Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

bayer new zealand limited - regorafenib monohydrate 41.49mg equivalent to regorafenib 40 mg - tablet - 40 mg - active: regorafenib monohydrate 41.49mg equivalent to regorafenib 40 mg excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry pink 85g35294 povidone - stivarga is indicated for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies. these include fluoropyrimidine-based chemotherapy, an anti-vegf therapy, and an anti-egfr therapy.

Stati Uniti - inglese - NLM (National Library of Medicine)

endo pharmaceuticals inc. - acrivastine (unii: a20f9xai7w) (acrivastine - unii:a20f9xai7w), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - acrivastine 8 mg - semprex-d capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. semprex-d capsules should be administered when both the antihistaminic activity of acrivastine and the nasal decongestant activity of pseudoephedrine are desired (see clinical pharmacology ). the efficacy of semprex-d capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials. semprex-d capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold. semprex-d capsules are contraindicated in patients with a known sensitivity to acrivastine, other alkylamine antihistamines (e.g., triprolidine), pseudoephedrine, other sympathomimetic amines (e.g., phenylpropanolamine), or to any other components of the formulation. semprex-d capsules are contraindicated in patients with severe hypertension or severe coronary arte

Stati Uniti - inglese - NLM (National Library of Medicine)

amgen inc - romiplostim (unii: gn5xu2dxkv) (romiplostim - unii:gn5xu2dxkv) - romiplostim 500 ug in 1 ml - nplate is indicated for the treatment of thrombocytopenia in: - adult patients with immune thrombocytopenia (itp) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. - pediatric patients 1 year of age and older with itp for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation [see clinical studies (14.3)] . limitations of use: - nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (mds) or any cause of thrombocytopenia other than itp [see warnings and precautions ( 5.1 )] .   - nplate should be used only in patients with itp whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. - nplate should not be used in an attempt to normalize platelet counts [see warnings and precautions ( 5.2 )]

Unione Europea - inglese - EMA (European Medicines Agency)

roche registration gmbh - mycophenolate mofetil - graft rejection - immunosuppressants - cellcept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Stati Uniti - inglese - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve hydrocodone bitartrate 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 hydrocodonebitartrate and acetaminophen tablets are 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 hydrocodone or acetamin

Stati Uniti - inglese - NLM (National Library of Medicine)

dash pharmaceuticals llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. see warnings, gastrointestinal effects - risk of ulceration, bleeding and perforation for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications. see boxed contraindications and warnings related to misoprostol. diclofenac sodium and misoprostol delayed-release tablets should not be taken by pregnant women. diclofenac sodium and misoprostol delayed-releas

Stati Uniti - inglese - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - primidone (unii: 13afd7670q) (primidone - unii:13afd7670q) - primidone 50 mg - primidone tablets used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. it may control grand mal seizures refractory to other anticonvulsant therapy. primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see clinical pharmacology ).

Stati Uniti - inglese - NLM (National Library of Medicine)

amneal pharmaceuticals llc - primidone (unii: 13afd7670q) (primidone - unii:13afd7670q) - primidone 50 mg - primidone tablets used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. it may control grand mal seizures refractory to other anticonvulsant therapy. primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see clinical pharmacology ).

Stati Uniti - inglese - NLM (National Library of Medicine)

citron pharma llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 250 mg - carefully consider the potential benefits and risks of naproxen tablets usp and other treatment options before deciding to use naproxen tablets usp. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings: gastrointestinal bleeding, ulceration, and perforation ) . naproxen tablets usp are indicated: - for the relief of the signs and symptoms of rheumatoid arthritis  - for the relief of the signs and symptoms of osteoarthritis  - for the relief of the signs and symptoms of ankylosing spondylitis  - for the relief of the signs and symptoms of juvenile arthritis  naproxen tablets usp are also indicated: - for relief of the signs and symptoms of tendonitis  - for relief of the signs and symptoms of bursitis  - for relief of the signs and symptoms of acute gout  - for the management of pain  - for the management of primary dysmenorrhea naproxen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic

Stati Uniti - inglese - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 375 mg - carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen tablets or naproxen sodium tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings: gastrointestinal bleeding, ulceration, and perforation). naproxen as naproxen tablets or naproxen sodium tablets are indicated: -   •for the relief of the signs and symptoms of rheumatoid arthritis •for the relief of the signs and symptoms of osteoarthritis •for the relief of the signs and symptoms of ankylosing spondylitis •for the relief of the signs and symptoms of juvenile arthritis - •for the relief of the signs and symptoms of rheumatoid arthritis - •for the relief of the signs and symptoms of osteoarthritis - •for the relief of the signs and symptoms of ankylosing spondylitis - •for the relief of the signs and symptoms of juvenile arthritis naproxen as naproxen tablets or naproxen sodium tablets are also in