Pharmacy Diabetes

Fixed_Dose-Kombiglyze XR

Saxagliptin (as hydrochloride)/ metformin hydrochloride

  • KOMBIGLYZE XR 5/500 tablets containing 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release.
  • KOMBIGLYZE XR 5/1000 tablets containing 5 mgsaxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release.
  • KOMBIGLYZE XR 2.5/1000 tablets containing 2.5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release.

  • For use in type 1 and type 2 diabetes mellitus
For the latest PBS indications for Humalog please see https://www.pbs.gov.au/pbs/search?term=humalog&analyse=false&search-type=medicines

  • Humalog Mix50 a should be given only by subcutaneous injection. It should not be administered intravenously. Humalog Mix50 can be given immediately (up to 15 minutes before a meal). The safety and efficacy of Humalog Mix50 given after a meal has not been established. The rapid onset and early peak activity of Humalog is observed following the subcutaneous administration of Humalog Mix50. The duration of action of the insulin lispro protamine suspension (NPL) component of Humalog Mix50 and is similar to that of basal insulin NPH.
  • Subcutaneous administration should be in the abdomen or thighs. The injection sites should be rotated so that the same site is not used more than approximately once a month to reduce the risk of lipodystrophy and localised cutaneous amyloidosis.
  • Care should be taken when injecting Humalog Mix50 to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Note: Diabetes MedsCheck with referral for blood glucose monitoring, referral to healthcare team for education on injection technique and counselling on hypoglycaemia.
  • Humalog Mix50 should not be used in insulin pumps.

  • Humalog Mix50 Cartridges - Cartridges should be rolled between the palms 10 times. Holding the cartridge by one end, invert it 180° slowly 10 times to allow the glass bead to travel the full length of the cartridge with each inversion. Cartridges should not be shaken vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The insulin should look uniformly cloudy after mixing. If it does not, the above steps should be repeated until the contents are mixed. Cartridges of insulin should be examined frequently and should not be used if the insulin substance (the white material) remains visibly separated from the liquid after mixing. Cartridges of insulin should not be used if there are clumps in the insulin after mixing or if solid white particles stick to the bottom or wall of the cartridge, giving a frosted appearance.
  • Humalog Mix50 (KwikPens) - KwikPen prefilled insulin pen delivery devices should be rolled between the palms 10 times. Holding the device by one end, invert it 180° slowly 10 times to allow the glass bead to travel the full length of the cartridge with each inversion. The devices should not be shaken vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The insulin should look uniformly cloudy after mixing. If it does not, the above steps should be repeated until the contents are mixed. KwikPen prefilled insulin pen delivery devices should be examined frequently and should not be used if the insulin substance (the white material) remains visibly separated from the liquid after mixing. KwikPen prefilled insulin pen delivery devices should not be used if there are clumps in the insulin after mixing or if solid white particles stick to the bottom or wall of the cartridge, giving a frosted appearance.

  • HUMALOG MIX50 can be used in renal impairment. As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.

  • Humalog Mix50 can be used in hepatic impairment. As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.

  • There is no data available.

  • The safety and efficacy of Humalog Mix50 in individuals less than 18 years of age has not been established.

  • Hypoglycaemia.
  • Hypersensitivity to insulin lispro or one of its excipients.

  • Humalog Mix50 should under no circumstances be administered intravenously. Mixing of Humalog Mix50 with other insulins has not been studied. Therefore, Humalog Mix50 should not be mixed with other insulins.
  • Hypoglycaemia: Hypoglycaemia is the most common adverse effect of insulins. As with all insulins, particular caution (including intensified blood glucose monitoring) should be exercised in individuals who are at greater risk of clinically significant sequelae from hypoglycaemic episodes. Some people can experience hypoglycaemic reactions after transfer from animal source insulin to human insulin. They report that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.

  • Hypoglycaemia: Hypoglycaemia is the most common adverse effect of insulins. As with all insulins, particular caution (including intensified blood glucose monitoring) should be exercised in individuals who are at greater risk of clinically significant sequelae from hypoglycaemic episodes.
    Note: Diabetes MedsCheck with counselling on hypoglycaemia, blood glucose monitoring, side effect profile - hypoglycaemia is part of the side effect profile and were happening regularly may require referral to prescriber for dose adjustment.
  • Injection site and allergic reactions: As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. Other injection site reactions with insulin therapy include redness, pain, itching, hives, swelling and inflammation.
    Note: Diabetes Medscheck with education on side effect profile and referral to healthcare team to establish correct injection technique.
  • Skin and subcutaneous tissue disorders: Some people must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia.
    Note: Diabetes Medscheck with referral to healthcare team for correct injection technique.
For more information on Humalog Mix50, please go to
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-04515-3&d=202105161016933

  • For use in type 1 and type 2 diabetes mellitus
For the latest PBS indications for Humalog please see https://www.pbs.gov.au/pbs/search?term=humalog&analyse=false&search-type=medicines

  • Humalog Mix50 a should be given only by subcutaneous injection. It should not be administered intravenously. Humalog Mix50 can be given immediately (up to 15 minutes before a meal). The safety and efficacy of Humalog Mix50 given after a meal has not been established. The rapid onset and early peak activity of Humalog is observed following the subcutaneous administration of Humalog Mix50. The duration of action of the insulin lispro protamine suspension (NPL) component of Humalog Mix50 and is similar to that of basal insulin NPH.
  • Subcutaneous administration should be in the abdomen or thighs. The injection sites should be rotated so that the same site is not used more than approximately once a month to reduce the risk of lipodystrophy and localised cutaneous amyloidosis.
  • Care should be taken when injecting Humalog Mix50 to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Note: Diabetes MedsCheck with referral for blood glucose monitoring, referral to healthcare team for education on injection technique and counselling on hypoglycaemia.
  • Humalog Mix50 should not be used in insulin pumps.

  • Humalog Mix50 Cartridges - Cartridges should be rolled between the palms 10 times. Holding the cartridge by one end, invert it 180° slowly 10 times to allow the glass bead to travel the full length of the cartridge with each inversion. Cartridges should not be shaken vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The insulin should look uniformly cloudy after mixing. If it does not, the above steps should be repeated until the contents are mixed. Cartridges of insulin should be examined frequently and should not be used if the insulin substance (the white material) remains visibly separated from the liquid after mixing. Cartridges of insulin should not be used if there are clumps in the insulin after mixing or if solid white particles stick to the bottom or wall of the cartridge, giving a frosted appearance.
  • Humalog Mix50 (KwikPens) - KwikPen prefilled insulin pen delivery devices should be rolled between the palms 10 times. Holding the device by one end, invert it 180° slowly 10 times to allow the glass bead to travel the full length of the cartridge with each inversion. The devices should not be shaken vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The insulin should look uniformly cloudy after mixing. If it does not, the above steps should be repeated until the contents are mixed. KwikPen prefilled insulin pen delivery devices should be examined frequently and should not be used if the insulin substance (the white material) remains visibly separated from the liquid after mixing. KwikPen prefilled insulin pen delivery devices should not be used if there are clumps in the insulin after mixing or if solid white particles stick to the bottom or wall of the cartridge, giving a frosted appearance.

  • HUMALOG MIX50 can be used in renal impairment. As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.

  • Humalog Mix50 can be used in hepatic impairment. As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.

  • There is no data available.

  • The safety and efficacy of Humalog Mix50 in individuals less than 18 years of age has not been established.

  • Hypoglycaemia.
  • Hypersensitivity to insulin lispro or one of its excipients.

  • Humalog Mix50 should under no circumstances be administered intravenously. Mixing of Humalog Mix50 with other insulins has not been studied. Therefore, Humalog Mix50 should not be mixed with other insulins.
  • Hypoglycaemia: Hypoglycaemia is the most common adverse effect of insulins. As with all insulins, particular caution (including intensified blood glucose monitoring) should be exercised in individuals who are at greater risk of clinically significant sequelae from hypoglycaemic episodes. Some people can experience hypoglycaemic reactions after transfer from animal source insulin to human insulin. They report that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.

  • Hypoglycaemia: Hypoglycaemia is the most common adverse effect of insulins. As with all insulins, particular caution (including intensified blood glucose monitoring) should be exercised in individuals who are at greater risk of clinically significant sequelae from hypoglycaemic episodes.
    Note: Diabetes MedsCheck with counselling on hypoglycaemia, blood glucose monitoring, side effect profile - hypoglycaemia is part of the side effect profile and were happening regularly may require referral to prescriber for dose adjustment.
  • Injection site and allergic reactions: As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. Other injection site reactions with insulin therapy include redness, pain, itching, hives, swelling and inflammation.
    Note: Diabetes Medscheck with education on side effect profile and referral to healthcare team to establish correct injection technique.
  • Skin and subcutaneous tissue disorders: Some people must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia.
    Note: Diabetes Medscheck with referral to healthcare team for correct injection technique.
For more information on Humalog Mix50, please go to
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-04515-3&d=202105161016933