Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 125 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for use in the prophylactic management of asthma in adults and children over 4 years of age.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam tablets, usp is indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients 2 years of age and older [ see clinical studies ( 14.2) ]. meloxicam is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. meloxicam should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients [ see warnings and precautions ( 5.7, 5.13) ]. meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1) ]. pregnancy category c; category d starting 30 weeks gestation there are no adequate and well-controlled studies in pregnant women. meloxicam crosses the placental barrier. prior to 30 weeks gestation, use meloxicam during pregnancy only if the potential benefit justifies the potential risk to the fetus. starting at 30 weeks gestation, avoid meloxicam and other nsaids, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur. if this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus [ see warnings and precautions ( 5.9) and patient counseling information ( 17.8) ]. teratogenic effects meloxicam was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the maximum recommended human daily dose [mrhd] based on body surface area [bsa] comparison). administration of meloxicam to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day. the no effect level was 20 mg/kg/day (26-fold greater than the mrhd based on bsa conversion). nonteratogenic effects in rats and rabbits, embryolethality occurred at oral meloxicam doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65-and 6.5-fold greater, respectively, than the mrhd based on bsa comparison) when administered throughout organogenesis. the effects of meloxicam on labor and delivery of pregnant women are unknown. oral administration of meloxicam to pregnant rats during late gestation through lactation increased the incidence of dystocia, delayed parturition, and decreased offspring survival at meloxicam doses of 0.125 mg/kg/day or greater (at least 12.5 times lower than the maximum recommended human daily dose based on body surface area comparison). it is not known whether this drug is excreted in human milk; however, meloxicam was excreted in the milk of lactating rats at concentrations higher than those in plasma. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from meloxicam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of meloxicam in pediatric jra patients from 2 to 17 years of age has been evaluated in three clinical trials [ see dosage and administration ( 2.3), adverse reactions ( 6.1), and clinical studies ( 14.2) ] as with any nsaid, caution should be exercised in treating the elderly (65 years and older). of the total number of subjects in clinical studies, 5157 were age 65 and over (4044 in oa studies and 1113 in ra studies). no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is necessary in patients with mild to moderate hepatic impairment. patients with severe hepatic impairment have not been adequately studied. since meloxicam is significantly metabolized in the liver; the use of meloxicam in these patients should be done with caution [ see warnings and precautions ( 5.3) and clinical pharmacology ( 12.3) ]. no dose adjustment is necessary in patients with mild to moderate renal impairment. patients with severe renal impairment have not been studied. the use of meloxicam in subjects with severe renal impairment is not recommended. following a single dose of meloxicam, the free c max plasma concentrations were higher in patients with renal failure on chronic hemodialysis (1% free fraction) in comparison to healthy volunteers (0.3% free fraction). therefore, it is recommended that meloxicam dosage in this population not exceed 7.5 mg per day hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. meloxicam is not dialyzable [ see dosage and administration ( 2.1), warnings and precautions ( 5.6), and clinical pharmacology ( 12.3) ]. data from several small studies in humans and from studies in animals indicate that nsaids, including meloxicam , may be associated with a reversible delay in ovulation. therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

puretek corporation - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product. for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation. tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensi

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

us continental - benzalkonium (unii: 7n6jud5x6y) (benzalkonium - unii:7n6jud5x6y) -

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

naari pte limited - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: ▪ smoke, if over age 35 [see boxed warning and warnings and precautions (5.1) ] ▪ have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1) ] ▪ have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] ▪ have cerebrovascular disease [see warnings and precautions (5.1) ] ▪ have coronary artery disease [see warnings and precautions (5.1) ] ▪ have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1) ] ▪ have uncontrolled hypertension [see warnings and precautions (5.4) ] ▪ have diabetes mellitus with vascular disease [see warnings and precautions (5.6) ] ▪ have headaches with focal neurological symptoms or have migraine headaches with aura [see warnings and precautions (5.7) ]       ▪ women over age 35 with any migraine headaches [see warnings and precautions (5.7) ] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2) ] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.9) ] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.9) and use in specific populations (8.1) ]. - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.11)] - hypersensitivity to any of the components. - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.3)] there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. do not use cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have been established in women of reproductive age. efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in women with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded [see contraindications (4) and warnings and precautions (5.2)]. the pharmacokinetics of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in women with renal impairment. instructions for use important information about taking - take 1 pill every day at the same time. take the pills in the order directed on your blister pack. - the norethindrone and ethinyl estradiol tablets, usp may be swallowed whole or chewed. if norethindrone and ethinyl estradiol tablets, usp are chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. - do not skip your pills, even if you do not have sex often. if you miss pills (including starting the pack late) you could get pregnant . the more pills you miss, the more likely you are to get pregnant. - if you have trouble remembering to take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, talk to your healthcare provider. when you first start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, spotting or light bleeding in between your periods may occur. contact your healthcare provider if this does not go away after a few months. - you may feel sick to your stomach (nauseous), especially during the first few months of taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if your nausea does not go away, call your healthcare provider. - missing pills can also cause spotting or light bleeding, even when you take the missed pills later. on the days you take 2 pills to make up for missed pills (see below), you could also feel a little sick to your stomach. - it is not uncommon to miss a period. however, if you miss a period and have not taken norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. if you have a positive pregnancy test, you should stop taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. - if you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. if you do not have an extra blister pack, take the next pill in your blister pack. continue taking all your remaining pills in order. start the first pill of your next blister pack the day after finishing your current blister pack. this will be 1 day earlier than originally scheduled. continue on your new schedule. - if you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider. - stop taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. be sure to use other forms of contraception (like condoms and spermicide) during this time period. before you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets: - decide what time of day you want to take your pill. it is important to take it at the same time every day and in the order as directed on your blister pack. - have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed. when should i start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets ? if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you have not used a hormonal birth control method before: - there are 2 ways to start taking your birth control pills. you can either start on a sunday (sunday start) or on the first day (day 1) of your natural menstrual period (day 1 start). your healthcare provider should tell you when to start taking your birth control pill. - if you use the sunday start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. you do not need back-up contraception if you use the day 1 start. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from another birth control pill: - start your new norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletspack on the same day that you would start the next pack of your previous birth control method. - do not continue taking the pills from your previous birth control pack. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and previously used a vaginal ring or transdermal patch: - start using norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day you would have reapplied the next ring or patch. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from a progestin-only method such as an implant or injection: - start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day of removal of your implant or on the day when you would have had your next injection. if you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets and you are switching from an intrauterine device or system (iud or ius): - start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tabletson the day of removal of your iud or ius. - you do not need back-up contraception if your iud or ius is removed on the first day (day 1) of your period. if your iud or ius is removed on any other day, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. keep a calendar to track your period: if this is the first time you are taking birth control pills, read, “ when should i start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets? ” above.follow these instructions for either a sunday start or a day 1 start. sunday start: you will use a sunday start if your healthcare provider told you to take your first pill on a sunday. - take pill 1 on the sunday after your period starts. - if your period starts on a sunday, take pill “ 1 ” that day and refer to day 1 start instructions below. - take 1 pill every day in the order on the blister pack at the same time each day for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack (sunday). take the first pill in the new pack whether or not you are having your period. - use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days of the first cycle that you take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. day 1 start: you will use a day 1 start if your doctor told you to take your first pill (day 1) on the first day of your period . - take 1 pill every day in the order of the blister pack, at the same time each day, for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack. take the first pill in the new pack whether or not you are having your period. instructions for using your pill pack: step 1 . look at your norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pill pack. see figure a. the norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pill pack has: - 21 white to off white (active) pills with hormone for week 1 through week 3. - 7 brown (inactive) pills without hormones for week 4. step 2. find: - where on your pack to start taking pills - in what order to take your pills (follow the arrows) - the week numbers step 3. remove the white to off white pill by pressing the pill through the foil in the bottom of the pill pack. see figure b . continue taking the white to off white pills for 21 days. figure b step 4. on the first day of week 4 start taking the brown pills. take the brown pill for 7 days . your period should start during this time. step 5. when you have taken all of the brown pills in your pill pack, get a new pill pack and start taking the white to off white pills. - for a day 1 start: begin your next pill pack on the same day of the week as your first cycle pill pack. - for a sunday start: begin your next pill pack on sunday. what should i do if i miss any norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets pills? if you miss 1 pill in weeks 1, 2, or 3, follow these steps : - take it as soon as you remember. take the next pill at your regular time. this means you may take 2 pills in 1 day. - then continue taking 1 pill every day until you finish the pack. - you do not need to use a back-up birth control method if you have sex. if you miss 2 pills in week 1 or week 2 of your pack, follow these steps: - take the 2 missed pills as soon as possible and the next 2 pills the next day. - then continue to take 1 pill every day until you finish the pack. - use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills. if you miss 2 pills in a row in week 3, or you miss 3 or more pills in a row during weeks 1, 2, or 3 of the pack, follow these steps: - if you are a day 1 starter: • throw out the rest of the pill pack and start a new pack that same day. - if you are a sunday starter: • keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. - you may not have your period this month but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. - you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. if you have any questions or are unsure about the information in this leaflet, call your healthcare provider. this patient information and instructions for use has been approved by the u.s. food and drug administration. manufactured for: naari pte limited 36 robinson road, #13-01 city house, singapore 068877 issued december 2021

Αυστραλία - Αγγλικά - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - enrofloxacin - parenteral liquid/solution/suspension - enrofloxacin antibiotic active 50.0 mg/ml - antibiotic & related - animal - exotic | cat | dog | avian species | bitch | castrate | cat - queen | cat - tom | exotic animals | kitten | puppy | rep - antibiotics - oral, parenteral | infections of the respiratory tract | infections of the urinary tracts | staphylococcus intermedius | wound infections | abscesses | acute respiratory infections | airsacculitis | amoxycillin sensitive bacteria | anaerobic bacterial infection | avian mycoplasmas | bronchiseptica | bronchitis | clavulanic acid sensitive | coccidiosis | coryza | crd | deep pyodermas | dermatoses | diarrhoea | endometritis | enteritis | enzootic pneumonia | escherichia coli | european brood disease | gentamicin sensitive | group d streptococcus | hypermotility | including secondary invaders | infected wounds | infections | klebsiella spp. | lactating | mastitis | pharyngitis | pneumonia | proteus spp. | protozoal infections | pseudomonas aeruginosa | pyometra | salmonellosis | seborrhoeic dermatitis | sinusitis | staphylococcus spp. | systemic bacterial infection | tonsillitis

Αυστραλία - Αγγλικά - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - enrofloxacin - oral solution/suspension - enrofloxacin antibiotic active 25.0 mg/ml - antibiotic & related - animal - exotic | cat | dog | avian species | bitch | castrate | cat - queen | cat - tom | exotic animals | kitten | puppy | rep - antibiotics - oral, parenteral | infections of the respiratory tract | infections of the urinary tracts | staphylococcus intermedius | wound infections | abscesses | acute respiratory infections | airsacculitis | amoxycillin sensitive bacteria | anaerobic bacterial infection | avian mycoplasmas | bronchiseptica | bronchitis | clavulanic acid sensitive | coccidiosis | coryza | crd | deep pyodermas | dermatoses | diarrhoea | endometritis | enteritis | enzootic pneumonia | escherichia coli | european brood disease | gentamicin sensitive | group d streptococcus | hypermotility | including secondary invaders | infected wounds | infections | klebsiella spp. | lactating | mastitis | pharyngitis | pneumonia | proteus spp. | protozoal infections | pseudomonas aeruginosa | pyometra | salmonellosis | seborrhoeic dermatitis | sinusitis | staphylococcus spp. | systemic bacterial infection | tonsillitis

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

cis bio international - tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate - kit for radiopharmaceutical preparation - 1 milligram(s) - technetium (99mtc) compounds; technetium (99mtc) sestamibi

Αυστραλία - Αγγλικά - APVMA (Australian Pesticides and Veterinary Medicines Authority)

kenso corporation (m) sdn. bhd. - epoxiconazole - suspoemulsion - epoxiconazole ungrouped active 125.0 g/l - fungicide

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 125 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for use in the prophylactic management of asthma in adults and children over 4 years of age.