Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Cefaclor monohydrate 524.7mg equivalent to cefaclor 500 mg
Sandoz New Zealand Limited
Cefaclor monohydrate 524.7 mg (equivalent to cefaclor 500 mg)
500 mg
Capsule
Active: Cefaclor monohydrate 524.7mg equivalent to cefaclor 500 mg Excipient: Croscarmellose sodium Dimeticone Gelatin Iron oxide red Magnesium stearate Titanium dioxide
Blister pack, PVC/PVDC/Al, 100 capsules
Prescription
Prescription
ACS Dobfar SpA
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 100 capsules - 36 months from date of manufacture stored at or below 30°C
2000-06-22
_ Version 01 _ 1 CEFACLOR SANDOZ ® _Cefaclor (as monohydrate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cefaclor Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Cefaclor Sandoz against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. WHAT CEFACLOR SANDOZ IS USED FOR The name of your medicine is Cefaclor Sandoz. It contains the active ingredient cefaclor monohydrate. Cefaclor Sandoz is an antibiotic used to treat infections in different parts of the body caused by bacteria. Cefaclor Sandoz belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection. Cefaclor Sandoz will not work against infections caused by viruses such as colds or the flu. Your doctor may have prescribed Cefaclor Sandoz for another reason. Ask your doctor if you have any questions about why Cefaclor Sandoz has been prescribed for you. This medicine is available only with a doctor’s prescription. This medicine is not addictive. BEFORE YOU TAKE CEFACLOR SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CEFACLOR SANDOZ IF YOU HAVE AN ALLERGY TO: CEFACLOR ANY OTHER CEPHALOSPORINS OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET UNDER PRODUCT DESCRIPTION. ANY OTHER SIMILAR MEDICINES Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips or tongue or other parts of the body which may cause difficulty in swallowing or breathing skin rash, itching or hives. Do not take this medicine if you have or have had any of the following medical conditions: A SERIOUS ALLERGIC REACTION TO ANY PENICILLINS. You may be more likely to have an allergic reaction to Cefacl Lue koko asiakirja
NEW ZEALAND DATASHEET CEFACLOR SANDOZ _CEFACLOR MONOHYDRATE PH EUR, POWDER FILLED CAPSULE, 250 MG AND 500 MG, _ _GRANULES FOR ORAL SUSPENSION 125 MG/5 ML AND 250 MG/5 ML (AS CEFACLOR) _ PRESENTATION _CEFACLOR SANDOZ CAPSULES _ 250 MG Capsule, powder filled, Size 2, reddish brown opaque cap and body. Each capsule contains cefaclor monohydrate equivalent to cefaclor 250 mg. 500 MG Capsule, powder filled, Size 0, reddish brown opaque cap and body. Each capsule contains cefaclor monohydrate equivalent to cefaclor 500 mg. _CEFACLOR SANDOZ GRANULES FOR ORAL SUSPENSION _ 125 MG/5 ML Suspension, oral, granules for, light yellow to orange yellow coloured. Reconstituted suspension contains in 5 ml, cefaclor monohydrate equivalent to cefaclor 125 mg. 250 MG/5 ML Suspension, oral, granules for, light yellow to orange yellow coloured. Reconstituted suspension contains in 5 ml, cefaclor monohydrate equivalent to cefaclor 250 mg. USES _ACTIONS _ PHARMACOTHERAPEUTIC GROUP J01DC04 – Second generation cephalosporins, cefaclor. MECHANISM OF ACTION Beta-lactam antibiotic. PHARMACODYNAMIC EFFECTS Inhibition of bacterial cell wall synthesis. ANTIBIOTIC CLASS Cefaclor monohydrate is a semi-synthetic cephalosporin for oral administration. ANTIBIOTIC NATURE AND MODE OF ACTION _In vitro _tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell- wall synthesis. SUSCEPTIBILITY DATA While _in vitro _studies have demonstrated the susceptibility of most strains of the following organisms to cefaclor, clinical efficacy for infections other than those included in the Indications section is unknown. Aerobes, Gram-positive: Staphylococci, including coagulase-positive, coagulase-negative, and penicillinase-producing strains; _Streptococcus pyogenes_ (Group A beta-haemolytic streptococci); _Streptococcus pneumoniae_;_ Corynebacterium_ spp. Aerobes, Gram-negative: _Moraxella (Branhamella) catarrhalis_; _Haemophilus influenzae_, including beta-lactamase-producing ampicillin-resistant strains; _Escherichia coli Lue koko asiakirja