Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
cefaclor monohydrate, Quantity: 26.23 mg/mL (Equivalent: cefaclor, Qty 25 mg/mL)
Sun Pharma ANZ Pty Ltd
cefaclor monohydrate
Oral Liquid, powder for
Excipient Ingredients: citric acid; xanthan gum; sucrose; sodium citrate dihydrate; colloidal anhydrous silica; sodium benzoate; allura red AC; Flavour; potable water; simethicone; cetostearyl alcohol
Oral
100mL (Reconstituted)
(S4) Prescription Only Medicine
Infections due to susceptible microorganisms. Lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. Upper respiratory tract infections, including pharyngitis and tonsillitis and otitis media. Skin and skin structure infections. Urinary tract infections, including pyelonephritis and cystitis. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor appears to be as effective as phenoxymethylpenicillin in the eradication of Streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.
Visual Identification: White to off-white granular powder forming a red suspension on reconstitution with water.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-09-02
CEFACLOR SUN 1 CEFACLOR SUN 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 CEFACLOR SUN? CEFACLOR SUN contains the active ingredient cefaclor monohydrate. CEFACLOR SUN is used to treat infections caused by bacteria in different parts of the body. For more information, see Section 1. Why am I using CEFACLOR SUN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CEFACLOR SUN? Do not use if you have ever had an allergic reaction to CEFACLOR SUN 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 CEFACLOR SUN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CEFACLOR SUN 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 CEFACLOR SUN? • Your doctor will tell you how much CEFACLOR SUN 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 CEFACLOR SUN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CEFACLOR SUN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using CEFACLOR SUN. • Tell your doctor if the symptoms of your infection do not improve within a few days, or if they become worse. • If you become pregnant while you are taking CEFACLOR SUN, tell your doctor immediately. THINGS YOU SHOULD NOT DO • Do not give CEFACLOR SUN to anyone else, even if they have the same condition as you. • Do not use CEFACLOR SUN to treat any other complaints unless your doctor tells you to. • Do not stop taking your medicine or change the dosage without checking with your doctor. DRIVING OR USING MACHINES • Lesen Sie das vollständige Dokument
Product Information – Australia Cefaclor SUN Suspension V1 Page 1 CEFACLOR SUN SUSPENSION NAME OF THE MEDICINE Cefaclor monohydrate Chemical name: 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. Structural formula: Molecular formula: C 15 H 14 CIN 3 O 4 S.H 2 O. Molecular Weight: 385.8 CAS Registry number: 70356-03-5. DESCRIPTION Cefaclor monohydrate is a white to off-white crystalline powder, slightly soluble in water, but is insoluble in alcohol and chloroform. Each bottle contains cefaclor monohydrate as the active ingredient. In addition, each bottle contains the following inactive ingredients: xanthan gum, sodium benzoate, sucrose, colloidal anhydrous silica, allura red AC, strawberry flavouring (PI), sodium citrate, anhydrous citric acid and simethicone emulsion (PI). PHARMACOLOGY Cefaclor is a semisynthetic, broad spectrum cephalosporin antibiotic for oral administration. PHARMACOKINETICS Cefaclor is well absorbed after oral administration, whether taken with food or while fasting. However, when it is taken with food, the peak concentration achieved is 50 to 75% of that observed when the drug is administered to fasting subjects and generally appears from 45 to 60 minutes later. The presence of food in the gastrointestinal tract does not alter the total amount of cefaclor absorbed. Following administration of 250 mg, 500 mg and 1 g doses to fasting subjects, average peak plasma levels of antibacterial activity (expressed as µg/mL of cefaclor) of 7, 13 and 23 µg/mL, respectively, were obtained at 30 to 60 minutes. The reduced peak serum levels resulting from the administration of cefaclor with food should be considered with reference to the sensitivity of the infecting organism, severity of illness, the dose being administered and the variability in the peak plasma levels which occur with cefaclor. The plasma half-life in healthy subjects is independent of dosage form and averages 40 to 60 minutes. In elderly subjects (>65 years) with normal serum creatinine values, a higher pe Lesen Sie das vollständige Dokument