Steritalc

5.4 Asbestos Content Talc products may contain trace amounts of asbestos. Asbestos is a known human carcinogen. Exposure to asbestos may increase the risk of mesotheliomas and other cancers including lung, larynx, and ovarian cancer. STERITALC is tested for asbestos and asbestiform fibers [see DESCRIPTION (11)]. Warnings and Precautions (5.4) 06/2025

1.INDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax. ___________ INDICATIONS AND USAGE__ __________ STERITALC® is a sclerosing agent indicated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1.1) In adults to decrease the recurrence of pneumothorax. (1.2)

2. DOSAGE AND ADMINISTRATION 2.1 Important Use Information STERITALC is for pleurodesis only - Do NOT administer STERITALC intravenously. Administer STERITALC after adequate drainage of the pleural effusion or air. 2.2 Recommended Dose for Malignant Pleural Effusion The recommended dose for malignant pleural effusion is 2 to 5 grams administered intrapleurally. According to the physician’s discretion, and in consideration of diagnosis and patient’s condition, different dosages may be applied, but a total dosage of 10 grams should not be exceeded. 2.3 Recommended Dose for Pneumothorax The recommended dose for pneumothorax is 2 grams administered intrapleurally. According to physician’s discretion and in consideration of diagnosis and patient’s condition, different dosages may be applied, but a cumulative dosage of 10 grams should not be exceeded. 2.4 Preparation Slurry for Tube Thoracostomy STERITALC 2 grams and 4 grams dosage forms Do not prepare the slurry in advance. Use the slurry immediately after preparation. Prepare the talc suspension using aseptic technique in an appropriate laminar flow hood as follows: Step 1 : Fully bend or remove the flap into the direction of the arrow. The top can now be punctured to mix the slurry. Step 2 : Using a 16 gauge needle attached to a 60-mL Luer Lok syringe, draw up 50 mL of 0.9 % Sodium Chloride injection, USP. Vent the talc bottle using a needle. Slowly inject the 50 mL of 0.9% Sodium Chloride Injection, USP into the glass vial. Step 3: Swirl the glass vial to disperse the talc powder. Step 4 : Divide the contents of the glass vial equally into two 60-mL Luer Lok syringes, each attached with a 16 gauge needle, by withdrawing 25 mL of the suspension into each syringe with continuous swirling. Add 0.9% Sodium Chloride Injection, USP to a total volume of 50 mL in each syringe. Draw 10 mL of air into each syringe to the 60 mL mark to serve as a headspace for mixing prior to administration. For STERITALC 2 grams, each syringe should contain 1 gram of Sterile Talc Powder in 50 mL of 0.9% Sodium Chloride Injection, USP with an air headspace of 10 mL. For STERITALC 4 grams, each syringe should contain 2 grams of Sterile Talc Powder in 50 mL of 0.9% Sodium Chloride Injection, USP with an air headspace of 10 mL. Step 5: Label the syringes with the talc concentration, the expiration date and time, the identity of the patient intended to receive the material, and the following statements: “SHAKE SYRINGE WELL to resuspend before administration” “FOR PLEURODESIS ONLY – not for intravenous administration” Step 6: If not used immediately, store prepared suspension in refrigerator. Discard the prepared suspension if not used within 12 hours. Insufflation/Poudrage STERITALC 2 grams and 4 grams dosage forms Use an FDA-approved or cleared device for STERITALC insufflation/poudrage. Step 1: Fully remove the top from the vial. Step 2 : Fill the content into the applicator for insufflation/poudrage. Step 3 : Follow the selected device manufacturer's instructions for insufflation/poudrage. STERITALC 3 grams dosage form STERITALC 3 grams is designed to be used for the administration of talc in combination with a compatible FDA approved or FDA cleared device intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis such as Novatech SA’s NOVATECH® TALCAIRTM. Step 1 : Remove the aluminum tear-off cap from the vial. Step 2: Remove the stopper from the vial. Step 3 : Close the vial with the vial coupling. Step 4 : Firmly press the vial coupling onto the vial until you feel and hear the lid "click" onto the vial top. To do this, place the vial on a firm and level base. Step 5 : Connect the insufflation bulb to the vial coupling using the Luer lock connector. Step 6 : Ensure that all components are firmly connected with each other. 2.5 Administration Slurry for Tube Thoracostomy STERITALC 2 grams and 4 grams dosage forms Prior to administration, continuously agitate the syrin …

3. DOSAGE FORMS AND STRENGTHS White or off-white to light gray sterile powder provided in the following strengths: Powder, for intrapleural use: STERITALC, 2 grams in a 50 mL single-dose vial Powder, for intrapleural use: STERITALC, 4 grams in a 50 mL single-dose vial Powder, for intrapleural use: STERITALC, 3 grams in a 10 mL single-dose vial, for use with Novatech SA’s NOVATECH® TALCAIRTM _______ DOSAGE FORMS AND STRENGTHS_ ______ Powder: 2 grams, in a 50 mL single-dose vial (3) Powder: 4 grams, in a 50 mL single-dose vial (3) Powder: 3 grams, in a 10 mL single-dose vial (3)

4. CONTRAINDICATIONS Due to lead content, STERITALC® is contraindicated in pregnant women and can cause fetal harm and potential loss of pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)]. _____________ CONTRAINDICATIONS_ ____________ Pregnancy. (4, 5.3, 8.1)

6. ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. Pneumonitis and Acute Respiratory Distress Syndrome (ARDS) [see Warnings and Precautions (5.1)] Lead Content [see Warnings and Precautions (5.3)] Asbestos Content [see Warnings and Precautions (5.4)] Common adverse reactions observed with intrapleural use of various talc products are fever and pain. Other adverse reactions include dyspnea, arrhythmia, empyema, pneumonitis and acute respiratory distress syndrome (ARDS). Procedure related adverse reactions such as bleeding, hemothorax, wound infections, atelectasis and pneumonia may occur. _____________ ADVERSE REACTIONS _____________ Common adverse reactions are fever and pain. (6) To report suspected adverse reactions contact Boston Medical Product Inc., at 508-898-9300 and FDA at 1-800-332-1088 or www.fda.gov/medwatch.

8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary STERITALC is contraindicated for use in pregnant women because it contains lead, which can cause fetal harm and potential loss of pregnancy [see Warnings and Precautions (5.3)] . There are no human data on the use of STERITALC in pregnant women. In an animal reproduction study, oral administration of talc in pregnant rabbits during organogenesis revealed no evidence of teratogenicity at dose up to approximately 5 times the human dose [see Data] . Data Animal Data In an embryo-fetal developmental toxicity study in rabbits, talc was administered to rabbits by oral gavage daily during the period of organogenesis at doses up to 900 mg/kg (approximately 5 times the human dose on a mg/m2 basis). No significant dose-related toxicity was reported except at maternally toxic doses. In multiple animal studies, intrapleurally administered talc was not absorbed systemically. 8.2 Lactation Risk Summary There is no information regarding the presence of talc in human milk, the effects on the breastfed infants, or the effects on milk production. STERITALC contains lead, which is known to have adverse effects on health and development in neonates, infants and children [see Warnings and Precautions (5.3)] . Because of the potential for serious adverse reactions in breast-fed infants from lead content in STERITALC, advise lactating women not to breastfeed during treatment with STERITALC and for 5 months after the final dose. 8.3 Females and Males of Reproductive Potential Contraception STERITALC contains lead, which can cause fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment and for 5 months following the final dose of STERITALC. Infertility STERITALC contains lead, which may impair fertility in males of reproductive potential [see Warnings and Precautions (5.3)]. 8.4 Pediatric Use Safety and effectiveness have not been established in pediatric patients. Lead is present in STERITALC as an impurity [see Warnings and Precautions (5.3)]. ------------USE IN SPECIFIC POPULATIONS -------------- Females and Males of Reproductive Potential: Advise females of reproductive potential to use effective contraception. (8.3) Lactation: Advise women not to breastfeed. (8.2)

11. DESCRIPTION STERITALC (talc) is a sclerosing agent for intrapleural administration. The molecular formula for talc is Mg3Si4O10(OH)2. The molecular weight is 379.3 g/mole. The chemical name of talc is hydrated magnesium silicate. The talc powder contains ≥ 95% of hydrated magnesium silicate; associated minerals include chlorites (hydrated aluminum and magnesium silicates), magnesite (magnesium carbonate), calcite (calcium carbonate), and dolomite (calcium and magnesium carbonate). The talc elementary sheet is composed of a layer of magnesium-oxygen/hydroxyl octahedra, sandwiched between two layers of silicon-oxygen tetrahedra. Talc is insoluble in water. STERITALC is tested for asbestos and asbestiform fibers consistent with USP standards for talc-containing products. STERITALC is supplied as 2 grams, 3 grams, and 4 grams white or off-white to light gray, sterile powder. STERITALC contains particle size-controlled talc, graded to decrease the proportion of smaller particles.

16. HOW SUPPLIED/STORAGE AND HANDLING STERITALC, white or off-white to light gray, sterile powder is supplied as two grams of talc powder in a single-dose 50 mL Type III glass vial, closed with a stopper, and crimped with an aluminum cap; with 4 vials packaged in one carton. NDC 62327-222-02 (vial) NDC 62327-222-42 (carton) four grams of talc powder in a single-dose 50 mL Type III glass vial, closed with a stopper, and crimped with an aluminum cap; with 4 vials packaged in one carton. NDC 62327-444-04 (vial) NDC 62327-444-44 (carton) three grams of talc powder in a single-dose 10 mL Type I brown glass vial, closed with a stopper, and crimped with an aluminum cap; with 4 vials packaged in one carton. NDC 62327-333-03 (vial) NDC 62327-333-43 (carton) Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect against sunlight.