澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 800 mg - tablet - excipient ingredients: colloidal anhydrous silica; brilliant blue fcf; indigo carmine; magnesium stearate; microcrystalline cellulose; croscarmellose sodium - for use in adult patients for: 1. the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients; 2. the treatment of acute attacks of herpes zoster (shingles), when the duration of rash is less than 72 hours; 3. the management of patients with advanced symptomatic hiv disease (cd4+ counts, < 150 x 10exp6/l). genital herpes initial episodes: the duration of viral shedding is reduced very significantly; the duration of pain and time to healing are also reduced. the promptness of initiation of therapy and/or the patient's prior exposure to herpes simples virus may influence the degree of benefit from therapy. intravenous therapy should be considered in patients in whom prostration, central nervous system involvement or inability to tak eoral medication requires hospitalisation and initiationof more aggressive management. aciclovir does not prevent the establishment of latency in primary episodes. recurrent episodes: a) suppression: in patients with frequent recurrences, suppressive therapy prevents or reduces the frequency and/or severity of recurrences in a high proportion of patients. abortive episodes (prodromal symptoms without vesicle formation) and occasional breakthrough episodes may, however, continue to occur during suppressive therapy. suppressive therapy is not considered appropriate for patiens in whom attacks are mild, last for short periods and/or occur infrequently (for example, less frequently than once a month). aciclovir is effective only during the period of intake and has no residual beneficial effect. it does not eradicate the body viral pool. following cessation of therapy the time to onset of recurrences, their frequency, severity and duration remain generally unaffected. some patients may experience increased severity of the first episode following cessation of therapy. the risk of inducing viral resistance and of potential long term adverse effects (see carcinogenicity, mutagenicity, effects on fertility) shoulld be weighed carefully before initiating suppressive therapy. asymptomatic cases of genital herpes are known to shed the virus with a high frequency. however, at present only limited data are available on the extent and frequency of vial shedding in patients receiving suppressive therapy. therefore, if therapy with aciclovir tablets is being used in the prenatal period (see use in pregnancy) it should not be assumed that viral shedding has ceased. pregnancy should be managed according to considerations normally applicable to patients with genital herpes. in view of the complex and variable natural history of genital herpes, suppressive thearpy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see dosage and administration). b) intermittent treatment: for certain patients intermittent short-term treatment of recurrences is effective. although the average patient would derive limited benefits from such treatment, a minority of patients who have experienced severe, prolonged recurrent episodes or recurrences complicated by eczema, burns or immunosuppression may experience more appreciable benefits. in those patients, intermittent treatment may be more appropriate than suppressive therapy when recurrences are infrequent. herpes zoster in controlled trials, aciclovir was shown to reduce acute pain and rash progression in adult patients of all ages with herpes zoster, in whom the duration of rash was less than 72 hours. the same treatment on controlled trials, aciclovir was shown to reduce acute pain and rash progression appeared to be relatively less effective in younger patients, in whom herpes zoster is generally a milder disease. in ophthalmic zoster, oral aciclovir has been shown to reduce the incidence of stromal keratitis and both the incidence and severity of anterior uveitis, but not other ocular complications oracute pain. note: in immune-competent patients with very severe herpes zoster, immune-compromised patients or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. patients with advanced symptomatic hiv disease (cd4+ counts, < 150 x 10exp6/l) studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease. in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effect was seen on prophylaxsis of cmv disease of eb v disease.

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

le vet bv - phenobarbital - tablet - 12.5 mg/tablet - phenobarbital - dogs - neurological preparations

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

le vet bv - phenobarbital - tablet - 50 mg/tablet - phenobarbital - dogs - neurological preparations

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - omeprazole, quantity: 20 mg - tablet, enteric coated - excipient ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate - omeprazole tablets are indicated for: a. gastro-oesophageal reflux disease (gord): 1. symptomatic gord: the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis: the treatment and prevention of relapse. b. peptic ulcers: 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with heliobacter pylori infection. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. c. zollinger-ellison syndrome: the treatment of zollinger-ellison syndrome.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - omeprazole, quantity: 20 mg - tablet, enteric coated - excipient ingredients: microcrystalline cellulose; ascorbyl palmitate; povidone; purified talc; iron oxide red; iron oxide black; lactose monohydrate; magnesium stearate; hypromellose phthalate; crospovidone; triacetin - omeprazole tablets are indicated for: a. gastro-oesophageal reflux disease (gord): 1. symptomatic gord: the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis: the treatment and prevention of relapse. b. peptic ulcers: 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with heliobacter pylori infection. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. c. zollinger-ellison syndrome: the treatment of zollinger-ellison syndrome.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - omeprazole, quantity: 20 mg - tablet, enteric coated - excipient ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate - omeprazole tablets are indicated for: a. gastro-oesophageal reflux disease (gord): 1. symptomatic gord: the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis: the treatment and prevention of relapse. b. peptic ulcers: 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with heliobacter pylori infection. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. c. zollinger-ellison syndrome: the treatment of zollinger-ellison syndrome.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - omeprazole, quantity: 20 mg - tablet, enteric coated - excipient ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate - omeprazole tablets are indicated for: a. gastro-oesophageal reflux disease (gord): 1. symptomatic gord: the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis: the treatment and prevention of relapse. b. peptic ulcers: 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with heliobacter pylori infection. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. c. zollinger-ellison syndrome: the treatment of zollinger-ellison syndrome.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levetiracetam, quantity: 1000 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - levetiracetam viatris tablets are indicated for: ? use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme) and, ? add-on therapy in the treatment of primary generalised tonic-clonic seizures (pgtc) in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levetiracetam, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - levetiracetam viatris tablets are indicated for: ? use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme) and, ? add-on therapy in the treatment of primary generalised tonic-clonic seizures (pgtc) in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levetiracetam, quantity: 250 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; povidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - levetiracetam viatris tablets are indicated for: ? use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme) and, ? add-on therapy in the treatment of primary generalised tonic-clonic seizures (pgtc) in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).