यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

tillomed laboratories ltd - treprostinil sodium - solution for infusion - 2.5mg/1ml

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

tillomed laboratories ltd - treprostinil sodium - solution for infusion - 5mg/1ml

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

dr reddy's laboratories (uk) ltd - treprostinil sodium - solution for infusion - 2.5mg/1ml

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

dr reddy's laboratories (uk) ltd - treprostinil sodium - solution for infusion - 10mg/1ml

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

dr reddy's laboratories (uk) ltd - treprostinil sodium - solution for infusion - 5mg/1ml

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

dr reddy's laboratories (uk) ltd - treprostinil sodium - solution for infusion - 1mg/1ml

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

tillomed laboratories ltd - treprostinil sodium - solution for infusion - 10mg/1ml

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

united therapeutics corporation - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - tyvaso dpi is indicated for the treatment of pulmonary arterial hypertension (pah; who group 1) to improve exercise ability. studies with tyvaso establishing effectiveness predominately included patients with nyha functional class iii symptoms and etiologies of idiopathic or heritable pah (56%) or pah associated with connective tissue diseases (33%). the effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities. while there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor. the controlled clinical experience with tyvaso was limited to 12 weeks in duration [see clinical studies (14)] . tyvaso dpi is indicated for the treatment of pulmonary hypertension associated with interstitial lung disease (ph-ild; who group 3) to improve exercise ability. the study with tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (iip) (45%) inclusive of idiopathic pulmonary fibrosis (ipf), combined pulmonary fibrosis and emphysema (cpfe) (25%), and who group 3 connective tissue disease (22%) [see clinical studies (14.3)] . none. risk summary limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. however, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal studies, no adverse reproductive and developmental effects were seen for treprostinil at ≥8 and ≥134 times the human exposure when based on cmax and auc, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder. the estimated background risk of major birth defects and miscarriage for the indicated populations 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. clinical considerations disease-associated maternal and embryo-fetal risk pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. data animal reproduction studies have been conducted with treprostinil via continuous subcutaneous administration and with treprostinil diolamine administered orally. in studies with orally administered treprostinil diolamine, no adverse effect doses for fetal viability/growth, fetal development (teratogenicity), and postnatal development were determined in rats. in pregnant rats, no evidence of harm to the fetus was observed following oral administration of treprostinil diolamine at the highest dose tested (20 mg/kg/day), which represents about 129 and 1366 times the human exposure, when based on cmax and auc, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder. in pregnant rabbits, external fetal and soft tissue malformations and fetal skeletal malformation occurred. the dose at which no adverse effects were seen (0.5 mg/kg/day) represents about 8 and 134 times the human exposure, when based on cmax and auc, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder. no treprostinil treatment-related effects on labor and delivery were seen in animal studies. animal reproduction studies are not always predictive of human response. risk summary there are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production. safety and effectiveness in pediatric patients have not been established. clinical studies of inhaled treprostinil did not include patients younger than 18 years to determine whether they respond differently from older patients. across clinical studies used to establish the effectiveness of tyvaso inhalation solution in patients with pah and ph-ild, 268 (47.8%) patients aged 65 years and over were enrolled. the treatment effects and safety profile observed in geriatric patients were similar to younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy. plasma clearance of treprostinil, delivered subcutaneously, was reduced up to 80% in subjects with mild-to-moderate hepatic insufficiency. uptitrate slowly when treating patients with hepatic insufficiency because of the risk of an increase in systemic exposure which may lead to an increase in dose-dependent adverse effects. treprostinil has not been studied in patients with severe hepatic insufficiency [see clinical pharmacology (12.3)] . no dose adjustments are required in patients with renal impairment. treprostinil is not cleared by dialysis [see clinical pharmacology (12.3)] . instructions for use tyvaso [ tī-vā'-sō ] dpi® (treprostinil) inhalation powder for oral inhalation only read before starting important information - take tyvaso dpi exactly as prescribed by your healthcare provider. - take tyvaso dpi 4 times per day while you are awake, about 4 hours apart. - if you miss a dose, take it as soon as possible at your usual dose. - if your prescribed dose is higher than 64 mcg per treatment session, you will need to use more than 1 cartridge. if using more than 1 cartridge, the cartridges can be used in any order, regardless of cartridge strength. - if you need to use more than 1 cartridge for your dose, remove the used cartridge from the inhaler before getting a new one. you can tell a cartridge has been used when the cartridge cup has moved from the front to the middle position in the cartridge base. - only tyvaso dpi cartridges should be used with the tyvaso dpi inhaler. - each cartridge is for 1 time (single use) only. use a new cartridge for each treatment session. after each treatment session, throw away the used cartridge right away. - do not open the cartridges. the inhaler opens the cartridge automatically during use. - warning: if any powder from the cartridge spills on your hands, throw away the cartridge right away into regular household trash and wash your hands. then start with a new cartridge. - do not breathe in the tyvaso dpi treprostinil powder in any other way. - do not put cartridges in your mouth. - do not swallow cartridges. - use only 1 inhaler at a time. the same inhaler should be used even when needing to use more than 1 cartridge for your dose. inhale 1 cartridge at a time. - the inhaler lasts for 7 days. after 7 days of use, throw away your used inhaler and get a new one. - store the inhaler in a clean, dry place with the mouthpiece cover on until your next dose. storing tyvaso dpi inhalers and cartridges preparing to inhale tyvaso dpi - remove cartridge(s) from the strip by pushing on the white plastic to push the cartridge out (see figure l ).   note: pushing on the cup will not damage the cartridge. - make sure to remove the right number of cartridges for your dose. - after you have removed a cartridge (or cartridges) from the strip, if any unused cartridges remain in the strip, store the strip at room temperature.   do not put a blister strip back into the refrigerator after being opened. - hold the cartridge with the cup facing down (see figure o ). - line up the cartridge with the opening in the inhaler. the pointed end of the cartridge should line up with the pointed end in the inhaler (see figure p ). - place the cartridge into the inhaler so that it lies flat. - wash your hands right away if the powder comes into contact with your hands, - throw away the cartridge into household trash, and - repeat steps 4, 5, and 6 to load a new cartridge inhaling tyvaso dpi before inhaling tyvaso dpi, fully review all parts of step 7 before you take your dose. - keeping your head level, place the mouthpiece in your mouth and close your lips around the mouthpiece to form a seal. - tilt the inhaler slightly downward while keeping your head level (see figure w ).   note: this helps prevent the powder from being blocked by your tongue. - with your mouth closed around the mouthpiece, inhale deeply through the inhaler (see figure x ). - then remove the inhaler from your mouth and hold your breath for as long as you comfortably can (see figure y ). - then blow out (exhale) and continue to breathe normally (see figure z ). removing the used cartridge - remove the used cartridge from the blue base (see figure ac ). - the cup should now be in the middle of the used cartridge (see figure ad ).   warning: if any powder from the cartridge spills on your hands, wash your hands right away. disposing of tyvaso dpi cartridges inhaling multiple cartridges of tyvaso dpi for further questions and information, or to report a problem with your device or any side effects with your tyvaso dpi, please call 1-877-unither (1-877-864-8437). this instructions for use has been approved by the u.s. food and drug administration. revised: november 2023 tyvaso dpi® is a registered trademark of united therapeutics corporation. patents: www.tyvasodpi.com/patent distributed by: united therapeutics corporation research triangle park, nc 27709 usa manufactured by: mannkind corporation danbury, ct 06810 usa 11/2023 30-1311-006-02

बेल्जियम - अंग्रेज़ी - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ferrer internacional s.a. - treprostinil sodium - eq. treprostinil 5 mg/ml - solution for infusion - 5 mg/ml - treprostinil sodium - treprostinil

बेल्जियम - अंग्रेज़ी - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ferrer internacional s.a. - treprostinil sodium - eq. treprostinil 10 mg/ml - solution for infusion - 10 mg/ml - treprostinil sodium - treprostinil