interactions (7.3) and clinical pharmacology (12.3)] . trileptal is indicated for use as adjunctive therapy for partial-onset seizures in patients aged 2 to 16 years. the safety and effectiveness for use as adjunctive therapy for partial-onset seizures in pediatric patients below the age of 2 have not been established. trileptal is also indicated as monotherapy for partial-onset seizures in patients aged 4 to 16 years. the safety and effectiveness for use as monotherapy for partial-onset seizures in pediatric patients below the age of 4 have not been established. trileptal has been given to 898 patients between the ages of 1 month to 17 years in controlled clinical trials (332 treated as monotherapy) and about 677 patients between the ages of 1 month to 17 years in other trials [s ee warnings and precautions (5.11), adverse reactions (6.1) , clinical pharmacology (12.3), and clinical studies (14 ) ]. there were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials. following administration of single (300 mg) and multiple (600 mg/day) doses of trileptal in elderly volunteers (60 to 82 years of age), the maximum plasma concentrations and area under the curve (auc) values of mhd were 30% to 60% higher than in younger volunteers (18 to 32 years of age). comparisons of creatinine clearance in young and elderly volunteers indicate that the difference was due to age-related reductions in creatinine clearance. close monitoring of sodium levels is required in elderly patients at risk for hyponatremia [see warnings and precautions (5.1) ]. dose adjustment is recommended for renally impaired patients (creatinine clearance < 30 ml/min) [see dosage and administration (2. 7 ) and clinical pharmacology (12.3) ]. the abuse potential of trileptal has not been evaluated in human studies. intragastric injections of oxcarbazepine to 4 cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer oxcarbazepine by lever pressing activity. trileptal® (oxcarbazepine) oral suspension           300 mg/5 ml each 5 ml contains 300 mg oxcarbazepine instructions for use read these instructions carefully to learn how to use the medicine dispensing system correctly. distributed by: novartis pharmaceuticals corporation east hanover, new jersey 07936 march 2018 t2018-33 © novartis

Filipijnen - Engels - FDA (Food And Drug Administration)

akums drugs & pharmaceuticals ltd. (plant iii-injectables) - drug - metronidazole - promeddazole

Filipijnen - Engels - FDA (Food And Drug Administration)

patriot pharmaceuticals corporation; distributor: patriot pharmaceuticals corporation - memantine hc1 - film-coated tablet - 10mg

Verenigde Staten - Engels - NLM (National Library of Medicine)

first horizon pharmaceutical corporation - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - spray - 400 ug - nitrolingual® pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. allergic reactions to organic nitrates are rare.  nitroglycerin is contraindicated in patients who are allergic to it.  nitrolingual® pumpspray is contraindicated in patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), as their concomitant use can cause severe hypotension.  the time course and dose-dependency of this interaction are not known. safety and effectiveness of nitroglycerin in pediatric patients have not been established.

Verenigde Staten - Engels - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - indacaterol maleate (unii: 2jec1itx7r) (indacaterol - unii:8or09251mq), glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - indacaterol 27.5 ug - utibrontm neohaler® is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. important limitations of use: utibron neohaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.2)] . all labas are contraindicated in patients with asthma without use of a long-term asthma control medication [see warnings and precautions (5.1)] . utibron neohaler is not indicated for the treatment of asthma. utibron neohaler is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients [see warnings and precautions (5.5)] . teratogenic effects: pregnancy category c there are no adequate and well-controlled studies with utibron neohaler or its individual components, indacaterol and glycopyrrolate, in pregnant women

Verenigde Staten - Engels - NLM (National Library of Medicine)

alembic pharmaceuticals limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. additional pediatric use information is approved for novartis pharmaceuticals corporation’s exjade® (deferasirox) tablets for oral suspension. however, due to novartis pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. the safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established. deferasirox tablets for oral suspension are contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; - poor performance status; [see warnings and precautions (5.1, 5.3)] - high-risk myelodysplastic syndromes; (this patient population was not studied and is not expected to benefit from chelatio

Verenigde Staten - Engels - NLM (National Library of Medicine)

alembic pharmaceuticals limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. additional pediatric use information is approved for novartis pharmaceuticals corporation’s jadenu® (deferasirox) tablets. however, due to novartis pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox tablets are contraindicated in patients with: • estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; • poor performance status [see warnings and precautions (5.1, 5.3)]; • high-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); • advanced malignancies [see warnings and precautions (5