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

amneal pharmaceuticals llc - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see adverse reactions (6) and description (11)] . risk summary data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. however, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data human data epidemiologic

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

american health packaging - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 200 mg - carbamazepine tablets, usp are indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine (see precautions, general ). carbamazepine tablets, usp are indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of prev

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

american health packaging - amitriptyline hydrochloride (unii: 26lud4jo9k) (amitriptyline - unii:1806d8d52k) - for the relief of symptoms of depression. endogenous depression is more likely to be alleviated than are other depressive states. amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. it should not be given concomitantly with monoamine oxidase inhibitors. hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. when it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. amitriptyline hydrochloride should not be given with cisapride due to the potential for increased qt interval and increased risk for arrhythmia. this drug is not recommended for use during the acute recovery phase following myocardial infarc

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

washington homeopathic products - jonesia - to relieve the symptoms of nausea. indications: jonesia   nausea if symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

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

global isotopes, llc d/b/a zevacor molecular - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 4 mci in 1 ml - choline c11 injection is indicated for positron emission tomography (pet) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (ct) or magnetic resonance imaging (mri). in these patients, 11 c-choline pet imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. suspected prostate recurrence is based upon elevated blood prostate specific antigen (psa) levels following initial therapy. in clinical studies, images were produced with pet/ct coregistration. limitation of use : 11 c-choline pet imaging is not a replacement for histologic verification of recurrent prostate cancer. none. there are no adequate and well controlled studies with choline c11 injection in pregnant women and the fetal radiation dose from a 11 c-choline pet imaging study is unknown. it is not known whether choline c11 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capa

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

washington university school of medicine - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 33.1 mci in 1 ml - choline c 11 injection is indicated for positron emission tomography (pet) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (ct) or magnetic resonance imaging (mri). in these patients, 11 c-choline pet imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. suspected prostate recurrence is based upon elevated blood prostate specific antigen (psa) levels following initial therapy. in clinical studies, images were produced with pet/ct coregistration. limitation of u se: 11 c-choline pet imaging is not a replacement for histologic verification of recurrent prostate cancer. none. pregnancy category c. there are no adequate and well controlled studies with choline c 11 injection in pregnant women and the fetal radiation dose from a 11 c-choline pet imaging study is unknown.  it is not known whether choline c 11 injection can cause f

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

mayo clinic - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 33.1 mci in 1 ml - choline c 11 injection is indicated for positron emission tomography (pet) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (ct) or magnetic resonance imaging (mri). in these patients, 11 c-choline pet imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. suspected prostate recurrence is based upon elevated blood prostate specific antigen (psa) levels following initial therapy. in clinical studies, images were produced with pet/ct coregistration. limitation of u se:   11 c-choline pet imaging is not a replacement for histologic verification of recurrent prostate cancer. none. pregnancy category c. there are no adequate and well controlled studies with choline c 11 injection in pregnant women and the fetal radiation dose from a 11 c-choline pet imaging study is unknown.  it is not known whether choline c 11 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. animal reproduction studies have not been conducted with 11 c-choline. all radiopharmaceuticals, including choline c 11 injection, have a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. assess pregnancy status before administering choline c 11 injection to a female of child bearing potential. choline c 11 injection should be given to a pregnant woman only if clearly needed. choline c 11 injection is not indicated for use in women. it is not known whether choline c 11 injection is excreted in human milk.  because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from choline c 11 injection, nursing mothers should use alternative infant nutrition sources (e.g., stored breast milk or infant formula) and pump and discard breast milk for 8 hours (>10 half lives of radioactive decay for 11 c isotope) after administration of the drug or avoid use of the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of choline c 11 injection have not been established in pediatric patients.

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 20 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 40 microgram; hpv type 18 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: aluminium; histidine; polysorbate 80; borax; water for injections; sodium chloride - gardasil is indicated in females aged 9 through 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, and 18 (which are included in the vaccine). gardasil is indicated in males 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by hpv types 6, 11, 16, and 18 (which are included in the vaccine). *immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations.

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

ucsf radiopharmaceutical facility - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 33.1 mci in 1 ml - choline c 11 injection is indicated for positron emission tomography (pet) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (ct) or magnetic resonance imaging (mri). in these patients, 11 c-choline pet imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. suspected prostate recurrence is based upon elevated blood prostate specific antigen (psa) levels following initial therapy. in clinical studies, images were produced with pet/ct coregistration. limitation of u se: 11 c-choline pet imaging is not a replacement for histologic verification of recurrent prostate cancer. none. pregnancy category c. there are no adequate and well controlled studies with choline c 11 injection in pregnant women and the fetal radiation dose from a 11 c-choline pet imaging study is unknown.  it is not known whether choline c 11 injection can cause fetal harm when administered to a pregnant w

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

seqirus inc. - influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: b8p3xn76w4) (influenza a virus a/georgia/12/2022 cvr-167 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:n8jks3vk2a), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: pv9k2r8hrm) (influenza a virus a/darwin/11/2021 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:c6pm4nxj3 - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 6 months of age and older. [see clinical studies (14)] do not administer flucelvax quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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. data collected in a prospective pregnancy exposure registry from 665 women vaccinated with flucelvax quadrivalent showed no evidence of a vaccine-associated increase in the risk of major birth defects and miscarriages when flucelvax quadrivalent is administered during any trime