Irland - engelska - HPRA (Health Products Regulatory Authority)

ethypharm - fentanyl - sublingual tablet - 400 microgram(s) - phenylpiperidine derivatives; fentanyl

Irland - engelska - HPRA (Health Products Regulatory Authority)

ethypharm - fentanyl - sublingual tablet - 533 microgram(s) - phenylpiperidine derivatives; fentanyl

Irland - engelska - HPRA (Health Products Regulatory Authority)

ethypharm - fentanyl - sublingual tablet - 800 microgram(s) - phenylpiperidine derivatives; fentanyl

USA - engelska - NLM (National Library of Medicine)

remedyrepack inc. - buprenorphine (unii: 40d3scr4gz) (buprenorphine - unii:40d3scr4gz), naloxone (unii: 36b82amq7n) (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 are 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

USA - engelska - NLM (National Library of Medicine)

remedyrepack inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine 2 mg - buprenorphine sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. buprenorphine sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9)]. risk summary the data on use of buprenorphine, the active ingredient in buprenorphine 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 congenital malformations among bup

USA - engelska - NLM (National Library of Medicine)

remedyrepack inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and is preferred for induction. buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. buprenorphine sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions  ( 5.9 ) ] . risk summary the data on use of buprenorphine, the active ingredient in buprenorphine 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 congenital malformations amo

USA - engelska - NLM (National Library of Medicine)

remedyrepack inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. buprenorphine sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9)]. risk summary the data on use of buprenorphine, the active ingredient in buprenorphine 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 st

Singapore - engelska - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - (tablet core, product) drospirenone; (tablet core, product) ethinylestradiol betadex clathrate - tablet, film coated - 3.000 mg - (tablet core, product) drospirenone 3.000 mg; (tablet core, product) ethinylestradiol betadex clathrate 0.020 mg

Australien - engelska - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - bromocriptine mesilate, quantity: 2.87 mg (equivalent: bromocriptine, qty 2.5 mg) - tablet, uncoated - excipient ingredients: maleic acid; colloidal anhydrous silica; magnesium stearate; maize starch; lactose monohydrate; disodium edetate - prevention of onset of lactation in the puerperium for clearly defined medical reasons. therapy should be continued for 14 days to prevent rebound lactation. parlodel should not be used to suppress established lactation. treatment of hyperprolactinaemia where surgery and/or radiotherapy are not indicated or have already been used with incomplete resolution. precautions should be taken to ensure that the hyperprolactinaemia is not due to severe primary hypothyroidism. where the cause of hyperprolactinaemia is a prolactin-secreting microadenoma or macroadenoma, parlodel is indicated for conservative treatment; prior to surgery in order to reduce tumour size and to facilitate removal; after surgery if prolactin level is still elevated. adjunctive therapy in the management of acromegaly when: (1) the patient refuses surgery and/or radiotherapy; (2) surgery and/or radiotherapy has been unsuccessful or full effects are not expected for some months; (3) a manifestation of the acromegaly needs to be brought under con

Australien - engelska - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 10 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose; hyprolose; microcrystalline cellulose - pryzex tablets are indicated for ? treatment of schizophrenia and related psychoses. ? short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder. ? preventing recurrence of manic, mixed or depressive episodes in bipolar 1 disorder.