Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

allergan, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - butalbital 50 mg - fiorinal with codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. limitations of use : because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see warnings and precautions ( 5.1 )] , reserve fiorinal with codeine for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate 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 fiorinal with codeine is contraindicated for: - all children younger than 12 years of age [see warnings and precautions ( 5.5 )] - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions ( 5.5 )] fiorinal with codeine is also contraindicated in patients with: - significant respirator

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

allergan, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - pancrelipase lipase 3000 [usp'u] - zenpep® (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 also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. zenpep 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 zenpep is administered to a nursing

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

allergan, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - fiorinal is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of fiorinal in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. fiorinal is contraindicated under the following conditions: - hypersensitivity or intolerance to aspirin, caffeine, or butalbital. - patients with a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von willebrand’s disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin k deficiency and severe liver damage). - patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs. anaphylactoid reactions have occurred in such patients. - peptic ulcer or other serious gastrointestinal lesions. - patients with porphyria. controlled substance fiorinal

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

allergan, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - pancrelipase lipase 10440 [usp'u] -       viokace  tablets, in combination with a proton pump inhibitor,  is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.       none.       risk summary  published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. animal reproduction studies have not been conducted with pancrelipase.       the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.       ri

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

allergan, inc. - polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), trimethoprim sulfate (unii: e377mf8eq8) (trimethoprim - unii:an164j8y0x) - polymyxin b 100000 [usp'u] in 1 ml - polytrim® ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: staphylococcus aureus , staphylococcus epidermidis, streptococcus pneumoniae, streptococcus viridans, haemophilus influenzae and pseudomonas aeruginosa.*       *efficacy for this organism in this organ system was studied in fewer than 10 infections. polytrim® ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

allergan, inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - assisted reproductive technology crinone 8% is indicated for progesterone supplementation or replacement as part of an assisted reproductive technology ("art") treatment for infertile women with progesterone deficiency. secondary amenorrhea crinone 4% is indicated for the treatment of secondary amenorrhea. crinone 8% is indicated for use in women who have failed to respond to treatment with crinone 4%. crinone should not be used in individuals with any of the following conditions: - known sensitivity to crinone (progesterone or any of the other ingredients) - undiagnosed vaginal bleeding - liver dysfunction or disease - known or suspected malignancy of the breast or genital organs - missed abortion - active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders crinone ® 4% and crinone ® 8% ("kri-noan") (progesterone gel) for vaginal use only you will need the following supplies: see figure a. step 1.  remove the applicator from the

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

allergan, inc. - fluorometholone (unii: sv0csg527l) (fluorometholone - unii:sv0csg527l), sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5) - suspension - 1.0 mg in 1 ml - fml-s® ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe, where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the anti-infective drug in this product, sulfacetamide, is active against the following common bacterial eye pathogens: esche

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

allergan, inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.2 g in 1 g - azelex ®  cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris. azelex ®  cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

allergan pharmaceuticals ireland - botulinum toxin type a - powder for solution for injection - 4 allergan units - other muscle relaxants, peripherally acting agents; botulinum toxin

Malta - engleză - Medicines Authority

abbvie limited citywest business campus, dublin 24, ireland - powder for solution for injection - botulinum toxin type a 100 allergan units/0.1 millilitre - muscle relaxants