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8-9850-26-002-7_v1-9:Layout 1 2008-07-19 8:01 AM Page 1 diet. Dosage adjustment may be necessary when transferring patients from one insulin preparation to another. RA Labelling & Graphics Insert: 550x210-003 Current 2.0 HI-CP/Standard file 3 ml NovoLet - Facelift Clear Colour: PMS 280C For the use only of registered medical practitioner or a hospital or a laboratory 100 IU/ml 3ml, Neutral solution for injection for s.c., i.v. use Soluble insulin injection I.P. Actrapid NovoLet Monocomponent human insulin biosynthetic (r-DNA Origin) Qualitative and quantitative composition Human insulin, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae). 1 ml contains 100 IU of human insulin. 1 pre-filled pen contains 3 ml equivalent to 300 IU. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin. Pharmaceutical form Solution for injection in a pre-filled pen. Actrapid NovoLet is a clear, colourless, aqueous solution. Clinical particulars Therapeutic indications Treatment of diabetes mellitus. Posology and method of administration Actrapid is a fast-acting insulin and may be used in combination with long-acting insulin products. Dosage Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0.3 and 1.0 IU/kg/day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production. In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications. Close blood glucose monitoring is therefore recommended. An injection should be followed within 30 minutes by a meal or snack containing carbohydrates. Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient s insulin requirement. Renal or hepatic impairment may reduce insulin requirement. Adjustment of dosage may also be necessary if patients change physical activity or their usual Contraindications Hypersensitivity to the active substance or to any of the excipients. Hypoglycaemia. The following substances may reduce insulin requirement: Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective betablocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides. The following substances may increase insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol. Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia. Octreotide/lanreotide may both decrease and increase insulin requirement. Alcohol may intensify and prolong the Pregnancy and lactation There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero. Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy values. Insulin treatment of the nursing mother presents no risk to the baby. However, the Actrapid dosage, diet or both may need to be adjusted. Effects on ability to drive and use machines The patient s ability to concentrate and react may be impaired as a result of hypoglycaemia. 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 signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances. Undesirable effects As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect. It may occur if the insulin dose is too high in relation to the insulin requirement. In clinical trials and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. Frequencies of adverse drug reactions from clinical trials that are considered related to Actrapid are listed below. The frequencies are defined as: uncommon ( 1/1,000 to <1/100). Isolated spontaneous cases are presented as very rare defined as <1/10,000, including isolated reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/loss of consciousness. Generalised hypersensitivity reactions are potentially life threatening. Nervous system disorders Uncommon - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy , which is usually reversible. Eye disorders Uncommon - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy. These symptoms are usually of transitory nature. Very rare - Diabetic retinopathy Long-term improved glycaemic control decreases 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. Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area. General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin. Most reactions are transitory and disappear during continued treatment. Uncommon - Oedema Oedema may occur upon initiation of insulin therapy. These symptoms are usually of transitory nature. Overdose A specific overdose of insulin cannot be defined. However, hypoglycaemia may develop over sequential stages: Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or glucose given intravenously by a medical professional. Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse. Pharmacological properties Pharmacodynamic properties Pharmacotherapeutic group: Insulins and analogues for injection, fast-acting, insulin (human). ATC code: A10A B01. The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/l) in 204 diabetic and 1344 nondiabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 - 6.1 mmol/l) induced by intravenous Actrapid reduced mortality by 42% (8% versus 4.6%). Actrapid is a fast-acting insulin. Onset of action is within hour, reaches a maximum effect within 1.5 - 3.5 hours and the entire duration of action is approximately 7 - 8 hours. Pharmacokinetic properties Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes). The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation. Absorption The maximum plasma concentration is reached within 1.5 - 2.5 hours after subcutaneous administration. Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed. Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase. A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active. Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue. The terminal half-life (t ) is therefore a measure of the absorption rather than of the elimination per se of insulin from plasma (insulin in the blood stream has a t of a few minutes). Trials have indicated a t of about 2 - 5 hours. The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6 - 12 years) and adolescents (aged 13 - 17 years). The data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults. However, there were differences between age groups in Cmax, stressing the importance of individual dose titration. Preclinical safety data Non-clinical data with Actrapid reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. Pharmaceutical particulars List of excipients Zinc chloride Glycerol Metacresol Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections must not be used. Insulin solutions should not be used if they do not appear water clear and colourless. Actrapid should not be used in insulin pumps for continuous subcutaneous insulin infusion. Any unused product or waste material should be disposed of in accordance with local requirements. Incompatibilities In general terms, insulin products should only be added to compounds with which it is known to be compatible. Medicinal products added to the insulin solution may cause degradation of the insulin, e.g. if the medicinal products contain thiols or sulphites. Special precautions for storage Actrapid NovoLet can be used or carried as a spare (below 30 C) for 6 weeks. Store in a refrigerator (2 C - 8 C) not in or too near the freezer section or cooling element. Do not freeze. During use: do not refrigerate. Do not store above 30 C. Keep the pen cap on in order to protect the insulin from light. Protect from excessive heat and sunlight. Nature and contents of container Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml). The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a bromobutyl/polyisoprene rubber stopper. The pen injector is made of plastic. Pack sizes: 5 and 10 pre-filled pens 3 ml. Not all pack sizes may be marketed. Instructions for use and handling For intravenous use, infusion systems with Actrapid at concentrations from 0.05 IU/ml to 1.0 IU/ml insulin human in the infusion fluids 0.9% sodium chloride, 5% dextrose and 10% dextrose inclusive 40 mmol/l potassium chloride using polypropylene infusion bags are stable at room temperature for 24 hours. Although stable over time, a certain amount of insulin will initially be absorbed to the material of the infusion bag. Monitoring of blood glucose is necessary during the infusion. Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively. Actrapid NovoLet is for single person use only. The container must not be refilled. Insulin preparations which have been frozen Actrapid , NovoLet , NovoFine and are trademarks owned by Novo Nordisk A/S and registered in Denmark. 2004/2008 Novo Nordisk A/S Imported by: Novo Nordisk India Private Limited P.O. Box 5243 Bangalore 560 001, India. www.novonordisk.co.in Manufactured by : Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd, Denmark. 8 Special warnings and precautions for use Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia. Usually, the first symptoms of hyperglycaemia set in gradually, over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth and loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Patients whose blood glucose control is greatly improved e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and Interaction with other medicinal products and other forms of interaction A number of medicinal products are known to interact with glucose metabolism. The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take. hypoglycaemic effect of insulin. 2 8-9850-26-002-7 Administration For subcutaneous use. Actrapid is usually administered subcutaneously in the abdominal wall. The thigh, the gluteal region or the deltoid region may also be used. Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites. Injection into a lifted skin fold minimises the risk of unintended intramuscular injection. Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. Intramuscular administrations are possible under guidance by a physician. The intravenous use of Actrapid from any pen or cartridge should be an exception only in situations where vials are not available. In this case Actrapid should be drawn into an insulin syringe, provided air is avoided, or infused with an infusion system. This procedure should only be carried out by health care professionals. Actrapid is accompanied by a package leaflet with detailed instruction for use to be followed. Actrapid NovoLet is designed to be used with NovoFine needles. NovoLet delivers 2-78 units in increments of 2 units. The NovoLet should be primed before injection so that the dose selector returns to zero and a drop of insulin appears at the needle tip. The dose is set by turning the selector, which returns to zero during the injection. should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes. Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage. If an adjustment is needed when switching the patients to Actrapid , it may occur with the first dose or during the first several weeks or months. As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation. Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of Actrapid . A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin. Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times. Due to the risk of precipitation in pump catheters, Actrapid should not be used in insulin pumps for continuous subcutaneous insulin infusion. Actrapid contains metacresol, which may cause allergic reactions. 1 78 29 50 Code start Code: 100% Direction Length: Max. 29 mm (100%) 50 29 Code start 2008-07-19 8:01 AM 29Page(100%) Direction Length: Max. mm 2 2 8 1 78 8-9850-26-002-7_v1-9:Layout 1 Code: 100% Instructions to be given to the patient on how to use Actrapid NovoLet Actrapid NovoLet is a simple, compact pre-filled pen. Doses from 2 to 78 units in increments of 2 units can be dialled. Actrapid NovoLet is designed to be used with NovoFine needles. Actrapid NovoLet is for single person use only. Do not use if it has not been stored correctly. As a precautionary measure, the patient should always carry a spare insulin device in case the NovoLet is lost or damaged. NovoLet NovoFine needle Big outer needle cap Protective tab Pen cap Inner needle cap Cap scale Needle Rubber membrane Insulin level indicator Insulin cartridge Dosage indicator Colour coding Push-button scale Push-button Getting started Check the label to make sure that Actrapid NovoLet contains the correct type of insulin. Take off the pen cap. Disinfect the rubber membrane with a medicinal swab Always use a new needle for injection to prevent contamination Remove the protective tab from a NovoFine needle Screw the needle straight and tightly onto Actrapid NovoLet (picture A) Pull off the big outer needle cap and the inner needle cap. Do not discard the big outer needle cap. Priming to expel air Small amounts of air may collect in the needle and cartridge during normal use. To avoid injection of air and ensure proper dosing: Hold Actrapid NovoLet with the needle pointing upwards Tap the cartridge gently with a finger a few times. Any air bubbles will collect at the top of the cartridge Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture B) Still with the needle upwards, press the push-button fully down (picture C) A drop of insulin must appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times. If a drop of insulin still does not appear, the device is defective and must not be used. A B C Setting the dose Put the cap back on the pen, with 0 next to the dosage indicator (picture D) Check that the push-button is fully down. If it is not, turn the cap until the push-button is fully depressed Hold Actrapid NovoLet horizontally. Now the dose needed can be set Turn the cap in the direction of the arrow (picture E) to set the right dose. The cap will click and the push-button will rise up Do not put the hand over the push-button when setting the dose. If the push-button cannot rise freely, some of the insulin will be pushed out of the needle The scale on the cap shows 0, 2, 4, 6, 8, 10, 12, 14, 16 and 18 units. For every click the cap is turned, an addition of 2 units is set. The push-button also rises as the cap is turned The scale under the push-button shows 20, 40 and 60 units. Every time the cap is fully turned, 20 units are set. Dosage examples To set 8 units: Turn the cap until 8 is opposite the dosage indicator; four clicks To select 26 units: Turn the cap round 1 full turn, so 0 is opposite the dosage indicator again. 20 units have now been set. Keep turning the cap until 6 is opposite the dosage indicator. On the push-button scale a 20-line will be seen. Add the 6 from the dosage indicator to the 20 on the push-button scale. Now 26 units have been set (picture F). To check the dosage set Note the figure on the cap next to the dosage indicator Note the highest figure on the push-button scale Add the two together to show the dosage set If a wrong dose has been set, simply turn the cap forwards or backwards until the right number of units is set. The maximum dose is 78 units Do not try to set a dose higher than 78 units. Otherwise, insulin will leak out of the needle and the dose will be incorrect If, by mistake, a dose above 78 units has been set, follow these steps: Turn the cap back as far as it can. Turn it till the push-button is fully down and resistance can be felt. Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator. Now set the dose again. Remember that 78 units is the maximum dose After the dose is set, remove the cap to inject the insulin. Go straight on to section Injecting the insulin. D E Injecting the insulin Insert the needle into the skin Deliver the dose by pressing the push-button fully down. Be careful only to push the push-button when injecting Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin. The needle must remain under the skin for at least 6 seconds. This will ensure that the full dose has been delivered. Subsequent injections Always check that the push-button is completely down. If not, turn the cap until the push-button is fully depressed, then proceed as described in Getting started A clicking sound will be heard when the push-button is pressed. Do not use this to set or check the dose; it may not be accurate A dose higher than the number of units left in the cartridge cannot be set The insulin level indicator can be used to estimate how much is left. But it cannot be used to set or select the dose. Removing the needle Replace the big outer needle cap and unscrew the needle. Dispose of it carefully. F Use a new needle for each injection. After each injection be sure to remove and discard the needle and store Actrapid NovoLet without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing. Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration. Close Actrapid NovoLet fully with 0 next to the dosage indicator. Dispose of the used Actrapid NovoLet carefully without the needle attached. Maintenance Actrapid NovoLet is designed to work accurately and safely. It must be handled with care. If it is dropped, damaged or crushed, there is a risk of leakage of insulin. Do not refill Actrapid NovoLet . Clean the exterior of Actrapid NovoLet by wiping it with a medicinal swab. Do not soak it, wash or lubricate it. This may damage the mechanism. Novo Nordisk A/S Electronic Signature Page 29 Jul 2008 11:30:11 Commodity no.: 8-9850-26-002-7 Version: 1.9 Documentum ObjectID : 0911b6048020f0b7 This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. Document signed by: Initials Full Name Capacity Reason krin Krishnananda A Nayak Affiliate 1st Proof reader sron 2nd Proof reader ekpe Erik Kofoed Petersen Graphics 1st Approver tnyj Tove Nygaard Jensen Quality Assurance 1st Approver Time Zone (Signer) Srinivasa Rao N Affiliate Date and Time of Signature (Server Time) 2008-07-26 08:55:25 GMT+5:30 2008-07-28 11:08:18 GMT+5:30 2008-07-28 14:07:54 GMT+1 2008-07-29 11:25:39 GMT+1

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