Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mayne pharma inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz), naloxone hydrochloride dihydrate (unii: 5q187997ee) (naloxone - unii:36b82amq7n) - buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. buprenorphine and naloxone sublingual tablets is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9)] . risk summary the data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data] . observational studies have reported on congen

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mayne pharma commercial llc - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam tablets usp are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mayne pharma - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 25 ug in 1 h - fentanyl transdermal system 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 fentanyl transdermal system 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 o

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mayne pharma inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 2.5 mg - oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone and acetaminophen tablets is contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings] - hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see warn

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mayne pharma inc. - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 10 mg - tamoxifen citrate tablets, usp are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. tamoxifen citrate tablets, usp are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets, usp are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen therapy is likely to b

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mayne pharma - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam 2 mg - diazepam tablets usp are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mayne pharma inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed warning , warnings and precautions: pediatric use ). tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.

Irska - engleski - HPRA (Health Products Regulatory Authority)

mayne pharma (ireland) limited - tablets - 10 milligram

Irska - engleski - HPRA (Health Products Regulatory Authority)

mayne pharma (ireland) limited - tablets - 25 milligram

Irska - engleski - HPRA (Health Products Regulatory Authority)

mayne pharma (ireland) limited - tablets - 50 milligram