Health Mart Nicotine

Health Mart Nicotine Manufacturers

• Mckesson
  

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  Health Mart Nicotine | Merck Sharp & Dohme Corp.

  

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  2.1 Patient Selection

  Select patients for second line or greater treatment of metastatic NSCLC with KEYTRUDA based on the presence of positive PD-L1 expression [see Clinical Studies (14.2)]. Information on FDA-approved tests for the detection of PD-L1 expression in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

  2.2 Recommended Dosing

  The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

  2.3 Dose Modifications

  Withhold KEYTRUDA for any of the following:

  Grade 2 pneumonitis [see Warnings and Precautions (5.1)] Grade 2 or 3 colitis [see Warnings and Precautions (5.2)] Grade 3 or 4 endocrinopathies [see Warnings and Precautions (5.4)] Grade 2 nephritis [see Warnings and Precautions (5.5)] Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN Any other severe or Grade 3 treatment-related adverse reaction [see Warnings and Precautions (5.6)]

  Resume KEYTRUDA in patients whose adverse reactions recover to Grade 0-1.

  Permanently discontinue KEYTRUDA for any of the following:

  Any life-threatening adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy) Grade 3 or 4 pneumonitis or recurrent pneumonitis of Grade 2 severity [see Warnings and Precautions (5.1)] Grade 3 or 4 nephritis [see Warnings and Precautions (5.5)] AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN For patients with liver metastasis who begin treatment with Grade 2 AST or ALT, if AST or ALT increases by greater than or equal to 50% relative to baseline and lasts for at least 1 week Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.7)] Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks Persistent Grade 2 or 3 adverse reactions (excluding endocrinopathies controlled with hormone replacement therapy) that do not recover to Grade 0-1 within 12 weeks after last dose of KEYTRUDA Any severe or Grade 3 treatment-related adverse reaction that recurs [see Warnings and Precautions (5.6)] 2.4 Preparation and Administration

  Reconstitution of KEYTRUDA for Injection (Lyophilized Powder)

  Add 2.3 mL of Sterile Water for Injection, USP by injecting the water along the walls of the vial and not directly on the lyophilized powder (resulting concentration 25 mg/mL). Slowly swirl the vial. Allow up to 5 minutes for the bubbles to clear. Do not shake the vial.

  Preparation for Intravenous Infusion

  Visually inspect the solution for particulate matter and discoloration prior to administration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed. Dilute KEYTRUDA injection (solution) or reconstituted lyophilized powder prior to intravenous administration. Withdraw the required volume from the vial(s) of KEYTRUDA and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL. Discard any unused portion left in the vial.

  Storage of Reconstituted and Diluted Solutions

  The product does not contain a preservative.

  Store the reconstituted and diluted solution from the KEYTRUDA 50 mg vial either:

  At room temperature for no more than 6 hours from the time of reconstitution. This includes room temperature storage of reconstituted vials, storage of the infusion solution in the IV bag, and the duration of infusion. Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of reconstitution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.

  Store the diluted solution from the KEYTRUDA 100 mg/4 mL vial either:

  At room temperature for no more than 6 hours from the time of dilution. This includes room temperature storage of the infusion solution in the IV bag, and the duration of infusion. Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.

  Do not freeze.

  Administration

  Administer infusion solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. Do not co-administer other drugs through the same infusion line.

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• Mckesson
  

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  Health Mart Nicotine | Mckesson

  

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  • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 lozenge every

  1 to 2 hours

  1 lozenge every

  2 to 4 hours

  1 lozenge every

  4 to 8 hours

  • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

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• Mckesson
  

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  Health Mart Nicotine | Apotheca Company

  

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  Directions:  10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.
  

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• Mckesson
  

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  Health Mart Nicotine | Mckesson

  

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  • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 lozenge every

  1 to 2 hours

  1 lozenge every

  2 to 4 hours

  1 lozenge every

  4 to 8 hours

  • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

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• Mckesson
  

  ×

  Health Mart Nicotine | Mckesson

  

  ---

  • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 lozenge every

  1 to 2 hours

  1 lozenge every

  2 to 4 hours

  1 lozenge every

  4 to 8 hours

  • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

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