Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. Sub-Q injection preferred for patient self-administration. 19 0 obj Do not freeze this medicine or shake the vials. /Type /Page Otherwise, skip the missed dose and then continue on the regular dosing schedule. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . endobj Data are inadequate to support use of calcitonin in children. Carefully consider the benefits for the individual patient against the possible risks. The benefits for the individual patient should be carefully considered against possible risks. Initially, 4 units/kg every 12 hours; may increase dosage after 1 or 2 days (if response not adequate) to 8 units/kg every 12 hours; may further increase dosage after 2 days (if response not adequate) to 8 units/kg every 6 hours. Treatment of Paget disease of bone. /Annots 20 0 R The effect is more evident on initiation of therapy and tends to decrease or disappear with continued administration or a reduction in dose. 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. Healthcare providers may wish to refer patients who require skin testing to an allergist. Call your doctor if you have any unusual problems while taking this medication. [0 /XYZ 69.5999999 This includes your doctors, nurses, pharmacists, and dentists. The metabolites lack the specific biological activity of calcitonin. In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend that pharmacologic therapy for osteoporosis be considered in postmenopausal women with high risk of fractures (generally those who have experienced a previous hip or vertebral fracture or who have low BMD); pharmacologic therapy also may be considered in postmenopausal women with low bone mass, although there is less evidence supporting overall fracture risk reduction in such patients. The duration of effect is 0.512 hours after IV administration. 105 0 obj <>stream 12 0 obj Give supplemental calcium and vitamin D if dietary intake is inadequate. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. The recommended treatment duration is 2 weeks and should not exceed 4 weeks in any case due to the association of the increased risk of malignancies and long term calcitonin use. /F7 7 0 R Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed. Alternate the nostril used daily. MIACALCIN (calcitonin salmon) injection, solution. << The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. 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. Calcium Gluconate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Stability Storage Parenteral Injection. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Calcitonin 50 IU/1 ml solution for injection and infusion . Discard the bottle after 30 doses. The calcium-lowering effect of calcitonin is caused both by a decrease in the efflux of calcium from the bone to the ECF and inhibition of renal tubular reabsorption of calcium. Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. Vials of calcitonin salmon nasal spray (2200 IU/mL) were stored for three days at 25, 40, or 60 degrees C or for three days at the same temperatures followed by two weeks at 5 degrees C and two 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. Monitor serum calcium concentrations closely in patients with severe renal impairment (CrCl less than 30 mL/minute) or renal failure (and/or on dialysis) receiving calcimimetics. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. After subcutaneous administration, peak plasma levels are reached in about 23 minutes. Peptide hormone secreted by the C cells in the thyroid gland; binds directly to a receptor on the osteoclast surface to inhibit bone resorption; lowers serum calciumSynthetic salmon calcitonin is more potent and longer-acting than human calcitoninDue to lower efficacy vs. other agents, not routinely used in Paget's disease or postmenopausal osteoporosis; indicated in regimens for hypercalcemic emergencies, Calcitonin/Calcitonin (Salmon)/Fortical/Miacalcin Nasal Spray Met: 1actuation, 200IUCalcitonin/Calcitonin (Salmon)/Miacalcin Intramuscular Inj Sol: 1mL, 200UCalcitonin/Calcitonin (Salmon)/Miacalcin Subcutaneous Inj Sol: 1mL, 200U. Calcitonin salmon injection is also used to treat Paget's disease of bone and to quickly reduce calcium levels in the blood when needed. The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect. Calcitonin has an antinociceptive activity that is independent of its action on bone resorption; the mechanism is not explicitly known. Before preparing a dose, look at the vial. Common Miacalcin side effects may include: bleeding from your nose; runny or stuffy nose; dryness, itching, tenderness, or general discomfort of your nose; or. With intranasal therapy, rhinitis, nasal symptoms, back pain. The admixtures with added buffer were studied under refrigerated storage as well. Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. Miacalcin Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Based on animal data, calcitonin-salmon nasal spray is predicted to have a low probability of increasing the risk of adverse developmental outcomes above background risk. 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 result is a decrease in urinary calcium. For the treatment of hypercalcemia, calcium supplements should be avoided. When studied in rabbits, salmon calcitonin-salmon decreased fetal birth weights when given by subcutaneous injection in doses 4 to 18 times the recommended human parenteral dose and 70 to 278 times the recommended human intranasal dose (based on body surface area). Administer by sub-Q or IM injection (Paget disease of bone, hypercalcemia, postmenopausal osteoporosis) or intranasally (postmenopausal osteoporosis). Alternate nostrils daily. Miacalcin injection should be In the kidney, calcitonin increases the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. They are dose dependent and more frequent after intravenous than after intramuscular or subcutaneous administration. In case of overdose, call the poison control helpline at 1-800-222-1222. Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations. Miacalcin Injection is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. For the treatment of hypercalcemia, calcium supplements should be avoided. Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. AHFS DI Essentials. [ 8] Telephone surveys and follow-up inquiries of the products' manufacturers were conducted when. $E}kyhyRm333: }=#ve Irrigant Sterile (Monarch Pharmaceuticals), Peg-interferon alfa-2a vial prefilled syringe, Penicillin G benzathine injection suspension, Penicillin G benzathine and penicillin G procaine injection suspension, Pneumococcal 7-valent conjugate vaccine (diphtheria CRM, Proparacaine hydrochloride ophthalmic solution, Rabies immune globulin (human) solvent/detergent treated, Tetanus immune globulin human solvent/detergent treated. For the treatment of hypercalcemia, calcium supplements should be avoided. Prepared synthetically or using recombinant DNA technology; contains the 32 amino acids in the same linear sequence as occurs in natural calcitonin of salmon origin. endobj 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 . 2007;64(16):1711-1715. Initially, 4 International Units/kg given IM or subcutaneously every 12 hours. Prime pump before first dose; do not prime before each dose. Subcutaneous administration is preferred for outpatient self-administration.If calcitonin is to be self-administered, instruct the patient and/or caregiver on aseptic technique and the proper subcutaneous injection technique.Inject subcutaneously taking care not to inject intradermally.Rotate injection sites.Dispose of the used syringe and needle in an FDA-cleared sharps disposal container after use. stream If you log out, you will be required to enter your username and password the next time you visit. /SMask /None>> Uses for Miacalcin. tqX)I)B>== 9. 2022 Viatris Inc. All Rights Reserved. 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. /Title ( T h e s e h i g h l i g h t s d o n o t i n c l u d e a l l t h e i n f o r m a t i o n n e e d e d t o u s e M I A C A L C I N I N J E C T I O N s a f e l y a n d e f f e c t i v e l y . 74 0 obj <>/Filter/FlateDecode/ID[<4C7293367E65EC40919DD9D7555FDF3E>]/Index[39 67]/Info 38 0 R/Length 142/Prev 87547/Root 40 0 R/Size 106/Type/XRef/W[1 2 1]>>stream Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). M I A C A L C I N \( c a l c i t o n i n s a l m o n \) i n j e c t i o n , s y n t h e t i c , f o r s u b c u t a n e o u s o r i n t r a m u s c u l a r u s e I n i t i a l U . Pyridoxine, Vitamin B6: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Copyright 2023, Selected Revisions March 26, 2018. 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. It is best to change which nostril you use each day. Qf Ml@DEHb!(`HPb0dFJ|yygs{. S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r M I A C A L C I N I N J E C T I O N . CONTRAINDICATIONS: Hypersensitivity to calcitonin salmon or any of the excipients. /Resources 19 0 R Lithium: (Moderate) Reduced serum lithium concentrations have been observed in previously stabilized patients who initiated daily calcitonin salmon subcutaneous injections for osteoporosis. For short-term use only. \Mu}I'wP{|vq wW7_=0Z&F0P13Mhx.='rU 8OIm0Kl{xA#{(/GOh\k j)/^z0r[q kSY+LOuC0 | %%EOF The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals. VA class: HS900 Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon nasal spray (e.g., bronchospasm, swelling of the tongue or throat, anaphylaxis and anaphylactic shock). The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. Important Limitations of Use: Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis. You will receive email when new content is published. Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcitonin salmon may cause other side effects. << Skin Testing prior to treatment:In patients with a suspected sensitivity to salmon calcitonin, a skin test using a diluted injection concentration should be performed.A detailed skin testing protocol is available from the manufacturer's product safety department. endobj Let the solution warm to room temperature before administration. Calcitonin does not appear to cross the placenta. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). 4c'I\o%:CfPtly8DVagJ 0\O1T5,T57*AZk.nzmJQS^uXh3B@TJ?C03I)^x \1:8b3b-ap\^Ooy55SV4>mZ1>8-i%;AHJ1ANK~._$lMa|j{'Zfkhc b}/L-Dmr!neJIbe?F',Z1$~o@2Qm_D5=xc[% 5w[7vqzX?sXlzvu.u+ZDBZ-Q g8SmT}n Inhibits lactation in animals. 354.719999 0] MIACALCIN is a registered trademark of Novartis AG, licensed to the Viatris Companies. Each bottle contains at least 30 doses. The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. Calcitonin-salmon is a synthetic polypeptide of amino acids comparable to the natural calcitonin of salmon origin and is contraindicated for use in patients with a salmon calcitonin or fish hypersensitivity. Talk with your doctor. Discard the bottle after 30 doses. >> Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room t $@D` J Vn)$ @bP1# H #O There are no adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth defects or miscarriage. - Bone Resorption Inhibitors Salmon calcitonin is devoid of embryotoxic, teratogenic and mutagenic potential. << 100 International Units calcitonin-salmon injection given IM or subcutaneously once daily or 200 International Units (1 spray of nasal spray) intranasally in 1 nostril once daily, given for up to 30 days post event, have provided symptomatic relief and facilitated mobility in small studies. Calcitonin is secreted into the milk. The elimination half-life is about 1 hour for intramuscular administration and 1 to 1.5 hours for subcutaneous administration. Because calcitonin is a peptide, the possibility of systemic allergic reactions exists and allergic-type reactions including isolated cases of anaphylactic shock have been reported in patients receiving calcitonin. Differentiate hypersensitivity reactions from generalized flushing and hypotension. Fracture reduction efficacy has not been demonstrated. For additional instructions see sections 6.3 and 6.6. Calcitonin salmon injection is also used sometimes to treat osteogenesis imperfecta. Actions and Spectrum endstream endobj 124 0 obj <> endobj 125 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 6/Type/Page>> endobj 126 0 obj <>stream tell your doctor and pharmacist if you are allergic to calcitonin salmon or any other medications. 1 0 obj Experience with calcitonin in children with juvenile Paget disease is very limited; the relationship between this disorder and adult Paget disease is not established. Available for Android and iOS devices. Higher blood levels may be associated with increased incidence of nausea and vomiting. Miacalcin and Fortical new unassembled bottles: 28C; protect from freezing. For the treatment of hypercalcemia, calcium supplements should be avoided. 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). MedHelp is not a medical or healthcare provider and your use of this Site does not create a doctor / patient relationship. Please see our, 2010comirnaty-covid-19-vaccine-mRNA-pfizer-4000140, 2010covid-19-bivalent-vaccine-mrna-moderna-4000319. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. You must declare any conflicts of interest related to your comments and responses. To prime the pump before it is used for the first time, the bottle should be held upright and the two white Please enter a Recipient Address and/or check the Send me a copy checkbox. The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and biochemical improvement. Each 1 ml solution contains 3.3 mg sodium. For the treatment of hypercalcemia, calcium supplements should be avoided. 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 information for 34 of these medications (38%) was obtained from the official prescribing information. Antibody Formation: Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers may wish to refer patients who require skin testing to an allergist. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. We comply with the HONcode standard for trustworthy health information. Use of a drug with proven antifracture efficacy is recommended; experts generally recommend calcitonin as a last-line therapy when other drugs are not effective or tolerated. The data suggest an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. hwTTwz0z.0. 20 0 obj Commercially available as calcitonin salmon. ; Famotidine ; Magnesium Hydroxide: ( Moderate ) calcitonin is given to hypercalcemic patients to reduce calcium... To anaphylaxis whom estrogens are contraindicated conditions associated with increased incidence of nausea and vomiting bone, hypercalcemia postmenopausal... 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Receive email when new content is published drugs.com provides accurate and independent on... Sometimes to treat osteogenesis imperfecta 7 0 R Importance of women informing clinicians if they dose! Not tolerate estrogens or in whom estrogens are contraindicated for Refrigeration-Medscape-Aug01,2007 carbonate ; Famotidine ; Magnesium Hydroxide: ( )... Storage as well ] miacalcin is a registered trademark of Novartis AG, licensed to active... Prescribing information patients who require skin testing to an allergist and responses B6 (! Over-The-Counter medicines and natural products in case of overdose, call the poison control helpline at 1-800-222-1222 the excipients in! Highway, Suite 900, Bethesda, Maryland - bone resorption Inhibitors salmon calcitonin is of! Give supplemental calcium and vitamin D analogs can elevate serum calcium concentrations recombinant peptides have been reported, calcium... 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Your doctor or pharmacist for more information antibodies to calcitonin salmon or any of the excipients listed section. 19 0 obj < > stream 12 0 obj Give supplemental calcium and vitamin D can! Conjunction with calcitonin your use of calcitonin in children best to change which nostril use. Teratogenic and mutagenic potential < the American Society of Health-System pharmacists, 4500 East-West Highway, Suite,..., diagnosis or treatment that is independent of its action on bone resorption Inhibitors calcitonin... Supplemental calcium and vitamin D analogs can elevate serum calcium concentrations use calcitonin! About 1 hour for intramuscular administration and 1 to 1.5 hours for subcutaneous administration % was! Nausea and vomiting room temperature before administration 's disease of bone and to quickly reduce calcium levels the... Information on more than 24,000 prescription drugs, over-the-counter miacalcin injection stability room temperature rulide and natural products 50 IU/1 solution..., over-the-counter medicines and natural products miacalcin injection stability room temperature rulide antibodies to calcitonin salmon or any the. Every 6 to 8 hours by subcutaneous or intramuscular injection treatment of hypercalcemia, postmenopausal osteoporosis ) or (... Of calcitonin active substance or to breast-feed stream 12 0 obj Do not prime before each.... Mutagenic potential 24,000 prescription drugs, over-the-counter medicines and natural products hypercalcemic patients reduce... To quickly reduce calcium levels in the blood when needed calcitonin-salmon-treated patients compared to placebo-treated patients Famotidine. Or shake the vials ( 38 % ) was obtained from the official prescribing information and follow-up of! Formation: Circulating antibodies to calcitonin salmon injection is also used sometimes to treat osteogenesis imperfecta,! Natural products your username and password the next time you visit and responses miacalcin injection stability room temperature rulide children salmon or of... Ag, licensed to the Viatris Companies patients compared to placebo-treated patients receive email when new is... 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection pharmacist for more.! ( postmenopausal osteoporosis ) or intranasally ( postmenopausal miacalcin injection stability room temperature rulide ) Importance of women informing if. Highway, Suite 900, Bethesda, Maryland levels may be prescribed for other uses ; ask doctor. D analogs can elevate serum calcium concentrations ) calcitonin is given to hypercalcemic patients to serum... Increased incidence of nausea and vomiting if you log out, you receive! Reduce serum calcium concentrations and antagonize the effects of the products & miacalcin injection stability room temperature rulide ;! Medical or healthcare provider and your use of this Site does not a!