Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
aciclovir, Quantity: 800 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet
Excipient Ingredients: colloidal anhydrous silica; brilliant blue FCF; indigo carmine; magnesium stearate; microcrystalline cellulose; croscarmellose sodium
Oral
35 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: Oval, blue, biconvex tablet. Engraved APO partial bisect 800 on one side, plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2000-08-07
GENRX ACICLOVIR _Aciclovir_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is GenRx Aciclovir. It contains the active ingredient aciclovir. The 200mg strength is used to: • treat genital herpes. It makes an outbreak of genital herpes shorter and less severe • prevent or reduce the number of outbreaks and/or severity of genital herpes in people who experience them often. The 800mg strength is used: • to treat shingles, also known as herpes zoster. Shingles is caused by the same virus which causes chicken pox. It usually involves nerve pain and a blistery rash, limited to one area of the body. If taken within 72 hours of first getting the rash, aciclovir makes an outbreak of shingles shorter and less severe • as part of the management program for certain infections in people who have the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Aciclovir does not cure AIDS or get rid of the HIV virus from your body, but it may prevent further damage to the immune system by stopping production of the herpes viruses. It belongs to a group of medicines called anti-virals. This medicine works by stopping the production of the virus that causes herpes and shingles. Aciclovir does not get rid of the virus from your body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medi Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION – GENRX ACICLOVIR (ACICLOVIR) 1 NAME OF THE MEDICINE Aciclovir 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Aciclovir is a synthetic acyclic purine nucleoside analogue. It is a white crystalline powder slightly soluble in water and practically insoluble in most organic solvents. Each tablet contains 200mg or 800mg of acyclovir as the active ingredient. In addition, each tablet contains the following inactive ingredients: lactose monohydrate (200mg tablet only), magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, –microcrystalline cellulose , brilliant blue FCF (800mg tablet only) and indigo carmine. Aciclovir 200mg tablets contains sugars as lactose. Aciclovir tablets are gluten free. 200mg tablets are round, blue flat faced, bevel-edged tablets, engraved “APO” over “200” on one side and the other side plain. 800mg tablets are oval, blue, biconvex tablets, scored. Engraved APO partial bisect 800 on one side, plain in the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aciclovir tablets are indicated for use in adult patients for: o the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients ; o the treatment of acute attacks of herpes zoster (shingles), when the duration of rash is less than 72 hours; o 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, central nervous system involvement or inability to take oral medication requires hospitalisation and initiation of more aggressive management. Aciclo Прочитајте комплетан документ