দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
aciclovir, Quantity: 25 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections
Intravenous Infusion
5 X 10mL
(S4) Prescription Only Medicine
Aciclovir Intravenous Infusion is indicated for the purpose of 1. Promoting resolution of acute clinical manifestations of mucocutaneous Herpes simplex virus infections in immunocompromised patients. 2. Treatment of severe first episode primary or non- primary genital herpes in immune competent patients. 3. Treatment of acute manifestations of Varicella zoster virus infection in immunocompromised patients. 4. Treatment of shingles (Varicella zoster virus infection) in immune competent patients who show very severe acute local or systemic manifestations of the disease. Benefits can be expected in patients with rash duration shorter than 72 hours. The use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles. 5. Treatment of Herpes simplex encephalitis.
Visual Identification: Clear, colourless or almost colourless solution, free from visible particulate matter.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1996-08-19
DBL™ ACICLOVIR INTRAVENOUS INFUSION _Aciclovir_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Aciclovir Intravenous Infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given aciclovir against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT DBL ACICLOVIR INTRAVENOUS INFUSION IS USED FOR This medicine is used for the management of a number of different infections caused by viruses, such as herpes and shingles. This medicine belongs to a group of medicines called antivirals. It works by preventing the reproduction of the virus which is causing the condition. 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 medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL ACICLOVIR INTRAVENOUS INFUSION _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU SHOULD NOT BE GIVEN DBL ACICLOVIR INTRAVENOUS INFUSION IF YOU HAVE AN ALLERGY TO: • any medicine containing aciclovir • valaciclovir. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU ARE GIVEN IT_ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • kidney disease • liver disease • any condition affecting your nervous system • irregular electrolyte levels • hypoxia (inadequate o সম্পূর্ণ নথি পড়ুন
Version pfpaciii10321 supersedes: hhpaciii11019 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – DBL ™ ACICLOVIR INTRAVENOUS INFUSION (ACICLOVIR) 1. NAME OF THE MEDICINE Aciclovir 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Aciclovir Intravenous Infusion contains the equivalent of 25 mg/mL of aciclovir in Water for Injections BP; the aciclovir is present as aciclovir sodium. Sodium hydroxide (4.65 mg/mL) is included in the formulation. The aciclovir is present as aciclovir sodium. Aciclovir sodium is a white crystalline powder. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. DBL Aciclovir Intravenous Infusion is a clear colourless or almost colourless sterile solution. DBL Aciclovir Intravenous Infusion has a pH of approximately 11. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Aciclovir Intravenous Infusion is indicated for the purpose of: 1. Promoting resolution of acute clinical manifestations of mucocutaneous _Herpes_ _simplex_ virus infections in immunocompromised patients. 2. Treatment of severe first episode primary or non-primary genital herpes in immune competent patients. 3. Treatment of acute manifestations of _Varicella _ _zoster_ virus infection in immunocompromised patients. 4. Treatment of shingles ( _Varicella zoster_ virus infection) in immune competent patients who show very severe acute local or systemic manifestations of the disease. Benefits can be expected in patients with rash duration shorter than 72 hours. The use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles. 5. Treatment of _Herpes simplex_ encephalitis. Version pfpaciii10321 supersedes: hhpaciii11019 Page 2 of 13 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE RAPID OR BOLUS INTRAVENOUS AND INTRAMUSCULAR OR SUBCUTANEOUS INJECTION OF ACICLOVIR MUST BE AVOIDED (see section 4.4 Special warnings and precautions for use and Method of Administration below). Indication Immune status Dosage _Herpes সম্পূর্ণ নথি পড়ুন