Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Clarithromycin 250mg; ; Clarithromycin 250mg
Viatris Limited
Clarithromycin 250 mg
250 mg
Film coated tablet
Active: Clarithromycin 250mg Excipient: Croscarmellose sodium Hydrated silica Hyprolose Hypromellose Magnesium stearate Microcrystalline cellulose Povidone Propylene glycol Purified talc Quinoline yellow Sorbic acid Sorbitan oleate Starch Stearic acid Titanium dioxide Vanillin Active: Clarithromycin 250mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Ethanol Hyprolose Hypromellose Magnesium stearate Microcrystalline cellulose Povidone Propylene glycol Purified talc Purified water Quinoline yellow Sorbic acid Sorbitan oleate Starch Stearic acid Titanium dioxide Vanillin
Blister pack, 10 tablets
Prescription
Prescription
Abbott Healthcare (Puerto Rico) Ltd
Klacid tablets are indicated for treatment of infections caused by susceptible organisms. Such infections include: · Respiratory tract infections including bronchitis, pneumonia, tonsillitis, sinusitis and pharyngitis. · Skin and soft tissue infections such as folliculitis, cellulitis and erysipelas. · Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii. · Prevention of disseminated Mycobacterium avium complex infection in HIV-infected patients with CD4 lymphocyte counts less than or equal to 100/mm3. · Clarithromycin in the presence of acid suppression is indicated for the treatment of duodenal ulcer and in reducing the rate of ulcer recurrence.
Package - Contents - Shelf Life: Blister pack, - 10 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, - 14 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture
1991-02-20
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION KLACID ® , KLACID ® IV _CLARITHROMYCIN POWDER FOR ORAL LIQUID 250 MG/5 ML_ _FILM COATED TABLETS 250 MG AND 500 MG_ _POWDER FOR INJECTION 500 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Klacid. This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Klacid against the benefits they expect it will have on you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT KLACID IS USED FOR Klacid is used to treat certain bacterial infections, including the following: • respiratory tract infections • skin infections • ear infections • peptic ulcer • certain types of bacterial infections Klacid is also used to prevent a specific bacterial infection associated with HIV infection. Klacid is an antibiotic that belongs to the group of medicines called macrolides. These medicines work by killing or stopping the growth of bacteria which cause infections. Klacid will not work against infections caused by viruses, such as colds or flu. Klacid is available only with a doctor's prescription. _KLACID TO TREAT PEPTIC _ _ULCER_ Peptic ulcers are associated with an infection in the intestine and stomach caused by a bacteria called Helicobacter pylori (H. pylori). Nearly all patients with peptic ulcers are infected with this bacterium. The H. pylori infection can be treated with a combination of Klacid (clarithromycin) and other appropriate antibiotic and stomach acid control treatments. Your doctor will determine the best combination for you. If your symptoms return, consult your doctor. It is possible that Klacid may no longer be effective in killing the H. pylori infection and a different antibiotic may be needed. Lue koko asiakirja
Page 1 of 33 NEW ZEALAND DATA SHEET KLACID ® , KLACID ® IV 1. PRODUCT NAME Klacid, 250 mg and 500 mg, film coated tablet. Klacid, 125 mg/5 mL and 250 mg/5 mL, granules for oral suspension. Klacid IV, 500 mg, powder for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Klacid 250 mg: Each film coated tablet contains 250 mg of clarithromycin. Klacid 500 mg: Each film coated tablet contains 500 mg of clarithromycin. Klacid 125 mg/5 ml: Each 5 ml of the granules for suspension contains 125 mg of clarithromycin. Klacid 250 mg/5 ml: Each 5 ml of the granules for suspension contains 250 mg of clarithromycin. Klacid IV: Each vial contains 739.5 mg clarithromycin lactobionate, corresponding to 500 mg of clarithromycin. For the full list of excipients, see section 6.1. Klacid Suspension: Contains sugars and sorbates. Klacid Tablet: Contains sorbates 3. PHARMACEUTICAL FORM Klacid 250 mg – yellow, ovaloid, film coated tablets. Klacid 500 mg – pale yellow, ovaloid, film coated tablets. Klacid 125 mg/5 ml: white to off-white granules. Klacid 250 mg/5 ml: white to off-white granules. Klacid IV: white to off-white caked, lyophilized powder. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Klacid I.V. is indicated whenever parenteral therapy is required for treatment of sensitive microorganisms in the following conditions: Page 2 of 33 Upper respiratory tract infections. Lower respiratory tract infections (see section 4.4 and 5.1 regarding Sensitivity testing). Skin and soft tissue infections (see section 4.4 and 5.1 regarding Sensitivity testing). Klacid Suspension is indicated for treatment of infections caused by susceptible organisms. Such infections include: Upper respiratory infections (e.g. streptococcal pharyngitis). Lower respiratory infections (e.g. bronchitis, pneumonia) (see section 4.4 and 5.1 regarding Sensitivity testing). Acute otitis media. Skin and skin structure infections (e.g. impetigo, folliculitis, cellulitis, abscesses) (see section 4.4 and 5.1 regarding Sensi Lue koko asiakirja