Καναδάς - Αγγλικά - Health Canada

icu medical canada inc - mannitol - solution - 20% - mannitol 20% - osmotic diuretics

Καναδάς - Αγγλικά - Health Canada

abbott laboratories, limited - mannitol - liquid - 100mg - mannitol 100mg - kidney function

Καναδάς - Αγγλικά - Health Canada

abbott laboratories, limited - mannitol - liquid - 50mg - mannitol 50mg - kidney function

Καναδάς - Αγγλικά - Health Canada

astra pharma inc. - mannitol - liquid - 250mg - mannitol 250mg - kidney function

Μάλτα - Αγγλικά - Medicines Authority

vioser s.a. taxiarches, 42100 trikala, greece - mannitol - solution for infusion - mannitol 20 g/100ml - blood substitutes and perfusion solutions

Μάλτα - Αγγλικά - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - mannitol - solution for infusion - mannitol 100 mg/ml - blood substitutes and perfusion solutions

Μάλτα - Αγγλικά - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - mannitol - solution for infusion - mannitol 150 mg/ml - blood substitutes and perfusion solutions

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - mannitol, quantity: 200 g/l - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections - osmitrol intravenous infusion (mannitol intravenous infusion, bp) can be used in: the promotion of diuresis in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established; the reduction of intraocular pressure when the pressure cannot be lowered by other means; the reduction of intracranial pressure and treatment of cerebral oedema by reducing brain mass and; promoting the urinary excretion of toxic substances.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

methapharm, inc. - mannitol (unii: 3owl53l36a) (mannitol - unii:3owl53l36a) - aridol is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. limitations of use: aridol is not a standalone test or a screening test for asthma. bronchial challenge testing with aridol should be used only as part of a physician's overall assessment of asthma. aridol is contraindicated in: - patients with known hypersensitivity to mannitol or to the gelatin used to make the capsules - patients with conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers. some examples include: aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction or cerebral vascular accident [see warnings and precautions (5.2)]. risk summary there are no available human data regarding inhaled mannitol to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. based on animal reproduction studies, no eviden

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

chiesi usa, inc. - mannitol (unii: 3owl53l36a) (mannitol - unii:3owl53l36a) - bronchitol is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with cystic fibrosis.  use bronchitol only for adults who have passed the bronchitol tolerance test [see dosage and administration (2.1)]. bronchitol is contraindicated in the following conditions: - hypersensitivity to mannitol or to any of the capsule components hypersensitivity to mannitol or to any of the capsule components - failure to pass the bronchitol tolerance test (btt) failure to pass the bronchitol tolerance test (btt) risk summary there are no adequate and well-controlled studies of bronchitol in pregnant women. the available data on bronchitol use in pregnant women are not sufficient to inform any drug-associated risks for major birth defects and miscarriage. based on animal reproduction studies, no evidence of structural alterations was observed when mannitol was administered to pregnant rats and mice during organogenesis at doses up to approximately 20 and 10 times, respectively, the maximum recommended daily inhalation dose (mrdid) in humans [see data ]. there are risks to the mother associated with cystic fibrosis in pregnancy [see clinial considerations]. bronchitol should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the united states 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/or embryo/fetal risk cystic fibrosis may increase the risk for preterm delivery. data animal data in animal reproduction studies, oral administration of mannitol to pregnant rats and mice during the period of organogenesis did not cause fetal structural alterations. the mannitol dose in rats and mice was approximately 20 and 10 times the maximum recommended human daily inhalation dose (mrdid) in humans, respectively, (on a mg/m2 basis at maternal doses of 1600 mg/kg/day in both species). risk summary it is not known whether bronchitol is excreted in human breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bronchitol and any potential adverse effects on the breastfed child from bronchitol or from the underlying maternal condition. bronchitol is not indicated for use in children and adolescents. the safety and effectivenss of bronchitol have not been established in pediatric patients for cystic fibrosis. patients aged 6 years to 17 years were included in two 26-week, double-blind clinical trials (trials 2 and 3). in these trials, 154 patients under 18 years of age received bronchitol and 105 patients received control (50 mg inhaled mannitol). hemoptysis was reported in 12 of 154 (7.8%)  patients who received bronchitol and in 2 of 105 (1.9%) patients who received control. clinical trials of bronchitol did not include sufficient numbers of patients with cystic fibrosis who were 65 years of age and older to allow evaluation of safety and efficacy in this population. clinical trials of bronchitol did not include patients with hepatic or renal impairment. no specific dose recommendations for these patient populations are available. however, an increase in systemic exposure of mannitol can be expected in patients with renal impairment based on the kidney being its primary route of elimination. patient instructions for use bronchitol® (mannitol) inhalation powder for oral inhalation use this patient instructions for use contains information on how to take bronchitol .  7-day treatment pack - 140 capsules (14 blister packs) - 1 inhaler - prescribing information 4-week treatment pack - 560 capsules (56 blister packs) - 4 inhalers - prescribing information  important information you need to know before using bronchitol - do not use bronchitol until your healthcare provider has performed the bronchitol tolerance test (btt) and approved you for treatment.   this is to make sure you get the right treatment if you have a severe reaction. - for oral inhalation only - do not swallow bronchitol capsules. - use an inhaled short-acting bronchodilator 5 to 15 minutes before every dose of bronchitol - use bronchitol 2 times each day.  inhale through your mouth (oral inhalation) the capsule contents in 10 single bronchitol capsules: 1 time in the morning 1 time at least 2 to 3 hours before bedtime - 1 time in the morning - 1 time at least 2 to 3 hours before bedtime preparing to use bronchitol bronchitol is supplied to people in cartons containing 140 or 560 capsules in blister packs. supplies you will need to use bronchitol: - 1 blister pack - 1 inhaler - bronchodilator (and spacer for bronchodilator if needed) - sink or hand washing station use an inhaled bronchodilator 5 to15 minutes before using bronchitol (see figure a ). clean and dry hands well (see figure b ). inhaler use steps for inhalation of the contents of a single capsule: step 1 .  remove cap (see figure c ) step 2. twist open inhaler by turning the mouthpiece to the right. (see figure d ). step 3. take 1 capsule out of the blister pack and put it in the chamber.(see figure e ). do not place capsule into the mouthpiece of the inhaler. step 4. hold inhaler upright and turn the mouthpiece to the left until it locks in place. (see figure f ). step 5. push both piercing buttons at the same time. release both piercing buttons at the same time (see figure g ). step 6. breathe out (exhale) fully (see figure h ). do not breathe out into inhaler. step 7. close lips around the mouthpiece and take a steady deep breath in through your mouth. do not breathe through your nose. remove inhaler from mouth. hold breath for 5 seconds before exhaling, do not breathe out (exhale) into inhaler (see figure i ).   you should hear a rattling sound while breathing in. if you do not, tap bottom of inhaler firmly and repeat steps 6 and 7. step 8. open the inhaler by turning the cap to the right. if powder is left in capsule, repeat steps 6 and 7. after the capsule is empty, throw away. (see figure j ). step 9 . repeat steps 3 to 8 for all 10 capsules in 1 blister pack (see figure k ).   breathe in (inhale) contents of each capsule one after another until all 10 capsules in the blister pack are used. step 10. after inhaling contents of all 10 capsules, close mouthpiece and place cap on inhaler (see figure l ). step 11. continue using bronchitol for 7 days then throw away (discard) the inhaler (see figure m ). how should i store bronchitol? - store bronchitol at room temperature between 68°f to77°f (20°c to 25°c). - if your bronchitol capsules are stored at temperatures more than 86°f (30°c), throw them away. - do not freeze bronchitol. - do not refrigerate bronchitol. - keep bronchitol and all medicines out of the reach of children. cleaning your bronchitol inhaler. - your inhaler should give you the correct dose of medicine for 7 days without needing cleaning. however, if your inhaler does need cleaning: - make sure your inhaler is empty. - wash your inhaler in warm water with the mouthpiece open. - shake it until there are no large water droplets left in the inhaler. - leave it to dry in the air by laying it on its side with the mouthpiece open. - allow the inhaler to dry fully (or completely) after it has been washed. caring for your bronchitol inhaler. - keep your inhaler dry and always make sure your hands are completely dry before using it. - do not breathe or cough into your inhaler. - do not take your inhaler apart. - do not place a capsule directly into the mouthpiece of your inhaler. - do not leave a used capsule in your inhaler chamber. - use a new inhaler after 7 days. - if your inhaler breaks, call to your healthcare provider. for more information about bronchitol or how to use your inhaler, call 1-888-661-9260. manufactured by: pharmaxis ltd 20 rodborough road frenchs forest nsw 2086 australia manufactured for: chiesi usa, inc. cary, nc 27518 usa 1-888-661-9260 bronchitol is registered in the us patent and trademark office. this patient instructions for use has been approved by the u.s. food and drug administration. revised: 1/2024 ctbr-009-0817-00-spl-1