Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
phenoxymethylpenicillin potassium, Quantity: 28.284 mg/mL (Equivalent: phenoxymethylpenicillin, Qty 25 mg/mL)
AFT Pharmaceuticals Pty Ltd
Phenoxymethylpenicillin potassium
Oral Liquid, powder for
Excipient Ingredients: sucrose; sodium benzoate; saccharin sodium; Colour; Flavour
Oral
100 mL after reconstitution as directed
(S4) Prescription Only Medicine
When oral therapy is required in the treatment of mild to moderately severe infections due to penicillin sensitive organisms such as penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci. 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. For the prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. 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: Pale orange dry granular powder. Reconstituted solution is a clear orange solution with orange odour and flavour; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2010-12-21
PHENOXYMETHYLPENICILLIN-AFT Powder for Oral Liquid BP, Phenoxymethylpenicillin potassium equivalent to Phenoxymethylpenicillin 125 mg/5 mL and 250 mg/5 mL WHAT IS IN THIS LEAFLET This leaflet contains some common questions about Phenoxymethylpenicillin- AFT. It does not contain all the available information. It does not take the place of talking with your doctor or pharmacist. KEEP THIS LEAFLET WITH YOUR MEDICINE. YOU MAY NEED TO REFER TO IT AGAIN. WHAT THE MEDICINE IS USED FOR Phenoxymethylpenicillin-AFT is an antibiotic that belongs to the group of medicines called penicillins. It is used to treat infections in different parts of the body caused by bacteria. It works by killing the bacteria that are causing the infection. It will not work against viruses such as colds or the flu. Your doctor may have prescribed Phenoxymethylpenicillin-AFT for another reason. Ask your doctor or pharmacist if you have any questions about why phenoxymethylpenicillin has been prescribed for you. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ You must not take Phenoxymethylpenicillin-AFT if: • You have had an allergic reaction to any penicillin • You have had an allergic reaction to a cephalosporin • You have an allergy to any of the ingredients listed at the end of this leaflet Do not take if the packaging shows signs of tampering. Do not take if the expiry date printed on the pack has passed. If you are uncertain whether you should take Phenoxymethylpenicillin-AFT, talk to your doctor first. _BEFORE YOU START TO TAKE THE MEDICINE _ Tell your doctor if: • You have any allergies to any medicines, foods, preservatives, colours • You have or have had any other health problems/medical conditions including asthma and kidney problems. • You are pregnant, intend to become pregnant or are breastfeeding • You are taking any other medicines including any that you get without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE THE MEDICINE Take the dose prescribed by your doctor. It may vary d Aqra d-dokument sħiħ
1 AUSTRALIAN PRODUCT INFORMATION – PHENOXYMETHYLPENICILLIN-AFT (PHENOXYMETHYLPENICILLIN (AS POTASSIUM)) POWDER FOR ORAL LIQUID 1. NAME OF THE MEDICINE Phenoxymethylpenicillin potassium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, each bottle of Phenoxymethylpenicillin-AFT contains phenoxymethylpenicillin (as potassium) 125 mg per 5 mL, or 250 mg per 5 mL. Excipients with known effect: benzoates, sugars and saccharin For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for oral liquid. Phenoxymethylpenicillin-AFT, powder for oral liquid is a pale orange granular powder which when reconstituted with purified water forms Phenoxymethylpenicillin-AFT oral solution which is a clear orange coloured solution with an orange odour and flavour which contains phenoxymethylpenicillin potassium equivalent to phenoxymethylpenicillin 125 mg/5 mL or 250 mg/5 mL respectively. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS When oral therapy is required in the treatment of mild to moderately severe infections due to penicillin sensitive organisms such as penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci. 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. For the prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. 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 Dilution Instructions 125 mg/5 mL: Add 63 mL of purified water and shake well. 250 mg/5 mL: Add 60 mL of purified water and shake well. 2 _Adults_ _ _ 250-500 mg e Aqra d-dokument sħiħ