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

epm packaging inc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - hydrocodone bitartrate and acetaminophen tablets, usp are indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen, or any other component of this product. patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone.

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

epm packaging inc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

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

epm packaging inc - phendimetrazine tartrate (unii: 6985ip0t80) (phendimetrazine - unii:ab2794w8kv) - phendimetrazine tartrate 35 mg - phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. body mass index (bmi), kg/m height (feet, inches ) weight(pounds) 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 3

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

epm packaging inc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 7.5 mg - oxycodone and acetaminophen tablets, usp are indicated for the relief of moderate to moderately severe pain. oxycodone and acetaminophen tablets, usp should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, usp, or any other component of this product. oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. oxycodone is contraindicated in the setting of suspected or known paralytic ileus. oxycodone and acetaminophen tablets are a schedule ii controlled substance. oxycodone is a muagonist opioid with an abuse liability similar to morphine. oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. drug addiction is defined as an abnormal, compulsive use, use fo

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

epm packaging, inc. - cefdinir (unii: ci0fao63wc) (cefdinir - unii:ci0fao63wc) - to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. community-acquired pneumonia caused by haemophilus influenzae (including β-lactamase producing strains), haemophilus parainfluenzae (including β-lactamase producing strains), streptococcus pneumoniae (penicillin-susceptible strains only), and

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

epm packaging inc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 7.5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

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

epm packaging inc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen tablets, usp are indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen, or any other component of this product. patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone.

Canada - English - Health Canada

emd serono, a division of emd inc., canada - tepotinib (tepotinib hydrochloride) - tablet - 225mg - tepotinib (tepotinib hydrochloride) 225mg - antineoplastic agents

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

emd serono, inc. - tepotinib hydrochloride (unii: vy5yx2tq1f) (tepotinib - unii:1ijv77ei07) - tepmetko is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) harboring mesenchymal-epithelial transition (met ) exon 14 skipping alterations. none. risk summary based on findings in animal studies and the mechanism of action [see clinical pharmacology (12.1)], tepmetko can cause fetal harm when administered to a pregnant woman. there are no available data on the use of tepmetko in pregnant women. oral administration of tepotinib to pregnant rabbits during the period of organogenesis resulted in malformations (teratogenicity) and anomalies at maternal exposures less than the human exposure based on area under the curve (auc) at the 450 mg daily clinical dose (see data) . advise pregnant women of the potential risk to a fetus. 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. data animal data in embryo-fetal development studies, pregnant rabbits received oral doses of 0.5, 5, 25, 50, 150, or 450 mg/kg tepotinib hydrochloride hydrate daily during organogenesis. severe maternal toxicity occurred at the 450 mg/kg dose (approximately 0.75 times the human exposure at the 450 mg clinical dose). at 150 mg/kg (approximately 0.5 times the human exposure by auc at the 450 mg clinical dose), two animals aborted and one animal died prematurely; mean fetal body weight was also decreased. a dose-dependent increase of skeletal malformations, including malrotations of fore and/or hind paws with concomitant misshapen scapula and/or malpositioned clavicle and/or calcaneous and/or talus, occurred at doses ≥ 5 mg/kg (approximately 0.003 times the human exposure by auc at the 450 mg clinical dose); there was also an incidence of spina bifida at the 5 mg/kg dose level. risk summary there are no data regarding the secretion of tepotinib or its metabolites in human milk or its effects on the breastfed infant or milk production. advise women not to breastfeed during treatment with tepmetko and for one week after the last dose. based on animal data, tepmetko can cause malformations at doses less than the human exposure based on auc at the 450 mg clinical dose [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating tepmetko [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during tepmetko treatment and for one week after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during tepmetko treatment and for one week after the last dose. the safety and efficacy of tepmetko in pediatric patients have not been established. of 313 patients with nsclc positive for met ex14 skipping alterations in vision who received 450 mg tepmetko once daily, 79% were 65 years or older, and 41% were 75 years or older. no clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients. no dosage modification is recommended in patients with mild or moderate renal impairment (creatinine clearance [clcr] 30 to 89 ml/min, estimated by cockcroft-gault). the recommended dosage has not been established for patients with severe renal impairment (clcr < 30 ml/min) [see clinical pharmacology (12.3)]. no dosage modification is recommended in patients with mild (child pugh class a) or moderate (child pugh class b) hepatic impairment. the pharmacokinetics and safety of tepotinib in patients with severe hepatic impairment (child pugh class c) have not been studied [see clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

merck serono ltd - tepotinib as hydrochloride hydrate - film coated tablets - tepotinib as hydrochloride hydrate 225 mg - tepotinib - tepmetko is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) harbouring a met tyrosine kinase receptor exon 14 (metex14) skipping mutation.