Sansulin Log-G Dispopen

Sansulin Log-G Dispopen

insulin glargine

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Insulin Glargine.
Description
Each mL contains: Insulin Glargine 3.64 mg equivalent to 100 IU.
Action
Pharmacology: Insulin Glargine is a human Insulin analogue designed to have a low solubility at neutral pH. It is completely soluble at the acidic pH of the Insulin Glargine injection solution (pH 4). After the injection into the subcutaneous tissue, the acidic solution is neutralized leading to formation of microprecipitates from which small amounts of Insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action.
Insulin receptor binding: Insulin Glargine is very similar to human Insulin with respect to Insulin receptor binding kinetics. It can, therefore, be considered to mediate the same type of effect via the Insulin receptor as Insulin.
The primary activity of Insulin, including Insulin Glargine, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. In clinical pharmacology studies, intravenous Insulin Glargine and human Insulin have been shown to be equipotent when given at the same doses. As with all Insulins, the time course of action of Insulin Glargine may be effected by physical activity and other variables.
Indications/Uses
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Dosage/Direction for Use
SANSULIN Log-G contains Insulin Glargine an Insulin analogue with a prolonged duration of action. It should be administered once daily at any time but the same time each day.
The dosage and timing of dose of SANSULIN Log-G should be individually adjusted. In patients with type 2 diabetes mellitus, SANSULIN Log-G can also be given together with orally active antidiabetic medicinal products.
Change-over to SANSULIN Log-G: When changing from a treatment regimen with an intermediate or another long-acting Insulin to a regimen with SANSULIN Log-G, the amount and timing of the short acting Insulin or fast-acting Insulin analogue or of the doses of any oral antidiabetic drug may need to be adjusted.
To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal Insulin regimen from twice daily NPH Insulin to a once daily regimen with SANSULIN Log-G should reduce their daily dose of basal Insulin by 20-30% during the first week of treatment.
During the first week the reduction should, at least partially, be compensated by an increase in mealtime Insulin, after this period the regimen should be adjusted individually.
A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter. As with all Insulin analogues, this is particularly true the patients which, due to antibodies to human Insulin, need high Insulin doses and may experience a markedly improved Insulin response with Insulin Glargine.
With improved metabolic control and resulting increase in Insulin sensitivity a further adjustment in dosage regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, changes of timing of Insulin dose or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia.
Administration: SANSULIN Log-G is administered by subcutaneous tissue injection.
SANSULIN Log-G is not intended for intravenous administration. The prolonged duration of the action of Insulin Glargine is dependent on injection into the subcutaneous space. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
There are no clinically relevant differences in serum Insulin or glucose levels after abdominal, deltoid or thigh administration of SANSULIN Log-G.
Injection sites must be rotated within a given injection area from one injection to the next.
SANSULIN Log-G must not be mixed with any another Insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Inspect each cartridge before use. Only use it if the solution is clear, colourless, with no solid particles visible and if it of a water-like consistency.
Pen in use or carried as a spare may be kept up to four weeks when stored below 30°C. When in use (in the pen), do not store in a refrigerator and protected from heat and light. After inserting a new cartridge, check to see that the pen is working properly prior to injecting the first dose. See the pen instruction booklet for further details.
Due to limited experience the efficacy and safety of SANSULIN Log-G could not be assessed in the following group of patients: Patients with impaired liver function or patients with moderate/severe renal impairment.
Overdosage
Symptoms: An excess of Insulin, may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Management: Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in dosage of the medicinal product, meal patterns, or physical activity may be needed.
More severe episodes culminating in coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Contraindications
SANSULIN Log-G must not be used in patients hypersensitive to Insulin Glargine or any of the excipient.
Special Precautions
SANSULIN Log-G is not the Insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular Insulin administered intravenously is recommended in such cases. Safety and efficacy of SANSULIN Log-G has been established in adolescents and children aged 2 years and above.
In patients with renal impairment, Insulin requirements may be diminished due to reduced Insulin metabolism. In the elderly, progressive deterioration of renal function may lead to steady decrease in Insulin requirements.
In patients with severe hepatic impairment, Insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced Insulin metabolism.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Patients must be instructed in the skills necessary for the self-management of diabetes, such as blood sugar monitoring, proper injection technique, measures for recognizing and managing reduced or increased blood sugar levels (hypo- or hyperglycaemia) as described as follows.
In addition, the patient must learn how to handle special situations such as skipped, inadequate or increase Insulin doses, inadequate food intake or missed meals.
Moreover, patients and their relatives must learn how to recognize the signs and symptoms of hypo- or hyperglycaemia, what corrective actions needed to be taken and when they must speak with the doctor.
Hypoglycemia: The time of occurrence of hypoglycaemia depends on the action profile of the Insulins used and may, therefore, change when the treatment regimen is changed. Due to more sustained basal Insulin supply with SANSULIN Log-G, less nocturnal but more early morning hypoglycaemia can be expected.
Hypoglycaemia is more likely to occur at the start of Insulin treatment, following transfer to a different Insulin preparation, where metabolic control is unstable, or in severe kidney or liver diseases.
Symptoms that may indicate the onset of hypoglycaemia may be e.g., sweating, clammy skin, anxiety, fast heart beat, chest pain (angina pectoris). In many patients, these signs and symtoms often develop before those of a low sugar level in the brain. The latter include headache, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behavior, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensation (paraesthesiae), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after oneself, convulsions, and loss of consciousness.
The initial symptoms pointing to the onset of hypoglycaemia ('warning symptoms') may change be milder, or be entirely absent e.g., in the following circumstances: Markedly improved blood sugar control, slow-developing hypoglycemia, advance age, a certain type of nervous disease (autonomic neuropathy), long-standing diabetes, a psychiatric illness, or concurrent use of other medicines (see "Interactions"). In such circumstances severe hypoglycaemia (and even loss of consciousness) may develop without the patients noticing it. Affected patients should try to keep familiar at all times with their individual warning symptoms. More frequent blood sugar testing can help to identify mild hypoglycaemic episodes which otherwise might be overlooked. Patients not confident of recognizing their warning symptoms should avoid situations (e.g.driving a car) that might result in danger to themselves or others.
As with all Insulins, particular caution should be exercised, and intensified blood glucose monitoring is advisable, in patients in whom hypoglycaemia episodes might be of particular clinical relevance. For example these could be patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients: In whom glycaemic control is markedly improved, In whom hypoglycaemia develops gradually, Who are elderly, After transfer from animal Insulin to human Insulin, In whom an autonomic neuropathy is present, With a long history of diabetes, Suffering from a psychiatric illness, Receiving concurrent treatment with certain other medical products.
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
The prolonged effect of subcutaneous Insulin Glargine may delay recovery from hypoglycaemia. If normal or decreased value for glycated haemoglobin are noted, the possibility of recurrent, unrecognized (especially nocturnal) episodes of hypoglycaemia must be considered.
Adherence of the patient to the dosage and dietary regimen, correct Insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These include: Change in the injection area; Improved Insulin sensitivity (by e.g. removal of stress factors); Unaccustomed, increased or prolonged physical activity; Intercurrent illness (e.g. vomiting, diarrhea); Inadequate food intake; Missed meals; Alcohol consumption; Certain uncompensated endocrine disorders (e.g. in hypothyroidism and anterior pituitary or adrenocortical insufficiency); Concomitant treatment with certain other medical products.
A hypoglycaemic attack can be corrected by immediately taking sugar e.g., in the form of glucose, Sugar cubes or sugar-sweetened beverages. In this regard, please note that food or beverages containing artificial sweeteners (e.g. diet foods and drinks) are not suitable. Subsequently, some food having a long acting blood-sugar-raising effect (e.g.bread) should be taken. The long action of SANSULIN Log-G may delay recovery from hypoglycaemia. If hypoglycaemia recurs, another 10 to 20 g of sugar should be taken. If a hypoglycaemia attack cannot be corrected or if it recurs, speak to the doctor immediately.
Carry at least 20 g of sugar at all times, together with some information identifying the patient as a diabetic. Inability to swallow or unconsciousness will make necessary injections of glucose solution or glucagons (a medicine increasing blood sugar), even where the presence of hypoglycaemia is uncertain.
Following intake of glucose, hypoglycaemia should be conformed by means of blood sugar testing.
Please inform the doctor in the event of intercurrent illness, since this situation necessitates intensified metabolic monitoring and, possibly, further special measures (e.g. dose adjustment, urine tests for ketones).
Hyperglycemia: Hyperglycemia may occur under certain circumstances. These include: Omission or reduction of injections or decrease in insulin effectiveness (e.g. due to incorrect storage); Pen malfunction; Decreased physical activity, stress situations (emotional distress, excitement), injuries, operations, feverish illnesses or certain other diseases; Concurrent use of other medicines (see "Interactions").
Thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat and high concentrations of sugar and ketones bodies in the urine may be signs of hyperglycaemia. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious metabolic condition (ketoacidosis) resulting from lack of the Insulin. Blood sugar testing or tests for ketones in urine must be carried out as soon as any such symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
Intercurrent illness: Intercurrent illness require intensified metabolic monitoring. In many cases urine tests for ketones are indicated, and often it is necessary to adjust the Insulin dose. The Insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat any little or no food, or are vomiting etc. and they must never omit Insulin entirely.
Use in Pregnancy and Lactation: For Insulin Glargine no clinical data on exposed preg­nancies are available. Animal studies do not indicate reproductive toxicity. The use of SANSULIN Log-G may be considered during pregnancy if necessary.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control through­out pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after deli­very, Insulin requirements decline rapidly (increase risk of hypoglycaemia), careful monitoring of glucose control is essential. It is unknown whether Insulin Glargine is excre­ted in human milk. No metabolic effect of ingested Insu­lin Glargine on the breast-fed newborn Infant are anti­cipated since Insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract. Breast-feeding women may require adjustment in insulin dose and diet.
Effects on ability to drive and use machines: The patients' ability to concentrate and react may be impaired as a result of, for example hypoglycaemia or hyperglycaemia or as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or operate machinery in these circumstances.
Use In Pregnancy & Lactation
For Insulin Glargine no clinical data on exposed preg­nancies are available. Animal studies do not indicate reproductive toxicity. The use of SANSULIN Log-G may be considered during pregnancy if necessary.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control through­out pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after deli­very, Insulin requirements decline rapidly (increase risk of hypoglycaemia), careful monitoring of glucose control is essential. It is unknown whether Insulin Glargine is excre­ted in human milk. No metabolic effect of ingested Insu­lin Glargine on the breast-fed newborn Infant are anti­cipated since Insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract. Breast-feeding women may require adjustment in insulin dose and diet.
Adverse Reactions
Hypoglycaemia: Hypoglycaemia, in general the most frequent undesirable effect of Insulin therapy, may occur if the Insulin dose is too high in relation to the Insulin requirement. Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episode may be life-threatening.
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Eyes: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Long-term improved glycaemic control decrease the risk of progression of diabetic retinopathy. However, intensification of Insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Lipodystrophy: As with any Insulin therapy, lipodystrophy may occur at the injection site and delay local Insulin absorption. In clinical studies, in regimens which included SANSULIN Log-G, lipohypertrophy was observed in 1 to 2% of patients, whereas lipoatrophy was uncommon. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Injection site and allergic reactions: In clinical studies, in regimens which included SANSULIN Log-G, reactions at the injection site were observed in 3 to 4% of patients. Such reactions include redness, pain, itching, hives, swelling, or inflammation. Most minor reactions to Insulins at the injection site usually resolve in a few days to a few weeks.
Immediate-type allergic reactions to Insulin are rare. Such reactions to Insulin (include Insulin Glargine) or the excipients may, for example, be associated with generalized skin reactions, angio-oedema, bronchospasm, hypotension and shock, and may be life-threatening.
Other reactions: Insulin administration may cause Insulin antibodies to form. In clinical studies, antibodies that cross-react with human Insulin and Insulin Glargine were observed with the same frequency in the both NPH-Insulin and Insulin Glargine treatment groups. In rare cases, the presence of such Insulin antibodies may necessitate adjustment of the Insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Rarely, Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified Insulin therapy.
Medication errors have been reported in which other Insulins, particularly short-acting Insulins, have been accidentally administered instead of Insulin Glargine.
Drug Interactions
A number of substances affect glucose metabolism and may require dose adjustment of Insulin Glargine.
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycemia include oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Substances thay may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic agents (e.g., epinephrine (adrenaline), salbutamol, terbutaline), and thyroid hormones. Beta-blockers, clonidine, lithium salts or 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 addition, under the influence of sympathomimetic medicinal products such as beta-blockers, clonidine, guanethidine and reserpin, the signs of adrenergic counter-regulation may be reduced or absent.
Caution For Usage
Instructions for Use: Read this manual completely and follow the directions carefully before using your SANSULIN Log­-G Dispopen, even if you have used a similar injection pen device before.
IMPORTANT INFORMATION: Always attach a new needle before each use.
Do not select a dose and/or press the injection button without a needle attached.
Always perform the functional test before each injec­tion (see step 2).
This pen is only for your use. Do not share it with anyone else.
Never use SANSULIN Log-G Dispopen if it is dam­aged or if you are not sure that it is working properly.
STEP 1: ATTACH PEN NEEDLE: 1.1 Pull off the pen cap.
1.2 Pull off the protective foil on the pen needle.
1.3 Put on the pen needle onto the SANSULIN Log-G Dispopen, keeping it straight. (screw or push on, de­pending on the needle type).
1.4 Pull off the outer pen needle cap and keep for use after the injection.
1.5 Pull off the inner pen needle cap and dispose of it.
STEP 2: PRIMING/FUNCTIONAL TEST: Important: Prior to the first injection, the SANSULIN Log-G Dispopen must be primed in order to remove air bubbles from the cartridge for accurate dosing and/or to ensure that the needle is not clogged.
2.1 Select a dose of 2 units by turning the dose knob clockwise (2 clicks).
If necessary the selected dose can be corrected by turning the dose knob counter-clockwise.
2.2 Hold the pen in an upright position (pen needle pointing up). Tap slightly with your finger on the cartridge holder to allow potential air bubbles within the car­tridge to rise up.
Note: Air bubbles are not al­ways present. Never­theless this step should be performed to check drug flow through the pen needle prior to each injection.
2.3 Press the push button all the way until a hard stop is felt to discharge the dose. Number '0' is visible in the display window and aligns with the dose indicator.
2.4 Check whether a droplet of liquid shows at the tip of the pen needle. If no drops appear repeat step 2.1 - 2.4 (Priming/functional Test) until a drop appears.
Important: In case no drops emerge after 5 attempts, replace the pen needle (see step 6) and repeat the functional test (see step 2.1 - 2.4).
STEP 3: SETTING THE DOSE: 3.1 Turn the dose knob clockwise until the prescribed dose aligns with the dose indicator in the display window. If necessary the dose can be corrected by turning the dose knob counter-clockwise.
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 your dose is larger than the remaining drug volume in the cartridge a new pen should be used for the remaining dose.
STEP 4: INJECTION: Read steps 4.1 and 5.1 first before proceeding with the injection.
4.1 Hold the pen so that the display window is visible during the injection. Insert the pen needle into the skin and press the push button all the way in until a hard stop is felt and the number '0' is visible in the display window and aligns with the dose indicator.
Note: Use the injection technique recommended by your doctor or healthcare professional.
STEP 5: HOLDING AFTER INJECTION: 5.1 When the complete dose has been delivered, keep the push button pressed for another 10 seconds. Then slowly remove the pen from the injection site at a 90° angle.
Important: Do not tilt the pen during injection and removal from skin to avoid pen needle damage.
Note: Holding ensures a complete discharge of the drug dose.
STEP 6: DISPOSAL OF PEN NEEDLE: 6.1 Replace the outer pen needle cap carefully.
6.2 Unscrew the pen needle counter-clockwise and dispose of the pen needle safely.
STEP 7: PEN CAP MOUNTING: 7.1 Firmly attach the pen cap to the pen for protection between injections.
MAINTENANCE: Protect your SANSULIN Log-G Dispopen from dust and dirt.
You can clean the outside of your SANSULIN Log-G Dispopen by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
Your SANSULIN Log-G Dispopen is designed to work accurately and safely. It should be handled with care.
Avoid situation where SANSULIN Log-G Dispopen might be damaged. If you are concerned that your SANSULIN Log-G Dispopen may be damaged, use a new one.
Storage
Store between 2° and 8°C. Do not freeze. Away from light.
Ensure that the container is not directly touching the freezer compartment of freezer packs.
Once in use, do not store above 30°C. The pen containing a cartridge must not be stored in the refrigerator.
Patient Counseling Information
Patient information: Accidental mix-ups between Insulin Glargine and other Insulins, particularly short-acting Insulins, have been reported. To avoid medication errors between Insulin Glargine and other Insulin, patients should be instructed to always check the Insulin label before each injection.
ATC Classification
A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Dispopen 100 IU/mL x 3 mL x 5's.
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