Talc

Consider the possible effects of the use of STERITALC on future diagnostic and therapeutic procedures prior to administration. 5.3 Lead Content Lead is present in STERITALC as an impurity. The main target organ for lead toxicity is the nervous system, but effects of lead exposure also include increased blood pressure, anemia, decreased sperm production, and damage to the kidneys in children and adults.

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® TALCAIR™. 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.

Administration Slurry for Tube Thoracostomy STERITALC 2 grams and 4 grams dosage forms Prior to administration, continuously agitate the syringes to evenly redisperse the talc and avoid settlement. Immediately prior to administration, vent the 10 mL air headspace from each syringe. Administer the talc suspension through the chest tube according to standard procedures.

Step 1: Inject the slurry through the pleural drainage into the pleural cavity. Step 2: Clamp the pleural drainage. Keep the negative pressure in the pleural cavity. Step 3 : While the slurry remains in the pleural cavity, reposition the patient regularly to achieve even distribution of the slurry. Step 4: Aspirate the slurry through the pleural drainage.

Insufflation/Poudrage Perform intervention by means of a tube thoracoscopy. Follow the selected device manufacturer's instructions for insufflation/poudrage. STERITALC 2 grams and 4 grams dosage forms Step 1 : Introduce the cannula into the trocar. Step 2: Distribute the talc evenly in the pleural cavity. To do this, carefully spray several times.

After spraying a few times, change the cannula direction. After use, some talc may remain in the vial. Discard unused portion. STERITALC 3 grams dosage form Keep the product upright during use. Avoid contact between the cannula tip and tissue/body fluids. Otherwise the cannula may be blocked. In case of blockage: Shorten the cannula with a scalpel to be able to continue the intervention.

Cut perpendicularly to the cannula and ensure that the cutting edge is straight and free of burs. Step 1: Introduce the cannula into the trocar. Step 2 : Distribute the talc evenly in the pleural cavity. To do this, press the insufflation bulb carefully and at regular intervals. After spraying a few times, change the cannula direction.

After use, some talc may remain in the vial. Discard unused portion ________ DOSAGE AND ADMINISTRATION ________ Malignant Pleural Effusion: The recommended dose is 2 to 5 grams administered intrapleurally. Pneumothorax: The recommended dose is 2 grams administered intrapleurally. Do not exceed a total cumulative dosage of 10 grams per procedure.

Prepare and administer as recommended.