Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLAVULANIC ACID; AMOXYCILLIN TRIHYDRATE
SPG PHARMA (MALAYSIA) SDN BHD
CLAVULANIC ACID; AMOXYCILLIN TRIHYDRATE
5 x 3s Tablets
SIAM BHEASACH CO LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CAVUMOX 625 MG TABLET AMOXICILLIN / CLAVULANIC ACID (500 MG / 125 MG) 1 WHAT IS IN THIS LEAFLET. 1. What CAVUMOX is used for 2. How CAVUMOX works 3. Before you use CAVUMOX 4. How to use CAVUMOX 5. While you are using it 6. Side effects 7. Storage and Disposal 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number 1. WHAT CAVUMOX IS USED FOR. Contains 500 mg amoxicillin and 125 mg clavulanic acid per tablet. It is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics. CAVUMOX should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. CAVUMOX oral presentations for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites: Upper respiratory tract infections, including ENT (e.g., tonsillitis, sinusitis, otitis media) Lower respiratory tract infections (e.g., acute exacerbation of chronic bronchitis, lobar and bronchopneumonia) Genito-urinary tract infections (e.g., cystitis, urethritis, pyelonephritis) Skin and soft tissue infections (e.g., boils, abscesses, cellulitis, wound infections) Bone and joint infections (e.g., osteomyelitis) Dental infections (e.g., dentoalveolar abscess) Other infections (e.g., septic abortion, puerperal sepsis, intra- abdominal sepsis) Susceptibility to CAVUMOX will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. 2. HOW CAVUMOX WORKS The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms Læs hele dokumentet
_ _ _ _ _ _ PRODUCT NAME CAVUMOX 625 MG TABLET NAME AND STRENGTH OF ACTIVE SUBSTANCE Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate) PRODUCT DESCRIPTION White, oblong, biconvex film coated tablet PHARMACODYNAMICS CAVUMOX is a combination of amoxicillin (as trihydrate), a broad-spectrum antibiotic and clavulanic acid (as potassium salt), a progressive and irreversible inhibitor of β-Lactamase enzymes produced by many Gram-positive and Gram-negative bacteria. The combination of amoxicillin/clavulanic acid extends the antibiotic spectrum of amoxicillin to include bacteria normally resistant to amoxicillin and β-lactam antibiotic. CAVUMOX is bactericidal to a wide range of Gram-positive and Gram-negative bacteria includes β- lactamase penicillin resistant organisms. PHARMACOKINETICS The pharmacokinetics of the two components of CAVUMOX are closely matched. Peak serum levels of both occur about 1 hour after oral administration. Absorption of CAVUMOX is optimized at the start of a meal. Doubling the dosage of CAVUMOX approximately doubles the serum levels achieved. Both amoxicillin and clavulanate have low levels of serum binding; about 70% remains free in the serum. INDICATION CAVUMOX is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics. CAVUMOX should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. CAVUMOX oral presentations for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites: ▪ Upper respiratory tract infections, including ENT (e.g. tonsillitis, sinusitis, otitis media) ▪ Lower respiratory tract infections (e.g. acute exacerbation of chronic bro Læs hele dokumentet