Beļģija - angļu - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

b. braun melsungen ag - ropivacaine hydrochloride monohydrate 10,58 mg/ml - eq. ropivacaine hydrochloride 10 mg/ml - solution for injection - 10 mg/ml - ropivacaine hydrochloride monohydrate 10.58 mg/ml - ropivacaine

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

b. braun medical inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb), magnesium chloride (unii: 02f3473h9o) (magnesium cation - unii:t6v3lhy838), sodium acetate (unii: 4550k0sc9b) (sodium cation - unii:lyr4m0nh37), sodium citrate (unii: 1q73q2julr) (sodium cation - unii:lyr4m0nh37) - for use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

avera mckennan hospital - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 20 mg - dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in patients aged 6 years and older. the effectiveness of dexmethylphenidate hydrochloride extended-release capsules in the treatment of adhd in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting dsm-iv criteria for adhd [see clinical studies (14) ]. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of atten

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

sandoz inc - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 5 mg - dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including dexmethylphenidate hydrochloride extended-release capsules, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations ). embryo-fetal

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

par pharmaceuticals, inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 15 mg - dexmethylphenidate hydrochloride extended-release capsules is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)] . - hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6.1)] . - concomitant treatment with monoamine oxidase inhibitors (maois) or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including dexmethylphenidate hydrochloride extended-release capsules, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhdmedications/. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. published studies and post-marketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy ( see clinical considerations ). embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (mrhd) of 20 mg/day given to adults based on plasma levels. a decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the mrhd of 20 mg/day given to adults based on plasma levels ( see data ). 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 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 fetal/neonatal adverse reactions cns stimulants such as dexmethylphenidate hydrochloride extended-release capsules, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. animal data in embryo-fetal development studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. no evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. when dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. at the highest doses tested, plasma levels [area under the curve (aucs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with 20 mg/day. plasma levels in adults were comparatively similar to plasma levels in adolescents. racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. limited published literature, based on milk sampling from seven mothers’ reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmethylphenidate hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from dexmethylphenidate hydrochloride extended-release capsules or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of dexmethylphenidate hydrochloride extended-release capsules in pediatric patients less than 6 years have not been established. the safety and effectiveness of dexmethylphenidate hydrochloride extended-release capsules for the treatment of adhd have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials [see clinical studies (14.2)] . the long-term efficacy of dexmethylphenidate hydrochloride extended-release capsules in pediatric patients has not been established. long term suppression of growth growth should be monitored during treatment with stimulants, including dexmethylphenidate hydrochloride extended-release capsules. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.7)] . juvenile animal toxicity data rats treated with racemic methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. a deficit in acquisition of a specific learning task was observed in females only. the doses at which these findings were observed are at least 6 times the mrhd of 60 mg/day given to children on a mg/m 2 basis. in a study conducted in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 to14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the mrhd of 60 mg/day of racemic methylphenidate given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the mrhd given to children on a mg/m 2 basis). the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the mrhd given to children on a mg/m 2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. dexmethylphenidate hydrochloride extended-release capsules have not been studied in the geriatric population. dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a schedule ii controlled substance. cns stimulants, including dexmethylphenidate hydrochloride extended-release capsules, other methylphenidate-containing products, and amphetamines have a high potential for abuse. abuse is characterized by impaired control over drug use despite harm, and craving. signs and symptoms of cns stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. abusers of cns stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see overdosage (10)] . to reduce the abuse of cns stimulants including dexmethylphenidate hydrochloride extended-release capsules, assess the risk of abuse prior to prescribing. after prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of cns stimulants [see how supplied/storage and handling (16)] , monitor for signs of abuse while on therapy, and reevaluate the need for dexmethylphenidate hydrochloride extended-release capsules use. tolerance tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) can occur during chronic therapy with cns stimulants, including dexmethylphenidate hydrochloride extended-release capsules. dependence physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with cns stimulants including dexmethylphenidate hydrochloride extended-release capsules. withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of cns stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

virtus pharmaceuticals - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr), clidinium bromide (unii: 91zqw5jf1z) (clidinium - unii:bo76jf850n) - chlordiazepoxide hydrochloride 5 mg - chlordiazepoxide hydrochloride/clidinium bromide is indicated to control the emotional and somatic factors in gastrointestinal disorders. chlordiazepoxide hydrochloride/clidinium bromide may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. chlordiazepoxide hydrochloride/clidinium bromide is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. it is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. the more severe withdrawal symptoms have

Malta - angļu - Medicines Authority

b braun melsungen ag carl-braun-strasse 1, d34212 melsungen, germany - sodium chloride - solution for injection - sodium chloride 0.9 % (w/v) - all other non-therapeutic products

Īrija - angļu - HPRA (Health Products Regulatory Authority)

b. braun medical limited - leucine isoleucine lysine hydrochloride dl-methionine phenylalanine threonine tryptophan, l- valine arginine histidine aminoacetic acid alanine proline aspartic acid aspargine monohydrate acetylcysteine glutamic acid ornithine hydrochloride serine tyrosine sodium acetate trihydrate potassium acetate magnesium acetate tetrahydrate sodium phosphate monobasic malic acid n-acetyltyrosine ph. eur. - solution for infusion - 10 %w/v

Īrija - angļu - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - poly(o-2-hydroxyethyl)starch sodium chloride - solution for infusion - 10% %w/v

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

b braun australia pty ltd - sodium chloride -