Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
phenoxymethylpenicillin benzathine, Quantity: 40.27 mg/mL (Equivalent: phenoxymethylpenicillin, Qty 30 mg/mL)
Viatris Pty Ltd
phenoxymethylpenicillin benzathine
Oral Liquid, suspension
Excipient Ingredients: sodium propyl hydroxybenzoate; sodium methyl hydroxybenzoate; butylated hydroxyanisole; polysorbate 80; xanthan gum; sucrose; purified water; sodium citrate dihydrate; potassium sorbate; citric acid; Flavour
Oral
100mL
(S4) Prescription Only Medicine
Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. Note: Oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.
Visual Identification: beige, dense, viscous creamy suspension, apricot flavour; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2010-06-09
CILICAINE ® V C I L I C A I N E ® V 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 CILICAINE V? CILICAINE V contains the active ingredient phenoxymethylpenicillin benzathine. CILICAINE V is used to treat infections in different parts of the body caused by bacteria. For more information, see Section 1. Why am I using CILICAINE V? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CILICAINE V? Do not use if you have ever had an allergic reaction to CILICAINE V 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 CILICAINE V? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CILICAINE V and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CILICAINE V? • Your doctor will tell you how much CILICAINE V you need to take. • This will depend on the type of infection you have. More instructions can be found in Section 4. How do I use CILICAINE V? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CILICAINE V? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using CILICAINE V. • If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor. • If you develop itching with swelling of skin rash or difficulty breathing while you are taking CILICAINE V do not take any more and contact your doctor immediately. THINGS YOU SHOULD NOT DO • Do not take CILICAINE V to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if they have the same condition as you. • Do not stop taking your medic Lue koko asiakirja
AUSTRALIAN PRODUCT INFORMATION CILICAINE ® V _Phenoxymethylpenicillin (as benzathine) oral suspension _ 1 NAME OF THE MEDICINE Phenoxymethylpenicillin (as benzathine) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of oral liquid suspension contains 150 mg of phenoxymethylpenicillin (as benzathine) as the active ingredient. Excipients with known effect: hydroxybenzoates, sorbates, sugars and soya bean products. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM CILICAINE V 150 mg/5 mL oral liquid suspension is a beige, dense, viscous creamy suspension and apricot flavoured. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham’s chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. Note: Oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS 250 mg to 500 mg every four to six hours, preferable one hour before food. The dosage should be determined according to sensitivity of the organisms and severity of the infection. Prevention of recurrence following rheumatic fever: 250 mg twice a day continuously. CHILDREN _Infants and small children_ - 15 to 50 mg/kg in three to six divided doses. If not calculated by bodyweight the following dosage schedule may be used. • UP TO 1 YEAR: 60 mg every six hours. • 1 TO 5 YEARS: 120 mg every six hours. • 6 TO 12 YEARS: 120 to Lue koko asiakirja