1.09B6 + SERUM PRESET PACKS FOR MAC FULL

Transfer MARGENZA into an intravenous bag containing 100 mL or 250 mL 0.9% Sodium Chloride Injection, USP.Withdraw appropriate volume of MARGENZA solution from the vial(s) using a syringe.

The calculated total dose volume should be rounded to the nearest 0.1 mL. Calculate the required volume of MARGENZA needed to obtain the appropriate dose according to patient's body weight.Some visible, translucent, inherent proteinaceous particles may be present. The solution is clear to slightly opalescent, colorless to pale yellow or pale brown. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Prepare solution for infusion, using aseptic technique, as follows:

1.09B6 + SERUM PRESET PACKS FOR MAC FULL

FULL PRESCRIBING INFORMATION: CONTENTS * WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Doses and Schedules 2.2Дќose Modification or Important Dosing Considerations 2.3 Preparation for Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Left Ventricular Dysfunction 5.2Дћmbryo-Fetal Toxicity 5.3 Infusion-Related Reactions 6 ADVERSE REACTIONS 6.1Дњlinical Trials Experience 6.2 Immunogenicity 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1Дњarcinogenesis, Mutagenesis, and Impairment of Fertility 14 CLINICAL STUDIES 14.1 Metastatic Breast Cancer 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.

1.09b6 + serum preset packs for mac