PACLITAXEL- paclitaxel_injection, powder, lyophilized, for suspension

1. 5 to 3 x ULN and AST <=10 x ULN) or severe (total bilirubin >3 to 5 x ULN) hepatic impairment had a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function (total bilirubin <=ULN and AST <=ULN) [see Dosage and Administration (2. 5) Use in Specific Populations (8. 7) The effect of severe renal impairment or end stage renal disease (creatinine clearance < 30 mL/min) on the pharmacokinetics of paclitaxel in paclitaxel protein-bound particles for injectable suspension (albumin-bound) is unknown.">Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis. The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of paclitaxel protein-bound particles for injectable suspension (albumin-bound) at dose levels of 80 to 375 mg/m 2 2 Following paclitaxel protein-bound particles for injectable suspension (albumin-bound) infusion, paclitaxel exhibited linear drug exposure (AUC) across clinical doses ranging from 80 to 300 mg/m 2 The pharmacokinetic data of 260 mg/m 2 2 Distribution Following paclitaxel protein-bound particles for injectable suspension (albumin-bound) administration to patients with solid tumors, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%). The total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel. In a within-patient comparison study, the fraction of unbound paclitaxel in plasma was significantly higher with paclitaxel protein-bound particles for injectable suspension (albumin-bound) (6. 2%) than with solvent-based paclitaxel (2. This contributes to significantly higher exposure to unbound paclitaxel with paclitaxel protein-bound particles for injectable suspension (albumin-bound) compared with solvent-based paclitaxel, when the total exposure is comparable. In vitro Elimination 2 2 Metabolism In vitro p p In vitro in vivo in vitro in vivo [see Drug Interactions (7) Excretion 2 p Specific Populations No clinically meaningful differences in the pharmacokinetics of paclitaxel in paclitaxel protein-bound particles for injectable suspension (albumin-bound) were observed based on body weight (40 to 143 kg), body surface area (1. 4 m 2 Patients with moderate (total bilirubin >1. 5 to 3 x ULN and AST <=10 x ULN) or severe (total bilirubin >3 to 5 x ULN) hepatic impairment had a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function (total bilirubin <=ULN and AST <=ULN) [see Dosage and Administration (2. 5) Use in Specific Populations (8. 7) The effect of severe renal impairment or end stage renal disease (creatinine clearance < 30 mL/min) on the pharmacokinetics of paclitaxel in paclitaxel protein-bound particles for injectable suspension (albumin-bound) is unknown.

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 1 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Do not substitute paclitaxel protein-bound particles for injectable suspension (albumin-bound) for other paclitaxel products. 1) Extravasation 2. 1 Metastatic Breast Cancer (MBC) 2 2. 2 Use in Patients with Hepatic Impairment: 2. 5 Dose Reductions for Adverse Reactions 2. 6 DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) has different dosage and administration instructions from other paclitaxel products. Closely monitor the infusion site for extravasation or drug infiltration during administration. Limiting the infusion of paclitaxel protein-bound particles for injectable suspension (albumin-bound) to 30 minutes may reduce the risk of infusion-related reactions [see Adverse Reactions (6. 2) Consider premedication in patients who have had prior hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound). Do not re-challenge patients who experience a severe hypersensitivity reaction to paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Contraindications (4) Warnings and Precautions (5. 5) After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for paclitaxel protein-bound particles for injectable suspension (albumin-bound) is 260 mg/m 2 For patients with moderate or severe hepatic impairment, reduce the starting dose of paclitaxel protein-bound particles for injectable suspension (albumin-bound) as shown in Table 1. Table 1: Recommendations for Starting Dose in Patients with Moderate and Severe Hepatic Impairment AST = Aspartate Aminotransferase; MBC = Metastatic Breast Cancer; ULN = Upper limit of normal. a b 2 AST Levels Bilirubin Levels Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) Dose a MBC Moderate < 10 x ULN AND > 1. 5 to <= 3 x ULN 200 mg/m 2 b Severe < 10 x ULN AND > 3 to <= 5 x ULN 200 mg/m 2 b > 10 x ULN OR > 5 x ULN not recommended Metastatic Breast Cancer 3 2 2 [see Contraindications (4) Warnings and Precautions (5. 2) Adverse Reactions (6. 1) Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is supplied as a sterile lyophilized powder for reconstitution before use. Read the entire preparation instructions prior to reconstitution. Aseptically, reconstitute each vial by injecting 20 mL of 0. 9% Sodium Chloride Injection, USP. Slowly inject the 20 mL of 0. 9% Sodium Chloride Injection, USP, over a minimum of 1 minute, using the DO NOT INJECT the 0. 9% Sodium Chloride Injection, USP, directly onto the lyophilized cake as this Once the injection is complete, allow the vial to sit for a minimum of 5 minutes to ensure proper wetting of Gently swirl and/or invert the vial slowly for at least 2 minutes until complete dissolution of any cake/powder If foaming or clumping occurs, stand solution for at least 15 minutes until foam subsides. Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel. The reconstituted suspension should be milky and homogenous without visible particulates. If particulates or settling are visible, the vial should be gently Calculate the exact total dosing volume of 5 mg/mL suspension required for the patient and slowly withdraw the dosing volume of the reconstituted suspension from the vial(s) into a syringe: Dosing volume (mL)=Total dose (mg)/5 (mg/mL). Inject the appropriate amount of reconstituted paclitaxel protein-bound particles for injectable suspension (albumin-bound) into an empty, sterile intravenous bag [plasticized polyvinyl chloride (PVC) containers, PVC or non-PVC type intravenous bag]. The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) infusions. The use of medical devices containing silicone oil as a lubricant (i. , syringes and intravenous bags) to reconstitute and administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) may result in the formation of proteinaceous strands. Visually inspect the reconstituted paclitaxel protein-bound particles for injectable suspension (albumin-bound) suspension in the intravenous bag prior to administration. Discard the reconstituted suspension if proteinaceous strands, particulate matter, or discoloration are observed. reconstitution Unopened vials of paclitaxel protein-bound particles for injectable suspension (albumin-bound) are stable until the date indicated on the package when stored between 20°C to 25°C (68°F to 77°F) in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Stability of Reconstituted Suspension in the Vial Stability of Reconstituted Suspension in the Infusion Bag The total combined refrigerated storage time of reconstituted paclitaxel protein-bound particles for injectable suspension (albumin-bound) in the vial and in the infusion bag is 24 hours. This may be followed by storage in the infusion bag at ambient temperature (approximately 25°C) and lighting conditions for a maximum of 4 hours. Discard any unused portion.

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 most common adverse reactions (>= 20%) with single-agent use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea [see Adverse Reactions (6. 1) The most common adverse reactions resulting in permanent discontinuation of paclitaxel protein-bound particles for injectable suspension (albumin-bound) are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common adverse reactions resulting in dose reduction of paclitaxel protein-bound particles for injectable suspension (albumin-bound) are neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common adverse reactions leading to withholding or delay in paclitaxel protein-bound particles for injectable suspension (albumin-bound) dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%). The most common serious adverse reactions of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (with a >= 1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%), and vomiting (4%). The most common adverse reactions resulting in permanent discontinuation of paclitaxel protein-bound particles for injectable suspension (albumin-bound) are peripheral neuropathy (8%), fatigue (4%), and thrombocytopenia (2%). The most common adverse reactions resulting in dose reduction of paclitaxel protein-bound particles for injectable suspension (albumin-bound) are neutropenia (10%) and peripheral neuropathy (6%). The most common adverse reactions leading to withholding or delay in paclitaxel protein-bound particles for injectable suspension (albumin-bound) dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%), and diarrhea (5%). The most common adverse reactions (>= 20%) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea. 1 To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www. gov/medwatch. Metastatic Breast Cancer Table 6 Table 6: Adverse Reactions in the Randomized Metastatic Breast Cancer Study on an Every-3-Weeks Schedule a b c Percent of Patients Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound) 2 Paclitaxel Injection 2 a Bone Marrow Neutropenia < 2 x 10 9 80 82 < 0. 5 x 10 9 9 22 Thrombocytopenia < 100 x 10 9 2 3 < 50 x 10 9 <1 <1 Anemia < 11 g/dL 33 25 < 8 g/dL 1 <1 Infections 24 20 Febrile Neutropenia 2 1 Neutropenic Sepsis <1 <1 Bleeding 2 2 Hypersensitivity Reaction b All 4 12 Severe c 0 2 Cardiovascular Vital Sign Changes During Administration Bradycardia <1 <1 Hypotension 5 5 Severe Cardiovascular Events c 3 4 Abnormal ECG All Patients 60 52 Patients with Normal Baseline 35 30 Respiratory Cough 7 6 Dyspnea 12 9 Sensory Neuropathy Any Symptoms 71 56 Severe Symptoms c 10 2 Myalgia / Arthralgia Any Symptoms 44 49 Severe Symptoms c 8 4 Asthenia Any Symptoms 47 39 Severe Symptoms c 8 3 Fluid Retention/Edema Any Symptoms 10 8 Severe Symptoms c 0 <1 Gastrointestinal Nausea Any Symptoms 30 22 Severe Symptoms c 3 <1 Vomiting Any Symptoms 18 10 Severe Symptoms c 4 1 Diarrhea Any Symptoms 27 15 Severe Symptoms c <1 1 Mucositis Any Symptoms 7 6 Severe Symptoms c <1 0 Alopecia 90 94 Hepatic Bilirubin Elevations 7 7 Alkaline Phosphatase Elevations 36 31 AST (SGOT) Elevations 39 32 Injection Site Reaction <1 1 Other Adverse Reactions Hematologic Disorders 3 2 2 Infections Hypersensitivity Reactions (HSRs) Cardiovascular Severe cardiovascular events possibly related to single-agent paclitaxel protein-bound particles for injectable suspension (albumin-bound) occurred in approximately 3% of patients. These events included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension. Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported. Electrocardiogram (ECG) abnormalities were common among patients at baseline. ECG abnormalities on study did not usually result in symptoms, were not dose-limiting, and required no intervention. ECG abnormalities were noted in 60% of patients. Among patients with a normal ECG prior to study entry, 35% of all patients developed an abnormal tracing while on study. The most frequently reported ECG modifications were non-specific repolarization abnormalities, sinus bradycardia, and sinus tachycardia. Respiratory Neurologic No Grade 4 sensory neuropathies were reported. Only one incident of motor neuropathy (Grade 2) was observed in either arm of the controlled trial. Vision Disorders 2 Arthralgia/Myalgia Hepatic Renal Other Clinical Events The following adverse reactions have been identified during postapproval use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) or with paclitaxel injection and may be expected to occur with paclitaxel protein-bound particles for injectable suspension (albumin-bound). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity Reactions Severe and sometimes fatal hypersensitivity reactions. Cross-hypersensitivity between paclitaxel protein-bound particles for injectable suspension (albumin-bound) and other taxanes has been reported. Cardiovascular Congestive heart failure, left ventricular dysfunction, and atrioventricular block. Most patients were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history. Respiratory Pneumonitis, interstitial pneumonia, and pulmonary embolism Radiation pneumonitis in patients receiving concurrent radiotherapy. Lung fibrosis has been reported with paclitaxel injection. Neurologic Cranial nerve palsies and vocal cord paresis, as well as autonomic neuropathy resulting in paralytic ileus. Vision Disorders Reduced visual acuity due to cystoid macular edema (CME). After cessation of treatment, CME may improve, and visual acuity may return to baseline. Abnormal visual evoked potentials in patients treated with paclitaxel injection suggest persistent optic nerve damage. Hepatic Hepatic necrosis and hepatic encephalopathy leading to death in patients treated with paclitaxel injection. Gastrointestinal (GI) Intestinal obstruction, intestinal perforation, pancreatitis, and ischemic colitis. In patients treated with paclitaxel injection, neutropenic enterocolitis (typhlitis) despite the coadministration of G-CSF, alone and in combination with other chemotherapeutic agents. Injection Site Reaction Extravasation. Closely monitor the paclitaxel protein-bound particles for injectable suspension (albumin-bound) infusion site for possible infiltration during drug administration [see Dosage and Administration 2. 1) Severe events such as phlebitis, cellulitis, induration, necrosis, and fibrosis have been reported with paclitaxel injection. In some cases, the onset of the injection site reaction occurred during a prolonged infusion or was delayed up to ten days. Recurrence of skin reactions at a site of previous extravasation following administration of paclitaxel injection at a different site has been reported. Metabolic and Nutritional Disorders Tumor lysis syndrome Other Clinical Events Skin reactions including generalized or maculopapular rash, erythema, and pruritus Photosensitivity reactions, radiation recall phenomenon, scleroderma, and in some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysesthesia. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Conjunctivitis, cellulitis, and increased lacrimation have been reported with paclitaxel injection. Accidental Exposure Upon inhalation of paclitaxel, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported. Following topical exposure, tingling, burning, and redness have been reported.

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with: Baseline neutrophil counts of < 1,500 cells/mm 3 [see Warnings and Precautions (5. 1) A history of severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Warnings and Precautions (5. 5) Neutrophil counts of < 1,500 cells/mm 3 4 Severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound).

Lactation 8. 2 Risk Summary Based on its mechanism of action and findings in animals, paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12. 1) In animal reproduction studies, administration of paclitaxel formulated as albumin-bound particles to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at doses approximately 2% of the daily maximum recommended human dose on a mg/m 2 Data The background rate of major birth defects and miscarriage is unknown for the indicated population. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryo-fetal development studies, intravenous administration of paclitaxel formulated as albumin-bound particles to rats during pregnancy, on gestation days 7 to 17 at doses of 6 mg/m 2 2 Risk Summary There are no data on the presence of paclitaxel in human milk, or its effect on the breastfed child or on milk production. In animal studies, paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see Data Data Animal Data Following intravenous administration of radiolabeled paclitaxel to rats on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations. Based on animal studies and mechanism of action, paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8. 1) Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to starting treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound). Contraception Females Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and for at least six months after the last dose of paclitaxel protein-bound particles for injectable suspension (albumin-bound). Males Based on findings in genetic toxicity and animal reproduction studies, advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and for at least three months after the last dose of paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Use in Specific Populations (8. 1) Nonclinical Toxicology (13. 1) Infertility Females and Males Based on findings in animals, paclitaxel protein-bound particles for injectable suspension (albumin-bound) may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology (13. 1) Safety and effectiveness in pediatric patients have not been established. Pharmacokinetics, safety, and antitumor activity of paclitaxel protein-bound particles for injectable suspension (albumin-bound) were assessed in an open-label, dose escalation, dose expansion study ( NCT01962103 Paclitaxel protein-bound exposures normalized by dose were higher in 96 pediatric patients (aged 1. 4 to < 17 years) as compared to those in adults. Of the 229 patients in the randomized study who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) for the treatment of metastatic breast cancer, 13% were at least 65 years of age and < 2% were 75 years or older. This study of paclitaxel protein-bound particles for injectable suspension (albumin-bound) did not include a sufficient number of patients with metastatic breast cancer who were 65 years and older to determine whether they respond differently from younger patients. A subsequent pooled analysis was conducted in 981 patients receiving paclitaxel protein-bound particles for injectable suspension (albumin-bound) monotherapy for metastatic breast cancer, of which 15% were 65 years of age or older and 2% were 75 years of age or older. A higher incidence of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema was found in patients 65 years of age or older. No adjustment of the starting paclitaxel protein-bound particles for injectable suspension (albumin-bound) dose is required for patients with mild to moderate renal impairment (estimated creatinine clearance 30 to <90 mL/min) [see Clinical Pharmacology (12. 3) No adjustment of the starting paclitaxel protein-bound particles for injectable suspension (albumin-bound) dose is required for patients with mild hepatic impairment (total bilirubin > ULN and <= 1. 5 x ULN and aspartate aminotransferase [AST] <= 10 x ULN). Reduce paclitaxel protein-bound particles for injectable suspension (albumin-bound) starting dose in patients with moderate to severe hepatic impairment [see Dosage and Administration (2. 5) Clinical Pharmacology (12. 3) [see Dosage and Administration (2. 5) Warnings and Precautions (5. 6) Clinical Pharmacology (12.

The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4. Use caution when concomitantly administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) with inhibitors or inducers of either CYP2C8 or CYP3A4.

OVERDOSAGE
There is no known antidote for paclitaxel protein-bound particles for injectable suspension (albumin-bound) overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.
NONCLINICAL TOXICOLOGY
The carcinogenic potential of paclitaxel protein-bound particles for injectable suspension (albumin-bound) has not been studied. Paclitaxel was clastogenic in vitro in vivo Administration of paclitaxel formulated as albumin-bound particles to male rats at 42 mg/m 2 2 2 2 2 Administration of paclitaxel prior to and during mating produced impairment of fertility in male and female rats. Paclitaxel caused reduced fertility and reproductive indices, and increased embryo-fetal toxicity.
CLINICAL STUDIES
Data from 106 patients accrued in two single arm open label studies and from 460 patients enrolled in a randomized comparative study were available to support the use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in metastatic breast cancer. Single Arm Open Label Studies 2 2 Randomized Comparative Study 2 2 In this trial, patients in the paclitaxel protein-bound particles for injectable suspension (albumin-bound) treatment arm had a statistically significantly higher reconciled target lesion response rate (the trial primary endpoint) of 21.5% (95% CI: 16.2% to 26.7%), compared to 11.1% (95% CI: 6.9% to 15.1%) for patients in the paclitaxel injection treatment arm. See Table 11 Table 11: Efficacy Results from Randomized Metastatic Breast Cancer Trial a b st st c Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound) 2 Paclitaxel Injectionn 2 Reconciled Target Lesion Response Rate (primary endpoint) a All randomized patients Response Rate 50/233 (21.5%) 25/227 (11.1%) p-value b 0.003 Patients who had failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy c Response Rate 20/129 (15.5%) 12/143 (8.4%)
REFERENCES
1. OSHA Hazardous Drugs. OSHA http://www.osha.gov/SLTC/hazardousdrugs/index.html

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PACLITAXEL- paclitaxel_injection, powder, lyophilized, for suspension Product manual source documgent