Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

chiesi usa, inc. - octreotide (unii: rwm8ccw8gp) (octreotide - unii:rwm8ccw8gp) - mycapssa is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. hypersensitivity to octreotide or any of the components of mycapssa. anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide [see adverse reactions (‎6.3)]. risk summary available data from case reports with octreotide acetate use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with mycapssa. no adverse developmental effects were observed with intravenous administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7 and 13 times, respectively, the clinical dose based on octreotide injection body surface area. transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at intravenous doses below the clinical dose based on octreotide injection body surface area (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of octreotide up to 1 mg/kg/day during the period of organogenesis. a slight reduction in body weight gain was noted in pregnant rats at 0.1 and 1 mg/kg/day. there were no maternal effects in rabbits or embryo-fetal effects in either species up to the maximum dose tested. at 1 mg/kg/day in rats and rabbits, the dose multiple was approximately 7 and 13 times, respectively, the clinical dose based on octreotide injection body surface area. in a pre- and post-natal development rat study at intravenous doses of 0.02-1 mg/kg/day, a transient growth retardation of the offspring was observed at all doses which was possibly a consequence of growth hormone inhibition by octreotide. the doses attributed to the delayed growth are below the clinical dose based on octreotide injection body surface area. risk summary there is no information available on the presence of octreotide in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. studies show that octreotide administered subcutaneously passes into the milk of lactating rats (see data ). 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 mycapssa and any potential adverse effects on the breastfed child from mycapssa or from the underlying maternal condition. data following a subcutaneous dose (1 mg/kg) of octreotide to lactating rats, transfer of octreotide into milk was observed at a low concentration compared to plasma (milk/plasma ratio of 0.009). discuss the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in gh levels and normalization of igf-1 concentration in acromegalic females treated with octreotide may lead to improved fertility. safety and efficacy of mycapssa in pediatric patients have not been established. in post-marketing reports, serious adverse reactions, including hypoxia, necrotizing enterocolitis, and death, have been reported with octreotide injection use in pediatric patients, most notably in children under 2 years of age. clinical studies of octreotide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in mycapssa clinical studies, 39 patients (21%) were age 65 years or over and 1 patient was age 75 years or over. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. in patients with mild, moderate, or severe renal impairment there is no dose adjustment recommended for mycapssa. there is a significant increase in octreotide exposure in patients with end stage renal disease (esrd). start patients with esrd on mycapssa 20 mg orally daily. adjust the maintenance dose thereafter based on igf-1 levels, patient's signs and symptoms, and tolerability [see dosage and administration (‎2.3) and clinical pharmacology (‎12.3)]. patients with liver cirrhosis and patients with fatty liver disease showed prolonged elimination of octreotide following subcutaneous administration of drug [see clinical pharmacology (‎12.3)]. read this instructions for use before you start taking mycapssa and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. talk to your healthcare provider or pharmacist if you have any questions about how to use mycapssa. important information: - each mycapssa wallet contains twenty-eight 20-mg capsules. the number of wallets required in a 28-day period depends on your prescribed dose. how to use the mycapssa wallet - each mycapssa wallet has a locking mechanism that helps to keep the medicine away from children. - become familiar with using the mycapssa wallet so you will know how to use it the right way. to open the wallet: step 1. with your left thumb, gently press the tip of the release button on the left side of the wallet (see figure a). step 2. while holding the release button, grasp the medicine card at the notch on the right side and pull it out (see figure a). step 3. unfold the medicine card (see figure a). figure a: how to open the mycapssa wallet how to remove a capsule from the mycapssa wallet capsules need to be removed carefully, because if they are cracked or broken they may not be as effective. follow these instructions to easily remove capsules without damaging them. - place the tip of a thumb at the edge of a capsule's plastic cavity (see figure b). - gently push the capsule until it is removed. collect the removed capsule in your hand. - do not use two thumbs to push a capsule as this could damage it. - do not press the middle of a capsule. this could also damage it. - if a capsule is cracked or broken, throw it away (discard it) and remove another capsule. figure b: how to remove a capsule from the medicine card inside the mycapssa wallet this instructions for use has been approved by the u.s. food and drug administration. approved: 01/2024

Europos Sąjunga - anglų - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - levofloxacin - cystic fibrosis; respiratory tract infections - antibacterials for systemic use, - quinsair is indicated for the management of chronic pulmonary infections due to pseudomonas aeruginosa in adult patients with cystic fibrosis.consideration should be given to official guidance on the appropriate use of antibacterial agents.

Europos Sąjunga - anglų - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - formoterol fumarate dihydrate, glycopyrronium, beclometasone dipropionate - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - deferiprone, quantity: 500 mg - tablet, film coated - excipient ingredients: titanium dioxide; macrogol 3350; hypromellose; microcrystalline cellulose; silicon dioxide; magnesium stearate - ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major who are unable to take desferrioxamine therapy; or in whom desferrioxamine therapy has proven ineffective.

Didžioji Britanija - anglų - myHealthbox

chiesi limited - felodipine - prolonged-release tablet - 5 mg - in the management of hypertension and prophylaxis of chronic stable angina pectoris

Didžioji Britanija - anglų - myHealthbox

chiesi limited - felodipine - prolonged-release tablet - 10 mg - in the management of hypertension and prophylaxis of chronic stable angina pectoris

Didžioji Britanija - anglų - myHealthbox

chiesi limited - salbutamol sulfate - modified release capsules, hard - 4.80mg - selective beta2 -adrenoceptor agonists for systemic use - continuous symptomatic treatment of asthma and other types of reversible obstructive airways disease

Didžioji Britanija - anglų - myHealthbox

chiesi limited - salbutamol sulfate - modified release capsules, hard - 9.60mg - selective beta2 -adrenoceptor agonists for systemic use - continuous symptomatic treatment of asthma and other types of reversible obstructive airways disease

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - metyrapone 250mg;   - soft gelatin capsule - 250 mg - active: metyrapone 250mg   excipient: acetanisole ethyl hydroxybenzoate as the sodium salt ethyl vanillin gelatin glycerol   ink macrogol 400 macrogol 4000 purified water sodium propyl hydroxybenzoate titanium dioxide - therapeutic applications metopirone can be employed as supplementary therapy in conditions associated with overproduction of glucocorticoids and mineralocorticoids, particularly when causal treatment is not possible. cushing's syndrome, especially when related to adrenal tumours hyperaldosteronism, resistant oedema

Europos Sąjunga - anglų - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - tacrolimus - graft rejection - immunosuppressants - prophylaxis of transplant rejection in adult kidney or liver allograft recipients. treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.