Malta - inglés - Medicines Authority

bayer limited 1st floor the grange offices the grange brewery road stillorgan co. dublin, a94 h2k7 , ireland - citric acid, acetylsalicylic acid, sodium hydrogen, carbonate - effervescent tablet - acetylsalicylic acid 324 mg citric acid 965 mg sodium hydrogen carbonate 1744 mg - analgesics

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

dermal laboratories (ireland) limited - salicylic acid; lactic acid - collodion - 16.7%w/w +16.7 percent weight/weight - wart and anti-corn preparations

Estados Unidos - inglés - NLM (National Library of Medicine)

deseret biologicals, inc. - ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), lactic acid, l- (unii: f9s9ffu82n) (lactic acid, l- - unii:f9s9ffu82n), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), prasterone (unii: 459ag36t1b) (prasterone - unii:459ag36t1b), adenosine triphosphate disodium (unii: 5l51b4dr1g) (adenosine triphosphate - unii:8l70q75fxe), thioctic acid (unii: 73y7p0k73y) (.alpha.-lipoic acid - unii:73y7p0k73y), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl), fumaric acid (unii: 88xhz13131) (fumaric acid - unii:88xhz13131), nadide (unii: 0u46u6e8uk) (nadide - unii:0u46u6e8uk), pantothenic acid (unii: 19f5hk2737) (pantothenic acid - unii:19f5hk2737), acetaldehyde (unii: go1n1zpr3b) (acetaldehyde - unii:go1n1zpr3b), insulin pork (unii: avt680jb39) (insulin pork - unii:avt680jb39), insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr), pork liver (unii: 6ec706hi7f) (pork liver - unii:6ec706hi7f), sus scrofa pancreas (unii: 9y3j3362ry) (sus scrofa pancreas - unii:9y3j3362ry), phlorizin (unii: cu9s17279x) (phlorizin - unii:cu9s17279x), alloxan (unii: 6sw5yha5ng) (alloxan - unii:6sw5yha5ng), berberis vulgaris root bark (unii: 1th8q20j0u) (berberis vulgaris root bark - unii:1th8q20j0u), human breast tumor cell (unii: c62oo7vd9k) (human breast tumor cell - unii:c62oo7vd9k), lycopodium clavatum spore (unii: c88x29y479) (lycopodium clavatum spore - unii:c88x29y479), momordica balsamina immature fruit (unii: wuw1665v10) (momordica balsamina immature fruit - unii:wuw1665v10), phosphoric acid (unii: e4ga8884nn) (phosphoric acid - unii:e4ga8884nn), phosphorus (unii: 27ylu75u4w) (phosphorus - unii:27ylu75u4w), syzygium cumini seed (unii: 820lsf646i) (syzygium cumini seed - unii:820lsf646i), salmonella enterica subsp. enterica serovar enteritidis (unii: y3v16d4pv4) (salmonella enterica enterica serovar enteritidis - unii:y3v16d4pv4), gymnema sylvestre leaf (unii: 2zk6zs8392) (gymnema sylvestre leaf - unii:2zk6zs8392), trigonella foenum-graecum whole (unii: 5610hf69ob) (trigonella foenum-graecum whole - unii:5610hf69ob), barium oxalosuccinate (unii: l7a49804zq) (barium cation - unii:v645272hln) - acetaldehyde - thirst, adenosinum triphosphoricum dinatrum – dry mouth, alloxanum – sugar cravings, alpha-lipoicum acidum – night sweats, ascorbic acid – sugar cravings, barium oxalsuccinicum – sugar cravings, berberis vulgaris - thirst, carcinosin – carbohydrate cravings, citricum acidum – dry mouth, dhea (dehydroepiandrosterone) – night sweats, fumaricum acidum – sugar cravings, gaertner bacillus (bach) – night sweats, gymnema sylvestre - thirst, hepar suis – dry mouth, insulinum – night sweats, insulinum (suis) – night sweats, lycopodium clavatum – sugar cravings, momordica balsamina – sugar cravings, nadidum – sugar cravings, pancreas suis – dry mouth, pantothenic acid – sugar cravings, phloridzinum – sugar cravings, phosphoricum acidum – dry mouth, phosphorus - thirst, pyridoxinum hydrochloricum – night sweats, riboflavinum - thirst, sarcolacticum acidum – dry mouth, syzygium jambolanum - thirst, thiaminum hydrochloricum – carbohydrate cravings, trigonella foenum-graecum – sugar cravings • for the temporary relief of symptoms including: • dry mouth • thirst • night sweats • sugar cravings • carbohydrate cravings these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration.

Estados Unidos - inglés - NLM (National Library of Medicine)

aurobindo pharma limited - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)]. triple therapy: lansoprazole delayed-release orally disintegrating tablets /amoxicillin/clarithromycin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole delayed-release orally disintegrating tablets /amoxicillin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, microbiology section). eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)]. please refer to the full prescribing information for amoxicillin. lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of duodenal ulcers. controlled studies do not extend beyond 12 months [see clinical studies (14.3)]. lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer [see clinical studies (14.4)]. lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the treatment of nsaid-associated gastric ulcer in patients who continue nsaid use. controlled studies did not extend beyond eight weeks [see clinical studies (14.5)]. lansoprazole delayed-release orally disintegrating tablets are indicated in adults for reducing the risk of nsaid-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an nsaid.  controlled studies did not extend beyond 12 weeks [see clinical studies (14.6)] . lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with gerd [see clinical studies (14.7)] . lansoprazole   delayed-release orally   disintegrating   tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of ee. for adults who do not heal with lansoprazole   delayed-release orally   disintegrating   tablets for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. if there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole   delayed-release orally   disintegrating   tablets may be considered [see clinical studies (14.8)] . lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of ee. controlled studies did not extend beyond 12 months [see clinical studies (14.9)] . lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome [see clinical studies (14.10)] . - lansoprazole delayed-release orally disintegrating tablets are contraindicated in patients with known hypersensitivity to any component of the formulation. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see warnings and precautions (5.2), adverse reactions (6)] . - proton pump inhibitors (ppis), including  lansoprazole delayed-release orally disintegrating tablets, are contraindicated with rilpivirine-containing products [see drug interactions  (7)]. - for information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release orally disintegrating tablets, refer to the contraindications section of their prescribing information. risk   summary available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment (see data). in animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 6.4 times the maximum recommended human dose produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal day 21 (see data) . these effects were associated with reduction in body weight gain. advise pregnant women of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are 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 to 4% and 15 to 20%, respectively. if lansoprazole delayed-release orally disintegrating tablets are administered with clarithromycin, the pregnancy information for clarithromycin also applies to the combination regimen. refer to the prescribing information for clarithromycin for more information on use in pregnancy. data human data available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use. methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. in a prospective study by the european network of teratology information services, outcomes from a group of 62 pregnant women administered median daily doses of 30 mg of lansoprazole were compared to a control group of 868 pregnant women who did not take any ppis. there was no difference in the rate of major malformations between women exposed to ppis and the control group, corresponding to a relative risk (rr)=1.04, [95% confidence interval (ci) 0.25 to 4.21]. in a population-based retrospective cohort study covering all live births in denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to lansoprazole in 794 live births. a meta-analysis that compared 1,530 pregnant women exposed to ppis in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to ppis (for major malformations odds ratio (or)=1.12, [95% ci 0.86 to 1.45] and for spontaneous abortions or=1.29, [95% ci 0.84 to 1.97]). animal data no adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 30 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis. a pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with lansoprazole at oral doses of 10 to 100 mg/kg/day (0.7 to 6.4 times the maximum recommended human lansoprazole dose of 30 mg based on auc [area under the plasma concentration-time curve]) administered during organogenesis through lactation. maternal effects observed at 100 mg/kg/day (6.4 times the maximum recommended human lansoprazole dose of 30 mg based on auc) included increased gestation period, decreased body weight gain during gestation, and decreased food consumption. the number of stillbirths was increased at this dose, which may have been secondary to maternal toxicity. body weight of pups was reduced at 100 mg/kg/day starting on postnatal day 11. femur weight, femur length, and crown-rump length were reduced at 100 mg/kg/day on postnatal day 21. femur weight was still decreased in the 100 mg/kg/day group at age 17 to 18 weeks. growth plate thickness was decreased in the 100 mg/kg/day males on postnatal day 21, and was increased in the 30 and 100 mg/kg/day males at age 17 to 18 weeks. the effects on bone parameters were associated with reduction in body weight gain. risk   summary there is no information regarding the presence of lansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production. however, lansoprazole and its metabolites are present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lansoprazole delayed-release orally disintegrating tablets and any potential adverse effects on the breastfed child from lansoprazole delayed-release orally disintegrating tablets or from the underlying maternal condition. the safety and effectiveness of lansoprazole delayed-release orally disintegrating tablets have been established in pediatric patients one year to 17 years of age for short-term treatment of symptomatic gerd and erosive esophagitis. in clinical studies of symptomatic gerd and erosive esophagitis, lansoprazole was not administered beyond 12 weeks in patients one year to 11 years of age. it is not known if lansoprazole delayed-release orally disintegrating tablets are safe and effective if used longer than the recommended duration. do not exceed the recommended dose and duration of use in pediatric patients (see juvenile animal toxicity data) . lansoprazole was not effective in pediatric patients with symptomatic gerd one month to less than one year of age in a multicenter, double-blind, placebo - controlled study. therefore, safety and effectiveness have not been established in patients less than one year of age. nonclinical studies in juvenile rats have demonstrated an adverse effect of heart valve thickening and bone changes at lansoprazole doses higher than the maximum recommended equivalent human dose. neonate to less than one year of age the pharmacokinetics of lansoprazole were studied in pediatric patients with gerd aged less than 28 days and one to 11 months. compared to healthy adults receiving 30 mg, neonates had higher exposure (mean weight-based normalized auc values 2.04 and 1.88 fold higher at doses of 0.5 and 1 mg/kg/day, respectively). infants aged ≤10 weeks had clearance and exposure values that were similar to neonates. infants aged greater than 10 weeks who received 1 mg/kg/day had mean auc values that were similar to adults who received a 30 mg dose. lansoprazole was not found to be effective in a u.s. and polish four week, multicenter, double-blind, placebo-controlled, parallel-group study of 162 patients between one month and less than 12 months of age with symptomatic gerd based on a medical history of crying/fussing/irritability associated with feedings who had not responded to conservative gerd management (i.e., nonpharmacologic intervention) for seven to 14 days. patients received lansoprazole as a suspension daily (0.2 to 0.3 mg/kg/day in infants ≤10 weeks of age or 1 to 1.5 mg/kg/day in infants greater than 10 weeks or placebo) for up to four weeks of double-blind treatment. the primary efficacy endpoint was assessed by greater than 50% reduction from baseline in either the percent of feedings with a crying/fussing/irritability episode or the duration (minutes) of a crying/fussing/irritability episode within one hour after feeding. there was no difference in the percentage of responders between the lansoprazole pediatric suspension group and placebo group (54% in both groups). there were no adverse events reported in pediatric clinical studies (one month to less than 12 months of age) that were not previously observed in adults. based on the results of the phase 3 efficacy study, lansoprazole was not shown to be effective. therefore, these results do not support the use of lansoprazole in treating symptomatic gerd in infants. one year to 11 years of age in an uncontrolled, open-label, u.s. multicenter study, 66 pediatric patients (one year to 11 years of age) with gerd were assigned, based on body weight, to receive an initial dose of either lansoprazole delayed-release orally disintegrating tablets 15 mg daily if ≤30 kg or lansoprazole delayed-release orally disintegrating tablets 30 mg daily if greater than 30 kg administered for eight to 12 weeks. the lansoprazole delayed-release orally disintegrating tablets dose was increased (up to 30 mg twice daily) in 24 of 66 pediatric patients after two or more weeks of treatment if they remained symptomatic. at baseline, 85% of patients had mild to moderate overall gerd symptoms (assessed by investigator interview), 58% had non-erosive gerd and 42% had erosive esophagitis (assessed by endoscopy). after eight to 12 weeks of lansoprazole delayed-release orally disintegrating tablets treatment, the intent-to-treat analysis demonstrated an approximate 50% reduction in frequency and severity of gerd symptoms. twenty-one of 27 erosive esophagitis patients were healed at eight weeks and 100% of patients were healed at 12 weeks by endoscopy (table 4). in a study of 66 pediatric patients in the age group one year to 11 years old after treatment with lansoprazole delayed-release orally disintegrating tablets given orally in doses of 15 mg daily to 30 mg twice daily, increases in serum gastrin levels were similar to those observed in adult studies. median fasting serum gastrin levels increased 89% from 51 pg/ml at baseline to 97 pg/ml [interquartile range (25th to 75th percentile) of 71 to 130 pg/ml] at the final visit. the pediatric safety of lansoprazole delayed-release capsules has been assessed in 66 pediatric patients aged one to 11 years of age. of the 66 patients with gerd, 85% (56/66) took lansoprazole for eight weeks and 15% (10/66) took it for 12 weeks. the most frequently reported (two or more patients) treatment-related adverse reactions in patients one to 11 years of age (n=66) were constipation (5%) and headache (3%). twelve years to 17 years of age in an uncontrolled, open-label, u.s. multicenter study, 87 adolescent patients (12 years to 17 years of age) with symptomatic gerd were treated with lansoprazole for eight to 12 weeks. baseline upper endoscopies classified these patients into two groups: 64 (74%) non-erosive gerd and 23 (26%) erosive esophagitis (ee). the non-erosive gerd patients received lansoprazole 15 mg daily for eight weeks and the ee patients received lansoprazole 30 mg daily for eight to 12 weeks. at baseline, 89% of these patients had mild to moderate overall gerd symptoms (assessed by investigator interviews). during eight weeks of lansoprazole treatment, adolescent patients experienced a 63% reduction in frequency and a 69% reduction in severity of gerd symptoms based on diary results. twenty-one of 22 (95.5%) adolescent erosive esophagitis patients were healed after eight weeks of lansoprazole treatment. one patient remained unhealed after 12 weeks of treatment (table 5). in these 87 adolescent patients, increases in serum gastrin levels were similar to those observed in adult studies, median fasting serum gastrin levels increased 42% from 45 pg/ml at baseline to 64 pg/ml [interquartile range (25th to 75th percentile) of 44 to 88 pg/ml] at the final visit. (normal serum gastrin levels are 25 to 111 pg/ml.) the safety of lansoprazole delayed-release capsules has been assessed in these 87 adolescent patients. of the 87 adolescent patients with gerd, 6% (5/87) took lansoprazole for less than six weeks, 93% (81/87) for six to 10 weeks, and 1% (1/87) for greater than 10 weeks. the most frequently reported (at least 3%) treatment-related adverse reactions in these patients were headache (7%), abdominal pain (5%), nausea (3%) and dizziness (3%). treatment-related dizziness, reported in this prescribing information as occurring in less than 1% of adult patients, was reported in this study by three adolescent patients with non-erosive gerd, who had dizziness concurrently with other reactions (such as migraine, dyspnea, and vomiting). juvenile animal toxicity data heart valve thickening in two oral toxicity studies, thickening of the mitral heart valve occurred in juvenile rats treated with lansoprazole. heart valve thickening was observed primarily with oral dosing initiated on postnatal day 7 (age equivalent to neonatal humans) and postnatal day 14 (human age equivalent of approximately one year) at doses of 250 mg/kg/day and higher (at postnatal day 7 and postnatal day 14, respectively 6.2 times and 4.2 times the daily pediatric dose of 15 mg in pediatric patients age one to 11 years weighing 30 kg or less, based on auc). the treatment durations associated with heart valve thickening ranged from 5 days to 8 weeks. the findings reversed or trended towards reversibility after a 4-week drug-free recovery period. the incidence of heart valve thickening after initiation of dosing on postnatal day 21 (human age equivalent of approximately two years) was limited to a single rat (1/24) in groups given 500 mg/kg/day for 4 or 8 weeks (approximately 5.2 times the daily pediatric dose of 15 mg in pediatric patients age one to 11 years weighing 30 kg or less, based on auc). based on exposure margins, the risk of heart valve injury does not appear to be relevant to patients one year of age and older. bone changes in an eight-week oral toxicity study in juvenile rats with dosing initiated on postnatal day 7, doses equal to or greater than 100 mg/kg/day (2.5 times the daily pediatric dose of 15 mg in children age one to 11 years weighing 30 kg or less, based on auc) produced delayed growth, with impairment of weight gain observed as early as postnatal day 10 (age equivalent to neonatal humans). at the end of treatment, the signs of impaired growth at 100 mg/kg/day and higher included reductions in body weight (14 to 44% compared to controls), absolute weight of multiple organs, femur weight, femur length, and crown-rump length. femoral growth plate thickness was reduced only in males and only at the 500 mg/kg/day dose. the effects related to delayed growth persisted through the end of the four-week recovery period. longer term data were not collected. of the total number of patients (n=21,486) in clinical studies of lansoprazole, 16% of patients were aged 65 years and over, while 4% were 75 years and over. no overall differences in safety or effectiveness were observed between these patients and younger patients and other reported clinical experience has not identified significant differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] . in patients with various degrees of chronic hepatic impairment the exposure to lansoprazole was increased compared to healthy subjects with normal hepatic function [see clinical pharmacology (12.3)] . no dosage adjustment for lansoprazole delayed-release orally disintegrating tablets is necessary for patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. the recommended dosage is 15 mg orally daily in patients with severe hepatic impairment (child-pugh class c)  [see dosage and administration (2.3)]. lansoprazole (lan soe′ pra zole) delayed-release orally disintegrating tablets important: -   take lansoprazole delayed-release orally disintegrating tablets before meals. -   do not crush or chew lansoprazole delayed-release orally disintegrating tablets. -   lansoprazole delayed-release orally disintegrating tablets should only be used with the foods and juices listed below. lansoprazole delayed-release orally disintegrating tablets - do not chew, crush, cut or break the tablets. - put the tablet on the tongue and let it dissolve, with or without water. - swallow after the tablet dissolves. - the tablet usually dissolves in less than 1 minute. for patients who have trouble swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be given as follows: giving lansoprazole delayed-release orally disintegrating tablets with water using an oral syringe: - put a 15 mg tablet in an oral syringe and draw up 4 ml of water into the oral syringe, or put a 30 mg tablet in an oral syringe and draw up 10 ml of water into the oral syringe. - gently shake the oral syringe to mix the tablet and the water. - after the tablet is mixed in the water, place the tip of the oral syringe in the mouth. give the medicine within 15 minutes of mixing. do not save the tablet and water mixture for later use. - refill the oral syringe with about 2 ml of water for the 15 mg tablet or 5 ml of water for the 30 mg tablet, and shake gently. place the tip of the oral syringe in the mouth and give the medicine that is left in the syringe. giving lansoprazole delayed-release orally disintegrating tablets with water through a nasogastric tube (ng tube) size 8 french or larger: - put a 15 mg tablet in a catheter-tip syringe and draw up 4 ml of water, or put a 30 mg tablet in a catheter-tip syringe and draw up 10 ml of water. - gently shake the catheter-tip syringe to mix the tablet and the water. - connect the catheter-tip syringe to the ng tube. - give the mixture right away through the ng tube that goes into the stomach. give the medicine within 15 minutes of mixing. do not save the granule and water mixture for later use. - refill the catheter-tip syringe with about 5 ml of water and shake gently. flush the ng tube with the water. how should i store lansoprazole delayed-release orally disintegrating tablets? - store lansoprazole delayed-release orally disintegrating tablets at room temperature between 20° to 25°c (68° to 77°f). keep lansoprazole delayed-release orally disintegrating tablets   and all medicines out of the reach of children. this instruction for use has been approved by the u.s. food and drug administration. the brands listed are trademarks of their respective owners and are not trademarks of aurobindo pharma limited.   distributed by: aurobindo pharma usa, inc. 279 princeton-hightstown road east windsor, nj 08520 manufactured by: aurobindo pharma limited hyderabad-500 032, india revised: 04/2024

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

nice-pak products (nz) ltd - lactic acid 16.7%{relative}; salicylic acid 16.7%{relative};  ; lactic acid 15%{relative} ((absolute)); salicylic acid 16.7%{relative} - topical solution - active: lactic acid 16.7%{relative} salicylic acid 16.7%{relative}   excipient: pyroxylin active: lactic acid 15%{relative} ((absolute)) salicylic acid 16.7%{relative} excipient: pyroxylin - latest regulatory activity

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

ennogen healthcare ltd - lactic acid; salicylic acid - paint - 150mg/1gram ; 167mg/1gram

Malasia - inglés - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn. bhd. - lactic acid; salicylic acid -

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

viatris limited - zoledronic acid monohydrate 0.8528 mg/ml equivalent to zoledronic acid 0.8 mg/ml;   - concentrate for infusion - 4 mg/5ml - active: zoledronic acid monohydrate 0.8528 mg/ml equivalent to zoledronic acid 0.8 mg/ml   excipient: hydrochloric acid sodium citrate sodium hydroxide water for injection - · treatment of tumour-induced hypercalcaemia.

Estados Unidos - inglés - NLM (National Library of Medicine)

cipla usa, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate 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. doxycycline is indicated for the treatment of the following infections: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae. - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agen

Estados Unidos - inglés - NLM (National Library of Medicine)

actavis pharma, inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 4 mg in 5 ml - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4.0 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see ad