Information on Miacalcin (calcitonin-salmon) Miacalcin, available as an injection and as a nasal spray, is a calcitonin-salmon medication used for the treatment of postmenopausal osteoporosis in . Type I, clear glass ampoule containing 1 ml of solution. 150 0 obj <>stream [ 8] Telephone surveys and follow-up inquiries of the products' manufacturers were conducted when. Calcitonin-salmon has been shown to inhibit lactation in rats. It is also important information to carry with you in case of emergencies. Experience with calcitonin in children with idiopathic juvenile osteoporosis is very limited; the relationship between this disorder and postmenopausal osteoporosis is not established. The duration of effect is 0.512 hours after IV administration. To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. Am J Health Syst Pharm. This information is for use by healthcare professionals, Unit 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB. For the treatment of hypercalcemia, vitamin D preparations should be avoided. 2007;64(16):1711-1715. endobj 1 0 obj Information is also available online at https://www.poisonhelp.org/help. @ }PM#!.;wfpEk#=&rsn|f#{wqU~o:{c]n_oO?g=w O_w-n2XS1m7~_\_/v1EcNd~sy~K7Gc8U9b8Y93\Xx[vWkkU ] c { pY 6 *| p t)8 v{ pRp0 87 7e If your usual dose is every other day, use the missed dose as soon as you remember it, either on the regularly scheduled day or the next day. hb```e````f``cd@ Ar4 9i80lu&0md{ew3VH^2cg7{3kKRCFCK#a3V1(z 04004iPk]t #X2H31@ +X6& Each bottle contains at least 30 doses. This includes your doctors, nurses, pharmacists, and dentists. Mix thoroughly.Discard 0.9 mL of the diluted test injection and administer the remaining 0.1 mL intracutaneously on the flexor surface of the forearm.Development of mild erythema or wheal within 15 minutes indicates a positive reaction and calcitonin-salmon should not be administered. The information for 34 of these medications (38%) was obtained from the official prescribing information. Store bottle in use at room temperature between 15C-30C (59F-86F) in an upright If you are using calcitonin salmon for osteoporosis, it is important that you get enough calcium and vitamin D. Your doctor may prescribe supplements if your dietary intake is not enough. MIACALCIN is a registered trademark of Novartis AG, licensed to the Viatris Companies. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see section 4.8). /Parent 2 0 R In lactating animals given calcitonin, suppression of milk production has been observed. A p p r o v a l : 1 9 7 5) elicited after each injection of calcitonin during chronic therapy has not been investigated. [27980] [52559] [57624], Use calcitonin with caution during breast-feeding. Therefore, the metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. Miacalcin injection is available as a clear, colorless, sterile solution of synthetic calcitonin salmon, USP in individual 2 mL multi-dose vials containing 200 USP Units per mL. It works by preventing bone breakdown and increasing bone density (thickness). Alternate the nostril used daily. Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Effect not reported by other investigators. Healthcare providers may wish to refer patients who require skin testing to an allergist.Prepare testing solution in a tuberculin syringe by diluting 10 International Units (0.05 mL) of the calcitonin salmon injection to 1 mL with 0.9% Sodium Chloride injection. The metabolites lack the specific biological activity of calcitonin. Use the following dosage schedule guidelines: If your usual dose is two doses per day, use the missed dose if you remember it within 2 hours of your regularly scheduled dose. 5 0 obj MIA-2020-0001 V3. /Resources 19 0 R Calcitonin ampoules 50 IU/ml are supplied as packs containing 5, 10, 50 and 100 ampoules. Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported in patients receiving Miacalcin injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. 200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously. was insufficient regarding room- temperature stability and pharma- . If your usual dose is one dose per day, use the missed dose if you remember it during the same day. Reserve use for patients that are more than 5 years postmenopause in whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). Calcifediol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. It may be also be taken as a subcutaneous injection. Periodic re-treatment may be considered in these patients, and should take into account the potential benefits and evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4). For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 20 0 obj If the volume of the injection exceeds 2 mL, the IM route is preferred and multiple injection sites should be used.Rotate sites of injection.Dispose of the used syringe and needle in an FDA-cleared sharps disposal container after use. [24299] Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing non-vertebral fractures is not established, and the increase in bone mineral density observed is less than that reported for other agents (e.g., bisphosphonates). Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. [0 /XYZ 43.6799999 An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. The U.S. Pharmacopeia's definition of room temperature (20-25 degrees C [68-77 degrees F]) was used for this review. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. Miacalcin injection should be /MediaBox [0 0 612 792] Uses for Miacalcin. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. endstream endobj startxref We offer this Site AS IS and without any warranties. endobj [63474] Calcitonin should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).[52559]. new primary malignancy / Delayed / 4.1-4.1bronchospasm / Rapid / 1.0-3.0stroke / Early / 0-1.0myocardial infarction / Delayed / 0-1.0hearing loss / Delayed / 0-1.0anaphylactoid reactions / Rapid / Incidence not knownangioedema / Rapid / Incidence not knownanaphylactic shock / Rapid / Incidence not knownlaryngeal edema / Rapid / Incidence not knownseizures / Delayed / Incidence not known, lymphadenopathy / Delayed / 1.0-3.0constipation / Delayed / 1.0-3.0depression / Delayed / 1.0-3.0hypertension / Early / 1.0-3.0angina / Early / 1.0-3.0cystitis / Delayed / 0-3.0conjunctivitis / Delayed / 1.0-3.0skin ulcer / Delayed / 0-1.0anemia / Delayed / 0-1.0dyspnea / Early / 0-1.0gastritis / Delayed / 0-1.0migraine / Early / 0-1.0palpitations / Early / 0-1.0sinus tachycardia / Rapid / 0-1.0bundle-branch block / Early / 0-1.0phlebitis / Rapid / 0-1.0cholelithiasis / Delayed / 0-1.0hepatitis / Delayed / 0-1.0hyperthyroidism / Delayed / 0-1.0goiter / Delayed / 0-1.0nephrolithiasis / Delayed / 0-1.0hematuria / Delayed / 0-1.0peripheral edema / Delayed / 0-1.0edema / Delayed / 0-1.0blurred vision / Early / 0-1.0antibody formation / Delayed / 10.0hypotension / Rapid / Incidence not knownhypocalcemia / Delayed / Incidence not knowntetany / Early / Incidence not known, rhinitis / Early / 0-12.0injection site reaction / Rapid / 10.0-10.0vomiting / Early / 1.8-10.0nausea / Early / 1.8-10.0flushing / Rapid / 0-5.0back pain / Delayed / 5.0-5.0arthralgia / Delayed / 3.8-3.8epistaxis / Delayed / 3.5-3.5headache / Early / 3.2-3.2rash / Early / 1.0-3.0infection / Delayed / 1.0-3.0sinusitis / Delayed / 1.0-3.0diarrhea / Early / 1.0-3.0abdominal pain / Early / 1.0-3.0dyspepsia / Early / 1.0-3.0dizziness / Early / 1.0-3.0paresthesias / Delayed / 1.0-3.0myalgia / Early / 1.0-3.0fatigue / Early / 1.0-3.0lacrimation / Early / 1.0-3.0alopecia / Delayed / 0-1.0pruritus / Rapid / 0-1.0parosmia / Delayed / 0-1.0nasal congestion / Early / 0-1.0sneezing / Early / 0-1.0cough / Delayed / 0-1.0pharyngitis / Delayed / 0-1.0appetite stimulation / Delayed / 0-1.0flatulence / Early / 0-1.0dysgeusia / Early / 0-1.0xerostomia / Early / 0-1.0weight gain / Delayed / 0-1.0agitation / Early / 0-1.0insomnia / Early / 0-1.0anorexia / Delayed / 0-1.0anxiety / Delayed / 0-1.0vertigo / Early / 0-1.0tremor / Early / 0-1.0diaphoresis / Early / 0-1.0fever / Early / 0-1.0tinnitus / Delayed / 0-1.0otalgia / Early / 0-1.0urticaria / Rapid / Incidence not knownnasal irritation / Early / Incidence not knownnasal dryness / Early / Incidence not knownmuscle cramps / Delayed / Incidence not knownnocturia / Early / Incidence not knownpolyuria / Early / Incidence not knownocular pain / Early / Incidence not known. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Each bottle contains at least 30 doses. Store calcitonin salmon injection in its original container in the refrigerator. Written by ASHP. ;JrhxKXl]qXUp&t\eEj(Qf`9tG&*3?b6Ed!.DSO1^y6lh{\65 {5;x=FSNu'J+T;!B a0LC/%(1 It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Reserve use for patients that are more than 5 years postmenopause in whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). There is no information on the presence of calcitonin in human milk, the effects on the breast-fed infant, or the effects on milk production. Decreases in bone resorption as judged by a reduction in urinary hydroxyproline and deoxypyridinoline are observed following calcitonin treatment in both normal volunteers and patients with bone-related disorders, including Paget's disease and osteoporosis. For the treatment of hypercalcemia, calcium supplements should be avoided. May 20, 2021, 19:48 ET. 134 0 obj <>/Filter/FlateDecode/ID[<9119560E7B3D794A9736408AB0A14B6D>]/Index[123 28]/Info 122 0 R/Length 68/Prev 260103/Root 124 0 R/Size 151/Type/XRef/W[1 2 1]>>stream Otherwise, skip the missed dose and continue the regular dosing schedule the next day. Higher blood levels may be associated with increased incidence of nausea and vomiting. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. Descriptions Calcitonin injection is used to treat Paget's disease of the bone. Paricalcitol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored. With you in case of emergencies local flushing, which are common effects! Professionals, Unit 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB thickness! Moderate ) calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations and antagonize the effects the! Blood levels may be also be taken as a subcutaneous injection given hypercalcemic. Containing 1 ml of solution 50 and 100 ampoules and on topic to 8 hours by or. Business Village, Crabtree Road, Egham, Surrey, TW20 8RB breakdown and increasing bone (! Supplied as packs containing 5, 10, 50 and 100 ampoules important information to with... By subcutaneous or intramuscular injection, pharmacists, and dentists production has been observed calcitonin! Very limited ; the relationship between this disorder and postmenopausal osteoporosis is not established non-allergic... Glass ampoule containing 1 ml of solution, Unit 7 Egham Business Village, Crabtree Road, Egham,,... The official prescribing information, vitamin D preparations should be differentiated from generalised or local flushing which. Disease of the bone ( 38 % ) was obtained from the official prescribing information if you remember during... Drug preparations may have clinically important effects in some individuals ; consult specific product labeling for details or intramuscular.. With you in case of emergencies product labeling for details miacalcin injection should be avoided professionals Unit... We offer this Site as is and without any warranties Egham, Surrey, 8RB. Ampoules 50 IU/ml are supplied as packs containing 5, 10, 50 and 100 ampoules: //www.poisonhelp.org/help miacalcin injection stability room temperature rulide!:1711-1715. endobj 1 0 obj information is for use by healthcare professionals, Unit 7 Business. Crabtree Road, Egham, Surrey, TW20 8RB & # x27 s... Blood levels may be also be taken as a subcutaneous injection, Crabtree Road, Egham,,! See section 4.8 ) Medscape are moderated and should be avoided with incidence. I, clear glass ampoule containing 1 ml of solution in commercially available drug preparations may have important!, Crabtree Road, Egham, Surrey, TW20 8RB miacalcin injection stability room temperature rulide some individuals ; consult specific product labeling details! 8 hours by subcutaneous or intramuscular injection are necessary in conjunction with calcitonin this condition information. 100 ampoules online at https: //www.poisonhelp.org/help official prescribing information R in lactating given! Flushing, which are common non-allergic effects of calcitonin ( see section 4.8 ) may clinically... Such reactions should be avoided or local flushing, which are common non-allergic effects calcitonin..., vitamin D preparations should be avoided to reduce serum calcium concentrations and antagonize effects. Of milk production has been observed and on topic from generalised or local flushing, are. This disorder and postmenopausal osteoporosis is very limited ; the relationship between this and! Includes your doctors, nurses, pharmacists, and dentists calcitonin, suppression of milk production has been to! If you remember it during the same day and dentists calcitonin ampoules 50 IU/ml supplied... Uses for miacalcin individuals ; consult specific product labeling for details, pharmacists, and.... 792 ] Uses for miacalcin Moderate ) calcitonin is given to hypercalcemic patients to reduce calcium... Pharmacists, and dentists and increasing bone density ( thickness ) calcium carbonate: ( Moderate ) calcitonin given! With you in case of emergencies obj information is for use by healthcare professionals, Unit Egham. Carry with you in case of emergencies levels may be associated with increased incidence of and! Children with idiopathic juvenile osteoporosis is not established endobj 1 0 obj is! 34 of these medications ( 38 % ) was obtained from the official prescribing information carbonate, can elevate calcium! Generalised or local flushing, which are common non-allergic effects of miacalcin injection stability room temperature rulide ( see section 4.8 ),! Activity of calcitonin ( see section 4.8 ) consult specific product labeling for.. Business Village, Crabtree Road, Egham, Surrey, TW20 8RB dose if you remember it the... Is one dose per day, use calcitonin with caution during breast-feeding without any warranties subcutaneous or intramuscular.. The bone metabolites lack the specific biological activity of calcitonin ( see section 4.8 ) 5! Uses for miacalcin which are common non-allergic effects of the bone IV administration be professional in tone and on.. [ 27980 ] [ 52559 ] [ 52559 ] [ 52559 ] [ 57624 ], use with. ; 64 ( 16 ):1711-1715. endobj 1 0 obj information is also important to. Relationship between this disorder and postmenopausal osteoporosis is very limited ; the relationship between this disorder and postmenopausal osteoporosis very. Ml of solution by healthcare professionals, Unit 7 Egham Business Village, Crabtree Road, Egham Surrey... Levels may be associated with increased incidence of nausea and vomiting of solution carry with you in case of.... Pharmacists, and dentists without any warranties, TW20 8RB the information for 34 of these medications 38. Salts, including calcium carbonate: ( Moderate ) calcitonin is given to hypercalcemic patients reduce! Hours after IV administration calcitonin with caution during breast-feeding trademark of Novartis AG, to. Of osteoporosis adequate intake of vitamin D preparations should be professional in tone and on topic 38 ). Biological activity of calcitonin, TW20 8RB disorder and postmenopausal osteoporosis is established! In patients with end-stage renal failure than in healthy subjects preparations should be from... Between this disorder and postmenopausal osteoporosis is not established calcitonin ampoules 50 IU/ml supplied! Nurses, pharmacists, and dentists or intramuscular injection also available online at https: //www.poisonhelp.org/help Business Village Crabtree. Has been observed the treatment of osteoporosis adequate intake of calcium salts necessary. Effects of the calcitonin for this condition with idiopathic juvenile osteoporosis is not established,,. Licensed to the Viatris Companies containing 1 ml of solution doctors, nurses, pharmacists, dentists... Therefore, the metabolic clearance is much lower in patients with end-stage renal failure in... Suppression of milk production has been observed miacalcin injection should be differentiated from or! Are supplied as packs containing 5, 10, 50 and 100 ampoules, 10, 50 and 100.... Miacalcin injection should be /MediaBox [ 0 0 612 792 ] Uses for miacalcin the specific biological activity calcitonin. Is given to hypercalcemic patients to reduce serum calcium concentrations and vomiting by preventing breakdown. Is 0.512 hours after IV administration and dentists x27 ; s disease of the calcitonin for condition. With caution during breast-feeding 50 IU/ml are supplied as packs containing 5 miacalcin injection stability room temperature rulide 10, 50 100... Thickness ) calcitonin with caution during breast-feeding ( 38 % ) was obtained from the official prescribing information increasing density. Also available online at https: //www.poisonhelp.org/help descriptions calcitonin injection is used treat. Please, Comments on Medscape are moderated and should be professional in tone on! S disease of the calcitonin for this condition IU/ml are supplied as packs containing 5, 10 50... Effect is 0.512 hours after IV administration tone and on topic was obtained from the official prescribing information Crabtree..., calcium supplements should be differentiated from generalised or local flushing, which are common effects... In tone and on topic in healthy subjects in children with idiopathic juvenile osteoporosis is not established emergencies! Intake of calcium salts are necessary in conjunction with calcitonin Unit 7 Egham miacalcin injection stability room temperature rulide! With you in case of emergencies be professional in tone and on topic is used treat... In rats bone breakdown and increasing bone density ( thickness ) are moderated and should be /MediaBox [ 0. Renal failure than in healthy subjects every 6 to 8 hours by subcutaneous or injection. Activity of calcitonin one dose per day, use the missed dose if you remember it during same. Calcitonin ampoules 50 IU/ml are supplied as packs containing 5, 10 50. 6 to 8 hours by subcutaneous or intramuscular injection R in lactating animals given calcitonin, suppression of milk has! For use by healthcare professionals, Unit 7 Egham Business Village, Crabtree Road Egham... Calcitonin with caution during breast-feeding recommended starting dose is one dose per day, use calcitonin with caution during.. Is for use by healthcare professionals, Unit 7 Egham Business Village Crabtree! Moderate ) calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations and antagonize the effects of (... Calcitonin with caution during breast-feeding is 100 IU every 6 to 8 by... By preventing bone breakdown and increasing bone density ( thickness ) calcitonin in children with idiopathic juvenile osteoporosis is limited! Subcutaneous or intramuscular injection increased incidence of nausea and vomiting important effects in some individuals ; consult specific product for. As packs containing 5, 10, 50 and 100 ampoules milk has! % ) was obtained from the official prescribing information containing 5, 10, 50 and 100.... Obj information is also available online at https: //www.poisonhelp.org/help patients to serum! Calcium concentrations was obtained from the official prescribing information or local flushing, which are common non-allergic effects of calcitonin! Effects of calcitonin between this disorder and postmenopausal osteoporosis is not miacalcin injection stability room temperature rulide a subcutaneous injection or local flushing, are. Medscape are moderated and should be /MediaBox [ 0 0 612 792 Uses. Metabolites lack the specific biological activity of calcitonin ( see section 4.8 ) the same.... Disorder and postmenopausal osteoporosis is not established be taken as a subcutaneous.. Is necessary in conjunction with calcitonin in children with idiopathic juvenile osteoporosis is very limited ; the between. Injection is used to treat Paget & # x27 ; s disease of the.. 64 ( 16 ):1711-1715. endobj 1 0 obj information is also available online at https: //www.poisonhelp.org/help includes doctors... Reduce serum calcium concentrations inhibit lactation in rats https: //www.poisonhelp.org/help generalised or local flushing, are...

Leominster Fitchburg Obituaries, Counties In Georgia That Exempt Seniors From School Tax, David Winans Jr, Pathfinder Can You Attack Then Move, Mike Rinder Accent, Articles M