![CALCITONIN SALMON 200 [USP'U]/mL Injection, Solution — NDC 69097-0770-32 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=97a1efc7-ff5a-43e5-bf9c-0d66dbe7e6d9&name=vial-cal.jpg)
CALCITONIN SALMON 200 [USP'U]/mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Calcitonin class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Calcitonin salmon injection is used to treat osteoporosis in postmenopausal women. Osteoporosis is a disease that causes bones to weaken and break more easily. Calcitonin salmon injection is also used to treat Paget's disease of bone and to quickly reduce calcium levels in the blood when needed. Calcitonin is a human hormone that is also found in salmon. It works by preventing bone breakdown and increasing bone density (thickness).
Read the full MedlinePlus article ↗- Miacalcin injection is used for three main conditions: Paget's disease of bone (a disorder where bones break down and rebuild abnormally), a dangerous spike in blood calcium called...
- What exactly is Miacalcin injection used for?
- You'll inject Miacalcin either just under the skin (subcutaneous) or into the muscle (intramuscular) — your prescriber will tell you which is right for your situation. If the dose...
- How do I give myself this injection, and does it matter where I inject it?
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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2.25 mg / 1 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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5 mg / 1 mL
UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
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2 mg / 1 mL
UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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7.5 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0630 | No ASP payment limit on file for J0630 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Calcitonin Salmon 200 [USP'U]/mL 24201-0400-02 | Hikma | 1 vial | — | AP | FDA listed | — |
| Calcitonin Salmon 400 [USP'U]/2mL 25021-0473-02 | Sagent | 1 vial | — | AP | FDA listed | — |
| Calcitonin Salmon 200 [iU]/mL 42023-0205-01 | Par | 1 vial | — | AP | FDA listed | — |
| Calcitonin Salmon 200 [USP'U]/mL 43598-0051-11 | Dr. | 1 vial | — | AP | FDA listed | — |
| Calcitonin Salmon 200 [iU]/mL 63323-0865-02 | Fresenius | 1 vial | — | AP | FDA listed | — |
| Miacalcin 200 [USP'U]/mL 67457-0675-02 | Mylan | 1 vial | — | AP | FDA listed | — |
| Calcitonin Salmon 200 [USP'U]/mLthis 69097-0770-32 | Cipla | 1 vial | — | AP | FDA listed | — |
| calcitonin salmon 200 [USP'U]/mL 70121-1650-02 | Amneal | 1 vial | — | AP | FDA listed | — |
| Calcitonin Salmon 200 [USP'U]/mL 70710-1875-01 | Zydus | 1 vial | — | AP | FDA listed | — |
| Calcitonin Salmon 200 [USP'U]/mL 70771-1971-01 | Zydus | 1 vial | — | AP | FDA listed | — |
| Miacalcin 200 [USP'U]/mL 72078-0038-02 | Mylan | 1 vial | — | AP | FDA listed | — |
| Miacalcin 200 [USP'U]/mL 72078-0039-02 | Mylan | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69097-0770-32 You're viewing this | 1 VIAL, MULTI-DOSE in 1 CARTON (69097-770-32) / 2 mL in 1 VIAL, MULTI-DOSE | 2024-10-25 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Calcitonin salmon injection is a calcitonin, indicated for the following conditions: Treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable ( 1.1 ) Treatment of hypercalcemia ( 1.2 ) Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) 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 ( 1.4 , 5.3 )
1.1Treatment of Paget’s Disease of Bone Calcitonin salmon injection is indicated for the treatment of symptomatic Paget's disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin-salmon is beneficial in asymptomatic patients. Calcitonin salmon injection 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).
1.2Treatment of Hypercalcemia Calcitonin salmon injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.
1.3Treatment of Postmenopausal Osteoporosis Calcitonin salmon injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin-salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated.
Calcitonin salmon injection should be reserved for patients for 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).
1.4Important 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 [see Warnings and Precautions ( 5.3 )] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Symptomatic Paget's disease of bone: 100 USP Units daily. Ensure adequate calcium and vitamin D intake ( 2.1 , 2.5) Hypercalcemia: start with 4 USP Units /kg body weight every 12 hours. Increase to 8 USP Units /kg every 12 hours if no improvement in 1-2 days.
Increase further to 8 USP Units /kg every 6 hours if no improvement after 2 more days ( 2.2 ) Postmenopausal osteoporosis: 100 USP Units daily. Ensure adequate calcium and vitamin D intake ( 2.3 , 2.5 )
2.1Paget’s Disease of Bone The recommended dose of calcitonin salmon injection for treatment of symptomatic Paget's disease of bone is 100 USP Units (0.5 mL) per day administered subcutaneously or intramuscularly.
2.2Hypercalcemia The recommended starting dose of calcitonin salmon injection for early treatment of hypercalcemia is 4 USP Units /kg body weight every 12 hours by subcutaneous or intramuscular injection. If the response to this dose is not satisfactory after one or two days, the dose may be increased to 8 USP Units /kg every 12 hours. If the response remains unsatisfactory after two more days, the dose may be further increased to a maximum of 8 USP Units /kg every 6 hours.
2.3Postmenopausal Osteoporosis The recommended dose of calcitonin salmon injection for treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause is 100 USP Units (0.5 mL) per day administered subcutaneously or intramuscularly. The minimum effective dose of calcitonin salmon injection for the prevention of vertebral bone mineral density loss has not been established.
2.4Preparation and Administration Visually inspect calcitonin salmon vials. Calcitonin salmon injection is a clear, colorless, solution. If the solution is not clear and colorless, or contains any particles, or if the vial is damaged, do not administer the solution.
If the volume of Calcitonin salmon injection to be injected exceeds 2 mL, intramuscular injection is preferable and the total dose should be distributed across multiple sites of injection. Instruct patients to use sterile injection technique when administering calcitonin salmon injection, and to dispose of needles properly.
2.5Recommendations for Calcium and Vitamin D Supplementation Patients who use Calcitonin salmon injection for treatment of postmenopausal osteoporosis should receive adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Calcitonin salmon injection is available as a clear, colorless, sterile solution of synthetic calcitonin-salmon in individual 2 mL multi-dose vials containing 200 USP Units per mL. Injection: 200 USP Units per mL sterile solution in 2 mL multi-dose vials ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to calcitonin-salmon or any of the excipients. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to calcitonin-salmon or any of the excipients ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious hypersensitivity reactions, including reports of fatal anaphylaxis have been reported. Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin-salmon ( 5.1 ) Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D ( 5.2 ) Malignancy: A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin-salmon-treated patients ( 5.3 , 6.1 ) Circulating antibodies to calcitonin-salmon may develop, and may cause loss of response to treatment ( 5.4 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions have been reported in patients receiving calcitonin salmon injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Appropriate medical support and monitoring measures should be readily available when calcitonin salmon injection is administered. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment [see Contraindications ( 4 )] .
For patients with suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of calcitonin salmon injection. Healthcare providers may wish to refer patients who require skin testing to an allergist.
5.2Hypocalcemia Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with calcitonin salmon injection therapy. Hypocalcemia must be corrected before initiating therapy. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated.
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. Use of calcitonin salmon for the treatment of Paget's disease or postmenopausal osteoporosis is recommended in conjunction with an adequate intake of calcium and vitamin D [see Dosage and Administration ( 2.5 )] .
5.3Malignancy In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously, intramuscularly, or intravenously.
The benefits for the individual patient should be carefully considered against possible risks [see Adverse Reactions ( 6.1 )] .
5.4Antibody Formation Circulating antibodies to calcitonin-salmon have been reported with calcitonin salmon injection. The possibility of antibody formation should be considered in any patient with an initial response to calcitonin salmon who later stops responding to treatment [see Adverse Reactions ( 6.3 )] .
5.5Urine Sediment Abnormalities Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment normalized after calcitonin-salmon was stopped. Periodic examinations of urine sediment should be considered.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity Reactions, including anaphylaxis [see Warnings and Precautions ( 5.1 )] Hypocalcemia [see Warnings and Precautions ( 5.2 )] Malignancy [see Warnings and Precautions ( 5.3 )] Most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of calcitonin-salmon injection was assessed in open-label trials several months to two years in duration. The most common adverse reactions are discussed below.
Nausea: Nausea with or without vomiting has been noted in about 10% of patients treated with calcitonin-salmon. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration. Dermatologic Reactions: Local inflammatory reactions at the site of subcutaneous or intramuscular injection have been reported in about 10% of patients.
Flushing of face or hands occurred in about 2% to 5% of patients. Skin rashes and pruritus of the ear lobes have also been reported. Other Adverse Reactions: Nocturia, feverish sensation, pain in the eyes, poor appetite, abdominal pain, pedal edema, and salty taste have been reported in patients treated with calcitonin-salmon injection.
Malignancy A meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations) was conducted to assess the risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. The trials in the meta-analysis ranged in duration from 6 months to 5 years and included a total of 10883 patients (6151 treated with calcitonin-salmon and 4732 treated with placebo). The overall incidence of malignancies reported in these 21 trials was higher among calcitonin-salmon-treated patients (254/6151 or 4.1%) compared with placebo-treated patients (137/4732 or 2.9%).
Findings were similar when analyses were restricted to the 18 nasal spray only trials [calcitonin-salmon 122/2712 (4.5%); placebo 30/1309 (2.3%)]. The meta-analysis results suggest an increased risk of overall malignancies in calcitonin-salmon treated patients compared to placebo-treated patients when all 21 trials are included and when the analysis is restricted to the 18 nasal spray only trials (see Table 1). It is not possible to exclude an increased risk when calcitonin-salmon is administered by the subcutaneous, intramuscular, or intravenous route because these routes of administration were not investigated in the meta-analysis.
The increased malignancy risk seen with the meta-analysis was heavily influenced by a single large 5-year trial, which had an observed risk difference of 3.4% [95% CI (0.4%, 6.5%)]. Imbalances in risks were still observed when analyses excluded basal cell carcinoma (see Table 1); the data were not sufficient for further analyses by type of malignancy. A mechanism for these observations has not been identified.
Although a definitive causal relationship between calcitonin-salmon use and malignancies cannot be established from this meta-analysis, the benefits for the individual patient should be carefully evaluated against all possible risks [see Warnings and Precautions ( 5.3 )] . Table 1: Risk Difference for Malignancies in Calcitonin-Salmon-Treated Patients Compared with Placebo-Treated Patients 1 The overall adjusted risk difference is the difference between the percentage of patients who had any malign…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No formal drug interaction studies have been performed with calcitonin salmon injection. Concomitant use of calcitonin-salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment.
Concomitant use of calcitonin-salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS There are no data to support use in children ( 8.4 )
8.1Pregnancy Risk Summary There are no studies with calcitonin salmon injection in pregnant women to inform a drug associated risk for birth defects or miscarriage. In an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 4-18 times the recommended parenteral human dose caused a decrease in fetal birth weights. No adverse developmental outcome was observed in the rat with subcutaneous administration of calcitonin-salmon at 9 times the recommended human parenteral dose based on body surface area (see Data ).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4 to 18 times the parenteral dose recommended for human use (of 54 International Units /m 2 ). No embryo/fetal toxicities related to calcitonin salmon were reported from maternal subcutaneous daily doses in rats up to 80 International Units /kg/day from gestation day 6 to 15.
8.2Lactation Risk Summary There is no information on the presence of calcitonin-salmon in human milk, the effects on the breastfed child, or the effects on milk production. Calcitonin has been shown to inhibit lactation in rats. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for calcitonin salmon injection and any potential adverse effects on the breastfed infant from calcitonin salmon injection or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of calcitonin salmon injection did not include sufficient numbers of subjects aged 65 years and older 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE The pharmacologic actions of calcitonin salmon injection suggest that hypocalcemic tetany could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose. A dose of calcitonin-salmon l000 International Units subcutaneously may produce nausea and vomiting.
Doses of 32 International Units per kg per day for 1 to 2 days demonstrate no other adverse effects. Data on chronic high-dose administration are insufficient to assess toxicity.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Calcitonin-salmon is a calcitonin receptor agonist. Calcitonin-salmon acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action.
The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts.
12.2Pharmacodynamics Bone Single injections of calcitonin-salmon caused a marked transient inhibition of the ongoing bone resorptive process. With prolonged use, there is a persistent, smaller decrease in the rate of bone resorption. Histologically, this is associated with a decreased number of osteoclasts and an apparent decrease in their resorptive activity.
In healthy adults, who have a relatively low rate of bone resorption, the administration of exogenous calcitonin-salmon results in decreases in serum calcium within the limits of the normal range. In healthy children and in patients whose bone resorption is more rapid, decreases in serum calcium are more pronounced in response to calcitonin-salmon. Kidney Studies with injectable calcitonin-salmon show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption.
Gastrointestinal Tract Some evidence from studies with injectable preparations suggests that calcitonin-salmon may have effects on the gastrointestinal tract. Short-term administration of injectable calcitonin salmon results in marked transient decreases in the volume and acidity of gastric juice and in the volume and the trypsin and amylase content of pancreatic juice. Whether these effects continue to be elicited after each injection of calcitonin-salmon during chronic therapy has not been investigated.
12.3Pharmacokinetics The absolute bioavailability of calcitonin-salmon is approximately 66% and 71% after intramuscular or subcutaneous injection, respectively. After subcutaneous administration, peak plasma levels are reached in approximately 23 minutes. The terminal half-life is approximately 58 minutes for intramuscular administration and 59 to 64 minutes for subcutaneous administration. The apparent volume of distribution is 0.15 to
0.3L/kg.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Calcitonin salmon injection, Synthetic is available as a sterile solution in individual 2 mL multi-dose vials containing 200 USP Units per mL. NDC 69097-770-32 carton containing 1 x 2 mL multi-dose vial Storage and Handling Store in refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.
📋 Description ▾
11 DESCRIPTION Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin-salmon injection, Synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula: It is provided in sterile solution for subcutaneous or intramuscular injection.
Each milliliter contains: calcitonin-salmon 200 USP Units. Inactive Ingredients (per mL): acetic acid, USP, 2.25 mg; phenol, USP, 5.0 mg; sodium acetate trihydrate, USP, 2.0 mg; sodium chloride, USP, 7.5 mg; water for injection, USP. The activity of calcitonin salmon injection is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute for Biological Standards and Control, Holly Hill, London. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Instruct patients and other persons who may administer calcitonin salmon injection in sterile injection technique. Also instruct patients to dispose of needles properly [see Dosage and Administration ( 2.4 )] . Inform patients of the potential increase in risk of malignancy [see Warnings and Precautions ( 5.3 )] .
Advise patients with postmenopausal osteoporosis or Paget's disease of bone to maintain an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day) intake [see Dosage and Administration ( 2.5 )] . Instruct patients to seek emergency medical help or go to the nearest hospital emergency room right away if they develop any signs or symptoms of a serious allergic reaction [see Warnings and Precautions ( 5.1 )] . Manufactured by: Cipla Ltd., India At M/s.
Immacule Lifesciences Pvt. Ltd., Nalagarh-174101, Himachal Pradesh, India Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, New Jersey - 07059 Issued: 7/2025