Active Substance: Drotrecogin alfa.
Overview
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This medicine contains an important and useful components, as it consists of
Drotrecogin alfais available in the market in concentration
Gadoversetamide
Before using **Gadoversetamide**, patients must consult their healthcare provider to ensure it is suitable for their condition. The following precautions should be carefully considered: - **Kidney Function**: **Gadoversetamide** is a **gadolinium-based contrast agent (GBCA)**, which can have a potential impact on kidney function, especially in patients with **renal impairment**. It should be used cautiously in those with mild to moderate kidney dysfunction, and avoided in those with severe renal failure or end-stage renal disease (ESRD). Patients with **chronic kidney disease (CKD)** or those at risk for acute renal failure should be closely monitored for any adverse kidney effects. - **Pregnancy and Breastfeeding**: **Gadoversetamide** falls under **Pregnancy Category C**, indicating that it should only be used when absolutely necessary and when the benefits outweigh the risks. It is advised that **Gadoversetamide** be avoided during pregnancy unless there are compelling medical reasons. For breastfeeding women, it is recommended to temporarily suspend breastfeeding for at least **24 hours** after the administration of the contrast agent to minimize any potential risks to the infant. - **Allergic Reactions**: While rare, some individuals may experience **allergic reactions** to gadolinium-based contrast agents. Symptoms of an allergic reaction may include **rash**, **hives**, **difficulty breathing**, or **swelling** of the face, lips, or throat. Immediate medical attention should be sought if any of these symptoms occur. - **Acute Dehydration or Hypotension**: **Gadoversetamide** should be used with caution in patients who are **dehydrated**, or in those who have low blood pressure (hypotension). These conditions could increase the risk of kidney-related adverse effects.
**Gadoversetamide** is primarily used as a **contrast agent** during **magnetic resonance imaging (MRI)**. It enhances the clarity and detail of MRI scans, making it easier to diagnose various conditions. The key indications include: - **MRI of the Brain and Spinal Cord**: Used to visualize abnormalities in the brain and spinal cord, including **tumors**, **lesions**, **inflammation**, and **vascular malformations**. - **Cardiac Imaging**: **Gadoversetamide** is used for **cardiac MRI** to assess heart function, detect **ischemic heart disease**, and evaluate myocardial infarction (heart attack) and myocardial scarring. - **Vascular Imaging**: It aids in visualizing blood vessels for conditions such as **arterial stenosis**, **aneurysms**, and **vascular malformations**. - **Musculoskeletal Imaging**: Helps improve the visualization of soft tissue structures, including joints, muscles, and tendons, to diagnose injuries, inflammation, and tumors. - **Oncology**: Used for evaluating and monitoring tumors by providing clearer MRI images of the growths, their size, and their relationship to surrounding tissues.
**Gadoversetamide** is contraindicated in the following situations: - **Severe Renal Impairment**: **Gadoversetamide** should not be used in patients with **severe renal failure** (creatinine clearance <30 mL/min) or those with **acute kidney injury**, as the contrast agent can increase the risk of **nephrogenic systemic fibrosis (NSF)**, a serious condition associated with gadolinium-based agents. - **Hypersensitivity to Gadolinium**: Patients who have a known **allergy or hypersensitivity** to **gadolinium-based contrast agents (GBCAs)** should not receive **Gadoversetamide**. - **Pregnancy**: Use during pregnancy should be avoided unless absolutely necessary, particularly during the first trimester. The potential risks to the developing fetus must be carefully weighed against the benefits of imaging. - **Severe Cardiovascular Disease**: **Gadoversetamide** should be avoided in patients with certain cardiovascular conditions that may predispose them to adverse effects, such as **severe hypotension** or **shock**.
Common and serious side effects of **Gadoversetamide** include: - **Common Side Effects**: - **Injection Site Reactions**: Pain, swelling, redness, or a warm sensation at the injection site are common. - **Headache or Dizziness**: Some patients may experience mild headaches or dizziness after the MRI procedure. - **Nausea and Vomiting**: Gastrointestinal discomfort such as nausea and vomiting may occur in some patients. - **Serious Side Effects**: - **Nephrogenic Systemic Fibrosis (NSF)**: This is a rare but severe condition primarily seen in patients with **severe renal impairment**. It involves fibrosis (scarring) of the skin, joints, and internal organs, and it can be life-threatening. - **Severe Allergic Reactions**: These can range from **rash** to **anaphylaxis** (severe allergic response), including difficulty breathing, swelling of the throat, or loss of consciousness. - **Acute Kidney Injury**: In patients with pre-existing kidney issues, **Gadoversetamide** can lead to worsening kidney function, including acute kidney injury. - **Hypotension**: A significant drop in blood pressure may occur, especially in patients with existing cardiovascular conditions. - **Cardiovascular Events**: Rare cases of tachycardia or arrhythmias may occur during or after the procedure.
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**Gadoversetamide** is a **gadolinium-based contrast agent (GBCA)** used in MRI to enhance the visibility of internal body structures. It works by: - **Magnetic Properties**: **Gadoversetamide** contains **gadolinium**, a paramagnetic metal that has the ability to shorten the **relaxation time** of protons in the body. This results in enhanced signal intensity in the MRI images, improving the contrast and clarity of the structures being imaged. - **Extracellular Distribution**: Once administered, **Gadoversetamide** is distributed throughout the extracellular space, where it interacts with water molecules in the tissues, allowing MRI scanners to better differentiate between normal and abnormal areas. - **Excretion**: The contrast agent is excreted primarily through the **kidneys** in unchanged form, making renal function critical for its safe use.
Several drug interactions may impact the safety or efficacy of **Gadoversetamide**: - **Nephrotoxic Agents**: Drugs that have nephrotoxic effects (e.g., **NSAIDs**, **aminoglycosides**, **ACE inhibitors**, **diuretics**) can enhance the risk of kidney damage when used in conjunction with **Gadoversetamide**. Patients with pre-existing kidney disease or those receiving these drugs should be carefully monitored. - **Metformin**: There is a concern for **lactic acidosis** in patients receiving **metformin** if they have impaired kidney function. It is recommended that metformin be temporarily discontinued after the administration of **Gadoversetamide** in these patients, particularly those with renal dysfunction. - **Other Gadolinium-Based Contrast Agents**: **Gadoversetamide** should not be combined with other **gadolinium-based contrast agents** (GBCA) because it may increase the risk of adverse effects such as nephrogenic systemic fibrosis (NSF). - **Blood Pressure-Lowering Drugs**: Caution is required when using **Gadoversetamide** with **antihypertensive medications**, especially in patients who are already prone to low blood pressure (hypotension).
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The standard adult dosage of **Gadoversetamide** typically depends on the specific MRI procedure being performed: - **General Dosage**: The recommended dose is **0.1 mmol/kg body weight** for most diagnostic MRI procedures. The contrast agent is usually injected as a single bolus injection into a vein. - **Higher Doses**: In certain cases, such as for more detailed imaging of cardiac, vascular, or oncological issues, higher doses or multiple injections may be required, as per the healthcare provider's discretion.
For pediatric patients, the dosage of **Gadoversetamide** is based on **body weight**: - **Standard Pediatric Dose**: The recommended dose is typically **0.1 mmol/kg body weight**, similar to the adult dose. In infants and younger children, the healthcare provider may adjust the dose based on the child's specific medical condition and size. --- As always, it is important for patients to consult with their healthcare provider before receiving **Gadoversetamide**, especially if they have a history of kidney problems, are pregnant, or have allergies to contrast agents. Regular monitoring of renal function is necessary to minimize the risk of complications.
In patients with **renal impairment**, especially those with **moderate to severe renal dysfunction**, the use of **Gadoversetamide** should be approached with caution. In cases of **severe renal failure** (creatinine clearance <30 mL/min), the use of this contrast agent is **contraindicated** due to the increased risk of **nephrogenic systemic fibrosis (NSF)**. For patients with **mild to moderate kidney dysfunction**, careful monitoring of kidney function before and after the procedure is essential.
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