United States - English - 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

United States - English - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

orthomolecular medisearch laboratories pty ltd trading as biological therapies - cyanocobalamin, quantity: 1 mg/ml - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride - 1. pernicious anaemia as a result of in situ b12 deficiency.

Australia - English - Department of Health (Therapeutic Goods Administration)

orthomolecular medisearch laboratories pty ltd trading as biological therapies - cyanocobalamin, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid - cobalamin deficiency may exist that is unable to be corrected by oral intake and in these cases parenteral administration may be preferable. oral administration of vitamin b12 may be insufficient in pernicious anaemia, malabsorption disorders, gastrectomy and gastrointestinal pathologies. specific indications may include: 1. pernicious anaemia as a result of in situ b12 deficiency.

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - cyanocobalamin (57co), quantity: 18.5 kbq - capsule, hard - excipient ingredients: benzyl alcohol; lactose monohydrate; gelatin; quinoline yellow; erythrosine - this product accepted for registration/listing as 'currently supplied' at the time of commencement of the act. indications held in artg paper records. (old code) indications as at 23 may 2005 : cyanocobalamin [57co] capsules are indicated for vitamin b12 malabsorption tests.

United States - English - NLM (National Library of Medicine)

qol medical, llc - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - spray - 500 ug - nascobal nasal spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin b12 therapy and who have no nervous system involvement. nascobal nasal spray is also indicated as a supplement for other vitamin b12 deficiencies, including:    i. dietary deficiency of vitamin b12 occurring in strict vegetarians (isolated vitamin b12 deficiency is very rare).    ii. malabsorption of vitamin b12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin b12 absorption. these conditions include hiv infection, aids, crohn's disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). folate deficiency in these patients is usually more severe than vitamin b12 deficiency.    iii. inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingesti

Malta - English - Medicines Authority

j. uraich & cia s.a. av. cami reial, 51-57, 08184 palau- solita i plegamans, barcelona, spain - cyanocobalamin, cyproheptadine acefyllinate, carnitine hydrochloride, thiamine hydrochloride, lysine hydrochloride, pyridoxine hydrochloride - oral solution - carnitine hydrochloride 7.5 % (w/v) thiamine hydrochloride 6 mg/ml cyanocobalamin 0.02 mg/ml cyproheptadine acefyllinate 0.35 mg/ml lysine hydrochloride 5 % (w/v) pyridoxine hydrochloride 6 mg/ml - appetite stimulants

Australia - English - Department of Health (Therapeutic Goods Administration)

cyanocobalamin -

Philippines - English - FDA (Food And Drug Administration)

total nutrition corp - cyanocobalamin (vit b12) - tablet, film coated - 1mg

United States - English - NLM (National Library of Medicine)

method pharmaceuticals, llc - vitamin a palmitate (unii: 1d1k0n0vvc) (vitamin a - unii:81g40h8b0t), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol succinate, d- (unii: lu4b53jyve) (.alpha.-tocopherol, d- - unii:n9pr3490h9), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin 5'-phosphate sodium (unii: 20rd1dzh99) (flavin mononucleotide - unii:7n464ure7e), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - vitamin a 1500 [iu] in 1 ml - supplementation of the diet with vitamins a, c and d. multi-vitamin drops with fluoride 0.25 mg also provides fluoride for caries prophylaxis. the american academy of pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. the american academy of pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 ml of multi-vitamin drops with fluoride 0.25 mg (see dosage and administration ). multi-vitamin drops with fluoride 0.25 mg supply significant amounts of vitamins a, c and d to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.