Product Images Cisplatin

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The following 31 images provide visual information about the product associated with Cisplatin NDC 60505-6277 by Apotex Corp., such as packaging, labeling, and the appearance of the drug itself. This resource could be helpful for medical professionals, pharmacists, and patients seeking to verify medication information and ensure they have the correct product.

appendix-1 - appendix 1

appendix-1 - appendix 1

This is a product description of "ClSplatin Injection" with a concentration of 50 mg per 50 mL. Each carton contains one vial with a barcode of 2770 and the linear barcode "3limle0505l6" is affixed both to the vial and the carton.*

appendix-2-1 - appendix 2 1

appendix-2-1 - appendix 2 1

This is a labeling information of a 200mg/200mL Cisplatin injection. The product is FDA approved and imported. There is also a label on the vial with some identification numbers and dosage information.*

appendix-2-2 - appendix 2 2

appendix-2-2 - appendix 2 2

CiSplatin Injection is a clear, colorless, and sterile aqueous solution that is administered through intravenous injection. It is available in amber vials with 50 mL or 100 mL infusion concentrate. Its main ingredient is CISplatin, containing 1 mg/mL of ClSplatin and 9 mg/mL of sodium chloride. It also contains excipients, such as dilute hydrochloric acid, sodium hydroxide, and water for injection.*

appendix-2-3 - appendix 2 3

appendix-2-3 - appendix 2 3

This text provides instructions on how to prepare and store ClSplatin solution in a volume of 50 mL or 100 L using water for injection. It advises on the storage condition which requires the solution to be stored at room temperature between 15°C to 25°C and protected from light, without refrigeration. Additionally, the text indicates that unopened containers must be protected from light and that the ClSplatin is stable for up to 28 days if kept protected from light or for up to 7 days under fluorescent room light.*

appendix-3-1 - appendix 3 1

appendix-3-1 - appendix 3 1

CiSplatin Injection is an imported and U.S. FDA approved product that contains the active ingredient Cisplatin. It is available in 50 mL, 100 mL, or 200 mL strengths with concentrations of 1 mg/mL for intravenous use via infusion or arterial perfusion and intrathoracic and intraperitoneal injection. The clear and colorless sterile aqueous solution comes in amber vials. Each vial of infusion concentrate contains 1 mg/mL CISplatin, 9 mg/mL sodium chloride, hydrochloric acid and sodium hydroxide to approximate pH of 4.0, and water for injection. Cisplatin is a heavy metal complex that is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207° C. Other constituents of CiSplatin Injection include sodium chloride, dilute hydrochloric acid, sodium hydroxide, and water for injection.*

appendix-3-10 - appendix 3 10

appendix-3-10 - appendix 3 10

This text provides information on the hematologic, metabolism and nutrition, nervous system, cardiac and vascular system disorders that can occur as a result of CISplatin treatment. Myelosuppression, which can lead to anemia, leukopenia, and thrombocytopenia, may occur in 25-30% of patients treated with CISplatin, with elderly patients possibly being more susceptible to myelosuppression. Other possible side effects include hyponatremia, hypomagnesemia, peripheral neuropathy, leukoencephalopathy, and cardiac abnormalities such as arrhythmia and myocardial infarction. The text also mentions Raynaud's phenomenon as a possible vascular system disorder.*

appendix-3-11 - appendix 3 11

appendix-3-11 - appendix 3 11

This text describes the potential side effects and risks associated with the use of CISplatin in cancer treatment. Such side effects include increased hemolysis, gastrointestinal issues like nausea and vomiting, and the risk of developing acute leukemia when used with other leukemogenic agents. There is also an increased risk of venous thrombotic events with its use, and vascular toxicities have been reported. The text urges healthcare providers to weigh the potential risks and benefits of initiating CISplatin treatment.*

appendix-3-12 - appendix 3 12

appendix-3-12 - appendix 3 12

The text provides information on negative side effects of using CISplatin as an antineoplastic agent. Such side effects can include vascular toxicities, electrolyte disturbances, hyperuricemia, skin/subcutaneous tissue disorders, musculoskeletal/connective tissue disorders, renal/urinary disorders, and reproductive system/breast disorders. Some of the common side effects mentioned include hypomagnesemia, hypocalcemia, and muscle cramps. It is important to monitor electrolyte levels regularly and supplement as needed.*

appendix-3-13 - appendix 3 13

appendix-3-13 - appendix 3 13

Allopurinol is an effective therapy used for reducing uric acid levels in hyperuricemia patients. Cisplatin therapy can cause neurotoxicity, including peripheral neuropathies, which could occur after a prolonged period of therapy or occur after a single dose. Patients should discontinue Cisplatin therapy when they first observe symptoms of neuropathy, although the condition may continue to progress even after stopping treatment. Muscle cramps, seizures, Lhermitte's sign, dorsal column myelopathy, and autonomic neuropathy have also been reported, as well as irreversible peripheral neuropathy, particularly in elderly patients. Reversible posterior leukoencephalopathy syndrome and leukoencephalopathy have also been reported in some patients receiving Cisplatin.*

appendix-3-14 - appendix 3 14

appendix-3-14 - appendix 3 14

doses. It is important for patients receiving CISplatin to be monitored for any signs of liver dysfunction such as yellowing of the skin or eyes, abdominal pain, or dark urine. Liver function tests should be performed regularly during treatment to detect any elevations in liver enzymes. In most cases, these elevations are reversible and resolve after discontinuation of CISplatin. However, in rare cases, severe hepatotoxicity and liver failure may occur. Therefore, caution should be exercised when administering CISplatin to patients with pre-existing liver dysfunction or a history of liver disease.*

appendix-3-15 - appendix 3 15

appendix-3-15 - appendix 3 15

This text provides information on the potential side effects, contraindications, and precautions for using CISplatin, a medication used in chemotherapy. The side effects include cardiac abnormalities, hiccups, rash, alopecia, and local soft tissue toxicity. It is contraindicated in patients with preexisting renal impairment, myelosuppressed patients, patients with hearing impairment, and those with a history of allergic reactions to CISplatin or other platinum-containing compounds. It is also contraindicated in pregnant or nursing women.*

appendix-3-16 - appendix 3 16

appendix-3-16 - appendix 3 16

This text provides precautions and considerations for the safe use of the drug CISplatin in patients with liver or renal impairment. Peripheral blood counts, liver function, and neurologic examination should be monitored regularly. The drug should only be used in patients experienced in anticancer therapy. In patients with liver impairment, careful dosing and monitoring of liver function are necessary due to the drug's uptake in the liver and the potential for elevations in aspartate aminotransferase. In patients with renal impairment, the drug's high tissue uptake in the kidney can lead to cumulative renal toxicity, necessitating the measurement of blood urea nitrogen, serum creatinine, and creatinine clearance, hydration to reduce renal toxicity, and caution in administering the drug to patients with pre-existing renal impairment. The text also notes the cumulative ototoxicity associated with CISplatin use and recommends audiometric testing before treatment and periodically thereafter.*

appendix-3-17 - appendix 3 17

appendix-3-17 - appendix 3 17

The text describes the potential side effects of CISplatin cancer treatment, including radiotherapy-induced ototoxicity, which may result in tinnitus and hearing loss, especially within the 4,000 to 8,000 Hz range. The text also indicated that Myelosuppression is a possible side effect, causing a decrease in leukocytes, thrombocytes, and hemoglobin, including anemia; thus, regular monitoring is necessary. Patients should wait until they have a certain level of platelets and leukocytes before initiating the next round of treatment. In rare cases, CISplatin may result in hemolytic anemia, leading to a positive direct Coomb's test. *

appendix-3-18 - appendix 3 18

appendix-3-18 - appendix 3 18

Anaphylaxis can occur in patients who have been previously exposed to CISplatin and are receiving retreatment. Patients with a history or family history of allergies are at a higher risk. Symptoms such as facial swelling, sneezing, low blood pressure, and rashes can occur immediately after injection. Epinephrine, antihistamines, and hormones can control severe reactions. To prevent anaphylactic-like reactions, patients must be closely monitored during CISplatin treatment, accompanied by supportive equipment and medication. CISplatin has been associated with cardiovascular toxicity, various thrombotic events, and pulmonary embolism. Hypomagnesemia is frequent, and hypocalcemia is less frequent with CISplatin.*

appendix-3-19 - appendix 3 19

appendix-3-19 - appendix 3 19

CISplatin is a medication that, if used for a prolonged period, could cause neurotoxicity and convulsions, peripheral neuropathy, postural hypotension, and delayed wound healing. Patients with significant clinical symptoms must avoid CISplatin therapy. There are increased risks of bleeding, bruising, and infection in patients treated with CISplatin; thus, dental procedures should be avoided during CISplatin therapy, and invasive operations must be carried out with caution. Additionally, the medication can interact negatively with other drugs, including aminoglycoside antibiotics and diuretics, among others. The stability of CISplatin is affected by bisulfite, metabisulfite, sodium bicarbonate, and fluorouracil. Therefore, needles, syringes, cannulas, or intravenous sets containing aluminum should not be used while administering CISplatin.*

appendix-3-2 - appendix 3 2

appendix-3-2 - appendix 3 2

This text is a warning about the use of CiSplatin Injection, which is used in cancer treatment. It emphasizes that treatment should only be administered by a qualified physician experienced in cancer chemotherapeutic agents and adequate diagnostic and treatment facilities should be available due to severe toxicities associated with the drug. These toxicities include renal toxicity, myelosuppression, nausea, vomiting, and ototoxicity. Anaphylactic-like reactions have also been reported. The text warns against overdosing and recommends exercising caution to avoid it. The precautions and adverse reactions sections should also be referred to.*

appendix-3-20 - appendix 3 20

appendix-3-20 - appendix 3 20

This is a warning label for the medication CISplatin. It is not safe for pregnant or breastfeeding women to use, as it is known to cause developmental and reproductive harm. It is also not established as safe and effective for use in pediatric patients. Audiometric monitoring is necessary for all children before and during treatment to detect potential hearing loss.*

appendix-3-21 - appendix 3 21

appendix-3-21 - appendix 3 21

The text describes the use of CISplatin in geriatric patients for the treatment of metastatic testicular tumors, advanced bladder cancer, and advanced ovarian carcinoma. Insufficient data is available to determine if elderly patients respond differently than younger patients. However, elderly patients are more susceptible to myelosuppression, infectious complications, and nephrotoxicity than younger patients. Therefore, it is essential to monitor renal function and take care in dose selection when using CISplatin in elderly patients, as it is contraindicated in those with pre-existing renal impairment.*

appendix-3-22 - appendix 3 22

appendix-3-22 - appendix 3 22

This text provides information on the potential risks and effects of overdosage with the drug CISplatin. The text discusses the various symptoms and toxicities that may occur with overdose, including kidney failure, liver failure, deafness, and nausea/vomiting. It notes that there are no established antidotes for overuse of this drug, and that general supportive measures should be taken to help the patient through any potential toxicities. The text also describes the unique pharmacological makeup of CISplatin, including its rapid binding with proteins and the way it interacts with DNA to create interstrand and intrastand cross-links. It concludes with notes on the drug's genotoxicity and reproductive toxicity, but does not provide details on these effects.*

appendix-3-23 - appendix 3 23

appendix-3-23 - appendix 3 23

This text provides information about the molecular species of CISplatin and its instability in biological matrices due to the displacement of chlorine atoms by sulfhydryl groups. The ratios of CISplatin to total free platinum in plasma vary between patients, and CISplatin becomes bound to several plasma proteins. The complexes between albumin and the platinum from CISplatin have a minimum half-life of five days or more. The text also discusses the teratogenic and carcinogenic effects observed in animals injected with CISplatin.*

appendix-3-24 - appendix 3 24

appendix-3-24 - appendix 3 24

After administering doses of CISplatin ranging from 20 to 120 mg/ m?, the concentration of platinum is highest in the liver, prostate, and kidney. It is also found in other organs such as the bladder, muscle, testicle, pancreas, and spleen in decreasing amounts. Platinum persists in tissues for up to 180 days after administration. Tumors generally contain lower concentrations of platinum than the organ in which they are located, although hepatic metastases have concentrations similar to normal liver platinum levels. The maximum concentration of platinum in red blood cells occurs within 90 to 150 minutes following a 100 mg/ m? dose and declines with a half-life of 36 to 47 days. Approximately 10% to 40% of administered platinum is excreted in urine over 24 hours. Over five days, between 14% and 51% of the dose is excreted in urine. The excreted platinum-containing species are the same as those produced when incubating CISplatin with urine from healthy subjects. The parent compound, CISplatin, accounts for 13% to 17% of the excreted dose.*

appendix-3-25 - appendix 3 25

appendix-3-25 - appendix 3 25

This text describes the pharmacokinetics and storage of CISplatin, a chemotherapy drug used in the treatment of cancer. It states that the drug is eliminated primarily through urine, and that renal clearance of free platinum exceeds creatinine clearance, indicating that the drug is actively secreted by the kidneys. The text also notes that ultrafilterable platinum concentrations may accumulate when the drug is administered daily, but not when given intermittently. It includes storage instructions for the drug, which should be kept at room temperature and protected from light.*

appendix-3-3 - appendix 3 3

appendix-3-3 - appendix 3 3

This text provides important information about the usage and potential side effects of CiSplatin, a chemotherapy drug commonly used to treat cancer. The text cautions against higher doses or more frequent administration than recommended, as it can lead to severe and potentially irreversible nerve damage, kidney damage, and loss of motor function. Audiometric testing is recommended prior to therapy to detect any potential ototoxicity. Elderly patients are particularly vulnerable to the drug's side effects including nephrotoxicity and peripheral neuropathy. Anaphylactic-like reactions have been reported in patients with prior exposure to the drug. It is important to differentiate daily doses from total dose per cycle when administering this drug.*

appendix-3-4 - appendix 3 4

appendix-3-4 - appendix 3 4

time. CISplatin is a medication used in pediatric patients and caution should be taken due to its potential to cause hearing damage and fetal harm in pregnant women. The drug has been found to be mutagenic in bacteria, cause chromosome aberrations in animal cells, and be teratogenic in mice. It has also been associated with malignancies, including leukemia, in rats and is known to cause injection site reactions. Infusion sites should be closely monitored during administration. There is currently no known specific treatment for extravasation reactions.*

appendix-3-5 - appendix 3 5

appendix-3-5 - appendix 3 5

CISplatin Injection is a chemotherapeutic agent used as a therapy for metastatic testicular and ovarian tumors in combination with other approved drugs, and as a single agent for advanced bladder cancer patients who have exhausted local treatments. It is also indicated as a palliative treatment for multiple cancers such as non-small cell lung cancer, refractory ovarian and bladder cancer, head and neck squamous cell carcinoma, gastric, and esophageal cancer. It can be used alone or in combination with other chemotherapeutic agents, radiotherapy, and surgery when necessary.*

appendix-3-6 - appendix 3 6

appendix-3-6 - appendix 3 6

CiSplatin Injection is a chemotherapy medication used to treat metastatic testicular tumors, metastatic ovarian tumors, and advanced bladder cancer. It is administered through slow intravenous infusion and aluminum-containing needles or sets should be avoided as they react with the medication and cause precipitate formation and a loss of potency. The dosage varies based on the type of cancer and prior exposure to radiation therapy and chemotherapy. Pre-treatment hydration is recommended and details for preparation and administration are provided in the package insert. The medication can be used for pediatric patients but the dose is adjusted based on weight.*

appendix-3-7 - appendix 3 7

appendix-3-7 - appendix 3 7

This text provides instructions and recommendations for the use of CISplatin Injection in adults, including dosing, hydration, and preparation of intravenous solutions. The recommended dose is 50 mg/m² per cycle repeated every 4 weeks, and patients should receive adequate hydration to minimize nephrotoxicity and maintain good urinary output. The drug should be diluted in 5% Dextrose in saline containing mannitol and infused over a 6-to 8-hour period. Hydration may be given intravenously with sodium chloride or dextrose saline, and post-treatment hydration is also recommended. Exercise caution when handling and disposing of the solution, and visually inspect for particulate matter and discoloration prior to administration. Pediatric use should be determined based on the child's weight.*

appendix-3-8 - appendix 3 8

appendix-3-8 - appendix 3 8

appendix-3-9 - appendix 3 9

appendix-3-9 - appendix 3 9

This text describes the potential side effects of CISplatin, a chemotherapy medication used to treat various types of cancer. The text explains that elderly patients may be more susceptible to kidney damage and hearing loss. Ototoxicity is a common side effect, which can result in tinnitus and hearing loss. The risk of ototoxicity may be increased by prior or simultaneous cranial irradiation, use of other ototoxic drugs, and genetic factors. The medication can also cause thrombocytopenia, leukopenia, anemia, and bone marrow failure. Other rare side effects include cardiac abnormalities, liver injury, and cortical blindness.*

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* The product label images have been analyzed using a combination of traditional computing and machine learning techniques. It should be noted that the descriptions provided may not be entirely accurate as they are experimental in nature. Use the information in this page at your own discretion and risk.