Healthy Accents Naproxen Sodium

Healthy Accents Naproxen Sodium Manufacturers

• Dza Brands Llc
  

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  Healthy Accents Naproxen Sodium | Dza Brands Llc

  

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  • do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose • if taken with food, this product may take longer to work

  adults and children 12 years and older:

  • take 1 capsule every 8 to 12 hours while symptoms last • for the first dose you may take 2 capsules within the first hour • do not exceed 2 capsules in any 8- to 12-hour period • do not exceed 3 capsules in a 24-hour period

  children under 12 years:

  • ask a doctor

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• Dza Brands Llc
  

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  Healthy Accents Naproxen Sodium | Dza Brands Llc

  

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  • do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose

  Adults and children 12 years and older:

  • take 1 tablet every 8 to 12 hours while symptoms last • for the first dose you may take 2 tablets within the first hour • do not exceed 2 tablets in any 8- to 12-hour period • do not exceed 3 tablets in a 24-hour period

  Children under 12 years:

  • ask a doctor

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• Dza Brands Llc
  

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  Healthy Accents Naproxen Sodium | Fresenius Kabi Usa, Llc

  

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  (see also WARNINGS).

  Multiple Sclerosis

  The recommended dosage of Mitoxantrone Injection, USP is 12 mg/m2 given as a short (approximately 5 to 15 minutes) intravenous infusion every 3 months.  Left ventricular ejection fraction (LVEF) should be evaluated by echocardiogram or MUGA prior to administration of the initial dose of Mitoxantrone Injection, USP and all subsequent doses.  In addition, LVEF evaluations are recommended if signs or symptoms of congestive heart failure develop at any time during treatment with Mitoxantrone Injection, USP.  Mitoxantrone Injection, USP should not be administered to multiple sclerosis patients with an LVEF <50%, with a clinically significant reduction in LVEF, or to those who have received a cumulative lifetime dose of ≥ 140 mg/m2.  Complete blood counts, including platelets, should be monitored prior to each course of Mitoxantrone Injection, USP and in the event that signs or symptoms of infection develop.  Mitoxantrone Injection, USP generally should not be administered to multiple sclerosis patients with neutrophil counts less than 1500 cells/mm3.  Liver function tests should also be monitored prior to each course.  Mitoxantrone Injection, USP therapy in multiple sclerosis patients with abnormal liver function tests is not recommended because Mitoxantrone Injection, USP clearance is reduced by hepatic impairment and no laboratory measurement can predict drug clearance and dose adjustments.

  Women with multiple sclerosis who are biologically capable of becoming pregnant, even if they are using birth control, should have a pregnancy test, and the results should be known, before receiving each dose of Mitoxantrone Injection, USP (see WARNINGS, Pregnancy).

  Hormone-Refractory Prostate Cancer

  Based on data from two Phase 3 comparative trials of mitoxantrone injection plus corticosteroids versus corticosteroids alone, the recommended dosage of mitoxantrone is 12 to 14 mg/m2 given as a short intravenous infusion every 21 days.

  Combination Initial Therapy for ANLL in Adults

  For induction, the recommended dosage is 12 mg/m2 of Mitoxantrone Injection daily on Days 1 to 3 given as an intravenous infusion, and 100 mg/m2 of cytarabine for 7 days given as a continuous 24-hour infusion on Days 1 to 7.

  Most complete remissions will occur following the initial course of induction therapy.  In the event of an incomplete antileukemic response, a second induction course may be given.  Mitoxantrone Injection should be given for 2 days and cytarabine for 5 days using the same daily dosage levels.

  If severe or life-threatening nonhematologic toxicity is observed during the first induction course, the second induction course should be withheld until toxicity resolves.

  Consolidation therapy which was used in two large randomized multicenter trials consisted of mitoxantrone, 12 mg/m2 given by intravenous infusion daily on Days 1 and 2 and cytarabine, 100 mg/m2 for 5 days given as a continuous 24-hour infusion on Days 1 to 5.  The first course was given approximately 6 weeks after the final induction course; the second was generally administered 4 weeks after the first.  Severe myelosuppression occurred (see CLINICAL PHARMACOLOGY).

  Hepatic Impairment

  For patients with hepatic impairment, there is at present no laboratory measurement that allows for dose adjustment recommendations (see CLINICAL PHARMACOLOGY,   Special Populations, Hepatic Impairment).

  Preparation and Administration Precautions

  MITOXANTRONE INJECTION, USP  (CONCENTRATE) MUST BE DILUTED PRIOR TO USE.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  The dose of mitoxantrone should be diluted to at least 50 mL with either 0.9% Sodium Chloride Injection (USP) or 5% Dextrose Injection (USP).  Mitoxantrone Injection, USP (concentrate) may be further diluted into Dextrose 5% in Water, Normal Saline or Dextrose 5% with Normal Saline and used immediately.  DO NOT FREEZE.

  Mitoxantrone should not be mixed in the same infusion as heparin since a precipitate may form.  Because specific compatibility data are not available, it is recommended that mitoxantrone not be mixed in the same infusion with other drugs.  The diluted solution should be introduced slowly into the tubing as a freely running intravenous infusion of 0.9% Sodium Chloride Injection (USP) or 5% Dextrose Injection (USP) over a period of not less than 3 minutes.  Unused infusion solutions should be discarded immediately in an appropriate fashion.  In the case of multidose use, after penetration of the stopper, the remaining portion of the undiluted Mitoxantrone Injection, USP (concentrate) should be stored not longer than 7 days between 15° to 25°C (59° to 77°F) or 14 days under refrigeration.  DO NOT FREEZE.  CONTAINS NO PRESERVATIVE.

  Care in the administration of mitoxantrone will reduce the chance of extravasation.  Mitoxantrone should be administered into the tubing of a freely running intravenous infusion of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.  The tubing should be attached to a Butterfly needle or other suitable device and inserted preferably into a large vein.  If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.  Care should be taken to avoid extravasation at the infusion site and to avoid contact of mitoxantrone with the skin, mucous membranes, or eyes.  MITOXANTRONE SHOULD NOT BE ADMINISTERED SUBCUTANEOUSLY.  If any signs or symptoms of extravasation have occurred, including burning, pain, pruritus, erythema, swelling, blue discoloration, or ulceration, the injection or infusion should be immediately terminated and restarted in another vein.  During intravenous administration of mitoxantrone extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle.  If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs be placed over the area of extravasation and that the affected extremity be elevated.  Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and surgery consultation obtained early if there is any sign of a local reaction.

  Skin accidentally exposed to mitoxantrone should be rinsed copiously with warm water and if the eyes are involved, standard irrigation techniques should be used immediately.  The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.

  Procedures for proper handling and disposal of anticancer drugs should be considered.  Several guidelines on this subject have been published.1-4  There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

  Multiple Sclerosis

  The recommended dosage of Mitoxantrone Injection, USP is 12 mg/m2 given as a short (approximately 5 to 15 minutes) intravenous infusion every 3 months.  Left ventricular ejection fraction (LVEF) should be evaluated by echocardiogram or MUGA prior to administration of the initial dose of Mitoxantrone Injection, USP and all subsequent doses.  In addition, LVEF evaluations are recommended if signs or symptoms of congestive heart failure develop at any time during treatment with Mitoxantrone Injection, USP.  Mitoxantrone Injection, USP should not be administered to multiple sclerosis patients with an LVEF <50%, with a clinically significant reduction in LVEF, or to those who have received a cumulative lifetime dose of ≥ 140 mg/m2.  Complete blood counts, including platelets, should be monitored prior to each course of Mitoxantrone Injection, USP and in the event that signs or symptoms of infection develop.  Mitoxantrone Injection, USP generally should not be administered to multiple sclerosis patients with neutrophil counts less than 1500 cells/mm3.  Liver function tests should also be monitored prior to each course.  Mitoxantrone Injection, USP therapy in multiple sclerosis patients with abnormal liver function tests is not recommended because Mitoxantrone Injection, USP clearance is reduced by hepatic impairment and no laboratory measurement can predict drug clearance and dose adjustments.

  Women with multiple sclerosis who are biologically capable of becoming pregnant, even if they are using birth control, should have a pregnancy test, and the results should be known, before receiving each dose of Mitoxantrone Injection, USP (see WARNINGS, Pregnancy).

  Hormone-Refractory Prostate Cancer

  Based on data from two Phase 3 comparative trials of mitoxantrone injection plus corticosteroids versus corticosteroids alone, the recommended dosage of mitoxantrone is 12 to 14 mg/m2 given as a short intravenous infusion every 21 days.

  Combination Initial Therapy for ANLL in Adults

  For induction, the recommended dosage is 12 mg/m2 of Mitoxantrone Injection daily on Days 1 to 3 given as an intravenous infusion, and 100 mg/m2 of cytarabine for 7 days given as a continuous 24-hour infusion on Days 1 to 7.

  Most complete remissions will occur following the initial course of induction therapy.  In the event of an incomplete antileukemic response, a second induction course may be given.  Mitoxantrone Injection should be given for 2 days and cytarabine for 5 days using the same daily dosage levels.

  If severe or life-threatening nonhematologic toxicity is observed during the first induction course, the second induction course should be withheld until toxicity resolves.

  Consolidation therapy which was used in two large randomized multicenter trials consisted of mitoxantrone, 12 mg/m2 given by intravenous infusion daily on Days 1 and 2 and cytarabine, 100 mg/m2 for 5 days given as a continuous 24-hour infusion on Days 1 to 5.  The first course was given approximately 6 weeks after the final induction course; the second was generally administered 4 weeks after the first.  Severe myelosuppression occurred (see CLINICAL PHARMACOLOGY).

  Hepatic Impairment

  For patients with hepatic impairment, there is at present no laboratory measurement that allows for dose adjustment recommendations (see CLINICAL PHARMACOLOGY,   Special Populations, Hepatic Impairment).

  Preparation and Administration Precautions

  MITOXANTRONE INJECTION, USP  (CONCENTRATE) MUST BE DILUTED PRIOR TO USE.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  The dose of mitoxantrone should be diluted to at least 50 mL with either 0.9% Sodium Chloride Injection (USP) or 5% Dextrose Injection (USP).  Mitoxantrone Injection, USP (concentrate) may be further diluted into Dextrose 5% in Water, Normal Saline or Dextrose 5% with Normal Saline and used immediately.  DO NOT FREEZE.

  Mitoxantrone should not be mixed in the same infusion as heparin since a precipitate may form.  Because specific compatibility data are not available, it is recommended that mitoxantrone not be mixed in the same infusion with other drugs.  The diluted solution should be introduced slowly into the tubing as a freely running intravenous infusion of 0.9% Sodium Chloride Injection (USP) or 5% Dextrose Injection (USP) over a period of not less than 3 minutes.  Unused infusion solutions should be discarded immediately in an appropriate fashion.  In the case of multidose use, after penetration of the stopper, the remaining portion of the undiluted Mitoxantrone Injection, USP (concentrate) should be stored not longer than 7 days between 15° to 25°C (59° to 77°F) or 14 days under refrigeration.  DO NOT FREEZE.  CONTAINS NO PRESERVATIVE.

  Care in the administration of mitoxantrone will reduce the chance of extravasation.  Mitoxantrone should be administered into the tubing of a freely running intravenous infusion of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.  The tubing should be attached to a Butterfly needle or other suitable device and inserted preferably into a large vein.  If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.  Care should be taken to avoid extravasation at the infusion site and to avoid contact of mitoxantrone with the skin, mucous membranes, or eyes.  MITOXANTRONE SHOULD NOT BE ADMINISTERED SUBCUTANEOUSLY.  If any signs or symptoms of extravasation have occurred, including burning, pain, pruritus, erythema, swelling, blue discoloration, or ulceration, the injection or infusion should be immediately terminated and restarted in another vein.  During intravenous administration of mitoxantrone extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle.  If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs be placed over the area of extravasation and that the affected extremity be elevated.  Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and surgery consultation obtained early if there is any sign of a local reaction.

  Skin accidentally exposed to mitoxantrone should be rinsed copiously with warm water and if the eyes are involved, standard irrigation techniques should be used immediately.  The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.

  Procedures for proper handling and disposal of anticancer drugs should be considered.  Several guidelines on this subject have been published.1-4  There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

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  More Info
• Dza Brands Llc
  

  ×

  Healthy Accents Naproxen Sodium | Dza Brands Llc

  

  ---

  • do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose

  Adults and children 12 years and older

  • take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period

  Children under 12 years

  • ask a doctor

  Close
  No Recall

  More Info