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

adler ortho australia pty ltd - 34199 - polyethylene patella prosthesis - constructed from uhmwpe. cemented to the underside of a resected patella. a patella component of a tricompartmental rotating platform prosthesis to be used in pcl (posterior cruciate ligament retaining/sacrificing tkr (total knee replacement) for primary and revision surgery. main indications: - primary and secondary arthrosis - rheumatoid arthritis - bone necrosis - revisions, where other devices or treatments have failed

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

adler ortho australia pty ltd - 34199 - polyethylene patella prosthesis - constructed from uhmwpe. attached to the underside of a resected patella. a patella component of a tricompartmental rotating platform prosthesis to be used in pcl (posterior cruciate ligament)retaining/sacrificing tkr (total knee replacement) for primary and revision surgery. main indications: - primary and secondary arthrosis - rheumatoid arthritis - bone necrosis - revisions, where other devices or treatments have failed

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

adler ortho australia pty ltd - 46585 - prosthesis, knee, internal, insert component - constructed of uhmwpe. the lateral slide insert has been shaped to reproduce the natural knee joint kinematics, and the longitudinal rotation tibial movements during flexion/extension. the medial and the lateral articular hemi-plates have different profiles as in the natural knee joint. as the knee joint the ls insert is asymmetric and therefore it?s available in a left and right version. the articular surface has no posterior inclination (0 degrees). a tibial insert component of a tricompartmental rotating platform prosthesis to be used in pcl (posterior cruciate ligament) retaining/sacrificing tkr (total knee replacement) for primary and revision surgery. main indications: - primary and secondary arthrosis - rheumatoid arthritis - bone necrosis - revisions, where other devices or treatments have failed.

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

ingenus pharmaceuticals, llc - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness. modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . teratogenic effects pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modaf

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

ingenus pharmaceuticals, llc - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - indomethacin extended-release capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease - moderate to severe ankylosing spondylitis - moderate to severe osteoarthritis - acute painful shoulder (bursitis and/or tendinitis) indomethacin extended-release capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1) ] risk summary use of nsaids, including indomethacin extended-release, during the third trimester of pregnancy increases the risk of pre

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

ingenus pharmaceuticals, llc - quinine sulfate (unii: kf7z0e0q2b) (quinine - unii:a7v27phc7a) - quinine sulfate 324 mg - quinine sulfate capsules, usp is an antimalarial drug indicated only for treatment of uncomplicated plasmodium falciparum malaria. quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see clinical studies (14)].   limitations of use: quinine sulfate is not approved for: - treatment of severe or complicated p. falciparum malaria. - prevention of malaria. - treatment or prevention of nocturnal leg cramps [see warnings and precautions (5.1)]. quinine sulfate is contraindicated in patients with the following: - prolonged qt interval. one case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged qt interval at baseline, who received quinine sulfate intravenously for p. falciparum malaria [see warnings and precautions (5.4) ]. - known hypersensitivity reactions to quinine. these include, but are not limited to, the following [see warnings and precautions (5.

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

ingenus pharmaceuticals, llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution, 1.5% w/w is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium topical solution, 1.5% w/w is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium or any components of the drug product [see warnings and precautions (5.7, 5.9)]. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)]. - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)]. risk summary use of nsaids, including diclofenac sodium topical solution, 1.5% w/w, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks,

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

ingenus pharmaceuticals, llc - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. triazolam is contraindicated in: - patients with known hypersensitivity to triazolam, any of component of triazolam tablets, or other benzodiazepines. reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal. - concomitant administration of strong cytochrome p450 (cyp 3a) enzyme inhibitors (e.g., ketoconazole, itraconazole, nefazodone, lopinavir, ritonavir) [ see warnings and precautions ( 5.8 ), drug interactions (7.1) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including triazolam, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. risk

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

ingenus pharmaceuticals, llc - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for the prevention of: - nausea and vomiting associated with motion sickness. - post-operative nausea and vomiting (ponv) associated with recovery from anesthesia and/or opiate analgesia and surgery. scopolamine transdermal system is contraindicated in patients with: - angle closure glaucoma [see warnings and precautions (5.1)]. - hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. reactions have included rash generalized and erythema [see adverse reactions (6.2), description (11)] . risk summary available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see dat

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

genus lifesciences inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), homatropine methylbromide (unii: 68jrs2hc1c) (methylhomatropine - unii:p97ogj7l1l) - hycodan is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. limitations of use: - not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4)] . - contraindicated in pediatric patients less than 6 years of age [see contraindications (4)] . - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)], reserve hycodan for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. hycodan is contraindicated for: - all pediatric patients younger than 6 years of age [see warnings and precautions (5.2, 5.3), use in specific populations (8.4)] . - significant respiratory depression [see warnings and precautions (5.2)] . - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precau