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

alphapharm pty ltd - vancomycin hydrochloride, quantity: 513 mg (equivalent: vancomycin, qty 500 mg) - injection, powder for - excipient ingredients: hydrochloric acid; water for injections; nitrogen - vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial medicine, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg enterococcus faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

morningside healthcare ltd - vancomycin hydrochloride - oral capsule - 125mg

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - vancomycin hydrochloride - powder for concentrate for solution for infusion - 1000 milligram(s) - glycopeptide antibacterials; vancomycin

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - vancomycin hydrochloride - powder for concentrate for solution for infusion - 500 milligram(s) - glycopeptide antibacterials; vancomycin

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

azurity pharmaceuticals, inc - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - firvanq is indicated for the treatment of clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age. firvanq is also indicated for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. important limitations of use - parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. - orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. to reduce the development of drug‑resistant bacteria and maintain the effectiveness of firvanq and other antibacterial drugs, firvanq should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. firvanq is contraindicated in patients with known hypersensitivity to vancomycin. there are no available data on firvanq use in pregnant women to inform a drug-associated risk of major birth defects or miscarriage. available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy-related outcomes (see data) . vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see data) . all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. human data a published study evaluated hearing loss and nephrotoxicity in infants of pregnant intravenous drug users treated with vancomycin for suspected or documented methicillin‑resistant s. aureus in the second or third trimester. the comparison groups were 10 non‑intravenous drug‑dependent patients who received no treatment, and 10 untreated intravenous drug‑dependent patients served as substance abuse controls. no infant in the vancomycin-exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. a published prospective study assessed outcomes in 55 pregnant women with a positive group b streptococcus culture and a high‑risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin at the time of delivery. vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). no major adverse reactions were recorded either in the mothers or their newborns. none of the newborns had sensorineural hearing loss. neonatal renal function was not examined, but all of the newborns were discharged in good condition. animal data vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day iv to rats or 120 mg/kg/day iv to rabbits. no effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively). maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). there are insufficient data to inform the levels of vancomycin in human milk. however, systemic absorption of vancomycin following oral administration is expected to be minimal [ see clinical pharmacology ( 12.3) ]. there are no data on the effects of firvanq on the breastfed infant or milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for firvanq and any potential adverse effects on the breastfed infant from firvanq or from the underlying maternal condition. firvanq is indicated in pediatric patients less than 18 years of age for the treatment of c. difficile ‑associated diarrhea and enterocolitis caused by s. aureus (including methicillin‑resistant strains) [ see indications and usage ( 1) and dosage and administration ( 2.3) ]. in clinical trials, 54% of vancomycin hydrochloride‑treated subjects were > 65 years of age. of these, 40% were between the ages of > 65 and 75, and 60% were > 75 years of age. clinical studies with vancomycin hydrochloride in c. difficile ‑associated diarrhea have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy. in patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin-induced nephrotoxicity [ see warnings and precautions( 5.3), adverse reactions ( 6.1) and clinical studies ( 14.1) ]. patients over 65 years of age may take longer to respond to therapy compared to patients 65 years of age and younger [ see clinical studies ( 14.1) ]. clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely.

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

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 1.03 mg (equivalent: estradiol, qty 1 mg); norethisterone acetate, quantity: 0.5 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; lactose monohydrate; purified talc; hypromellose; triacetin; magnesium stearate - short term treatment of menopausal symptoms related to oestrogen deficiency in women more than one year after menopause (see dosage and administration and clinical trials). for the prevention of postmenopausal bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. life style modifications and the risk benefit profiles of kliovance should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. see precautions and dosage and administration.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - vancomycin hydrochloride 513mg equivalent to 500 mg vancomycin;  ;  ;   - powder for infusion - 500 mg - active: vancomycin hydrochloride 513mg equivalent to 500 mg vancomycin       - vancomycin hydrochloride is indicated for potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. vancomycin hydrochloride is useful in therapy of severe staphylococcal (including methicillin resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin hydrochloride is effective alone or in combination with an aminoglycoside for endocarditis caused by streptococcus viridans or s. bovis. for endocarditis caused by enterococci (e.g. strep. faecalis), vancomycin hydrochloride is effective only in combination with an aminoglycoside. vancomycin hydrochloride is effective for the treatment of diptheroid endocarditis. vancomycin hydrochloride is used in combination with rifampicin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by staph. epidermidis or diptheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin hydrochloride. vancomycin hydrochloride should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin hydrochloride alone is inappropriate for this indication.

Ireland - English - HPRA (Health Products Regulatory Authority)

generics (uk) limited - vancomycin hydrochloride - pdr/conc/soln for infus - 1000 milligram - vancomycin - antibacterials for systemic use: glycopeptide antibacterials - it is used for severe infections, caused by gram-positive bacteria susceptible to vancomycin which cannot be treated with or failed to respond or are resistant to other antibiotics such as penicillins and cephalosporins.

Ireland - English - HPRA (Health Products Regulatory Authority)

generics (uk) limited - vancomycin hydrochloride - pdr/conc/soln for infus - 500 milligram - vancomycin - antibacterials for systemic use: glycopeptide antibacterials - it is used for severe infections, caused by gram-positive bacteria susceptible to vancomycin which cannot be treated with or failed to respond or are resistant to other antibiotics such as penicillins and cephalosporins

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

civica, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (ß-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp is effective in the treatment of staphylococcal endocarditis. its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. when staphylococcal infecti