Acilog^® Mix Biopen

Acilog® Mix Biopen is a human insulin analog suspension, which is a preparation of 30% soluble Insulin Aspart and 70% Insulin Aspart Protamine (rDNA) crystals. Acilog® Mix Biopen is a blood glucose lowering agent with an earlier onset and an intermediate duration of action. Insulin Aspart is homologous with regular human insulin with the exception of a single substitution of proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast). Primary function of Insulin Aspart is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, primarily by skeletal muscle, fat and by inhibiting hepatic glucose production. Insulin inhibits lipolysis, proteolysis and enhances protein synthesis.

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Acilog® Mix Biopen is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Instructions of using Acilog® Mix Biopen

Please read this manual completely and follow the directions carefully before using Acilog® Biopen.

Important information

• Use Biopen only after receiving adequate training from healthcare professional.
• Always use a new pen needle for each injection.
• Replace the pen needle after every use and do not store the pen with attached pen needle.
• Always keep the cap on the pen when it is not in use.
• Prior to using the pen always check if the proper pen with the correct drug is chosen as per recommendation of healthcare professionals.
• Always check the expiry date before use.
• To clean the Biopen, a moist cloth is sufficient. Do not use other solvents or cleaning agents.
• Always dispose of Biopen in compliance with local regulations after using it.

 

Technical characteristics

Acilog® Biopencan deliver doses between 10 µl (microliter) and 600 µl in 10 µl increments.

Attaching the pen needle:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Priming or functional test:

Important:

Prior to the first injection, the Biopen must be primed in order to remove air bubbles from the cartridge for accurate dosing and to ensure that the needle is not clogged.

 

Important:

In case no drops emerge after 6 attempts (6×2 units), replace the pen needle (see step 13) and repeat the priming or functional test (see steps 6-9).

 

Important:

Make sure not to press the push button while dialing the dose to avoid loss of drug.

Notes:

• A dose larger than the amount of drug remaining in the pen cannot be dialed.
• If the dose is larger than the remaining drug volume in the cartridge a new pen should be used for the remaining dose.
• Either inject the residual drug and complete the dose with a new pen, or apply the full dose with a new pen.

Injection:

Important:

Read steps 11 and 12 first before proceeding with the injection.

Note: Use the injection technique recommended by the doctor or healthcare professional

Holding after injection:

Note: Holding the push button for 10 seconds which ensures a complete discharge of the drug dose.

 

Important:

Do not tilt the pen during injection and removal from skin to avoid pen needle damage.

Disposal of the pen needle:

 

 

 

 

 

 

 

 

Note for healthcare professionals: Always adhere to the specific regulations that apply for concerning replacement of the needle cap (recapping) and disposal.

Pen cap mounting:

 

Note: After each use, remove (dispose of) the attached pen needle and attach the pen cap properly.

 

 

Subcutaneous injection: Acilog® Biopen should be administered by subcutaneous injection in the abdomen, buttocks, thigh or upper arm. Because Acilog® Biopen has a more rapid and a shorter duration of activity than human regular insulin, it should be injected immediately. Blood glucose monitoring is essential in all patients with diabetes. Patients who change their level of physical activity or meal plan may require adjustment of insulin dosage. Injection sites should be rotated within the same region (abdomen, buttocks, thigh or upper arm) from one injection to the next.

Intravenous injection: Acilog® Biopen can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.  For intravenous use, Acilog® Biopen should be used at concentrations from 0.5 U/ml to 1.0 U/ml insulin aspart in infusion systems using polypropylene infusion bags. Acilog® Biopen has been shown to be stable in infusion fluids such as 0.9% sodium chloride. Inspect Acilog® Biopen for particulate matter and discoloration prior to parenteral administration. 

Pregnancy

Insulin aspart is pregnancy category B. Careful monitoring of glucose control is essential in pregnant patients because insulin requirements change during different stages of pregnancy. Therefore female patients should be advised to tell their physician if they intend to become or if they become pregnant while taking insulin aspart.

Lactation

It is unknown whether insulin aspart is excreted in human milk. This drug should be prescribed to lactating mother only if the potential benefits of the drug outweigh the risks.

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Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Reduction in the insulin aspart dose may require in patients with renal and hepatic impairment.

The most common side effects of insulin aspart are hypoglycemia, lipodystrophy, weight gain and peripheral edema.

Insulin aspart is contraindicated in patients with known history of hypersensitivity to insulin aspart or any components of this product. It is also contraindicated during the episodes of hypoglycemia.

A number of substances affect glucose metabolism and may require dose adjustment and particularly close monitoring.

• The following are examples that may increase the blood glucose lowering effect and susceptibility to hypoglycemia: oral anti-diabetic products, pramlintide and angiotensin converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, salicylates and sulfonamide antibiotics.
• The following substances are examples that may reduce the blood glucose lowering effect: corticosteroids, niacin, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, estrogens, progestogens, atypical antipsychotics and danazol.
• Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood glucose lowering effect of insulin.
• Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

In case of insulin aspart overdose, hypoglycemia may occur. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Severe hypoglycemia may be treated with parenteral glucose or injections of glucagon. Adjustments in drug dosage, meal patterns or exercise may be needed.

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Store at 2ºC to 8ºC in a refrigerator. Do not freeze. Do not mix with other insulin. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature (below 30ºC) for a month.

Special precaution for disposal and other handling

Acilog® Biopen is designed to be used with disposable needles up to length of 8 mm. The pre-filled pen is for single patient use only.

Acilog® Mix Biopen Injection 100 U/ml: Each ml suspension contains Insulin Aspart (rDNA) BP 100 units (equivalent to 3.5 mg) as 30% soluble Insulin Aspart and 70% Insulin Aspart Protamine.

Acilog® Biopen Injection 100 U/ml: Carton of 5 pens and each pen contains 3 ml sterile solution in a glass cartridge.