Tolmar Pharmaceuticals, Inc.

Tolmar Pharmaceuticals, Inc. Drugs

• Eligard
  

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  Eligard

  

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  ELIGARD® is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period (Table 1).  The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation.

  Table 1. ELIGARD® Recommended Dosing

  Dosage 7.5 mg 22.5 mg 30 mg 45 mg Recommended Dose 1 injection every month 1 injection every 3 months 1 injection every 4 months 1 injection every 6 months

  Once mixed, ELIGARD® should be discarded if not administered within 30 minutes.

  As with other drugs administered by subcutaneous injection, the injection site should vary periodically.  The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue.  In clinical trials, the injection was administered in the upper- or mid-abdominal area.  Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with a belt or clothing waistband).

  2.1 Mixing Procedure

  IMPORTANT:  Allow the product to reach room temperature before using.  Once mixed, the product must be administered within 30 minutes.

  Follow the instructions as directed to ensure proper preparation of ELIGARD® prior to administration:

  ELIGARD® is packaged in either thermoformed trays or pouches. Each carton contains:

  One sterile Syringe A pre-filled with the ATRIGEL® Delivery System One Syringe B pre-filled with leuprolide acetate powder One long white plunger rod for use with Syringe B One sterile needle Desiccant pack(s)

  1. On a clean field, open all of the packages and remove the contents.  Discard the desiccant pack(s).

  2. Pull out the blue-tipped short plunger rod and attached stopper from Syringe B and discard (Figure 1).  Gently insert the long, white replacement plunger rod into the gray primary stopper remaining in Syringe B by twisting it in place (Figure 2).

  3. Unscrew the clear cap from Syringe A (Figure 3).  Remove the gray rubber cap from Syringe B (Figure 4).

  4. Join the two syringes together by pushing in and twisting until secure (Figure 5).

  5. Inject the liquid contents of Syringe A into Syringe B containing the leuprolide acetate.  Thoroughly mix the product by pushing the contents of both syringes back and forth between syringes (approximately 45 seconds) to obtain a uniform suspension (Figure 6). When thoroughly mixed, the suspension will appear light tan to tan (ELIGARD® 7.5 mg) or colorless to pale yellow (ELIGARD®, 22.5 mg, 30 mg and 45 mg) in color. Please Note:  Product must be mixed as described; shaking will not provide adequate mixing of the product.

  6. Hold the syringes vertically with Syringe B on the bottom.  The syringes should remain securely coupled.  Draw the entire mixed product into Syringe B (short, wide syringe) by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger.  Uncouple Syringe A while continuing to push down on the Syringe A plunger (Figure 7).  Note:  Small air bubbles will remain in the formulation – this is acceptable.

  7. Hold Syringe B upright.  Remove the cap on the bottom of the sterile needle cartridge by twisting it (Figure 8).  Attach the needle cartridge to the end of Syringe B (Figure 9) by pushing in and turning the needle until it is firmly seated.  Do not twist the needle onto the syringe until it is stripped.  Pull off the clear needle cartridge cover prior to administration (Figure 10).

  2.2 Administration Procedure

  IMPORTANT:  Allow the product to reach room temperature before using.  Once mixed, the product must be administered within 30 minutes. 

  1. Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair.  Since you can vary the injection site with a subcutaneous injection, choose an area that hasn’t recently been used.

  2. Cleanse the injection-site area with an alcohol swab.

  3. Using the thumb and forefinger of your non-dominant hand, grab and bunch the area of skin around the injection site.

  4. Using your dominant hand, insert the needle quickly at a 90º angle.  The approximate angle you use will depend on the amount and fullness of the subcutaneous tissue and the length of the needle. After the needle is inserted, release the skin with your nondominant hand.

  5. Inject the drug using a slow, steady push.  Press down on the plunger until the syringe is empty.

  6. Withdraw the needle quickly at the same angle used for insertion.

  7. Discard all components safely in an appropriate biohazard container.

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• Fluvoxamine Maleate
  

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  Fluvoxamine Maleate

  

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  As with other similar agents, the use of gloves is recommended during mixing and administration.1

  ELIGARD® is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period (Table 1).  The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation.

  Table 1. ELIGARD® Recommended Dosing

   Dosage  7.5 mg  22.5 mg  30 mg  45 mg  Recommended Dose  1 injection every month  1 injection every 3 months  1 injection every 4 months  1 injection every 6 months

  Once mixed, ELIGARD® should be discarded if not administered within 30 minutes.

  As with other drugs administered by subcutaneous injection, the injection site should vary periodically.  The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue.  In clinical trials, the injection was administered in the upper- or mid-abdominal area.  Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with a belt or clothing waistband).

  2.1 Mixing Procedure

  IMPORTANT:  Allow the product to reach room temperature before using.  Once mixed, the product must be administered within 30 minutes.

  Follow the instructions as directed to ensure proper preparation of ELIGARD® prior to administration:

  ELIGARD® is packaged in either thermoformed trays or pouches. Each carton contains:

  One sterile Syringe A pre-filled with the ATRIGEL® Delivery System One Syringe B pre-filled with leuprolide acetate powder One long white plunger rod for use with Syringe B One sterile needle  or One sterile safety needle Desiccant pack(s)

  1. On a clean field, open all of the packages and remove the contents.  Discard the desiccant pack(s).

  2. Pull out the blue-tipped short plunger rod and attached stopper from Syringe B and discard (Figure 1).  Gently insert the long, white replacement plunger rod into the gray primary stopper remaining in Syringe B by twisting it in place (Figure 2).

  3. Unscrew the clear cap from Syringe A (Figure 3).  Remove the gray rubber cap from Syringe B (Figure 4).

  4. Join the two syringes together by pushing in and twisting until secure (Figure 5).

  5. Inject the liquid contents of Syringe A into Syringe B containing the leuprolide acetate.  Thoroughly mix the product by pushing the contents of both syringes back and forth between syringes (approximately 45 seconds) to obtain a uniform suspension (Figure 6). When thoroughly mixed, the suspension will appear light tan to tan (ELIGARD® 7.5 mg) or colorless to pale yellow (ELIGARD®, 22.5 mg, 30 mg and 45 mg) in color. Please Note:  Product must be mixed as described; shaking will not provide adequate mixing of the product.

  6. Hold the syringes vertically with Syringe B on the bottom.  The syringes should remain securely coupled.  Draw the entire mixed product into Syringe B (short, wide syringe) by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger.  Uncouple Syringe A while continuing to push down on the Syringe A plunger (Figure 7).  Note:  Small air bubbles will remain in the formulation – this is acceptable.

  [Applies to ELIGARD® single use kit of a two syringe-mixing system with sterile needle]

  7. Hold Syringe B upright.  Remove the cap on the bottom of the sterile needle cartridge by twisting it (Figure 8).  Attach the needle cartridge to the end of Syringe B (Figure 9) by pushing in and turning the needle until it is firmly seated.  Do not twist the needle onto the syringe until it is stripped.  Pull off the clear needle cartridge cover prior to administration (Figure 10).

  [Applies to ELIGARD® single use kit of a two syringe-mixing system with sterile safety needle]

  8. Hold Syringe B upright.  Open the sterile safety needle package by peeling back the paper tab and remove the safety needle (Figure 11).  Secure the needle to the end of Syringe B by holding the protective needle sheath and twisting the syringe clockwise to fully seat the needle (Figure 12).  Remove the protective needle sheath prior to administration (Figure 13).

  2.2 Administration Procedure

  IMPORTANT:  Allow the product to reach room temperature before using.  Once mixed, the product must be administered within 30 minutes. 

  1. Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair.  Since you can vary the injection site with a subcutaneous injection, choose an area that hasn’t recently been used.

  2. Cleanse the injection-site area with an alcohol swab.

  3. Using the thumb and forefinger of your non-dominant hand, grab and bunch the area of skin around the injection site.

  4. Using your dominant hand, insert the needle quickly at a 90º angle.  The approximate angle you use will depend on the amount and fullness of the subcutaneous tissue and the length of the needle. After the needle is inserted, release the skin with your nondominant hand.

  5. Inject the drug using a slow, steady push.  Press down on the plunger until the syringe is empty.

  6. Withdraw the needle quickly at the same angle used for insertion.

  [Step 7 only applies to ELIGARD® single use kit of a two syringe-mixing system with sterile safety needle]

  7. Immediately following the withdrawal of the needle, activate the safety shield on the needle by using a thumb (Figure 14) or finger (Figure 15) or a flat surface (Figure 16) to push the safety shield forward until it completely covers the needle tip and locks into place.  An audible and tactile “click” verifies a locked position for the safety shield (Figure 17).

  8. Discard all components safely in an appropriate biohazard container.

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