Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
aciclovir, Quantity: 25 mg/mL
Accord Healthcare Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid
Intravenous Infusion
1
(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: A clear, colourless or almost colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-06-17
Aciclovir Accord - version 2 1 ACICLOIR ACCORD CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ACICLOVIR ACCORD? Aciclovir Accord contains the active ingredient aciclovir. Aciclovir belongs to a group of medicines called antivirals. It works by preventing the reproduction of the virus which is causing the condition. Aciclovir Accord is used for the management of several different infections caused by viruses, such as herpes and shingles. For more information, see Section 1. Why am I using Aciclovir Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ACICLOVIR ACCORD? Do not use if you have ever had an allergic reaction to aciclovir, valaciclovir or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Aciclovir Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Aciclovir Accord and affect how it works. See Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ACICLOVIR ACCORD? Aciclovir Accord is an injection and will be given to you by your doctor or nurse. More instructions can be found in Section 4. How do I use Aciclovir Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ACICLOVIR ACCORD? THINGS YOU SHOULD DO You should drink plenty of fluids as instructed by your doctor or nurse. If you are unable to drink, due to your condition, your doctor will ensure that you receive plenty of fluids. DRIVING OR USING MACHINES Be careful driving or operating machinery until you know how Aciclovir Accord affects you. This medicine may cause dizziness, light-headedness, tiredness, or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery Прочитать полный документ
Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION ACICLOVIR ACCORD (ACICLOVIR) INJECTION 1 NAME OF THE MEDICINE Aciclovir 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aciclovir sodium is a synthetic acyclic purine nucleoside analogue. Aciclovir sodium is a white crystalline powder. Aciclovir Accord contains the equivalent of 25 mg/mL of aciclovir; the aciclovir is present as aciclovir sodium. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Aciclovir Accord is a clear colourless or almost colourless sterile solution. Aciclovir Accord has a pH of approximately 11. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Aciclovir Accord 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. 4.2 D OSE AND METHOD OF ADMINISTRATION 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 ADMINISTRATION below ). Indication Immune status Dosage _Herpes simplex _ infection Normal or immunocompromised 5 mg/kg every 8 hours Very severe _Herpes zoster _ infection (shingles) Normal 5 mg/kg every 8 hours _Varicella zoster _ infection Immunocompromised 10 mg/kg every 8 hours _Herpes simplex _ encephalitis Normal or immunocompromised 10 mg/ Прочитать полный документ