Izrael - angličtina - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - ceftolozane as sulfate; tazobactam as sodium - powder for concentrate for solution for infusion - tazobactam as sodium 0.5 g; ceftolozane as sulfate 1 g - ceftolozane and enzyme inhibitor - zerbaxa is indicated for the treatment of the following infections in adults:-complicated intra abdominal infections;-acute pyelonephritis caused by pathogens resistant to other treatments as confirmed by urine culture-complicated urinary tract infections.-hospital-acquired pneumonia (hap), including ventilator-associated pneumonia (vap).consideration should be given to official guidance on the appropriate use of antibacterial agents

Spojené státy - angličtina - NLM (National Library of Medicine)

remedyrepack inc. - irbesartan (unii: j0e2756z7n) (irbesartan - unii:j0e2756z7n), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. the choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. the decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy. data from studies v and vi [ see clinical studies ( 14.2) ] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or hydrochlorothiazide (hctz) monotherapy. the relationship between baseline blood pressure and achievement of a sesbp <140 or <130 mmhg or sedbp <90 or <80 mmhg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or hctz monotherapy are shown in figures 1a through 2b.  figure 1a: probability of achieving sbp <140 mmhg in patients from initial therapy studies v (week 8) and vi (week 7) * figure 1b: probability of achieving sbp <130 mmhg in patients from initial therapy studies v (week 8) and vi (week 7) * figure 2a: probability of achieving dbp <90 mmhg in patients from initial therapy studies v (week 8) and vi (week 7) * figure 2b: probability of achieving dbp <80 mmhg in patients from initial therapy studies v (week 8) and vi (week 7) * * for all probability curves, patients without blood pressure measurements at week 7 (study vi) and week 8 (study v) were counted as not reaching goal (intent-to-treat analysis). the above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., week 8 sitting systolic blood pressure ≤140 mmhg) for the treatment groups. the curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. the estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. for example, a patient with a blood pressure of 180/105 mmhg has about a 25% likelihood of achieving a goal of <140 mmhg (systolic) and 50% likelihood of achieving <90 mmhg (diastolic) on irbesartan alone (and lower still likelihoods on hctz alone). the likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic). - irbesartan and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. - because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. - do not coadminister aliskiren with irbesartan and hydrochlorothiazide tablets in patients with diabetes [ see drug interactions ( 7) ]. risk summary irbesartan and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [ see clinical considerations ] . most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. when pregnancy is detected, discontinue irbesartan and hydrochlorothiazide as soon as possible. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes regardless of drug exposure. 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. clinical considerations disease-associated maternal and/or embryo-fetal risk hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and postpartum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of pregnancy. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to irbesartan and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment. in neonates with a history of in utero exposure to irbesartan and hydrochlorothiazide, if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.   thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults [ see warnings and precautions ( 5.1) ] . data animal data irbesartan crosses the placenta in rats and rabbits. in female rats given irbesartan prior to mating through gestation and lactation at oral doses of 50, 180, or 650 mg/kg/day (1.6 to 21.1 times the maximum recommended human dose (mrhd) based on body surface area), fetuses examined on gestation day 20 showed increased incidences of hydroureter and renal pelvic cavitation and/or absence of renal papilla in all irbesartan-treated groups. subcutaneous edema also occurred in fetuses at maternal doses ≥180 mg/kg/day (5.8 times the mrhd). these anomalies occurred when female rats received irbesartan from prior to mating through day 20 of gestation but were not observed in pups postnatally in the same study, or when irbesartan was given to pregnant rats only during organogenesis (gestation day 6 through gestation day 15) at oral doses from 50 to 450 mg/kg/day (up to 14.6 times the mrhd). in addition, no adverse effects on kidney development were observed in pups from dams given irbesartan from gestation day 15 through lactation day 24 at doses of 50, 180, or 650 mg/kg/day (up to 21.1 times the mrhd). the observed effects are believed to be late gestational effects of the drug. pregnant rabbits given oral doses of irbesartan of 30 mg/kg/day (1.9 times the mrhd based on body surface area) experienced a high rate of maternal mortality and abortion. surviving females had a slight increase in early resorptions and a corresponding decrease in live fetuses. radioactivity was present in the rat and rabbit fetuses during late gestation following oral doses of radiolabeled irbesartan. when pregnant mice and rats were given hydrochlorothiazide at doses up to 3000 and 1000 mg/kg/day, respectively (about 600 and 400 times the mrhd) during their respective periods of major organogenesis, there was no evidence of fetal harm. a development toxicity study was performed in rats with doses of 50/50 mg/kg/day and 150/150 mg/kg/day irbesartan and hydrochlorothiazide. although the high dose combination appeared to be more toxic to the dams than either drug alone, there did not appear to be an increase in toxicity to the developing embryos. there are no available data on the presence of irbesartan in human milk, effects on milk production, or the breastfed infant. irbesartan or some metabolite of irbesartan is secreted in the milk of lactating rats. thiazides appear in human milk [ see clinical pharmacology ( 12.3) ] . because of the potential for adverse effects on the nursing infant, the use of irbesartan and hydrochlorothiazide in breastfeeding women is not recommended. safety and effectiveness in pediatric patients have not been established. of 1694 patients receiving irbesartan and hydrochlorothiazide in controlled clinical studies of hypertension, 264 (15.6%) were 65 years and over, while 45 (2.7%) were 75 years and over. no overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out [ see clinical pharmacology ( 12.3) and clinical studies ( 14) ].

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

corcym pty ltd - 45578 - mitral/tricuspid annuloplasty ring - the memo 4d consists of a nickel - titanium alloy inner core enclosed in a sewing ring of silicone and knitted polyester fabric. the fabric is coated with carbofilm?, a thin layer of turbostratic carbon. the ring exhibits flexibility to accommodate the three-dimensional annulus motion. to support the remodeling, the flexibility is maximal in the posterior curved portion and gradually decreases towards the anterior linear segment memo 4d device is intended for correction of mitral insufficiencies or steno-insufficiencies. the use of the memo 4d device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus.

Spojené státy - angličtina - NLM (National Library of Medicine)

genentech inc. - risdiplam (unii: 76rs4s2et1) (risdiplam - unii:76rs4s2et1) - evrysdi is indicated for the treatment of spinal muscular atrophy (sma) in pediatric and adult patients. none. there is a pregnancy exposure registry that monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to evrysdi during pregnancy. physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-760-1098 or visiting https://www.evrysdipregnancyregistry.com. risk summary there are no adequate data on the developmental risk associated with the use of evrysdi in pregnant women. in animal studies, administration of risdiplam during pregnancy or throughout pregnancy and lactation resulted in adverse effects on development (embryofetal mortality, malformations, decreased fetal body weights, and reproductive impairment in offspring) at or above clinically relevant drug exposures [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. based on animal data, advise pregnant women of the potential risk to the fetus. data animal data oral administration of risdiplam (0, 1, 3, or 7.5 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal body weights and increased incidences of fetal structural variations at the highest dose tested, which was not associated with maternal toxicity. the no-effect level for adverse effects on embryofetal development (3 mg/kg/day) was associated with maternal plasma exposure (auc) approximately 2 times that in humans at the maximum recommended human dose (mrhd) of 5 mg. oral administration of risdiplam (0, 1, 4, or 12 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in embryofetal mortality, fetal malformations (hydrocephaly), and structural variations at the highest dose tested, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development (4 mg/kg/day) was associated with maternal plasma exposure (auc) approximately 4 times that in humans at the mrhd. when risdiplam (0, 0.75, 1.5, or 3 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, gestation was prolonged in the dams, and delayed sexual maturation (vaginal opening) and impaired reproductive function (decreased numbers of corpora lutea, implantation sites, and live embryos) were observed in female offspring at the highest dose. the no-effect dose for adverse effects on pre- and postnatal development in rats (1.5 mg/kg/day) was associated with maternal plasma exposure (auc) similar to that in humans at the mrhd. risk summary there are no data on the presence of risdiplam in human milk, the effects on the breastfed infant, or the effects on milk production. risdiplam was excreted in the milk of lactating rats orally administered risdiplam. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for evrysdi and any potential adverse effects on the breastfed infant from evrysdi or from the underlying maternal condition. studies of risdiplam in juvenile and adult rats and in monkeys demonstrated adverse effects on the reproductive organs, including germ cells, in males at clinically-relevant plasma exposures [see use in specific populations (8.4) and nonclinical toxicology (13.1)] . pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating evrysdi [see use in specific populations (8.1)] . contraception evrysdi may cause embryofetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. female patients advise female patients of reproductive potential to use effective contraception during treatment with evrysdi and for at least 1 month after her last dose. infertility male patients male fertility may be compromised by treatment with evrysdi [see nonclinical toxicology (13.1)] . counsel male patients of reproductive potential receiving evrysdi about the potential effects on fertility. male patients may consider sperm preservation prior to treatment. the safety and effectiveness of evrysdi in pediatric patients (neonates and older) have been established. use of evrysdi for sma is supported by evidence from adequate and well-controlled studies of evrysdi in patients 2 months of age and older with sma. use of evrysdi for sma in patients 2 months of age and younger is supported by pharmacokinetic and safety data from pediatric patients 16 days and older, and pharmacokinetic modeling and simulation to identify the dosing regimen [see clinical pharmacology (12.3) and clinical studies (14)] . juvenile animal toxicity data oral administration of risdiplam (0, 0.75, 1.5, 2.5 mg/kg/day) to young rats from postnatal day (pnd) 4 through pnd 31 resulted in decreased growth (body weight, tibia length) and delayed sexual maturation in males at the mid and high dose. the skeletal and body weight deficits persisted after cessation of dosing. ophthalmic changes consisting of vacuoles in the anterior vitreous were seen at the high dose. decreases in absolute b lymphocyte counts were observed at all doses after cessation of dosing. decreases in testis and epididymis weights, which correlated with degeneration of the seminiferous epithelium in the testis, occurred at the mid and high doses; the histopathology findings were reversible, but organ weight persisted after cessation of dosing. impaired female reproductive performance (decreased mating index, fertility index, and conception rate) was observed at the high dose. a no-effect dose for adverse developmental effects on preweaning rats was not identified. the lowest dose tested (0.75 mg/kg/day) was associated with plasma exposures (auc) lower than that in humans at the maximum recommended human dose (mrhd) of 5 mg/day. oral administration of risdiplam (0, 1, 3, or 7.5 mg/kg/day) to young rats from pnd 22 through pnd 112 produced a marked increase in micronuclei in the bone marrow, male reproductive organ histopathology (degeneration/necrosis of the seminiferous tubule epithelium, oligo/aspermia in the epididymis, spermatic granulomas), and adverse effects on sperm parameters (decreased sperm concentration and motility, increased sperm morphology abnormalities) at the highest dose tested. increases in t lymphocytes (total, helper, and cytotoxic) were observed at the mid and high doses. the reproductive and immune effects persisted after cessation of dosing. the no-effect dose (1 mg/kg/day) for adverse effects on postweaning juvenile rats was associated with plasma exposures (auc) lower than that in humans at the mrhd. clinical studies of evrysdi did not include patients aged 65 years and older to determine whether they respond differently from younger adult patients. instructions for use evrysdi® [ev-riz-dee] (risdiplam) for oral solution please read and understand this instructions for use and the patient information leaflet before you start taking evrysdi for information about evrysdi and how to prepare and give evrysdi through an oral syringe, gastrostomy tube (g-tube), or nasogastric tube (ng-tube). if you have any questions about how to take evrysdi, contact your healthcare provider. evrysdi should come as a liquid in a bottle when you receive it from the pharmacy. do not take evrysdi and contact your pharmacist if the medicine in the bottle is a powder. each evrysdi carton contains (see figure a): important information about evrysdi - ask your healthcare provider to show you the correct oral syringe you should use and how to measure your prescribed daily dose. - always use the reusable oral syringes that come with evrysdi to measure your prescribed daily dose. if your carton does not contain two identical syringes, contact your pharmacist. - always take evrysdi exactly as your healthcare provider tells you to take it. - take evrysdi 1 time daily after a meal at approximately the same time each day. - do not take evrysdi if the bottle adapter is not in the bottle. if the bottle adapter is not in the bottle, contact your pharmacist. - do not mix evrysdi into food or liquids. do not mix evrysdi with formula or milk. - do not take evrysdi if the bottle or oral syringes are damaged. - avoid getting evrysdi on your skin or in your eyes. if evrysdi gets on your skin, wash the area with soap and water. if evrysdi gets in your eyes, rinse your eyes with water. - if you spill evrysdi, dry the area with a dry paper towel and then clean with water. throw away the paper towel in the trash and wash your hands well with soap and water. - if there is not enough evrysdi left in the bottle for your prescribed dose, throw away (discard) the bottle with remaining evrysdi and used oral syringes according to your local requirements. - use a new bottle of evrysdi to get your prescribed dose. do not mix evrysdi from the new bottle with the bottle you are currently using. how to store evrysdi - store evrysdi in the refrigerator between 36°f to 46°f (2°c to 8°c). do not freeze. - if necessary, evrysdi can be kept at room temperature up to 104°f (up to 40°c) for a combined total of 5 days. evrysdi can be removed from, and returned to, a refrigerator. the total combined time out of refrigeration should not be more than 5 days. throw away evrysdi if it has been kept at room temperature for more than 5 days. - store evrysdi in the original amber bottle in an upright position with the cap tightly closed. - throw away (discard) any unused portion of evrysdi 64 days after mixed by the pharmacist (constitution) when stored in the refrigerator at 36°f to 46°f (2°c to 8°c). please see the discard after date written on the bottle label (see figure c). - ask your pharmacist for the discard after date if it is not written on the bottle label. - throw away any unused portion of evrysdi that has been kept above 104°f (40°c). - keep evrysdi, all medicines and syringes out of the reach of children. a) preparing and withdrawing your dose how to prepare your dose of evrysdi if you are taking your dose of evrysdi by mouth, follow the instructions in "b) how to take a dose of evrysdi by mouth ". if you are taking your dose of evrysdi through a gastrostomy tube, follow the instructions in "c) how to give a dose of evrysdi through a gastrostomy tube ". if you are taking your dose of evrysdi through a nasogastric tube, follow the instructions in "d) how to give a dose of evrysdi through a nasogastric tube ". b) how to take a dose of evrysdi by mouth sit upright when taking a dose of evrysdi by mouth. c) how to give a dose of evrysdi through a gastrostomy tube if you are giving evrysdi through a gastrostomy tube, ask your healthcare provider to show you how to inspect the gastrostomy tube before giving evrysdi. d) how to give a dose of evrysdi through a nasogastric tube if you are giving evrysdi through a nasogastric tube, ask your healthcare provider to show you how to inspect the nasogastric tube before giving evrysdi. e) how to clean the oral syringe after use evrysdi is a registered trademark of genentech, inc. distributed by: genentech, inc. 1 dna way south san francisco, ca 94080-4990 approved: 3/2023 this instructions for use has been approved by the u.s. food and drug administration. ©2023 genentech, inc. all rights reserved

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

health care surgical - 17751 - bone matrix implant, synthetic - the injectable bone substitute contains a soluble carrier which acts as a spacer and a binder of the particles. this device provides an environment for bone ingrowth. the injectable bone substitute is progressively replaced by new bone according to the remodeling process. the injectable bone substitute is intended for use to reconstruct bony voids or bone gaps of the skeletal system (e.g. extremities, spine and pelvis).the performances of the injectable bone substitute are the filling of bone defects and the bony ingrowth from local osseous tissue onto the surface of the product (osteoconduction process).the total resorption of the product depends on numerous factors such as its size and volume, the location of the defect, the surgical technique, the health status of the patient. the bone reconstruction time is always inferior to the total resorption time.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

arthrex australia pty ltd - 45039 - fixation screw, bone, biodegradable - the biocomposite interference screw is comprised of tcp, pldla and ha. significant strength is added to the implant by virtually eliminating stress risers while creating a macro and micro porous matrix to aid in the bone remodeling and replacement process. the screw provides the necessary pull-out strength during the healing period and is absorbed. intended to provide interference fixations of bone-tendon-bone or soft tissue grafts during acl reconstruction.

Spojené státy - angličtina - NLM (National Library of Medicine)

a-s medication solutions - valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin ii receptor blocker (arb) class to which valsartan principally belongs. there are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. add-on therapy valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. replacement therapy valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.  initial therapy valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. the choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. the decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. individual blood pressure goals may vary based upon the patient's risk. data from the high dose multifactorial trial [see clinical studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. the figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. the curve of each treatment group was estimated by logistic regression modeling. the estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. figure 1: probability of achieving systolic blood pressure <140 mmhg at week 8 figure 2: probability of achieving diastolic blood pressure <90 mmhg at week 8 figure 3: probability of achieving systolic blood pressure <130 mmhg at week 8 figure 4: probability of achieving diastolic blood pressure <80 mmhg at week 8 for example, a patient with a baseline blood pressure of 160/100 mmhg has about a 41% likelihood of achieving a goal of < 140 mmhg (systolic) and 60% likelihood of achieving < 90 mmhg (diastolic) on valsartan alone and the likelihood of achieving these goals on hctz alone is about 50% (systolic) or 57% (diastolic). the likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). the likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic). valsartan and hydrochlorothiazide tablets is contraindicated in patients who are hypersensitive to any component of this product. because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.   do not coadminister aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes [see drug interactions (7)]. risk summary valsartan and hydrochlorothiazide tablet can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see clinical considerations).   when pregnancy is detected discontinue valsartan and hydrochlorothiazide tablet as soon as possible.   the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions valsartan oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of gestation. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. if oligohydramnios is observed, consider alternative drug treatment. closely observe neonates with histories of in utero exposure to valsartan and hydrochlorothiazide tablet for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to valsartan and hydrochlorothiazide tablet, if oliguria or hypotension occurs, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. hydrochlorothiazide thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. it accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma. use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. since they do not prevent or alter the course of eph (edema, proteinuria, hypertension) gestosis (pre-eclampsia), these drugs should not be used to treat hypertension in pregnant women. the use of hydrochlorothiazide for other indications (e.g., heart disease) in pregnancy should be avoided. data animal data valsartan plus hydrochlorothiazide there was no evidence of teratogenicity in mice, rats, or rabbits treated orally with valsartan at doses of up to 600, 100, and 10 mg/kg/day [9, 3.5 and 0.5 times the maximum recommended human dose (mrhd)], respectively, in combination with hydrochlorothiazide at doses up to 188, 31, and 3 mg/kg/day (38, 13 and 2 times the mrhd). fetotoxicity was observed in association with maternal toxicity in rats at valsartan/hydrochlorothiazide doses of ≥ 200/63 mg/kg/day and in rabbits at valsartan/hydrochlorothiazide doses of 10/3 mg/kg/day. evidence of fetotoxicity in rats consisted of decreased fetal weight and fetal variations of sternebrae, vertebrae, ribs, and/or renal papillae. evidence of fetotoxicity in rabbits included increased numbers of late resorptions with resultant increases in total resorptions, post-implantation losses, and decreased number of live fetuses. risk summary there is limited information regarding the presence of  valsartan and hydrochlorothiazide tablet in human milk, the effects on the breastfed infant, or the effects on milk production. valsartan is present in rat milk. hydrochlorothiazide is present in human breast milk. because of the potential for serious adverse reactions in breastfed infants, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan and hydrochlorothiazide tablet. data valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. safety and effectiveness of valsartan and hydrochlorothiazide tablet in pediatric patients have not been established. in the controlled clinical trials of valsartan and hydrochlorothiazide tablets, 764 (17.5%) patients treated with valsartan-hydrochlorothiazide were ≥ 65 years and 118 (2.7%) were ≥ 75 years. no overall difference in the efficacy or safety of valsartan-hydrochlorothiazide was observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. safety and effectiveness of valsartan and hydrochlorothiazide tablets in patients with severe renal impairment (crcl ≤ 30 ml/min) have not been established. no dose adjustment is required in patients with mild (crcl 60 to 90 ml/min) or moderate (crcl 30 to 60ml/min) renal impairment. valsartan no dose adjustment is necessary for patients with mild-to-moderate liver disease. no dosing recommendations can be provided for patients with severe liver disease. hydrochlorothiazide minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.

Malajsie - angličtina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - adalimumab -

Malajsie - angličtina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - adalimumab -

Malajsie - angličtina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - adalimumab -