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

physicians total care, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - jintelitm (norethindrone acetate and ethinyl estradiol tablets, usp) are indicated in women with an intact uterus for the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis. non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin d intake, and when indicated, pharmacologic therapy. postmenopausal women require an average of 1500 mg/day of elemental calcium. therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. vitamin d supplementation of 400-800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. risk factors for osteoporosis include low bone mineral dens

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

teva pharmaceuticals usa, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. jinteli is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions ( 5.2)]. - breast cancer or a history of breast cancer [see warnings and pr ecautions (5.2)]. - estrogen-dependent neoplasia [see warnings and precautions (5.2)]. - active dvt, pe or a history of these conditions [see warnings and precautions (5.1)]. - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)]. - known anaphylactic reaction, angioedema, or hypersensitivity to jinteli - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders.  risk summary jinteli is not indicated for use in pregnancy. there are no data with the use of jinteli in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined (estrogens and progestins) product before conception or during early pregnancy. 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. risk summary estrogens plus progestogens are present in human milk and can reduce milk production in breastfeeding women. this reduction can occur at any time but is less likely to occur once breastfeeding is well-established. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for jinteli and any potential adverse effects on the breastfed child from jinteli or from the underlying maternal condition. jinteli is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing jinteli to determine whether those over 65 years of age differ from younger subjects in their response to jinteli. the women’s health initiative studies in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.5)] . in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.5)] . the women’s health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin or estrogen-alone when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.6)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.6)] .

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - clinical chemistry - inteliq specialty immunoassay control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for 25-hydroxy vitamin d, anti-tg, anti-thyroperoxidase (anti-tpo), c-peptide, erythropoietin (epo), igf-1/ somatomedin c, osteocalcin, pth (intact).

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - clinical chemistry - inteliq cardiac markers plus control lt is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert:- b-type natriuretic peptide (bnp), ck-mb isoenzyme, c-reactive protein (crp), creatine kinase (ck), digitoxin, myoglobin, n-terminal pro-brain natriuretic peptide (nt-probnp), troponin i & troponin t.

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - clinical toxicology - inteliq ethanol/ammonia control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: ammonia and ethanol.

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - clinical chemistry - inteliq homocysteine control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - clinical chemistry - inteliq urine chemistry control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for amylase, calcium, chloride, cortisol, creatinine, glucose, magnesium, microalbumin, osmolality, ph, phosphorous, potassium, pregnancy/hcg (qualitative), protein (total), sodium, specific gravity, urea, urea nitrogen (bun), uric acid.

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - immunology - inteliq immunology control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for adnase b (antideoxyribonuclease-b), albumin, alpha 1-antitrypsin, alpha 2-macroglobulin, alpha-1-acid glycoprotein, anti-cyclic citrullinated peptide (anti-ccp), antistreptolysin-o, antithrombin iii (at iii), apolipoprotein a-i, apolipoprotein b, beta-2-microglobulin, c1 inhibitor, ceruloplasmin, complement c3, complement c4, c-reactive protein (crp), cystatin c, ferritin, haptoglobin, igg subclass i, igg subclass 2, igg subclass 3, igg subclass 4, immunoglobulin a (iga), immunoglobulin e (ige), immunoglobulin g (igg), immunoglobulin m (igm), kappa light chain, lambda light chain, lipoprotein (a), prealbumin, properdin factor b, protein serum (total), retinol binding protein (rbp), rheumatoid factor, transferrin.

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - clinical chemistry - inteliq tumor marker control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. (afp, beta-2- microglobulin, ca 125, ca15-3, ca 19-9, ca 27.29, ca 72-4, cea, cyfra 21-1, ferritin, hcg, he4 (human epididymis protein 4, her-2/neu, ifg- 1/somatomedin c, progrp (progastrin-releasing peptide), prolactin, prostatic acid phosphatase (pap), psa (free), psa (total), squamous cell carcinoma(scc) and thyroglobulin).

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - clinical chemistry - inteliq diabetes control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the hemoglobin a1c.