Download The Gansulin 30R Recombinant Human Insulin Injection

The Gansulin 30R Recombinant
Human Insulin Injection
Name:
Generic Name: 30/70 mixture Recombinant Human Insulin Injection
Commercial Name: Gansulin 30R
Ingredients:
Active ingredients: recombinant human insulin
Inactive ingredients: glycerin, phenol, protamin, disodium hydrogen
phosphate
For Treatment of: Diabetes Mellitus Type 1 and 2
Structure
MF: C257H338N65O77S6
Molecular Weight: 5807.69
Properties
The product is a Vial/Cartridge of white or white-like aseptic suspension.
The pH ranges from 7.0 to 7.8.
Specifications
Vial: 10 ml: 400 units
Cartridge: 3ml: 300 units
Storage
Store at a temperature between 2-8°C. It is better to keep the drug in the
refrigerator, however do not store it in or close to the freezer. If there is no
refrigerator available, try to keep it in a cool place from heat and light.
Insulin can be stored at room temperature for a month.
Packaging
One vial or cartridge per box
Vial Packing materials: Tube for antibiotic use, Butyl Rubber Stopper
Cartridge Packing materials: Tube vial for antibiotic use, Butyl Rubber
Stopper, Compound Aluminium Cap
Expiry Date
30 days after opening
Pharmacology and Toxicology:
This product is human insulin made through the use of recombinant DNA
technology, having the same structure and function as natural insulin. The
product can regulate the glucose metabolism and stimulate the ingestion
and utilization of glucose by liver, bone, and fat tissue. It can accelerate
transformation from glucose to glycogen stored in muscle and the liver and
inhibit gluconeogenesis, thus lowering blood glucose levels.
Pharmacokinetics:
The starting time and duration of the effect can vary considerably after
subcutaneous injection of insulin due to the individual differences. On
average, Gansulin 30R takes effect within 30 minutes after injection,
reaches its peak within 2-8 hours and lasts about 24 hours.
Use
This Insulin should be injected subcutaneously approximately 15 minutes
before breakfast and dinner. As individual cases vary, for an exact time for
administration please consult your physician. Preparation before use:
Clean your hands thoroughly
Shake or rotate the vial gently to mix the suspension and check if the
insulin has a uniform appearance.
Flip off the plastic protective cap but do not remove the rubber
stopper, then wipe the rubber stopper with a 75% alcohol solution.
Draw air into your syringe equal to the amount of Insulin needed.
Puncture the needle into the vial and inject the air, and then turn the
bottle and syringe upside down.
Hold them in one hand and shake gently. Make sure that the tip of
the needle is still in the insulin.
Withdraw correct dose of insulin into the syringe.
Before pulling out the needle, check if there are any air bubbles
remaining in the syringe. If so, put the syringe upright and tap the
syringe to discharge the air bubbles.
Lastly, pull out the needle with your dosage. Do not let the needle
touch anything to avoid contamination.
Injection Site and Method
Choose the area where skin is less tight, such as the upper arm, thigh,
buttock and abdomen, etc. The site for injection should be rotated, that is,
one site should not be injected twice in two consecutive weeks. The site
should be at least 1 cm from the previous one.
After you have chosen the injection site, you should sterilize the skin with
the use of alcohol and swab or pad. After 1-2 minutes, stabilize the skin by
pinching it by hand. Put the needle in such a position as to form a 45 Degree
angle with the skin. Puncture the needle as instructed by doctors and then
inject the insulin. Then pull the needle out and apply gentle pressure over
the injected site for several seconds with alcohol and swab or pad. Do not
rub the injection site as this can damage the subcutaneous tissue below and
cause the insulin to effuse.
Dosage
The dosage form, the dosage and the administration time of the insulin differ
with respect to each patient’s individual requirements. In addition, the
dosage is also affected by food, work and lifestyle, and exercising intensity.
Therefore, patients should follow their Doctor’s instructions when using
insulin. Consult your doctor for necessary adjustment in your insulin use in
case of illness such as nausea or vomit, significant increase in exercising
intensity, or before travel.
Adverse effects:
Lipodystrophy (Loss of Fat around Injection site)
In some cases subcutaneous injection of insulin can cause lipid atrophy or
hyperplasia. If so happens, the doctor should be informed. The situation
may be improved by changing your injection method.
Allergies
Though very few are affected by allergies, cases of allergic reactions; such
as local red and swollen, itching, or lipid atrophy and hyperplasia have been
reported. These symptoms are seen in localized Allergies, which usually
disappear in a few days or weeks. In some instances, the allergy may be
caused by other factors than the insulin, such as skin disinfectant and poor
injection techniques. If a localized allergy occurs, please contact the doctor
immediately.
Systemic allergic reactions, whereby the whole body is allergic to the insulin,
are extremely rare but highly severe, and can cause shortness of breath,
asthma, blood pressure drops, pulse acceleration, excessive perspiration,
and in the worst cases death. If systemic allergy happens, please contact
your doctor immediately.
This drug is strictly prohibited for patients who have an allergic reaction
when using insulin.
Recommendations:
Diabetes patients should regularly test their blood glucose or urine
glucose levels. If the results of these tests consistently show blood and
urine glucose levels above or below normal, your diabetes is not under
proper control and you should contact your physician. Always keep an
extra supply of insulin as well as a spare injection system on hand, and
wear Diabetes identification when away from home to ensure treatment
can be given if complications occur.
Any change of insulin application should be made cautiously and only
under instructions of the doctors. Before each use of a new brand you
should carefully examine whether the purity, valence, registered
trademark, type, species (cattle, pig or human), method of manufacture
(recombinant human insulin, insulin extracted from animals) are
recommended by your doctor. Any of the above changes will require an
adjustment of dosage.
Patients, who were on treatment with animal insulin, should adjust
dosage under doctor’s instruction when changing to human insulin.
Before using, check whether the cap of each vial, or head of each
cartridge, is well-sealed, and examine the brand name, letter
designation on the label so as to assure that the drug is in accordance
with the doctor’s prescription. In any case where the insulin is not well
sealed, please return it to the pharmacy
Before withdrawing the drug, check the appearance of the solution in the
bottle first. This product should be a white or white-like suspension. If
there is any sediment or floating material remaining after shaking, do
not use it. In the case of anything unusual happening, or the need to
change your dosage, contact your doctors immediately for advice.
Insulin should be stored in the refrigerator between 2-8゜C, do not
freeze it or place it near the freezer.
Never use insulin that has passed its expiration date
Disposable syringes and pins should not be reused. Needles and
syringes should not be shared. Reusable syringes must be sterilized
before use by boiling or with a 91% isopropanol soluction.
Pregnancy and nursing:
It is more difficult to treatment diabetes during pregnancy. Female patients,
who plan to become pregnant, are pregnant or nursing babies should follow
doctor’s instructions.
Children:
Special attention should be paid to children’s exercise intensity and diet in
order to control blood glucose level when using insulin. Injection should be
done by parents or doctors according to prescribed dosage.
Elderly patients:
With the change of structures and functions of tissues and organs, the
decline of physiological and biochemical strength, and the decline of
regulatory function and adaptability, older patients should pay strict
attention to the use of insulin.
Changes in the adrenal gland, pituitary and hypothyroid or deterioration
caused by liver or kidney disease easily leads to hypoglycemia.
The skipping or delaying of meals will result in hypoglycemia.
Designated family members or friends should take care of the dosage
and injection if necessary.
Use with other drugs:
When using drugs that can result in the rise of blood glucose for example
oral contraceptive drugs, adrenal cortical hormones and hypothyroid
hormones, you might need to increase the amount of Insulin per dose.
When using drugs with hypoglycemic activities, salicylate, sulfanilamide and
other anti-depressants, which will result in the decrease of blood glucose,
the dosage of insulin should be reduced.
Pay attention to your diet and avoid alcoholic drinks.
When using other drugs at the same time as insulin, please consult your
doctor’s.
Excessive dosages of insulin:
Excessive dosage of insulin may lead to hypoglycemia during the treatment.
Slight to moderate hypoglycemosis may suddenly occur with the
following symptoms:
Sweating, Drowsiness, Dizziness, Insomnia, Palpitations, Anxiety, Tremors,
Blurred vision, Hunger, Slurred speech, Restlessness, Depressed moods,
Tingling in the hands, feet, tongue and lips, Irritability, Lightheadedness,
Abnormal behavior, Inability to concentrate, Unsteady movement,
Headache, Personality changes.
The symptoms of severe hypoglycemosis can include the following:
Disorientation, Seizures, Unconsciousness, Death.
It is important to get immediate treatment when hypoglycemia occurs. Early
warning symptoms of hypoglycemia may be difficult to observe under
certain conditions, in those who have had lifelong diabetes, diabetic nerve
disease, administration of β -receptor inhibitors, change in insulin
preparations or intensified control (3 or more insulin injections per day) of
diabetes. A few patients who have experienced hypoglycemic reactions after
change from animal insulin to human insulin have reported the early
warning symptoms of hypoglycemia were less pronounced or different from
those experienced with their previous insulin. Without recognition of early
warning symptoms, it may be then difficult to avoid more serious
hypoglycemia. Therefore it is necessary to monitor blood glucose frequently
in order to avoid the occurrence of hypoglycemia. Slight to moderate
hypoglycemia can be adjusted through eating and drinking beverages with
sugar. Patients should always carry candy or other glucose tablets. Patients
with serious hypoglycemia need other’s assistance. Patients who lose their
consciousness and cannot take sugar by themselves require an injection of
glucagon or should be treated with intravenous administration of glucose at
a medical facility. Patients must learn to recognize their own symptoms of
hypoglycemia. If you are not sure about these symptoms, you should
monitor your blood glucose frequently to help you learn to recognize the
symptoms that you experience with hypoglycemia. If you have frequent
hypoglycemia or experience difficulty in recognizing the symptoms, you
should consult your doctor to discuss possible changes in therapy, diet plans,
and/or exercise programs to help you avoid hypoglycemia.
Approval Number
State Drug Approval No. S20020031
Manufacturer
Company Name: Tonghua Dongbao Pharmaceutical Co., Ltd.
Address: No 1, Dongbao Street, Dongbao Xincun, Tonghua County, Jilin Province
Zip: 134123
Tel: 0435-3198588
Fax: 0435-3198581
Toll Free Call: 800 846 5777