Singapore - English - HSA (Health Sciences Authority)

lotus international pte. ltd. - raloxifene hcl - tablet, film coated - 60 mg - raloxifene hcl 60 mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

deeplaid pharmaco ltd. (homoeo) - bovista - liquid

Bangladesh - English - DGDA (Directorate General of Drug Administration)

green homoeo laboratories - bovista - liquid

Bangladesh - English - DGDA (Directorate General of Drug Administration)

new life & company (pvt) ltd. (homoeo) - bovista - liquid

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

vistapharm, llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus oral solution 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 sirolimus oral solution be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2) ].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 sirolimus oral solution 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 sirolimus oral solution 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 sirolimus oral solution 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 sirolimus oral solution 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 sirolimus oral solution  in maintenance renal transplantpatients have not been established [see clinical studies (14.4) ]. sirolimus oral solution is contraindicated in patients with a hypersensitivity to sirolimus [see warnings and precautions (5.4) ]. risk summary based on animal studies and the mechanism of action, sirolimus 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 sirolimus and any potential adverse effects on the breastfed child from sirolimus. contraception females should not be pregnant or become pregnant while receiving sirolimus. advise females of reproductive potential that animal studies have been shown sirolimus 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 sirolimus therapy, during sirolimus therapy, and for 12 weeks after sirolimus 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 sirolimus [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 sirolimus. azoospermia has been reported in males with the use of sirolimus and has been reversible upon discontinuation of sirolimus in most cases. renal transplant the safety and efficacy of sirolimus in pediatric patients < 13 years have not been established. the safety and efficacy of sirolimus oral solution 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 sirolimus oral solution in this subpopulation of children ≥ 13 years is supported by evidence from adequate and well-controlled trials of sirolimus 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 sirolimus oral solution 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) ]. clinical studies of sirolimus oral solution 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 sirolimus 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) ]. sirolimus (sir-oh-li-mus) oral solution be sure that you read and understand the following instructions for the correct way to dilute and take sirolimus oral solution. ask your pharmacist or doctor if you are not sure. important: - always keep the bottle in an upright position. - you may store sirolimus oral solution that is in a syringe at room temperature up to 77°f (25°c) or in the refrigerator at 36°f to 46°f (2°c to 8°c) for up to 24 hours. see “how should i store sirolimus oral solution?” at the end of these instructions for use. - sirolimus oral solution can develop a slight haze when it is refrigerated. if this happens, bring the sirolimus oral solution to room temperature and then gently shake the bottle until the haze goes away. - only use a glass or plastic cup to dilute sirolimus oral solution. - if you are a caregiver, do not let sirolimus oral solution come in contact with your skin or eyes. if you get the oral solution on your skin, wash the area well with soap and water. if you get the oral solution in your eyes, rinse with plain water. - if you spill sirolimus oral solution, dry the area with a dry paper towel and then wipe the area with a wet paper towel. throw away the paper towels in the trash and wash your hands well with soap and water. each sirolimus oral solution carton contains: a) a 2 oz. (60 ml fill) amber glass bottle of sirolimus (concentration of 1 mg/ml) b) 1 oral syringe adapter for fitting into the neck of the bottle c) enough disposable amber oral syringes and caps for daily dosing d) 1 carrying case you will also need: - glass or plastic cup - 6 oz. of water or orange juice only. 1. opening the solution bottle. - remove the safety cap by pushing down and turning counterclockwise (figure 1). 2. the first time you use a bottle of sirolimus oral solution: - insert the oral syringe adapter (plastic tube with stopper) tightly into the bottle until it is even with the top of the bottle (figure 2). - do not remove the oral syringe adapter from the bottle once inserted.  3. use a new disposable amber oral syringe for each dose of sirolimus oral solution. - fully push down (depress) on the plunger of the disposable amber oral syringe. - then, tightly insert the oral syringe into the opening in the adapter (figure 3). 4. withdraw the prescribed amount of sirolimus oral solution: - gently pull back the plunger of the syringe until the level of the oral solution is even with the marking on the syringe for your prescribed dose. - always keep the bottle in an upright position. - if bubbles form within the oral solution in the syringe, empty the syringe into the bottle and repeat step 4 (figure 4). - you may need to repeat step 4 more than once to draw up your prescribed dose. 5. if your doctor tells you to carry your medicine with you: - each dose of sirolimus oral solution should be placed in an oral syringe. place a cap securely on each syringe. the cap should snap into place (figure 5). figure 6: placing syringe in carrying case - place the capped syringe in the enclosed carrying case (figure 6). if you need more than 1 carrying case, talk with your doctor or pharmacist. - see `how should i store sirolimus oral solution? ' for storage instructions. figure 7: emptying syringe into glass 6. taking a dose of sirolimus oral solution: - choose a clean flat work surface. place a clean paper towel on the work surface. wash and dry your hands. - empty the syringe into a glass or plastic cup containing at least 2 ounces (1/4 cup, 60 ml) of water or orange juice, stir vigorously for 1 minute and drink right away (figure 7). - if more than 1 syringe is needed for your prescribed dose, empty the oral solution from each syringe into the same glass or plastic cup of water or orange juice. - refill the container with at least 4 ounces (1/2 cup, 120 ml) of water or orange juice, stir vigorously again and drink the rinse solution.do not mix sirolimus oral solution with apple juice, grapefruit juice, or other liquids. only glass or plastic cups should be used to mix sirolimus oral solution. - the syringe and cap should be used only one time and then thrown away. - throw away the paper towel and clean the work surface. wash your hands. 7. always store the bottles of medication in the refrigerator. how should i store sirolimus oral solution? - store bottles of sirolimus oral solution in the refrigerator at 36°f to 46°f (2°c to 8°c) - protect from light - store sirolimus oral solution that is in a syringe at room temperature up to 77°f (25°c) or in the refrigerator at 36°f to 46°f (2°c to 8°c) for up to 24 hours - if necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°f (25°c) for up to 15 days - when a bottle of sirolimus oral solution is opened, it should be used within 1 month - use any diluted sirolimus oral solution right away keep sirolimus oral solution and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: novitium pharma llc 70 lake drive, east windsor new jersey 08520 distributed by: vistapharm, inc. largo, fl 33771 usa trademarks are the property of their respective owners. revised: april, 2022 lb4062-05

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

lotus pharmaceutical co ltd - raloxifene hydrochloride -

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

interpharma pty ltd - bortezomib, quantity: 3.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib ever pharma, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

interpharma pty ltd - bortezomib, quantity: 2.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib ever pharma, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Ireland - English - HPRA (Health Products Regulatory Authority)

abbvie limited - botulinum toxin type a - powder for solution for injection - other muscle relaxants, peripherally acting agents; botulinum toxin

Malta - English - Medicines Authority

abbvie limited citywest business campus, dublin 24, ireland - powder for solution for injection - botulinum toxin type a 4 allergan units/0.1 millilitre - muscle relaxants