Biosulin 30:70

Biosulin 30:70

Manufacturer:

M. J. Biopharm

Distributor:

BJC Healthcare

Marketer:

BJC Healthcare
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Contents
Human insulin (30% soluble insulin, 70% isophane insulin).
Description
Biosulin 30:70 (MIX): Insulin Injection, Biphasic Isophane Ph.Eur. 100 IU/ml.
The insulin preparations have been made from crystals of monocomponent human insulin rDNA. Insulin in these preparations is derived from recombinant DNA technology. All these preparations are available in a concentration of Insulin Human 100 IU/ml.
Indications/Uses
Insulin is indicated for the treatment of Diabetes mellitus.
Dosage/Direction for Use
The insulin requirement of every patient is different and the doctor will decide the dose considering the blood glucose values, age, daily activities etc. The time course of action of an insulin preparation may vary considerably in different individuals or at different times in the same individuals. Therefore, the dosage schedule will be individualized. The patient must, therefore follow the doctor's instructions carefully.
Warnings
Any change in the dose, frequency and/or route of administration of insulin must be made only as per the advise of the physician and only under medical supervision. Changes in purity, strength, brand, types, species and/or methods of manufacture of insulin or its formulation may result in the need for a change in dosage. If an adjustment is needed, it may occur with the first dose or during the first several weeks or months.
Special Precautions
The usual insulin dose may be affected by various factors. Hence, it is necessary to anticipate change in the dose of insulin required and seek the doctor's advice well on time. Some of such factors are as follows: Illness: During an illness the requirement may actually go up even if the patient is not eating well. The patient should therefore, establish a sick day plan with the doctor's advice. The patient may require to test urine and/or blood glucose more frequently for proper monitoring of the insulin dose.
Medication: Insulin requirements may be modified by the effect of a number of medications the patient may require to take during illness. Do not forget to point out to the doctor about taking insulin while consulting him for any health advice.
Exercise: Exercise may lower the body's need for insulin during and for some time after the activity. Exercise may also speed up the effect of an insulin dose, especially if it involves the area of injection site (e.g. the leg should not be used for injection just prior to running). Discuss with the doctor how the patient should adjust the regimen to accommodate exercise.
Travel: When travelling across two or more time zones, consult the doctor well in advance and seek his advice about dosage adjustments and schedule.
Use in Pregnancy: During pregnancy it is important that the diabetes is controlled properly for the patient as well as for the unborn baby. Hence, the patient must consult the doctor immediately if planning to have a baby or is pregnant.
Use In Pregnancy & Lactation
Pregnancy: During pregnancy it is important that the diabetes is controlled properly for the patient as well as for the unborn baby. Hence, the patient must consult the doctor immediately if planning to have a baby or is pregnant.
Adverse Reactions
Common Problems Associated with Insulin: Hypoglycemia: Excessive lowering of blood glucose is called as Hypoglycemia.
This is one of the most frequent problems faced by patients taking insulin. This can occur due to the following reasons: 1. Taking higher dose of insulin than is required.
2. Missing or delaying meals.
3. Exercising or working more than usual.
4. An infection or illness (especially with diarrhoea or vomiting).
A change in the body's need for insulin consumption of alcoholic beverages.
The symptoms of mild to moderate hypoglycemia may include sweating, dizziness, palpitation, tremors, hunger, restlessness, tingling in the hands, feet, lip or tongue, lightheadedness, inability to concentrate, headache, drowsiness, sleep disturbance, anxiety, blurred vision, slurred speech, depressive mood, abnormal behavior, unsteady movements, personality changes.
Signs and symptoms of severe hypoglycemia can include disorientation, seizures, unconsciousness, death.
Mild to moderate hypoglycemia may be treated by consuming food or drinks that contain sugar. Patients should always carry a quick source of sugar, such as sugar candies or glucose tablets. More severe hypoglycemia may require the assistance of another person and/or hospitalisation. If the patient has frequent episodes of hypoglycemia or experience difficulty in recognizing the symptoms, consult the doctor to discuss possible changes in therapy, meal plans and/or exercise program to help avoid hypoglycemia.
Hyperglycemia and Diabetic Acidosis: Hyperglycemia or high glucose levels in the blood may develop if the body has too little insulin.
Hyperglycemia can be brought about by: Omitting insulin or taking less than the doctor has prescribed.
Eating significantly more than the meal plan suggests.
Developing a fever or infection: In patients with type 1 diabetes, prolonged hyperglycemia can result in diabetic acidosis usually come on gradually, over a period of hours or days and include a drowsy feeling, flushed face, thirst, loss of appetite and breath smelling of fruity odor. Urine tests would show large amounts of glucose and acetone. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or diabetic acidosis can result in loss of consciousness or death. Therefore, it is important to obtain medical assistance immediately.
Lipodystrophy: Administration of insulin subcutaneously may result in lipotrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue). If the patient notices either of these conditions, consult the doctor. A change in the injection technique may help alleviate the problem.
Allergy to insulin: Local Allergy: Patients occasionally experience redness, swelling and itching at the site of injection of insulin. If the patient has local reactions contact the doctor.
Systemic Allergy: Less common, but potentially more serious is generalized allergy to insulin which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse or sweating. Severe case of generalized allergy may be life threatening. If the patient thinks of having a generalized allergic reaction to insulin, seek medical help immediately.
Caution For Usage
Identification of Insulin Preparations: The doctor has advised to take insulin injections regularly because the pancreas is unable to produce the required amount of insulin to meet the daily needs. Please follow the doctor's advice meticulously in every respect. Please check the carton and the vial for the name and type of insulin prescribed. In the event of any doubt, always seek clarification from the doctor.
The vial of BIOSULIN-30:70 insulin preparations should look uniformly milky after mixing. Do not use it if the white material remains at the bottom of the vial after mixing. If the patient notices anything unusual in the appearance of the vial of insulin or notices the insulin requirements changing frequently, consult the doctor immediately.
Injection technique: Correct Syringe: The dose of insulin is always expressed in international Units (IU). All the insulin preparations marketed by M. J. BIOPHARM PVT. LTD. are available in a strength of 100 IU/ml. Please study the markings made on the insulin syringe carefully and understand calculation of the dose in ML. Do make sure to use only a syringe calibrated to 100 IU per ML. The volume of insulin injected depends upon the dose required. Hence, do use a syringe marked for the use of insulin. If proper syringe is not used, it may lead to an error in the dosage. This may cause serious problems such as blood glucose may become too low or high.
Sterilisation of Insulin Syringe: Do not share syringe or needles with anyone else.
Reusable syringes and needles must be sterilised before each injection. Separate the syringe, plunger (piston) and the needle. Place them in water in a covered container. Bring the water to boiling and continue to boil at least for 5 minutes. Allow it to cool completely. Follow all the instructions mentioned on the package of the syringe.
Whenever disposable syringe and needles are used, use them only once and then discard.
Preparing the Dose and Injection: Wash hands with soap and water.
Insert the plunger into the syringe, fix the needle with a slight twist. Push the plunger in and out several times to remove all the water that might have remained inside. Now the syringe is ready for use. However, this step is not necessary while using a sterile disposable syringe and a needle.
Gently rotate the insulin vial several times to ensure that the contents are properly mixed. This is particularly important for BIOSULIN-30:70 type of insulins. The vials of BIOSULIN-30:70 should have a uniform milky appearance. Do not use the insulin if anything unusual is detected in the appearance of the vial.
When using a new vial, remove the plastic protective cap on the stopper. However, do not remove the stopper. Wipe the top of the vial with a spirit swab immediately before drawing insulin into the syringe and allow it to dry.
If the doctor has advised to mix different types of insulins, ensure to follow the same sequence for drawing insulin from the vials every time. The insulin mixture should be prepared just prior to the injection.
Pull the plunger down to the required mark and draw air into the syringe equivalent to the volume of insulin to be withdrawn for administration. Push the needle through the rubber stopper into the vial and inject the air into the vial. Please note that it will be difficult to draw insulin into the syringe unless an equal volume or at least half of the required volume of air is injected into the vial. Ensure that the tip of the needle is in insulin and then invert the vial along with the needle and the syringe and draw the required dose of insulin.
Pull the needle out of the insulin vial. If there are any air bubbles in the syringe, hold the syringe vertical with the needle on the top and gently tap the syringe. This will make the air bubbles move towards the needle. Then remove the air bubble by pushing the plunger slowly. Check that the correct dose of insulin has been drawn into the syringe.
Injection: Clean the site of injection thoroughly using a cotton swab soaked in spirit or alcohol. Pinch a fold of skin and hold it using the thumb and index finger. Hold the syringe and needle at angle of about 45° and without touching the cleaned area push the needle into the skin fold. Release the skin fold and gently withdraw the plunger. Make sure that blood does not appear into the syringe; this is rare, if this happens pull out the needle and inject it elsewhere. If no blood appears, then inject the insulin by pushing the plunger steadily. After the injection is complete, remove the needle swiftly and wipe the area lightly with cotton. Do not rub or massage the injection site. To minimise discomfort, change the injection site for every injection.
Storage
Insulin should be stored in a refrigerator but never in a freezer. Do not use insulin if it has frozen. If it is not possible to store it in a refrigerator, it should be kept as cool as possible below 30°C while in use. At this temperature, the preparations are likely to remain stable for about a month.
MIMS Class
Insulin Preparations
ATC Classification
A10AD01 - insulin (human) ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.
Presentation/Packing
Inj (cartridge) 100 IU/mL x 3 mL x 5's, (vial) 100 IU/mL x 10 mL.
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