Združene države Amerike - angleščina - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - concerta 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)] . hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with concerta. therefore, concerta is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.5)] . concerta is 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/m 2 basis

Južnoafriška republika - angleščina - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - tablet - see ingredients - each tablet contains paracetamol 325,0 mg tramadol hydrochloride 37,5 mg

Južnoafriška republika - angleščina - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - tablet - see ingredients - each tablet contains paracetamol 325,0 mg tramadol hydrochloride 37,5 mg

Južnoafriška republika - angleščina - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - injection - see ingredients - each 0,5 ml dose contains ad26.cov2.s, recombinant 5 x 10(10) virus particles

Združene države Amerike - angleščina - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 12.5 ug in 1 h - duragesic is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see warnings and precautions (5.1)] , reserve duragesic for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide suffi

Združene države Amerike - angleščina - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50) - pancrelipase lipase 4200 [usp'u] - pancreaze (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. none. teratogenic effects pregnancy category c: animal reproduction studies have not been conducted with pancrelipase. it is not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. pancreaze should be given to a pregnant woman only if clearly needed. the risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when pancreaze is administered to a nursing

Združene države Amerike - angleščina - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - pentosan polysulfate sodium (unii: 914032762y) (pentosan polysulfate - unii:f59p8b75r4) - pentosan polysulfate sodium 100 mg - elmiron ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. elmiron ® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levaquin® is indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus , pseudomonas aeruginosa , serratia marcescens , escherichia coli , klebsiella pneumoniae , haemophilus influenzae , or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levaquin® is indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus , streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae , haemophilus parainfluenzae , klebsiella pneumoniae , moraxella catarrhalis , chlamydophila pneumoniae , legionella pneumophila , or mycoplasma pneumoniae [see dosage and administration (2.1) and clinical studies (14.2)] . mdrsp isolates are is

Združene države Amerike - angleščina - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - tapentadol 50 mg - nucynta (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve nucynta tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia nucynta tablets are contraindicated in patients with: - 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 precautions (5.5)] - known or suspected gastrointestinal obstruction, including suspected paralytic ileus [see warnings and precauti

Združene države Amerike - angleščina - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - tapentadol 50 mg - nucynta er (tapentadol) is indicated for the management of: - pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate - neuropathic pain associated with diabetic peripheral neuropathy (dpn) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve nucynta er for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. nucynta er is not indicated as an as-needed (prn) analgesic. - nucynta er is not indicated as an as-neede