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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 4.5 mg - tablet, modified release - excipient ingredients: calcium hydrogen phosphate; hypromellose; magnesium stearate; silicon dioxide - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 3 mg - tablet, modified release - excipient ingredients: silicon dioxide; calcium hydrogen phosphate; hypromellose; magnesium stearate - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 2.25 mg - tablet, modified release - excipient ingredients: hypromellose; silicon dioxide; calcium hydrogen phosphate; magnesium stearate - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 3.75 mg - tablet, modified release - excipient ingredients: calcium hydrogen phosphate; hypromellose; silicon dioxide; magnesium stearate - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets usp is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [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 two 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 six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use of medical and special psychological, educational, and social resources. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of dsm-iv characteristics. methylphenidate hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational, social). drug treatment may not be indicated for all patients with adhd. stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms. hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hydrochloride extended-release tablets. therefore, methylphenidate hydrochloride extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.6)] . methylphenidate hydrochloride extended-release tablets are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with glaucoma. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with motor tics or with a family history or diagnosis of tourette's syndrome [see adverse reactions (6.4)] . methylphenidate hydrochloride extended-release tablets are contraindicated during treatment with monoamine oxidase (mao) inhibitors, and also within a minimum of 14 days following discontinuation of a mao inhibitor (hypertensive crises may result) [see drug interactions (7.1)] . pregnancy category c methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. a reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of methylphenidate hydrochloride extended-release tablets on a mg/kg and mg/m2 basis, respectively. the approximate plasma exposure to methylphenidate plus its main metabolite ppaa in pregnant rats was 1–2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hydrochloride extended-release tablets based on the auc. the safety of methylphenidate for use during human pregnancy has not been established. there are no adequate and well-controlled studies in pregnant women. methylphenidate hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hydrochloride extended-release tablets on labor and delivery in humans is unknown. it is not known whether methylphenidate is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised if methylphenidate hydrochloride extended-release tablets are administered to a nursing woman. in lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma. methylphenidate hydrochloride extended-release tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. long-term effects of methylphenidate in children have not been well established. methylphenidate hydrochloride extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate is a schedule ii controlled substance under the controlled substances act. as noted in the box warning, methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. frank psychotic episodes can occur, especially with parenteral abuse. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hydrochloride extended-release tablets were compared to single oral doses of immediate-release methylphenidate (ir mph) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. for the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration. in one study (n=40), both methylphenidate hydrochloride extended-release tablets (108 mg) and 60 mg ir mph compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. in comparisons between the two active treatments, however, methylphenidate hydrochloride extended-release tablets (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (abuse potential, drug liking, amphetamine, and morphine benzedrine group [euphoria]) or statistically less than (stimulation – euphoria) responses produced by 60 mg ir mph. in another study (n=49), both doses of methylphenidate hydrochloride extended-release tablets (54 mg and 108 mg) and both doses of ir mph (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (drug liking, euphoria). when doses of methylphenidate hydrochloride extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hydrochloride extended-release tablets (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by ir mph (50 mg). differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in methylphenidate hydrochloride extended-release tablets is available for immediate release from the drug overcoat [see system components and performance (11.1)] . although these findings reveal a relatively lower response to methylphenidate hydrochloride extended-release tablets on subjective measures suggestive of abuse potential compared to ir mph at roughly equivalent total mph doses, the relevance of these findings to the abuse potential of methylphenidate hydrochloride extended-release tablets in the community is unknown. as noted in the box warning, careful supervision is required during withdrawal from abusive use since severe depression may occur. withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

haleon belgium sa-nv - xylometazoline hydrochloride 0,1 g/100 ml - nasal spray, solution - 1 mg/ml - xylometazoline hydrochloride 1 mg/ml - xylometazoline

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.75 mg - tablet, modified release - excipient ingredients: hypromellose; magnesium stearate; silicon dioxide; calcium hydrogen phosphate - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 4.5 mg - tablet, modified release - excipient ingredients: hypromellose; calcium hydrogen phosphate; silicon dioxide; magnesium stearate - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

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

arrotex pharmaceuticals pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.375 mg - tablet, modified release - excipient ingredients: calcium hydrogen phosphate; magnesium stearate; hypromellose; silicon dioxide - for the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ami medical ltd -