Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - aciclovir, quantity: 400 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - aciclovir tablets are indicated 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 10(6)/l). in accordance with details specified in the "indications" and the "dosage and administration" sections of the approved product information provided as attachment 1.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - aciclovir, quantity: 200 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - aciclovir tablets are indicated 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 10(6)/l). in accordance with details specified in the "indications" and the "dosage and adminsitration" sections of the approved product information provided as attachment 1.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 800 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - arx-aciclovir tablets are indicated 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 advaned symptomatic hiv disease cd4 + counts < 150 x 10(6)/l). in accordance with details specified in the "indications" and the "dosage and administration" sections of the approved product information provided as attachment 1.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 200 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - arx-aciclovir tablets are indicated 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 10(6)/l). in accordance with details specified in the "indications" and the "dosage and adminsitration" sections of the approved product information provided as attachment 1.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: silicon dioxide; microcrystalline cellulose; magnesium stearate; crospovidone; purified water; lactose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus,glycaemic control,forxiga is indicated in adults with type 2 diabetes mellitus:,? as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated.,? as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin a1c [hba1c] levels).,? in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions for use for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure,forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 pharmacodynamic properties ? clinical trials). heart failure,forxiga is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties). chronic kidney disease,forxiga is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (ckd stage 2,3 or 4 and urine acr ? 30 mg/g)

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

elanco gmbh - benazepril hydrochloride - tablet - 5 mg/tablet - benazepril

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

ecuphar nv - benazepril hydrochloride - tablet - 20 mg/tablet - benazepril

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

ecuphar nv - benazepril hydrochloride - tablet - 5 mg/tablet - benazepril

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - aciclovir, quantity: 800 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; copovidone; magnesium stearate - adults; treatment of first episode (primary or nonprimary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. the management of patients with advanced symptomatic hiv disease (cd4+ counts <150 x 10 6/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 simplex virus may influence the degree of benefit from therapy. intravenous aciclovir should be considered in patients in whom prostration, cns involvement or inability to take oral medication requires hospitalisation and initiation or more aggressive management. aciclovir does not prevent the establishment of latency in initial episodes.,recurrent episodes. 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 patients in whom attacks are mild, last short periods and/or occur infrequently (e.g. 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 precautions, carcinogenesis, mutagenesis and impairment of fertility) should 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 viral shedding in patients receiving suppressive therapy. therefore, if therapy with aciclovir tablets is being used in prenatal period (see precautions, 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 therapy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see dosage and administration). intermittent treatment. for certain patients, intermittent short-term treatment of recurrences is effective. although the average patients 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 tablets were 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. aciclovir tablets appeared to be relatively less effective in younger adults, 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 or acute pain. note. in immunocompetent patients with very severe herpes zoster, immunocompromised patients, or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. advanced symptomatic hiv disease. studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease (cd4+ count < 150 x 10 6/l). in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effect was seen on the prophylaxis of cytomegalovirus (cmv) disease or epstein-barr virus (ebv) disease.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - aciclovir, quantity: 200 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; copovidone; magnesium stearate - adults; treatment of first episode (primary or nonprimary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. the management of patients with advanced symptomatic hiv disease (cd4+ counts <150 x 10 6/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 simplex virus may influence the degree of benefit from therapy. intravenous aciclovir should be considered in patients in whom prostration, cns involvement or inability to take oral medication requires hospitalisation and initiation or more aggressive management. aciclovir does not prevent the establishment of latency in initial episodes.,recurrent episodes. 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 patients in whom attacks are mild, last short periods and/or occur infrequently (e.g. 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 precautions, carcinogenesis, mutagenesis and impairment of fertility) should 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 viral shedding in patients receiving suppressive therapy. therefore, if therapy with aciclovir tablets is being used in prenatal period (see precautions, 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 therapy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see dosage and administration). intermittent treatment. for certain patients, intermittent short-term treatment of recurrences is effective. although the average patients 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 tablets were 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. aciclovir tablets appeared to be relatively less effective in younger adults, 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 or acute pain. note. in immunocompetent patients with very severe herpes zoster, immunocompromised patients, or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. advanced symptomatic hiv disease. studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease (cd4+ count < 150 x 10 6/l). in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effect was seen on the prophylaxis of cytomegalovirus (cmv) disease or epstein-barr virus (ebv) disease.