Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir disoproxil fumarate; rilpivirine hydrochloride; emtricitabine -

Stati Uniti - Ingliż - NLM (National Library of Medicine)

viiv healthcare company - cabotegravir (unii: hmh0132z1q) (cabotegravir - unii:hmh0132z1q) - cabenuva is indicated as a complete regimen for the treatment of hiv-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine [see microbiology (12.4), clinical studies (14.1)] . cabenuva is contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to cabenuva during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary there are insufficient human data on the use of cabenuva during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage. while there are insufficient human data to assess the risk of neural tube defects (ntds) with exposure to cabenuva during pregnancy, ntds were associated with dolutegravir, another integrase inhibitor. discuss the benefit-risk of using cabenuva with individuals of childbearing potential or during pregnancy. cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of cabenuva; therefore, consideration should be given to the potential for fetal exposure during pregnancy [see warnings and precautions (5.6), drug interactions (7.2)] . cabotegravir use in pregnant individuals has not been evaluated. available data from the apr show no difference in the overall risk of birth defects for rilpivirine compared with the background rate for major birth defects of 2.7% in a united states (u.s.) reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage is not reported in the apr. the background risk for major birth defects and miscarriage for the indicated population is unknown. the background rate for major birth defects in a u.s. reference population of the macdp is 2.7%. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15% to 20%. the apr uses the macdp as the u.s. reference population for birth defects in the general population. the macdp evaluates mothers and infants from a limited geographic area and does not include outcomes for births that occurred at <20 weeks’ gestation. in animal reproduction studies with oral cabotegravir, a delay in the onset of parturition and increased stillbirths and neonatal deaths were observed in a rat pre- and postnatal development study at >28 times the exposure at the recommended human dose (rhd). no evidence of adverse developmental outcomes was observed with oral cabotegravir in rats or rabbits (>28 times or similar to the exposure at the rhd, respectively) given during organogenesis (see data) . no adverse developmental outcomes were observed when rilpivirine was administered orally at exposures 15 (rats) and 70 (rabbits) times the exposure in humans at the rhd (see data) . clinical considerations lower exposures with oral rilpivirine were observed during pregnancy. viral load should be monitored closely if the patient remains on cabenuva during pregnancy. cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of cabenuva; therefore, consideration should be given to the potential for fetal exposure during pregnancy [see warnings and precautions (5.6)] . data human data: cabotegravir: data from a birth outcome surveillance study in botswana showed that dolutegravir, another integrase inhibitor, was associated with increased risk of ntds when administered at the time of conception and in early pregnancy. data from clinical trials are insufficient to address this risk with cabotegravir.             rilpivirine: based on prospective reports to the apr of over 580 exposures to oral rilpivirine-containing regimens during the first trimester of pregnancy and over 200 during second/third trimester of pregnancy, the prevalence of birth defects in live births was 1.5% (95% ci: 0.7% to 2.9%) and 1.5% (95% ci: 0.3% to 4.2%) following first and second/third trimester exposures, respectively, compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. in a clinical trial, total oral rilpivirine exposures were generally lower during pregnancy compared with the postpartum period. refer to the prescribing information for edurant (rilpivirine) for additional information on rilpivirine. animal data: cabotegravir: cabotegravir was administered orally to pregnant rats at 0, 0.5, 5, or 1,000 mg/kg/day from 15 days before cohabitation, during cohabitation, and from gestation days 0 to 17. there were no effects on fetal viability when fetuses were delivered by caesarean, although a minor decrease in fetal body weight was observed at 1,000 mg/kg/day (>28 times the exposure in humans at the rhd). no drug-related fetal toxicities were observed at 5 mg/kg/day (approximately 13 times the exposure in humans at the rhd), and no drug-related fetal malformations were observed at any dose. cabotegravir was administered orally to pregnant rabbits at 0, 30, 500, or 2,000 mg/kg/day from gestation days 7 to 19. no drug-related fetal toxicities were observed at 2,000 mg/kg/day (approximately 0.7 times the exposure in humans at the rhd). in a rat pre- and postnatal development study, cabotegravir was administered orally to pregnant rats at 0, 0.5, 5, or 1,000 mg/kg/day from gestation day 6 to lactation day 21. a delay in the onset of parturition and increases in the number of stillbirths and neonatal deaths by lactation day 4 were observed at 1,000 mg/kg/day (>28 times the exposure in humans at the rhd); there were no alterations to growth and development of surviving offspring. in a cross-fostering study, similar incidences of stillbirths and early postnatal deaths were observed when rat pups born to cabotegravir-treated mothers were nursed from birth by control mothers. there was no effect on neonatal survival of control pups nursed from birth by cabotegravir-treated mothers. a lower dose of 5 mg/kg/day (13 times the exposure at the rhd) was not associated with delayed parturition or neonatal mortality in rats. studies in pregnant rats showed that cabotegravir crosses the placenta and can be detected in fetal tissue.             rilpivirine: rilpivirine was administered orally to pregnant rats (40, 120, or 400 mg/kg/day) and rabbits (5, 10, or 20 mg/kg/day) through organogenesis (on gestation days 6 through 17 and 6 through 19, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with rilpivirine in rats and rabbits at exposures 15 (rats) and 70 (rabbits) times the exposure in humans at the rhd. in a pre- and postnatal development study, rilpivirine was administered orally up to 400 mg/kg/day through lactation. no adverse effects were noted in the offspring at maternal exposures up to 63 times the exposure in humans at the rhd. risk summary based on limited data after oral administration, rilpivirine is present in human breast milk. the data do not allow determination of the amount of rilpivirine that is transferred to milk. there are no data on the presence of cabotegravir in human milk. cabotegravir is present in animal milk (see data). when a drug is present in animal milk, it is likely that the drug will be present in human milk. it is not known if the components of cabenuva affect human milk production or have effects on the breastfed infant. residual exposures in human milk of cabotegravir (if present) and rilpivirine may remain for 12 months or longer after the last injections have been administered [see warnings and precautions (5.6)] . potential risks of breastfeeding include: (1) hiv‑1 transmission (in hiv-1–negative infants), (2) developing viral resistance (in hiv-1–positive infants), and (3) adverse reactions in a breastfed infant similar to those seen in adults. data cabotegravir: animal lactation studies with cabotegravir have not been conducted. however, cabotegravir was detected in the plasma of nursing pups on lactation day 10 in the rat pre- and postnatal development study. the safety and effectiveness of cabenuva have been established in adolescents aged 12 to younger than 18 years and weighing at least 35 kg, which is supported by the following: mocha trial the safety, tolerability, and pharmacokinetics of oral and injectable cabotegravir and oral and injectable rilpivirine are being assessed in an ongoing phase 1/2 multicenter, open-label, non-comparative study, mocha (impaact 2017). data are available from the week 16 interim analysis from mocha. the primary objective at week 16 was to confirm the use of the adult dose, through the evaluation of safety and pharmacokinetics, for oral and injectable cabotegravir and injectable rilpivirine in hiv-1–infected virologically suppressed adolescents. twenty-three hiv-1–infected and virologically suppressed adolescents aged 12 to younger than 18 years and weighing at least 35 kg were assigned to 1 of 2 cohorts, 1c or 1r, based on their background antiretroviral regimen. in cohort 1c, participants (n = 8) received one 30-mg cabotegravir tablet daily for 1 month, followed by monthly cabotegravir injections (month 1: 600-mg injection, months 2 and 3: 400-mg injection) for an additional 3 months, while continuing background antiretroviral therapy. in cohort 1r, participants received one 25-mg rilpivirine tablet (n = 15) daily for 1 month, followed by monthly rilpivirine injections (n = 13) (month 1: 900-mg injection, months 2 and 3: 600-mg injection) for an additional 3 months, while continuing background antiretroviral therapy. at baseline, in cohort 1c, the median age of participants was 14.5 years; the median weight was 57.2 kg (range: 43.0, 73.5); 25% were female; 100% were non-white; and no participant had a cd4+ cell count <350 cells per mm3 . at baseline, median cd4+ cell count was 725 cells per mm3 (range: 629 to 924). in cohort 1r, the median age of participants was 17 years; the median weight was 63.0 kg (range: 44.1, 98.5); 53% were female; 73% were non-white; and no participant had a cd4+ cell count <350 cells per mm3 . at baseline, median cd4+ cell count was 827 cells per mm3 (range: 439 to 1,509). the safety of cabenuva in adolescents is expected to be similar to adults, as there was no clinically significant difference in drug exposure for the components of cabenuva [see adverse reactions (6.1)] . the efficacy of cabenuva in adolescents is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure [see clinical pharmacology (12.3)] . the safety, efficacy, and pharmacokinetics of cabenuva have not been established in pediatric patients younger than 12 years of age or weighing <35 kg. clinical trials of cabenuva did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. in general, caution should be exercised in administration of cabenuva in elderly patients, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . based on studies with oral cabotegravir and population pharmacokinetic analyses of oral rilpivirine, no dosage adjustment of cabenuva is necessary for patients with mild (creatinine clearance ≥60 to <90 ml/min) or moderate renal impairment (creatinine clearance ≥30 to <60 ml/min). in patients with severe renal impairment (creatinine clearance 15 to <30 ml/min) or end-stage renal disease (creatinine clearance <15 ml/min), increased monitoring for adverse effects is recommended [see clinical pharmacology (12.3)] . in patients with end-stage renal disease not on dialysis, effects on the pharmacokinetics of cabotegravir or rilpivirine are unknown. as cabotegravir and rilpivirine are >99% protein bound, dialysis is not expected to alter exposures of cabotegravir or rilpivirine. based on separate studies with oral cabotegravir and oral rilpivirine, no dosage adjustment of cabenuva is necessary for patients with mild or moderate hepatic impairment (child-pugh a or b). the effect of severe hepatic impairment (child-pugh c) on the pharmacokinetics of cabotegravir or rilpivirine is unknown [see clinical pharmacology (12.3)] . overview: a complete dose of cabenuva requires two injections: 400 mg (2 ml) of cabotegravir and 600 mg (2 ml) of rilpivirine. cabotegravir and rilpivirine are suspensions that do not need further dilution or reconstitution. the preparation steps for both medicines are the same. carefully follow these instructions when preparing the suspension for injection to avoid leakage. cabotegravir and rilpivirine are for gluteal intramuscular use only. each injection must be administered to separate gluteal intramuscular sites (on opposite sides or at least 2 cm apart). note: the ventrogluteal site is recommended. the administration order is not important. storage information store in refrigerator at 2°c to 8°c (36°f to 46°f). do not freeze. prior to administration: your pack contains: consider the patient’s build and use medical judgment to select an appropriate injection needle length. you will also need: preparation: 4. inspect suspension. figure d 8. lift off the packaging. figure h 11. press the plunger. figure k injection: injections must be administered to a gluteal site. see figure o . select from the following areas for the injection: use the z-track injection technique to minimize medicine leakage from the injection site. figure w after injection: repeat for 2nd medicine. questions and answers manufactured for: viiv healthcare durham, nc 27701 trademarks are owned by or licensed to the viiv healthcare group of companies. ©2023 viiv healthcare group of companies or its licensor. cbn:5ifu2 this instructions for use has been approved by the u.s. food and drug administration.                          revised: 12/2023 overview: a complete dose of cabenuva requires two injections: 600 mg (3 ml) of cabotegravir and 900 mg (3 ml) of rilpivirine. cabotegravir and rilpivirine are suspensions that do not need further dilution or reconstitution. the preparation steps for both medicines are the same. carefully follow these instructions when preparing the suspension for injection to avoid leakage. cabotegravir and rilpivirine are for gluteal intramuscular use only. each injection must be administered to separate gluteal intramuscular sites (on opposite sides or at least 2 cm apart). note: the ventrogluteal site is recommended. the administration order is not important. storage information store in refrigerator at 2°c to 8°c (36°f to 46°f). do not freeze. prior to administration: your pack contains: consider the patient’s build and use medical judgment to select an appropriate injection needle length. you will also need: preparation: 4. inspect suspension. figure d 8. lift off the packaging. figure h 11. press the plunger. figure k figure l figure n injection: injections must be administered to a gluteal site. see figure o. select from the following areas for the injection: use the z-track injection technique to minimize medicine leakage from the injection site. figure w after injection: repeat for 2nd medicine. questions and answers manufactured for: viiv healthcare durham, nc 27701 trademarks are owned by or licensed to the viiv healthcare group of companies. ©2023 viiv healthcare group of companies or its licensor. cbn:6ifu3 this instructions for use has been approved by the u.s. food and drug administration.                          revised: 12/2023

Stati Uniti - Ingliż - NLM (National Library of Medicine)

boehringer ingelheim animal health usa inc. - cephapirin benzathine (unii: 90g868409o) (cephapirin - unii:89b59h32vn) - cephapirin 300 mg in 10 ml - for the treatment of mastitis in dairy cows during the dry period. tomorrow has been shown by extensive clinical studies to be efficacious in the treatment of mastitis in dry cows, when caused by streptococcus agalactiae and staphylococcus aureus including penicillin-resistant strains. treatment of the dry cow with tomorrow is indicated in any cow known to harbor any of these organisms in the udder at drying off. indicaciones para el tratamiento de mastitis bovina durante el período seco. extensos estudios clínicos han demostrado que tomorrow es eficaz en el tratamiento de la mastitis en vacas secas, cuando ésta es causada por el streptococcus agalactiae y el staphylococcus aureus, incluyendo cepas resistentes a la penicilina. el tratamiento de la vaca seca con tomorrow es recomendado para cualquier vaca que se sepa alberga a cualquiera de estos organismos en la ubre al momento del período de secado. not for human use. este producto no es para administrarse en humanos.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

boehringer ingelheim animal health usa inc. - cephapirin benzathine (unii: 90g868409o) (cephapirin - unii:89b59h32vn) - for the treatment of mastitis in dairy cows during the dry period. tomorrow has been shown by extensive clinical studies to be efficacious in the treatment of mastitis in dry cows, when caused by streptococcus agalactiae and staphylococcus aureus including penicillin-resistant strains. treatment of the dry cow with tomorrow is indicated in any cow known to harbor any of these organisms in the udder at drying off. indicaciones para el tratamiento de mastitis bovina durante el período seco. extensos estudios clínicos han demostrado que tomorrow es eficaz en el tratamiento de la mastitis en vacas secas, cuando ésta es causada por el streptococcus agalactiae y el staphylococcus aureus, incluyendo cepas resistentes a la penicilina. el tratamiento de la vaca seca con tomorrow es recomendado para cualquier vaca que se sepa alberga a cualquiera de estos organismos en la ubre al momento del período de secado.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

stearns packaging corporation - chlorhexidine gluconate (unii: mor84mud8e) (chlorhexidine - unii:r4ko0dy52l), didecyldimonium chloride (unii: jxn40o9y9b) (didecyldimonium - unii:z7f472xqpa) - chlorhexidine gluconate 0.35 l in 100 l - take time observe label directions first-aid: eyes: if contact with eyes occurs, flush with plenty of cool water for 15 minutes. consult a physician. internal: may be harmful if swallowed. if ingested, drink large amounts of water. do not induce vomiting. get medical attention immediately. primeros auxilios: ojos: si ocurre contacto con los ojos, lavar con abundante agua fría durante 15 minutos. consulte a un médico. interno: puede ser nocivo en caso de ingestión. beba grandes cantidades de agua si se ingiere este producto. no induzca el vómito. obtenga atención médica inmediatamente. 24 hour emergency contact 24 horas servico telefónico de repuesta a emergencies: 1-800-255-3924

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gojo industries, inc. - chlorhexidine gluconate (unii: mor84mud8e) (chlorhexidine - unii:r4ko0dy52l) - antiseptic if you are allergic to chlorhexidine gluconate or any other ingredients si es alérgico al gluconato de chlorhexidina o a cualquier otro ingrediente keep out of eyes, ear and mouth. may cause serious and permenant eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle of the ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water. evite el contacto con los ojos, oídos, y boca. puede causar daño ocular serio y permanente si se coloca o permanece en el ojo durante procedimientos quirúrgicos o puede causar sordera si se instila en el oído medio a través de tímpano perforado. si la solución llegara a tener contacto con estas àreas, enjuague lo más pronto posible con suficiente agua. irrititation, sensitization or allergic reaction occurs. these may be signs of a serious condition. reacciones de irritación, sensibilización o reacciones alérgicas aparecen. estos son signos de una co

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astrazeneca pharmaceuticals lp - omeprazole magnesium (unii: 426qfe7xlk) (omeprazole - unii:kg60484qx9) - omeprazole 10 mg - prilosec is indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy prilosec in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy prilosec in combination with clarithromycin is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, prilosec with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibility testing should be done. if resistance to clarithromycin is demonstrated or susceptibility testing is not pos

Stati Uniti - Ingliż - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 15 mg - lansoprazole delayed-release capsules 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/amoxicillin/clarithromycin lansoprazole delayed-release capsules 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/amoxicillin lansoprazole delayed-release capsules 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

Stati Uniti - Ingliż - NLM (National Library of Medicine)

actavis pharma, inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 15 mg - lansoprazole delayed-release capsules are indicated 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 capsules/amoxicillin/clarithromycin   lansoprazole delayed-release capsules 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 capsules/amoxicillin   lansoprazole delayed-release capsules 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

Stati Uniti - Ingliż - NLM (National Library of Medicine)

remedyrepack inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 30 mg - prevacid and prevacid solutab 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: prevacid or prevacid solutab/amoxicillin/clarithromycin prevacid or prevacid solutab 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: prevacid or prevacid solutab/amoxicillin prevacid or prevacid solutab 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