ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - tacrolimus 5mg - modified release capsule - 5 mg - active: tacrolimus 5mg excipient: ethanol ethylcellulose gelatin hypromellose opacode s-1-15083 red (trace, see tt70-) iron oxide red iron oxide yellow lactose monohydrate magnesium stearate sodium laurilsulfate titanium dioxide - primary immunosuppression in liver, kidney, pancreas, kidney-pancreas, lung or heart allograft recipients and rescue use in liver, kidney or other solid organ (heart, lung, pancreas or kidney-pancreas) transplantation, that has either failed conventional immunosuppressive agents, or where such agents are producing intolerable side effects.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - mycophenolic acid (unii: hu9dx48n0t) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolic acid 180 mg - mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. mycophenolic acid delayed-release tablets are to be used in combination with cyclosporine and corticosteroids. mycophenolic acid delayed-release tablets and mycophenolate mofetil (mmf) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (mpa), mycophenolate mofetil, or to any of its excipients. reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing

ארצות הברית - אנגלית - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus 1 mg in 1 ml - rapamune (sirolimus) is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low-to moderate-immunologic risk , it is recommended that rapamune be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2) ]. in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level >80%]), it is recommended that rapamune be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration (2.3) , clinical studies (14.3) ]. cyclosporine withdrawal has not been studied in patients with banff grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those with serum creatinine >4.5 mg/dl, black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies [see clinical studies (14.2) ]. in patients at high-immunologic risk , the safety and efficacy of rapamune used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient [see clinical studies (14.3) ]. in pediatric patients , the safety and efficacy of rapamune have not been established in patients <13 years old, or in pediatric (<18 years) renal transplant patients considered at high-immunologic risk [see adverse reactions (6.5), clinical studies (14.6) ]. the safety and efficacy of de novo use of rapamune without cyclosporine have not been established in renal transplant patients [see warnings and precautions (5.12) ]. the safety and efficacy of conversion from calcineurin inhibitors to rapamune in maintenance renal transplant patients have not been established [see clinical studies (14.4) ]. rapamune (sirolimus) is indicated for the treatment of patients with lymphangioleiomyomatosis (lam). rapamune is contraindicated in patients with a hypersensitivity to rapamune [see warnings and precautions (5.4) ]. risk summary based on animal studies and the mechanism of action, rapamune can cause fetal harm when administered to a pregnant woman [see data, clinical pharmacology (12.1) ]. there are limited data on the use of sirolimus during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal studies, sirolimus was embryo/fetotoxic in rats at sub-therapeutic doses [see data ]. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data sirolimus crossed the placenta and was toxic to the conceptus. in rat embryo-fetal development studies, pregnant rats were administered sirolimus orally during the period of organogenesis (gestational day 6–15). sirolimus produced embryo-fetal lethality at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg, on a body surface area basis) and reduced fetal weight at 1 mg/kg (5-fold the clinical dose of 2 mg). the no observed adverse effect level (noael) for fetal toxicity in rats was 0.1 mg/kg (0.5-fold the clinical dose of 2 mg). maternal toxicity (weight loss) was observed at 2 mg/kg (10-fold the clinical dose of 2 mg). the noael for maternal toxicity was 1 mg/kg. in combination with cyclosporine, rats had increased embryo-fetal mortality compared with sirolimus alone. in rabbit embryo-fetal development studies, pregnant rabbits were administered sirolimus orally during the period of organogenesis (gestational day 6–18). there were no effects on embryo-fetal development at doses up to 0.05 mg/kg (0.5-fold the clinical dose of 2 mg, on a body surface area basis); however, at doses of 0.05 mg/kg and above, the ability to sustain a successful pregnancy was impaired (i.e., embryo-fetal abortion or early resorption). maternal toxicity (decreased body weight) was observed at 0.05 mg/kg. the noael for maternal toxicity was 0.025 mg/kg (0.25-fold the clinical dose of 2 mg). in a pre- and post-natal development study in rats, pregnant females were dosed during gestation and lactation (gestational day 6 through lactation day 20). an increased incidence of dead pups, resulting in reduced live litter size, occurred at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg/kg on a body surface area basis). at 0.1 mg/kg (0.5-fold the clinical dose of 2 mg), there were no adverse effects on offspring. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg, the highest dose tested. risk summary it is not known whether sirolimus is present in human milk. there are no data on its effects on the breastfed infant or milk production. the pharmacokinetic and safety profiles of sirolimus in infants are not known. sirolimus is present in the milk of lactating rats. there is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action [see clinical pharmacology (12.1)]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rapamune and any potential adverse effects on the breastfed child from rapamune. contraception females should not be pregnant or become pregnant while receiving rapamune. advise females of reproductive potential that animal studies have been shown rapamune to be harmful to the developing fetus. females of reproductive potential are recommended to use highly effective contraceptive method. effective contraception must be initiated before rapamune therapy, during rapamune therapy, and for 12 weeks after rapamune therapy has been stopped [see warnings and precautions (5.15), use in specific populations (8.1) ]. infertility based on clinical findings and findings in animals, male and female fertility may be compromised by the treatment with rapamune [see adverse reactions (6.7), nonclinical toxicology (13.1) ]. ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of rapamune. azoospermia has been reported in males with the use of rapamune and has been reversible upon discontinuation of rapamune in most cases. renal transplant the safety and efficacy of rapamune in pediatric patients <13 years have not been established. the safety and efficacy of rapamune oral solution and rapamune tablets have been established for prophylaxis of organ rejection in renal transplantation in children ≥13 years judged to be at low- to moderate-immunologic risk. use of rapamune oral solution and rapamune tablets in this subpopulation of children ≥ 13 years is supported by evidence from adequate and well-controlled trials of rapamune oral solution in adults with additional pharmacokinetic data in pediatric renal transplantation patients [see clinical pharmacology (12.3) ]. safety and efficacy information from a controlled clinical trial in pediatric and adolescent (< 18 years of age) renal transplant patients judged to be at high-immunologic risk, defined as a history of one or more acute rejection episodes and/or the presence of chronic allograft nephropathy, do not support the chronic use of rapamune oral solution or tablets in combination with calcineurin inhibitors and corticosteroids, due to the higher incidence of lipid abnormalities and deterioration of renal function associated with these immunosuppressive regimens compared to calcineurin inhibitors, without increased benefit with respect to acute rejection, graft survival, or patient survival [see clinical studies (14.6) ]. lymphangioleiomyomatosis the safety and efficacy of rapamune in pediatric patients <18 years have not been established. clinical studies of rapamune oral solution or tablets did not include sufficient numbers of patients ≥65 years to determine whether they respond differently from younger patients. data pertaining to sirolimus trough concentrations suggest that dose adjustments based upon age in geriatric renal patients are not necessary. differences in responses between the elderly and younger patients have not been identified. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, or cardiac function, and of concomitant disease or other drug therapy. the maintenance dose of rapamune should be reduced in patients with hepatic impairment [see dosage and administration (2.7), clinical pharmacology (12.3) ]. dosage adjustment is not required in patients with renal impairment [see dosage and administration (2.8), clinical pharmacology (12.3) ]. rapamune / raap-a-mune/ (sirolimus) oral solution be sure that you read and understand the following instructions for the correct way to dilute and take rapamune oral solution. ask your pharmacist or doctor if you are not sure. important: each rapamune oral solution carton contains: you will also need: figure 1: opening the bottle 1. open the solution bottle. figure 2: inserting adapter 2. the first time you use a bottle of rapamune oral solution: figure 3: inserting syringe 3. use a new disposable amber oral syringe for each dose of rapamune oral solution. figure 4: withdrawing solution 4. withdraw the prescribed amount of rapamune oral solution: figure 5: capping syringe 5. if your doctor tells you to carry your medicine with you: figure 6: placing syringe in carrying case figure 7: emptying syringe into glass 6. taking a dose of rapamune oral solution: 7. always store the bottles of medication in the refrigerator. how should i store rapamune? keep rapamune and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. lab-0579-6.0 revised: august 2022

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - basiliximab, quantity: 20 mg - injection, powder for - excipient ingredients: sucrose; mannitol; glycine; monobasic potassium phosphate; sodium chloride; dibasic sodium phosphate - simulect is indicated for the prophylaxis of acute organ rejection in renal transplantation.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - baclofen, quantity: 50 microgram/ml - injection, solution - excipient ingredients: water for injections; sodium chloride - lioresal intrathecal is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - baclofen, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections - lioresal intrathecal is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - baclofen, quantity: 500 microgram/ml - injection, solution - excipient ingredients: water for injections; sodium chloride - lioresal intrathecal is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

archis pharma llc - mycophenolic acid (unii: hu9dx48n0t) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. mycophenolic acid delayed-release tablets are to be used in combination with cyclosporine and corticosteroids. mycophenolic acid delayed-release tablets and mycophenolate mofetil (mmf) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (mpa), mycophenolate mofetil, or to any of its excipients. reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 10 mg - capsule, soft - excipient ingredients: corn glycerides; ethanol; propylene glycol; dl-alpha-tocopherol; peg-40 hydrogenated castor oil; glycerol; gelatin; titanium dioxide; isopropyl alcohol; hypromellose; purified water; cochineal; aluminium chloride; sodium hydroxide - as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. for induction and/or maintenance of remission in the nephrotic syndrome. cyclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see precautions). for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with the quality of life. for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: dl-alpha-tocopherol; ethanol; corn glycerides; propylene glycol; peg-40 hydrogenated castor oil - as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. for induction and/or maintenance of remission in the nephrotic syndrome. cyclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cystostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see warnings). for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. additional indication from 11 june 1997: for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.