Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 200 mg - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; lactose monohydrate; indigo carmine; croscarmellose sodium; magnesium stearate - 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 prostation, central nervous system involvement or inability to take oral medication requires hospitalisation and initiation of 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 patients 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 residula beneficial effect. it does not eradicate the body viral pool. following cessation of therapy of 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) 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 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). 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 complicationsor acute pain. note: in im mune-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 effective was seen on prophylaxsis of cmv disease of ebv disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - valaciclovir hydrochloride monohydrate -

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - valaciclovir hydrochloride monohydrate -

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - valaciclovir, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; magnesium stearate; indigo carmine aluminium lake; crospovidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 6000; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. treatment of ophthalmic zoster. treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of > 15 ml/min. for the reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices (see precautions). for prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Ireland - English - HPRA (Health Products Regulatory Authority)

hospira uk limited - aciclovir sodium - concentrate for soln for inf - 25 mg/ml - nucleosides and nucleotides excl. reverse transcriptase inhibitors

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - aciclovir sodium - solution for infusion - 25mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - aciclovir sodium - powder for solution for infusion - 250mg

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

hospira benelux bv-srl - aciclovir sodium - eq. aciclovir 25 mg/ml - concentrate for solution for infusion - 25 mg/ml - aciclovir sodium - aciclovir

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

hospira benelux bv-srl - aciclovir sodium - eq. aciclovir 25 mg/ml - concentrate for solution for infusion - 25 mg/ml - aciclovir sodium - aciclovir