Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
potassium clavulanate, Quantity: 7.4 mg/mL (Equivalent: clavulanic acid, Qty 6.25 mg/mL); amoxicillin trihydrate, Quantity: 28.7 mg/mL (Equivalent: amoxicillin, Qty 25 mg/mL)
Aspen Pharmacare Australia Pty Ltd
amoxicillin trihydrate,potassium clavulanate
Oral Liquid, powder for
Excipient Ingredients: silicon dioxide; hypromellose; aspartame; succinic acid; xanthan gum; colloidal anhydrous silica; Flavour
Oral
powder for 75mL Syrup, powder for 5mL, powder for 100mL Syrup(E), powder for 60mL Syrup(E), powder for 10mL(E)
Medicine Registered
(S4) Prescription Only Medicine, Not scheduled. Not considered by committee
AUGMENTIN is indicated in the treatment of the following infections when caused by AUGMENTIN sensitive, beta-lactamase producing organisms: Skin and Skin Structure Infections, including cases caused by beta-lactamase producing S. aureus, E. coli and Klebsiella spp. (only some strains may be sensitive). Urinary Tract Infections, including cases caused by beta-lactamase producing E. coli, P. mirabilis & Klebsiella spp. Upper Respiratory Tract Infections, such as sinusitis, including cases caused by beta-lactamase producing H.influenzae and M.catarrhalis, and otitis media, especially cases caused by beta-lactamase producing H. influenzae, M. catarrhalis and S. aureus. Lower Respiratory Tract Infections, especially cases caused by beta-lactamase producing H.influenzae and M.catarrhalis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to AUGMENTIN. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to AUGMENTIN should not require the addition of another antibiotic due to the amoxicillin content of AUGMENTIN.
Visual Identification: White to off-white free flowing powder; Container Type: Bottle; Container Material: Glass Type III Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-10-25
1 AUGMENTIN ® SYRUP _Amoxycillin and Clavulanic Acid _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you give AUGMENTIN SYRUP. This leaflet answers some common questions about AUGMENTIN SYRUP. It does not contain all of the available information. It does not take the place of talking to your child’s doctor or pharmacist. All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your child’s doctor has weighed the expected benefits of your child taking AUGMENTIN SYRUP against the risks this medicine could have for your child. AUGMENTIN must be given to your child as instructed. If you have any concerns about giving this medicine to your child, ask your child’s doctor or pharmacist. Keep this leaflet until your child has finished the course of AUGMENTIN SYRUP. You may need to read it again. WHAT IS AUGMENTIN SYRUP USED FOR? AUGMENTIN SYRUP contains two active ingredients. One of these is a penicillin called amoxycillin and the other is clavulanate. AUGMENTIN SYRUP belongs to the penicillin group of antibiotics. AUGMENTIN SYRUP is used to treat a wide range of infections caused by bacteria. These infections may affect the chest (e.g. bronchitis or pneumonia), bladder (e.g. cystitis), sinuses (e.g. sinusitis), the ears (e.g. otitis media) or the skin. AUGMENTIN SYRUP works by killing the bacteria that cause these infections. AUGMENTIN SYRUP is used for the treatment of the infections listed. However the doctor may prescribe this medicine for another use. If you want more information ask the doctor. Your doctor may have prescribed AUGMENTIN SYRUP for another reason. There is no evidence that AUGMENTIN SYRUP is addictive. BEFORE YOU GIVE AUGMENTIN SYRUP _ _ _AUGMENTIN SYRUP MUST _ _NOT BE GIVEN IF: _ your child is allergic to penicillin or similar types of antibiotics (such as cephalosporins) or any of the ingredients contained in AUGMENTIN SYRUP. If your child has ever had an allergic reaction (s Прочетете целия документ
1 AUGMENTIN™ PRODUCT INFORMATION (AMOXYCILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE) NAME OF THE MEDICINE AUGMENTIN is a combination product containing the semisynthetic antibiotic amoxycillin and the -lactamase inhibitor, potassium clavulanate (the potassium salt of clavulanic acid). Chemically, amoxycillin is D-(-)- -amino-p-hydroxybenzyl-penicillin trihydrate. It is susceptible to hydrolysis by -lactamases. Clavulanic acid is produced by the fermentation of _Streptomyces clavuligerus_. It is an irreversible inhibitor of many -lactamase enzymes except type 1 (Richmond). It is a -lactam compound with only weak antibacterial activity. Chemically potassium clavulanate is potassium Z-(2R,5R)-3-(B- hydroxyethylidene) clavam-2-carboxylate. DESCRIPTION AUGMENTIN SYRUP also contains the inactive ingredients xanthum gum, aspartame, silicon dioxide, colloidal anhydrous silica, succinic acid, hypromellose and mixed fruit flavour. PHARMACOLOGY AUGMENTIN is stable in the presence of gastric acid. Its two components are rapidly absorbed if administered before or with a meal, but if given after meals, the serum levels of clavulanic acid are significantly reduced. In fasting subjects mean peak serum levels after 1 Augmentin tablet were 2.98 mg/L (range 1.2 to 5.1 ) for clavulanic acid and 3.89 mg/L (range 2.4 to 6.0 ) for amoxycillin. These levels occurred at 30 to 120 minutes and 60 to 240 minutes respectively after dosing. Following 1 Augmentin Forte tablet peak serum levels in fasting subjects were 3.28 to 4.72 mg/L for clavulanic acid, and 10.28 to 12.06 mg/L for amoxycillin, and were achieved 60 to 120 minutes after dosing. Following oral administration of Augmentin syrup at a dose of 8.3 mg/Kg (amoxycillin 6.6mg/Kg + clavulanic acid 1.7mg/Kg) to children with otitis media the means of peak concentrations were 2.76 mg/L for amoxycillin and 0.78 mg/L for clavulanic acid. In children given Augmentin Forte syrup 2 16.6 mg/Kg,(amoxycillin 13.3mg/Kg + clavulanic acid 3.3mg/Kg) the means of peak values were Прочетете целия документ