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

sandoz inc - rivastigmine (unii: pki06m3iw0) (rivastigmine - unii:pki06m3iw0) - rivastigmine 4.6 mg in 24 h - rivastigmine transdermal system is indicated for the treatment of dementia of the alzheimer’s type (ad). efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer’s disease. rivastigmine transdermal system is indicated for the treatment of mild-to-moderate dementia associated with parkinson’s disease (pdd). rivastigmine transdermal system is contraindicated in patients with: isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)] . risk summary there are no adequate data on the developmental risks associated with the use of rivastigmine in pregnant women. in animals, no adverse effects on embryo-fetal development were observed at oral doses 2-4 times the maximum recommended human dose (mrhd) (see data) . the 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 r

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

alvogen inc. - rivastigmine (unii: pki06m3iw0) (rivastigmine - unii:pki06m3iw0) - rivastigmine 4.6 mg - rivastigmine transdermal system is indicated for the treatment of dementia of the alzheimer’s type (ad). efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer’s disease. rivastigmine transdermal system is indicated for the treatment of mild-to-moderate dementia associated with parkinson’s disease (pdd). rivastigmine transdermal system is contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see description (11)] . - previous history of application site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis [see warnings and precautions (5.3)] . isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)] . risk summary   there are no adequate data on the developmental risks associated with the use of rivastigmine transdermal system in pregnant women. in animals, no adverse effects on embryo-

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

cadila pharmaceuticals limited - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules, usp are indicated for the treatment of mild-to-moderate dementia of the alzheimer's type (ad). rivastigmine tartrate capsules, usp are indicated for the treatment of mild-to-moderate dementia associated with parkinson's disease (pd).  rivastigmine tartrate capsules are contraindicated in patients with: • known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11)]. • a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2)]. isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)]. risk summary there are no adequate data on the developmental risks associated with the use of rivastigmine tartrate in pregnant women. in animals, no adverse effects on embryo-fetal development were obs

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

apotex corp. - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia of the alzheimer's type (ad). rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia associated with parkinson’s disease (pd). rivastigmine tartrate capsules are contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11)] - a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2)] isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)] . risk summary there are no adequate data on the developmental risks associated with the use of rivastigmine in pregnant women. in animals, no adverse effects on embryo-fetal development were observed at oral doses 2-4 times the maximu

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

sun pharmaceutical industries, inc. - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the alzheimer's type (ad). rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with parkinson’s disease (pd). rivastigmine tartrate capsules are contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11)] - a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2)]  isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)] . risk summary there are no adequate data on the developmental risks associated with the use of rivastigmine tartrate in pregnant women. in animals, no adverse effects on embryo-fetal development were observed at oral doses 2 to 4 tim

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

dr. reddy's laboratories limited - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the alzheimer's type (ad). rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with parkinson’s disease (pd). rivastigmine tartrate is contraindicated in patients with:   - known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11) ]  - a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2) ] isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2) ]. risk summary there are no adequate data on the developmental risks associated with the use of rivastigmine tartrate in pregnant women. in animals, no adverse effects on embryo-fetal development were observed at oral doses 2 to 4 times the

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

alembic pharmaceuticals limited - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia of the alzheimer's type. rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia associated with parkinson’s disease. rivastigmine tartrate capsules are contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11)]. -  a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2)]. isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)]. pregnancy category b there are no adequate and well-controlled studies in pregnant women. reproduction studies conducted in pregnant rats and rabbits at oral doses up to 2.3 mg-base/kg/day, or 2 (rat) and 4 (rabbit) times the maximum recomme

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

nivagen pharmaceuticals, inc. - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules, usp are indicated for the treatment of mild to moderate dementia of the alzheimer's type. rivastigmine tartrate capsules, usp are indicated for the treatment of mild to moderate dementia associated with parkinson's disease. rivastigmine tartrate capsules are contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11)] . - a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2)] . isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)] . pregnancy category b there are no adequate and well-controlled studies in pregnant women. reproduction studies conducted in pregnant rats and rabbits at oral doses up to 2.3 mg base/kg/day, or 2 (rat) and 4 (rabbit) times the max

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

sandoz inc - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia of the alzheimer's type. rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia associated with parkinson’s disease. rivastigmine tartrate is contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11)] . - a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2)] . isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)] . pregnancy category b there are no adequate and well-controlled studies in pregnant women. reproduction studies conducted in pregnant rats and rabbits at oral doses up to 2.3 mg-base/kg/day, or 2 (rat) and 4 (rabbit) times the maximum recommended hu

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

macleods pharmaceuticals limited - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the alzheimer's type (ad). rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with parkinson's disease (pd).  rivastigmine tartrate capsules are contraindicated in patients with: • known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11)] • a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2)] isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions  (6.2)]. risk summary there are no adequate data on the developmental risks associated with the use of rivastigmine in pregnant women. in animals, no adverse effects on embryo-fetal development were observed at oral doses 2-4 times th