United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin 12 mg in 1 g - clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled trials in pregnant women treated with clindamycin phosphate and tretinoin gel. clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clindamycin phosphate and tretinoin gel was tested for maternal and developmental toxicity in new zealand white rabbits with topical doses of 60, 180 and 600 mg/kg/day. clindamycin phosphate and tretinoin gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (noael) for maternal and developmental toxicity following dermal administration of clindamycin phosphate and tretinoin gel for two weeks prior to artificial insemination and continuing until gestation day 18, inclusive. for purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of clindamycin phosphate and tretinoin gel applied daily to a 60 kg person. clindamycin teratology (segment ii) studies using clindamycin were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) or with subcutaneous doses of clindamycin up to 180 mg/kg/day (175 and 88 times the amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity. tretinoin in oral segment iii studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~ 78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison). with widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). the significance of these spontaneous reports in terms of risk to the fetus is not known. dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on a body surface area comparison. oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on a body surface area comparison. it is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate and tretinoin gel. however, orally and parenterally administered clindamycin has been reported to appear in breast milk. because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. it is not known whether tretinoin is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and tretinoin gel is administered to a nursing woman. safety and effectiveness of clindamycin phosphate and tretinoin gel in pediatric patients under the age of 12 have not been established. clinical trials of clindamycin phosphate and tretinoin gel included patients 12 to 17 years of age. [see clinical studies (14)] clinical studies of clindamycin phosphate and tretinoin gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - clindamycin phosphate, quantity: 0 qs (equivalent: clindamycin, qty 150 mg/ml) - injection, solution - excipient ingredients: water for injections; benzyl alcohol; sodium hydroxide; disodium edetate; hydrochloric acid - indications as at 20 june 2005 : dalacin c phosphate is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. dalacin c phosphate is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. its use should be reserved for penicillin - allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. anaerobes - serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection, all when given in conjunction with an antibiotic of appropriate gram

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - clindamycin phosphate, quantity: 0 qs (equivalent: clindamycin, qty 150 mg/ml) - injection, solution - excipient ingredients: disodium edetate; hydrochloric acid; water for injections; sodium hydroxide; benzyl alcohol - indications as at 20 june 2005 : dalacin c phosphate is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. dalacin c phosphate is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. its use should be reserved for penicillin - allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. anaerobes - serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract) and infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection, all when given in conjunction with an antibiotic of appropriate g

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - tilmicosin phosphate - oral solution/suspension - tilmicosin phosphate antibiotic active 250.0 mg/ml - antibiotic & related - pigs | boar | gilt | piglet | sow | swine - actinobacillus pleuropneumoniae (haemoph | actinomyces pyogenes | mycoplasma hyopneumoniae | pasteurella multocida | fowl cholera | reduction of lung lesions | respiratory disease | swine enzootic pneumonia

United States - English - NLM (National Library of Medicine)

hospira, inc. - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 50 mg in 2 ml - fludarabine phosphate for injection, usp is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate, usp in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate, usp is contraindicated in those patients who are hypersensitive to this drug or its components.

United States - English - NLM (National Library of Medicine)

sandoz inc - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - fludarabine phosphate injection is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate injection in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate injection should not be used in patients with severe renal impairment (creatinine clearance less than 30 ml/min/1.73 m2 ). [see warnings and precautions (5.7) ] none pregnancy category d. [see warnings and precautions (5.9) ] it is not known whether fludarabine phosphate is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions including tumorigenicity in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug for the mother

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520), butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - codeine phosphate 30 mg - butalbital, acetaminophen, caffeine, and codeine phosphate capsules is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of butalbital, acetaminophen, caffeine, and codeine phosphate capsules in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable. butalbital, acetaminophen, caffeine, and codeine phosphate capsules is contraindicated under the following conditions: −  hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine. −  patients with porphyria. butalbital, acetaminophen, caffeine, and codeine phosphate capsules is controlled by the drug enforcement administration and is classified under schedule iii. codeine codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence,

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor viii, quantity: 1000 iu; von willebrand factor, quantity: 2400 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - von willebrand factor, quantity: 1200 iu; factor viii, quantity: 500 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - fludarabine phosphate, quantity: 50 mg - injection, concentrated - excipient ingredients: dibasic sodium phosphate dihydrate; sodium hydroxide; water for injections; nitrogen - fludarabine ebewe is indicated for the treatment of b-cell chronic lymphocytic leukaemia.