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NPLATE 250 MCG POWDER FOR SOLUTION FOR INJECTION 250 µg Powder and solvent for solution for injection Vial
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10331014340
NPLATE 250 µg Powder for Solution for Injection is a prescription medication containing Romiplostim, used to treat low platelet counts (thrombocytopenia) in adults and children (1 year and older) with chronic immune thrombocytopenia (ITP). It works by stimulating the body's natural platelet production, effectively reducing the risk of bleeding. This injectable treatment is administered subcutaneously by a healthcare professional. It's a crucial option for patients who have not responded adequately to other ITP therapies.
Product Overview
NPLATE 250 µg Powder for Solution for Injection contains the active ingredient Romiplostim, a thrombopoietin receptor agonist.
It is designed to stimulate the production of platelets, vital blood cells that help stop bleeding.
This medication is specifically indicated for the treatment of thrombocytopenia (low platelet counts) in adult and pediatric patients (1 year of age and older) with chronic immune (idiopathic) thrombocytopenia (ITP).
NPLATE is typically used in patients who have had an insufficient response to other treatments such as corticosteroids, immunoglobulins, or splenectomy.
It is administered as a subcutaneous injection under the supervision of a healthcare professional.
Benefits of NPLATE
NPLATE provides a targeted approach to managing chronic ITP by directly increasing the body's platelet count.
It effectively reduces the risk of bleeding events, which are a major concern for individuals with low platelet levels.
By stimulating megakaryopoiesis (platelet production), NPLATE offers a sustained improvement in platelet counts.
It is a valuable treatment option for patients who have not responded to conventional therapies, improving their quality of life.
How to Use
- NPLATE is to be prepared and administered by a trained healthcare professional.
- The dosage of NPLATE is individualized based on the patient's body weight and target platelet count.
- It is typically given as a once-weekly subcutaneous injection.
- The powder must be reconstituted with sterile water for injection before administration, following specific instructions to ensure proper dosage and efficacy.
- Regular monitoring of platelet counts is essential to adjust the dose and ensure treatment safety and effectiveness.
Caution & Warnings
- Risk of bone marrow fibrosis and worsening of pre-existing myelodysplastic syndrome (MDS).
- Thrombotic/thromboembolic complications, including deep vein thrombosis and pulmonary embolism, may occur.
- Discontinue NPLATE if platelet counts become elevated or if there is no response after 4 weeks of maximum dose.
- Patients with a history of thrombotic events should be carefully monitored.
- Not recommended for use in patients with myeloid malignancies as it may accelerate disease progression.
- Pregnant and breastfeeding women should consult their doctor before using NPLATE, as the effects on fetal and infant development are not fully established.
- Do not shake the vial during reconstitution.
Ingredients
Active Ingredient: Romiplostim
Excipients: Mannitol, Sucrose, Histidine, Polysorbate 20
Product Details
Strength: 250 µg per vial
Form: Powder for solution for injection
Manufacturer: Amgen
Storage: Store refrigerated (2°C to 8°C) in the original carton to protect from light. Do not freeze.
| Gtin | 1508245769 |
|---|---|
| Recommended Sale Price | 2701.95 |
| Is Wasfaty Product | No |
| Brand | Not Defined |
| Ingredient Name | ROMIPLOSTIM |
| SFDA Reg. No | 1508245769 |
| IBC | 1508245769 |
| Drug Type | Prescription |
| Scientific Name | Romiplostim |
| Strength | 250 |
| Strength Unit | µg |
| Form | Powder for solution for injection |
| Admin Route | Subcutaneous |
| Size | 1 |
| Size Unit | Vial |
| Package Types | Vial |
| Package Size | 1 Vial |
| shelfLife | 36 months (unreconstituted) |
| Storage conditions | Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. |
| Refrigerator Storage | Yes |
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