United States - English - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel 19.5 mg - kyleena is indicated to prevent pregnancy for up to 5 years. replace the system after 5 years if continued use is desired. the use of kyleena is contraindicated when one or more of the following conditions exist: the use of kyleena is contraindicated in pregnancy or with a suspected and kyleena may cause adverse pregnancy outcomes [see contraindications (4), warnings and precautions (5.1, 5.2)]. if a woman becomes pregnant with kyleena in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery. remove kyleena, if possible, if pregnancy occurs in a woman using kyleena. if kyleena cannot be removed, follow the pregnancy closely [see warnings and precautions (5.1, 5.2)] . there have been isolated cases of virilization of the external genitalia of the female fetus following local exposure to lng during pregnancy with an lng ius in place. animal reproduction studies have not been conducted with kyleena. published studi

United States - English - NLM (National Library of Medicine)

amag pharmaceuticals, inc. - bremelanotide acetate (unii: pv2wi7495p) (bremelanotide - unii:6y24o4f92s) - vyleesi is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (hsdd), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: - a co-existing medical or psychiatric condition, - problems with the relationship, or - the effects of a medication or drug substance. acquired hsdd refers to hsdd that develops in a patient who previously had no problems with sexual desire. generalized hsdd refers to hsdd that occurs regardless of the type of stimulation, situation or partner. limitations of use - vyleesi is not indicated for the treatment of hsdd in postmenopausal women or in men. - vyleesi is not indicated to enhance sexual performance. vyleesi is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease [see warnings and precautions (5.1)]. pregnancy exposure registry there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed t

United States - English - NLM (National Library of Medicine)

bioactive nutritional, inc. - bos taurus spleen (unii: 190q9mb3u3) (bos taurus spleen - unii:190q9mb3u3) - bos taurus spleen 6 [hp_x] in 1 ml - for temporary relief of symptoms due to spleen dysregulation. for temporary relief of symptoms due to spleen dysregulation.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - methylphenidate hydrochloride, quantity: 60 mg - capsule, modified release - excipient ingredients: purified talc; methacrylic acid copolymer; ammonio methacrylate copolymer; triethyl citrate; iron oxide yellow; gelatin; macrogol 6000; titanium dioxide; iron oxide black; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; ethanol absolute; potassium hydroxide; maize starch; sucrose - ritalin 10 tablets and ritalin la capsules are indicated for the treatment of adhd. ritalin 10 tablets are also indicated for the treatment of narcolepsy. attention-deficit hyperactivity disorder (adhd) adhd was previously known as attention-deficit disorder. other terms used to describe this behavioural syndrome include: minimal brain dysfunction in children, hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psycho-organic syndrome of children. ritalin 10 / ritalin la are indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. special diagnostic considerations for adhd in children: the aetiology of this syndrome is unknown and there is no single diagnostic test. adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and an abnormal eeg. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. drug treatment is not indicated for all children with this syndrome. stimulants are not intended for use in children who exhibit symptoms secondary to environmental factors (e.g. child abuse in particular) or primary psychiatric disorders. appropriate educational placement is essential and psychosocial intervention is generally necessary. when remedial measures alone are insufficient, the decision to prescribe stimulant medicine will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. continuation of treatment in adolescent and special diagnostic considerations for adhd in adults: there is limited information to guide clinicians about how long older adolescents should continue to receive treatment with drugs for attention deficit hyperactivity disorder (adhd). the decision should be based on the extent to which symptoms of adhd and social functioning have improved to a point that medication is no longer needed. if older adolescents have been largely symptom-free for a year and are functioning well, a trial without medication is warranted. this should be undertaken at times of low stress such as during holidays or in a period when a school routine is well established. adhd needs to be considered in adults who present with longstanding symptoms suggestive of adhd (inattention, impulsivity, disorganisation) that appear to have started in childhood and are persisting into adult life. further, people with personality disorder and/or problems with drug use accompanied by a significant level of impulsivity and inattention should be referred for evaluation by a psychiatrist with the training and skills required to assess and treat adhd. this expertise is necessary due to the overlap of adhd symptoms with anxiety, mood and personality disorders. narcolepsy the symptoms include daytime sleepiness, inappropriate sleep episodes and rapidly occurring loss of voluntary muscle tone. ritalin 10 is effective for symptoms of sleepiness but not for loss of voluntary muscle tone.

European Union - English - EMA (European Medicines Agency)

vanda pharmaceuticals netherlands b.v. - tasimelteon - sleep disorders, circadian rhythm - psycholeptics - hetlioz is indicated for the treatment of non-24-hour sleep-wake disorder (non-24) in totally blind adults.,

European Union - English - EMA (European Medicines Agency)

rad neurim pharmaceuticals eec sarl - melatonin - sleep initiation and maintenance disorders; autistic disorder - psycholeptics - slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (asd) and / or smith-magenis syndrome, where sleep hygiene measures have been insufficient.

United States - English - NLM (National Library of Medicine)

guangzhou renuma medical systems co., ltd - sus scrofa spleen (unii: 92amn5j79y) (sus scrofa spleen - unii:92amn5j79y), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), activated charcoal (unii: 2p3vwu3h10) (activated charcoal - unii:2p3vwu3h10), ceanothus americanus leaf (unii: 25b1y14t8n) (ceanothus americanus leaf - unii:25b1y14t8n), quinine sulfate (unii: kf7z0e0q2b) (quinine - unii:a7v27phc7a), strychnos ignatii seed (unii: 1nm3m2487k) (strychnos ignatii seed - unii:1nm3m2487k), iodine (unii: 9679tc07x4) (iodin - spleen support, immune system support. spleen support, immune system support.

Australia - English - Department of Health (Therapeutic Goods Administration)

sleep eazi pty ltd - 34488 - massager, electrical, bed/chair - this device provides a type of therapeutic massage commonly known as whole body vibration therapy. the device is a lift recliner chair or an adjustable bed. it will provide a massaging therapeutic effect to the person occupying the bed or chair and may assist in the reduction of musculoskeletal pain. this device may help reduce excess oedema fluid whether the cause is lymphatic or vascular, may increase local area blood flow and may assist in the treatment of numerous conditions including wounds, cellulitis and pressure ulcers where improvement in blood circulation is a factor. it may also assist in joint mobilisation and help to ease aches and pains in the body. this device may also assist in improving sleep quality

Malta - English - Medicines Authority

vale pharmaceuticals limited 3 anglesea street, clonmel, co. tipperary, e91 d6c5, ireland - clopidogrel - film-coated tablet - clopidogrel 75 mg - antithrombotic agents

United States - English - NLM (National Library of Medicine)

mylan specialty l.p. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. limitations of use semglee is not recommended for the treatment of diabetic ketoacidosis. semglee is contraindicated: published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dose of 0.2 units/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see data). the estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with an hba1c >7 and has been repo