Združene države Amerike - angleščina - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - cyanocobalamin nasal spray is indicated for: limitations of use cyanocobalamin nasal spray is contraindicated in patients with hypersensitivity to cobalt and/or vitamin b12 or any of its excipients [see warnings and precautions (5.2)] . anaphylactic shock and death have been reported after parenteral vitamin b12 administration in sensitive patients. risk summary the limited available data on cyanocobalamin nasal spray in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. however, vitamin b12 is an essential vitamin and requirements are increased during pregnancy. animal reproduction studies have not been conducted with vitamin b12 . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary vitamin b12 is present in the milk of lactating women in concentrations which approximate the mother’s vitamin b12 blood level. vitamin b12 does not appear to pose more than a minimal risk to breastfeeding children. safety and effectiveness have not been established in pediatric patients. clinical studies of cyanocobalamin nasal spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. cyanocobalamin (sye-an-oh-koe-bal-a-min) nasal spray cyanocobalamin nasal spray is for use in your nose only. read this instructions for use before you start using cyanocobalamin nasal spray and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. your healthcare provider should teach you how to use cyanocobalamin nasal spray before you use it for the first time. if you have any questions or do not understand the instructions, talk with your healthcare provider or pharmacist. cyanocobalamin nasal spray contains only 1 spray. you do not need to prime cyanocobalamin nasal spray before you use it. if you are eating hot foods or liquids, use cyanocobalamin nasal spray at least one hour before or one hour afterwards because eating hot food or drinking hot liquids too soon before or after taking cyanocobalamin nasal spray can cause you to have a runny nose and can affect the amount of cyanocobalamin nasal spray you receive. how to use cyanocobalamin nasal spray? step 1. blow your nose gently to clear both nostrils. step 2. hold cyanocobalamin nasal spray with your thumb on the bottom and your index (pointer) finger and middle finger on either side of the nozzle (see figure a). (figure a) step 3. gently close 1 side of your nose (nostril) with your other index finger. insert the nozzle into the open nostril about half an inch or as far as it feels comfortable and tilt your head slightly forward (see figure b). do not press the plunger yet. (figure b) step 4. breathe in gently through your nose, close your mouth, and at the same time press the plunger firmly upwards with your thumb. step 5. remove the nozzle from your nostril. at the same time, keep your head straight for 10 to 20 seconds while gently breathing in through your nose and breathing out through your mouth. how to dispose of (throw away) cyanocobalamin nasal spray? cyanocobalamin nasal spray can be disposed of in your household trash. place the cyanocobalamin nasal spray in a container such as a zip-top or sealable plastic bag, and throw the container away in your household trash. manufactured by padagis® yeruham, israel www.padagis.com rev 02-23 0h800 rc ph1 this instructions for use has been approved by the u.s. food and drug administration                          revised: 02/2023

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - cyanocobalamin nasal spray is indicated for: - vitamin b12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin b12 therapy and who have no nervous system involvement - treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin b12 deficiency not due to pernicious anemia - prevention of vitamin b12 deficiency in adult patients with vitamin b12 requirements in excess of normal limitations of use: - cyanocobalamin nasal spray should not be used for the vitamin b12 absorption test (schilling test). - in patients with correctible or temporary causes of vitamin b12 deficiency, the benefit of continued long  term use of cyanocobalamin nasal spray following adequate correction of vitamin b12 deficiency and underlying disease has not been established. - the effectiveness of cyanocobalamin nasal spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. treatment with cyanocobalamin nasal spray should be deferred until symptoms have subsided. cyanocobalamin nasal spray is contraindicated in patients with hypersensitivity to cobalt and/or vitamin b12 or any of its excipients [see warnings and precautions (5.2)] . anaphylactic shock and death have been reported after parenteral vitamin b12 administration in sensitive patients. risk summary the limited available data on cyanocobalamin nasal spray in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. however, vitamin b12 is an essential vitamin and requirements are increased during pregnancy. animal reproduction studies have not been conducted with vitamin b12. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary vitamin b12 is present in the milk of lactating women in concentrations which approximate the mother's vitamin b12 blood level. vitamin b12 does not appear to pose more than a minimal risk to breastfeeding children. safety and effectiveness have not been established in pediatric patients. clinical studies of cyanocobalamin nasal spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. cyanocobalamin nasal spray cyanocobalamin nasal spray is for use in your nose only. read this instructions for use before you start using cyanocobalamin nasal spray and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. your healthcare provider should teach you how to use cyanocobalamin nasal spray before you use it for the first time. if you have any questions or do not understand the instructions, talk with your healthcare provider or pharmacist. cyanocobalamin nasal spray contains only 1 spray. you do not need to prime cyanocobalamin nasal spray before you use it. if you are eating hot foods or liquids, use cyanocobalamin nasal spray at least one hour before or one hour afterwards because eating hot food or drinking hot liquids too soon before or after taking cyanocobalamin nasal spray can cause you to have a runny nose and can affect the amount of cyanocobalamin nasal spray you receive. how to use cyanocobalamin nasal spray? step 1 . blow your nose gently to clear both nostrils. step 2 . hold cyanocobalamin nasal spray with your thumb on the bottom and your index (pointer) finger and middle finger on either side of the nozzle (see figure a). step 3 . gently close 1 side of your nose (nostril) with your other index finger. insert the nozzle into the open nostril about half an inch or as far as it feels comfortable and tilt your head slightly forward (see figure b). do not press the plunger yet. step 4 . breathe in gently through your nose, close your mouth, and at the same time press the plunger firmly upwards with your thumb. step 5 . remove the nozzle from your nostril. at the same time, keep your head straight for 10 to 20 seconds while gently breathing in through your nose and breathing out through your mouth. how to dispose of (throw away) cyanocobalamin nasal spray? cyanocobalamin nasal spray can be disposed of in your household trash. place the cyanocobalamin nasal spray nasal spray in a container such as a zip- top or sealable plastic bag, and throw the container away in your household trash. this instructions for use has been approved by the u.s. food and drug administration revised: 07/2023

Avstralija - angleščina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

novavive australasia pty ltd - mycobacterium cell wall fraction; gentamicin - parenteral liquid/solution/suspension - mycobacterium cell wall fraction ungrouped active 1.0 mg/ml; gentamicin antibiotic other 30.0 ug/ml - immunotherapy - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - equine respiratory tract infections vira | infections of viral origin

Avstralija - angleščina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - zinc edta; levamisole hydrochloride; cobalt edta; sodium selenate; oxfendazole - oral solution/suspension - zinc edta ungrouped active 8.6 g/l; levamisole hydrochloride anthelmintic active 80.0 g/l; cobalt edta chelating agent-mineral active 2.9 g/l; sodium selenate mineral-selenium active 2.4 g/l; oxfendazole triazole active 45.3 g/l - parasiticides - lamb | sheep | ewe | hogget | lamb | ovine | ram | weaner | wether - barber's pole worm-haemonchus contortus | black scour worm - trichostrongylus spp. | cobalt deficiency | large bowel worm - o. venulosum | large mouthed bowel worm | lungworm | nodule worm - o. columbianum | roundworm | selenium deficiency | small brown stomach worm-ostertagia spp. | small intestinal worm - cooperia spp. | stomach hair worm | tapeworm | thin necked intestinal worm | thin necked intestinal worm-n. spathiger | zinc deficiency | hair worm | intestinal hair worm | small hair worm | teladorsagia | thin necked intestinal worm-ad | toxocara mystax | toxocara spp. | trichostrongylus colubriformis | trichostrongylus vitrinus | white muscle disease

Evropska unija - angleščina - EMA (European Medicines Agency)

infai, institut für biomedizinische analytik nmr-imaging gmbh - urea (13c) - breath tests; helicobacter infections - diagnostic agents - helicobacter test infai may be used for in vivo diagnosis of gastroduodenal helicobacter pylori infection in:adults;adolescents, who are likely to have peptic ulcer disease.helicobacter test infai for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal helicobacter pylori infection:for the evaluation of the success of eradication treatment, or;when invasive tests cannot be performed, or;when there are discordant results arising from invasive tests.this medicinal product is for diagnostic use only.

Irska - angleščina - HPRA (Health Products Regulatory Authority)

chanelle pharmaceuticals manufacturing limited - cobalt sulphate heptahydrate - oral solution - 2.1 milligram(s)/millilitre - other nutrients - cattle, sheep - vitamins and minerals

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - cobicistat, quantity: 150 mg; atazanavir, quantity: 300 mg - tablet, film coated - excipient ingredients: stearic acid; croscarmellose sodium; hyprolose; crospovidone; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide red - evotaz is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

ax pharmaceutical corp - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - cyanocobalamin 497.5 g in 500 g

Združene države Amerike - angleščina - NLM (National Library of Medicine)

mylan institutional llc - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - cyanocobalamin 1000 ug in 1 ml - cyanocobalamin is indicated for vitamin b12 deficiencies due to malabsorption which may be associated with the following conditions: it may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see drug interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. such measures remove the need for long-term administration of cyanocobalamin. requirements of vitamin b12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. cyanocobalamin injection, usp is also suitable for the vitamin b12 absorption test (schilling test). sensitivity to cobalt and/or vitamin b12 is a contraindication.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotheca company - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrenal gland - unii:398iyq16yv), pork liver (unii: 6ec706hi7f) (pork liver - unii:6ec706hi7f), sus scrofa thyroid (unii: 6rv024oauq) (sus scrofa thyroid - unii:6rv024oauq), magnesium phosphate, dibasic trihydrate (unii: hf539g9l3q) (magnesium cation - unii:t6v3lhy838), sodium phosphate, dibasic anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37), human chorionic gon - cyanocobalamin 60 [hp_x] in 1 ml - indications:   supports weight loss by facilitating male and female hormone functions.  may temporarily decrease appetite and increase energy while maintaining a low calorie diet. indications:   supports weight loss by facilitating male and female hormone functions.  may temporarily decrease appetite and increase energy while maintaining a low calorie diet.