देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
doxycycline monohydrate, Quantity: 104.1 mg (Equivalent: doxycycline, Qty 100 mg)
Sandoz Pty Ltd
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate; hydrogenated castor oil; povidone; magnesium stearate
Oral
7 tablets
(S4) Prescription Only Medicine
Infections caused by the following micro-organisms: Mycoplasma pneumoniae (primary atypical pneumonia); Rickettsiae (Queensland tick typhus, epidemic typhus fever, Q fever, murine endemic typhus fever, Australo-Pacific endemic scrub typhus); Chlamydia psittaci (psittacosis); Chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always elminated, as judged by immunofluorescence. Inclusion conjunctivitis may be treated with oral doxycycline, or in combination with topical agents.) Borreliae (relapsing fever); Calymmatobacterium (Donovania) granulomatis (granuloma inguinale). DOXYCYCLINE SANDOZ is indicated for the treatment of Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis (see Dosage and Administration). Infections caused by the following Gram-negative micro-organisms: Vibrio sp. (cholera); Brucella sp. (brucellosis; in conjunction with streptomycin); Yersinia pestis (plague); Francisella tularensis (tularaemia); Bartonella bacilliformis (bartonellosis); Bacteriodes sp. When penicillin is contraindicated, doxycycline is an alternative medicine in the treatment of infections due to: Treponema pallidum (syphilis); Treponema pertenue (yaws); Neisseria gonorrhoea (see Dosage and Administration). Note: DOXYCYCLINE SANDOZ is not the medicine of choice in the treatment of any type of staphylococcal infection or infections caused by Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, Streptococcus faecalis or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. DOXYCYCLINE SANDOZ should not be used in these infections unless the organism has been shown to be sensitive. For upper respiratory infections due to group A beta-haemolytic streptococci (including prophylaxis of rheumatic fever), penicillin is the usual medicine of choice. In acute intestinal amoebiasis DOXYCYCLINE SANDOZ may be a useful adjunct to amoebicides. In severe acne doxycycline may be a useful adjunctive therapy. Doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by Plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by Plasmodium vivax. Doxycycline is only able to suppress malaria caused by Plasmodium vivax. As there are relatively few locations where P. vivax does not coexist to some extent with P. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine.
Visual Identification: Dull yellow, round, biplane tablets with single sided score notch.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1998-10-08
DOXYCYCLINE SANDOZ ® 1 DOXYCYCLINE SANDOZ ® _doxycycline monohydrate tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Doxycycline 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 this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DOXYCYCLINE SANDOZ IS USED FOR This medicine is used to: • treat certain infections • control acne • prevent a form of malaria • treat anthrax infection or for use after exposure to anthrax. It contains the active ingredient doxycycline. Doxycycline belongs to a group of medicines called tetracyclines. It works by killing or stopping the growth of bacteria which cause infections or make acne worse. They also work against parasites that cause malaria. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE DOXYCYCLINE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • doxycycline, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description • any other similar medicines such as tetracyclines. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE TAKING PREPARATIONS CONTAINING ISOTRETINOIN, ETRETINATE OR VITAMIN A. ASK YOUR DOCTOR OR PHARMACIST IF YOU ARE NOT SURE IF YOU ARE TAKING ONE OF THESE MEDICINES. DO NOT पूरा दस्तावेज़ पढ़ें
190731-Doxycycline Sandoz-pi Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION DOXYCYCLINE SANDOZ ® (DOXYCYCLINE MONOHYDRATE) TABLETS 1 NAME OF THE MEDICINE Doxycycline monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Doxycycline Sandoz 50 mg tablets contains 50 mg doxycycline (as monohydrate). Each Doxycycline Sandoz 100 mg tablets contains 100 mg doxycycline (as monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Doxycycline Sandoz 50 mg tablets – dull yellow, round, biconvex tablets. Doxycycline Sandoz 100 mg tablets – dull yellow, round, biplane tablets with a single-sided score notch. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Infections caused by the following micro-organisms: _Mycoplasma pneumoniae_ (primary atypical pneumonia); Rickettsiae (Queensland tick typhus, epidemic typhus fever, Q fever, murine endemic typhus fever, Australo-Pacific endemic scrub typhus); _Chlamydia psittaci_ (psittacosis); _Chlamydia _ _trachomatis_ (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis may be treated with oral doxycycline, or in combination with topical agents.) Borreliae (relapsing fever); _Calymmatobacterium _ _(Donovania)_ _granulomatis_ (granuloma inguinale). Doxycycline Sandoz is indicated for _ _ the treatment of Anthrax due to _Bacillus anthracis_ , including inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized _Bacillus anthracis _ (see Section 4.2 Dose and method of administration). _ _ Infections caused by the following Gram-negative micro-organisms: _Vibrio_ sp. (cholera); _Brucella_ sp. (brucellosis; in conjunction with streptomycin); _Yersinia _ _pestis_ (plague); _Francisella tularensis_ (tularaemia); _Bartonella bacilliformis_ (bartonellosis); _Bacteroides_ sp. When penicillin is cont पूरा दस्तावेज़ पढ़ें