Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. Reconstitute with only preservative free SWFI (add 0.72 mL to 250 mcg vial or 1.2 mL to 500 mcg vial) RxNorm Concept 1728092 romiPLOStim 250 MCG Injection Very low platelet counts can lead to serious bleeding and . Romiplostim injection is used to increase the number of platelets (cells that help the blood to clot in order to decrease the risk of bleeding in adults who have immune thrombocytopenia (ITP; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding. After reconstitution, a deliverable volume of 0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL). document.write(new Date().getFullYear()) PDR, LLC. Introduction: Romiset 250mcg Injection contains the active constituent romiplostim. nplate solucion inyectable 500 mcg de Mxico - Vademecum.es Romiplostim Injection is available in the strength of 250 mcg/0.5 Ml, For the generic brand of Romiplostim injection price Call/WhatsApp on +91-9929277766" Protect from light Thousand Oaks, CA; Amgen Inc; October 2017. The recommended initial dose. Parenteral thrombopoietin receptor agonistUsed for treatment of immune thrombocytopenia and hematopoietic syndrome of acute radiation syndromeNot to be used to normalize platelet counts, Nplate/Romiplostim Subcutaneous Inj Pwd F/Sol: 125mcg, 250mcg, 500mcg, 1 mcg/kg/week subcutaneously initially; adjust dose based on platelet counts only. romiplostim is not used to make your platelet count normal. This medicine is used by injecting it into the skin. Romiplostim is an Fc-peptide fusion protein that binds to and activates the thrombopoietin (TPO) receptor, thereby increasing platelet production. Nplate 250 micrograms powder and solvent for solution for injection Dose. To minimize the risk of thromboembolic complications in patients with immune thrombocytopenia, do not use romiplostim to normalize platelet counts. Romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) in order to decrease the risk of bleeding in adults who have immune thrombocytopenia (ITP; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding due to an abnormally low number of platelets in the blood)Patient Support Number +91-9555306364, 9 am - 8 pm IST or send us a request on email (urgent@lucknowpharma.com) /WhatsApp for the same. Romiplostim 250 MCG Injection is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood. Follow dose adjustment guidelines to achieve and maintain a platelet count of at least 50,000/mm3. Only one PSN per . Nplate J2796, injection, romiplostim, 10 mcg Nplate is supplied in single-use vials containing 125 mcg, 250 mcg and 500 mcg deliverable romiplostim The NDC numbers for Nplate, in the 11-digit format, are as follows: - 125-mcg vial: 55513-0223-01 - 250-mcg vial: 55513-0221-01 - 500-mcg vial: 55513-0222-01 Administration 96372, therapeutic . Monitor CBC weekly during the dose adjustment phase and then monthly thereafter. 1 VIAL (s) OF 0.5ML. It induces the cells in the bone marrow to increase the formation of Platelets. Romiplostim Injection: MedlinePlus Drug Information Intas Liquid Romiplostim 250 MCG Injection, Packaging Size: 1 Vail There are no drug interactions associated with Romiplostim products. If the platelet count is more than 400,000/mm3, temporarily withhold treatment and monitor the platelet count weekly; resume at a dose reduced by 1 mcg/kg/week after the platelet count is less than 200,000/mm3. Packaging Type: 250mg/0.5ml vial. PDF Nplate (romiplostim) Label - Food and Drug Administration The initial dose is 1mcg/kg but not more than 10mcg/kg/week. Nplate is supplied as either 125 mcg per vial, 250 mcg per vial or 500 mcg per vial of romiplostim and requires reconstitution with Sterile Water for Injection to obtain a concentration of 500 mcg/mL. Reconstitution - Reconstitute with only preservative free SWFI (add 0.72 mL to 250 mcg vial or 1.2 mL to 500 mcg vial) - Do not use bacteriostatic water for injection - Gently invert vial and swirl; do not shake - Usually dissolves within 2 minutes Storage Intact Vials - Store intact vials at 2C to 8C (36F to 46F) - Do not freeze [34386], Romiplostim may cause fetal harm when administered during human pregnancy. Do not inject into an area that has scars or stretch marks or is tender, red, bruised, or hard. Nplate (RomiPLOStim) 125mcg/Vial Injection - Apothera This reduces the bleeding events in patients with Thrombocytopenia. romiset 250 mcg injection is Protein-based Therapy responsible for Hematopoietic growth that results in the management og ITP. There was a higher incidence of death in the romiplostim arm in the baseline low IPSS group (41.3% vs. 30.4%; HR 1.59, 95% CI 0.67 to 3.8). It is not necessary that it works for everyone; some patients might not get a response to this drug; in such case, your doctor may discontinue this treatment option. It should be administered by a Professional Health worker or Specialist or trained medical staff only, and one should avoid Self-administration. Additional dilution with 1.38 mL of 0.9% Sodium Chloride Injection is required (final concentration of 125 mcg/mL).Dilute the 250 mcg vial (total vial content, 375 mcg) with 0.72 mL of Sterile Water for Injection. PDR.net is to be used only as a reference aid. US-based MDs, DOs, NPs and PAs in full-time patient practice can register for free on PDR.net. For bleeding disorder. Additional dilution with 3.75 mL of 0.9% Sodium Chloride Injection is required (final concentration of 125 mcg/mL).Gently swirl and invert the vial. Romiplostim is a subcutaneous injection into the skin; It is supplied in 250 mcg and 500 mcg vials. Romiplostim injection is used to increase the number of platelets enough to lower the risk of bleeding, but it is not used to increase the number of platelets to a normal level. - Reconstitute with only preservative free SWFI (add 0.72 mL to 250 mcg) - Do not use bacteriostatic water for injection - Gently invert vial and swirl; do not shake - Usually dissolves within 2 minutes Storage Intact Vials - Store intact vials at 2C to 8C (36F to 46F) - Do not freeze - Protect from light - Store in original carton until use Gently swirl and invert the vial to reconstitute. Hipersensibilidad a romiplostim o a protenas de E. coli. Usually dissolves within 2 minutes, Storage Romiplostim is produced by recombinant DNA technology in Escherichia coli (E coli). Administration . Initial: 1 mcg/kg subcutaneously weekly . Rotate injection sites. Product reconstituted with Sterile Water for Injection and not further diluted can remain in the original vial at room temperature or refrigerated at 2 to 8 degrees C (36 to 46 degrees F) for up to 24 hours, or held in a syringe at room temperature for up to 4 hours. Romiplostim has no amino acid sequence homology to endogenous TPO. It activates the TPO receptor on megakaryocyte precursors by binding with it, promoting cell proliferation and viability, resulting in increased platelet production. Introduction: Romy 250mcg Injection contains the active constituent romiplostim. Of the 250 patients, 210 entered a long-term follow-up study. Separate multiple email address with a comma. The initial dose is 1mcg/kg but not more than 10mcg/kg/week. J2796 - Injection, romiplostim, 10 micrograms: 10 mcg = 1 billable unit NDC(s): Nplate 250 mcg single-dose vial: 55513-0221-xx Nplate 500 mcg single-dose vial: 55513-0222-xx VII. ITP Injection Dosing & Administration | Nplate (romiplostim) Romy 250 mcg Injection comes as a Powder form that should be mixed with liquid to be injected Subcutaneous route. Do not inject into an area that has scars or stretch marks or is tender, red, bruised, or hard. Nplate 250 micrograms powder for solution for injection. the 75 mcg dose is divided by 500 mcg/mL, resulting in an injection volume of 0.15 mL. Send the page "" PDF HIGHLIGHTS OF PRESCRIBING INFORMATION Do not shake during Romiplostim should be clear and colorless.[34386]. of Romiplostim Sterile Water for Injection* Deliverable Product and Volume Final Concentration 250 mcg 375 mcg add 0.72 mL = 250 mcg in 0.5 mL 500 mcg/mL 500 mcg 625 mcg add 1.2 mL = 500 mcg in 1 mL 500 mcg/mL *Use preservative-free Sterile Water for Injection. [34386]Subcutaneous InjectionOverdoses have been reported due to medication errors. During the 58-week study period, 14 patients (10 in the romiplostim group; 4 in placebo) progressed to AML (HR 1.2, 95% CI 0.38 to 3.84). Store in original carton until use Half-life ranges from 1 to 34 days (median: 3.5 days). Romiplostim 250 MCG /0.5ML. Romiplostim. Treatment consists of a weekly subQ injection. Discontinue romiplostim if the platelet count does not increase to a level sufficient to avoid clinically significant bleeding after 4 weeks at the maximum dose of 10 mcg/kg/week. Limited data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Romiplostim 250 MCG Injection. PDF HIGHLIGHTS OF PRESCRIBING INFORMATION Discontinuation of Nplate may of romiset injection Nplate must be reconstituted with preservative-free Sterile Water for Injection. Do not freeze A randomized, double-blind, placebo-controlled trial (n = 250) of patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS was terminated early because of more cases of AML seen in the romiplostim treatment arm. Adjust dose in 1 mcg/kg/week increments to achieve a platelet count of 50,000/mm3 or more. In a single-arm study of 72 patients with MDS, 8 patients developed possible disease progression, 3 of which had confirmation of AML. BuySM is India's best online pharmacy for specialty medicines, super specialty medicines, life-saving drugs, critical care injections, and ICU products with a patient-centric approach, Tech-enabled & Business Services. If needed, unopened vials may be stored in the original carton at room temperature up to a maximum of 25C (77F) for a single period of up to 30 days Do not use bacteriostatic water for injection A 40, Sector-62 Noida Noida - 201309, Gautam Budh Nagar, Uttar Pradesh, India, Romiplostim injection is usedto increase the number of platelets (cells that help the blood to clotin order to decrease the risk of bleeding in adults who have immune thrombocytopenia (ITP; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding, South Africa | Iran | Italy | Japan | Nepal | Kenya | Korea | Yemen | Turkey | Vietnam | United Arab Emirates | Afghanistan | Venezuela | Uzbekistan | United States Of America | United Kingdom | Tanzania | Trinidad And Tobago | Norway | The Netherlands | Malaysia | Mexico | Morocco | Kuwait | Armenia | Australia | Azerbaijan | Bosnia And Herzegovina | Bangladesh | Brazil | Canada | Switzerland | China | Colombia | Czech Republic | Germany | Denmark | Zimbabwe | Ecuador | Tunisia | Thailand | Egypt | Spain | Slovenia | Singapore | Sweden | Sudan | Saudi Arabia | Russia | Ethiopia | Serbia | Romania | Qatar | Palestinian National Authority | Puerto Rico | Poland | Pakistan | Philippines | Peru | Oman | New Zealand | France | China (Hong Kong S.A.R.) Descriptions. Each vial contains 250 mcg of . If the platelet count is less than 50,000/mm3, increase the dose by 1 mcg/kg/week. Romy 250 mcg Injection comes as a Powder form that should be mixed with liquid to be injected Subcutaneous route. [34386], Progression from myelodysplastic syndrome (MDS) to acute myelogenous leukemia (AML) has been observed in adult clinical trials with romiplostim. We do not record any personal information entered above. An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered. After a single dose of 1 to 10 mcg/kg in patients with chronic immune thrombocytopenic purpura (ITP), platelet counts were 1.3 to 14.9 times higher than baseline over a 2 to 3 week period. [34386], Peak serum concentrations are observed approximately 7 to 50 hours (median: 14 hours) after administration. ITP is a disorder in which the body's immune system destroys its own platelets, the blood cells which help seal cuts and form blood cuts. romiset 250 mcg injection should not be used in the patient with Myelodysplastic Syndrome, a condition in which bone marrow is unable to produce healthy cells. Adjust dose in 1 mcg/kg/week increments to achieve a platelet count of 50,000/mm3 or more. Also find Injectable Products price list | ID: 21394144273 [34386], 1 mcg/kg/week subcutaneously initially; adjust dose based on platelet counts and changes in body weight. Generally, it is given after other medications fail to produce enough results. Romiplostim Injection 250 mcg. Romiplostim is also given to people whose ability to make platelets is reduced due to exposure to large amounts of. 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