États-Unis - anglais - 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

États-Unis - anglais - 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

États-Unis - anglais - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - cyanocobalamin is indicated for vitamin b12 deficiencies due to malabsorption which may be associated with the following conditions: addisonian (pernicious) anemia gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy fish tapeworm infestation malignancy of pancreas or bowel folic acid deficiency 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.

États-Unis - anglais - NLM (National Library of Medicine)

alaven pharmaceutical llc - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), heme iron polypeptide (unii: 31vdo12cjy) (heme iron polypeptide - unii:31vdo12cjy), iron dextran (unii: 95hr524n2m) (iron dextran - unii:95hr524n2m), potassium iodide (unii: 1c4qk22f9j) (potassium cation - unii:295o53k152), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z), selenium (unii: h6241uj22b) (selenium - unii:h6241uj22b), cupric sulfate (unii: lrx7aj16dt) (cupric cation - unii:8cbv67279l), cholecalciferol (unii: 1c6v77qf41) (c - folic acid 1 mg - preferaob® is a prescription multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. preferaob® is also beneficial in improving the nutritional status of women prior to conception. this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

États-Unis - anglais - NLM (National Library of Medicine)

alaven pharmaceutical llc - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), heme iron polypeptide (unii: 31vdo12cjy) (heme iron polypeptide - unii:31vdo12cjy), iron dextran (unii: 95hr524n2m) (iron dextran - unii:95hr524n2m), potassium iodide (unii: 1c4qk22f9j) (iodine - unii:9679tc07x4), zinc oxide (unii: soi2loh54z) (zinc - unii:j41csq7qds), selenium (unii: h6241uj22b) (selenium - unii:h6241uj22b), cupric sulfate (unii: lrx7aj16dt) (copper - unii:789u1901c5), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1 - folic acid 1 mg - preferaob + dha™ is a prescription multivitamin/multimineral (preferaob ® ) and omega-3 fatty acid (life'sdha ™) nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. preferaob + dha™ is also beneficial in improving the nutritional status of women prior to conception. this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

États-Unis - anglais - NLM (National Library of Medicine)

alaven pharmaceutical llc - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), heme iron polypeptide (unii: 31vdo12cjy) (heme iron polypeptide - unii:31vdo12cjy), iron dextran (unii: 95hr524n2m) (iron dextran - unii:95hr524n2m), potassium iodide (unii: 1c4qk22f9j) (iodine - unii:9679tc07x4), zinc oxide (unii: soi2loh54z) (zinc - unii:j41csq7qds), selenium (unii: h6241uj22b) (selenium - unii:h6241uj22b), cupric sulfate (unii: lrx7aj16dt) (copper - unii:789u1901c5), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1 - folic acid 1 mg - preferaob® + dha is a prescription multivitamin/multimineral (preferaob ® ) and omega-3 fatty acid (life'sdha ™) nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. preferaob® + dha is also beneficial in improving the nutritional status of women prior to conception. this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

États-Unis - anglais - NLM (National Library of Medicine)

alaven pharmaceutical llc - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), heme iron polypeptide (unii: 31vdo12cjy) (heme iron polypeptide - unii:31vdo12cjy), iron dextran (unii: 95hr524n2m) (iron dextran - unii:95hr524n2m), potassium iodide (unii: 1c4qk22f9j) (potassium cation - unii:295o53k152), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), doconexent (unii: zad9ok - folic acid 1 mg - preferaob one™ is a prescription multivitamin/multimineral nutritional supplement with omega-3 fatty acid (life'sdha™ ) indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. preferaob one™ is also beneficial in improving the nutritional status of women prior to conception. this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

États-Unis - anglais - NLM (National Library of Medicine)

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

États-Unis - anglais - 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.

États-Unis - anglais - NLM (National Library of Medicine)

marlex pharmaceuticals inc - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - cyanocobalamin 1000 ug