New Zealand Datasheet 1 Product Name Penmix Mixtard Protaphane-Free PDF

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usually given once or twice daily when a rapid initial effect together with a more prolonged. effect is desired, PROTAPHANE is a long acting insulin The physician determines whether one or several. daily injections of PROTAPHANE are necessary PROTAPHANE may be used alone or. mixed with a fast acting insulin In intensive insulin therapy PROTAPHANE may be used as. basal insulin evening and or morning injection with fast acting insulin given at meals. Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0 5 and 1 0 IU kg day The daily insulin. requirement may be higher in patients with insulin resistance e g during puberty in the. young or due to obesity and lower in patients with residual endogenous insulin production. An injection of PENMIX or MIXTARD should be followed by a meal or snack containing. carbohydrates within 30 minutes, In patients with diabetes mellitus optimised glycaemic control delays the onset of late. diabetic complications Close blood glucose monitoring is recommended. Concomitant illness especially infections and feverish conditions usually increases the. patient s insulin requirement Concomitant diseases in the kidney liver or affecting the. adrenal pituitary or thyroid gland can require changes in the insulin dose. Adjustment of the dosage may also be necessary if patients change physical activity or their. usual diet Dosage adjustment may be necessary when transferring patients from one. insulin preparation to another see section 4 4, Insulin suspensions are never to be administered intravenously. PENMIX or MIXTARD are administered subcutaneously in the thigh or abdominal wall If. convenient the gluteal region or deltoid region may be used A subcutaneous injection into. the abdominal wall results in a faster absorption than from other injection sites. PROTAPHANE is administered subcutaneously in the thigh If convenient the abdominal. wall the gluteal region or the deltoid region may also be used Subcutaneous injection into. the thigh results in a slower and less variable absorption compared to the other injection. Injection into a lifted skin fold minimises the risk of intramuscular injection Keep the needle. under the skin for at least 6 seconds to make sure the entire dose is injected. Injection sites should always be rotated within the same region in order to reduce the risk of. lipodystrophy,4 3 Contraindications,Hypoglycaemia, Hypersensitivity to human insulin or any of the excipients. 4 4 Special warnings and precautions for use,Hyperglycaemia.
Inadequate dosing or discontinuation of treatment especially in type 1 diabetes may lead to. hyperglycaemia Usually the first symptoms of hyperglycaemia usually 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 loss of appetite as well as acetone. breath In type 1 diabetes untreated hyperglycaemic events eventually leads to diabetic. ketoacidosis witch is potentially lethal,Hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. see sections 4 8 and 4 9, 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. my experience a change in their usual warning symptoms of hypoglycaemia and should be. advised accordingly Usual warning symptoms may disappear in patients with longstanding. Transfer from other insulin products, Transferring a patient to another type or brand of insulin should be done under strict medical. supervision Changes in strength brand manufacturer type origin human insulin insulin. analogue and or method of manufacturer may result in a change in dosage Patients. transferred to PENMIX MIXTARD or PROTAPHANE from another type of insulin may. require an increased number of daily injections or a change in dosage from that used with. their usual insulin products If an adjustment is needed when switching the patient to. PENMIX MIXTARD or PROTAPHANE it may occur with the first dose or during the first. few weeks or months, 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. Avoidance of accidental mix ups medication errors, Patients must be instructed to always check the insulin label before each injection to avoid.
accidental mix ups between PENMIX MIXTARD or PROTAPHANE and other insulin. Injection site reactions, As with any insulin therapy injection site reactions may occur and include pain redness. hives inflammation bruising swelling and itching 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 PENMIX MIXTARD or PROTAPHANE, Before travelling between different time zones the patient should be advised to consult the. doctor since this may mean that the patient has to take insulin and meals at different times. Insulin suspensions are not to be used in insulin infusion pumps. Combination of thiazolidinediones and insulin products. Cases of congestive heart failure have been reported when thiazolidinediones were used in. combination with insulin especially in patients with risk factors for development of. congestive heart failure This should be kept in mind if treatment with the combination of. thiazolidinediones and insulin medicinal products is considered If the combination is used. patients should be observed for signs and symptoms of congestive heart failure weight gain. and oedema Thiazolidinediones should be discontinued if any deterioration in cardiac. symptoms occurs, PENMIX MIXTARD and PROTAPHANE contain metacresol which may cause allergic. 4 5 Interaction with other medicines and other forms of interaction. A number of drugs are known to interact with the glucose metabolism. The following substances may reduce the insulin requirements. Oral anti diabetic products monoamine oxidase inhibitors MAOI non selective beta. blocking agents angiotensin converting enzyme ACE inhibitors salicylates anabolic. steroids and sulphonamides, The following substances may increase the insulin requirements. Oral contraceptives thiazides glucocorticoids thyroid hormones sympathomimetics. growth hormone and danazol, Beta blocking agents may mask the symptoms of hypoglycaemia and delay recovery from.
hypoglycaemia, Octreotide lanreotide may either increase or decrease the insulin requirement. Alcohol may intensify and prolong the hypoglycaemic effect of insulin. 4 6 Fertility pregnancy and lactation, There are no restrictions on the 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 blood. glucose control and monitoring of pregnant women with diabetes are recommended. throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the. second and third trimester After delivery insulin requirements normally return rapidly to pre. pregnancy values,Breast feeding, There is no restriction on treatment with PENMIX MIXTARD or PROTAPHANE during. breast feeding Insulin treatment of the nursing mother involves no risk to the baby. However the insulin dosage diet or both may need to be adjusted. Effects on Fertility,Not applicable,4 7 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,4 8 Undesirable effects. a Summary of the safety profile, The most frequently reported adverse reaction during treatment is hypoglycaemia In clinical. trials and during marketed use the frequencies of hypoglycaemia vary with patient. population dose regimens and level of glycaemic control please see section c below. At the beginning of the insulin treatment refraction anomalies oedema and injection site. reactions pain redness hives inflammation bruising swelling and itching at the injection. site may occur These reactions are usually of transitory nature Fast improvement in blood. glucose control may be associated with acute painful neuropathy which is usually. reversible Intensification of insulin therapy with abrupt improvement in glycaemic control. may be associated with temporary worsening of diabetic retinopathy while long term. improved glycaemic control decreases the risk of progression of diabetic retinopathy. b Tabulated list of adverse reactions, Adverse reactions listed below are based on clinical trial data and classified according to. MedDRA frequency and System Organ Class Frequency categories are defined according. to the following convention Very common 1 10 common 1 100 to 1 10 uncommon. 1 1 000 to 1 100 rare 1 10 000 to 1 1 000 very rare 1 10 000 not known. cannot be estimated from the available data,Immune system disorders Uncommon Urticaria rash.
Very rare Anaphylactic reactions, Metabolism and nutrition Very common Hypoglycaemia. Nervous system disorders Uncommon Peripheral neuropathy Painful. neuropathy PENMIX MIXTARD,Very rare Peripheral neuropathy Painful. neuropathy PROTAPHANE,Eye disorders Very rare Refraction disorders. Uncommon Diabetic retinopathy,Skin and subcutaneous Uncommon Lipodystrophy. tissue disorders, General disorders and Uncommon Injection site reactions.
administration site Uncommon Oedema,conditions,see section c. c Description of selected adverse reactions,Anaphylactic reactions. The occurrence of generalised hypersensitivity reactions including generalised skin rash. itching sweating gastrointestinal upset angioneurotic oedema difficulties in breathing. palpitation reduction in blood pressure and fainting loss of consciousness is very rare but. can potentially be life threatening,Hypoglycaemia, The most frequently reported adverse reaction is hypoglycaemia It may occur if the insulin. dose is too high in relation to the insulin requirement Severe hypoglycaemia may lead to. unconsciousness and or convulsions and may result in temporary or permanent impairment. of brain function or even death The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats cool pale skin fatigue nervousness or tremor anxiousness. unusual tiredness or weakness confusion difficulty in concentration drowsiness excessive. hunger vision changes headache nausea and palpitation. Lipodystrophy, Lipodystrophy is reported as uncommon Lipodystrophy may occur at the injection site. Reporting of suspected adverse reactions, Reporting suspected adverse reactions after authorisation of the medicine is important It.
allows continued monitoring of the benefit risk balance of the medicine Healthcare. professionals are asked to report any suspected adverse reactions. https nzphvc otago ac nz reporting,4 9 Overdose, A specific overdose of insulin cannot be defined however hypoglycaemia may. develop over sequential stages if too high doses relative to the patient s requirement. are administered, Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary. products It is therefore recommended that the diabetic patient always carries sugar. containing products, Severe hypoglycaemic episodes where the patient has become unconscious can be. treated with glucagon 0 5 to 1 mg given intramuscularly or subcutaneously by a trained. person or with glucose given intravenously by a healthcare 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 a relapse. For advice on the management of overdose please contact the National Poisons Centre on. 0800 POISON 0800 764766,5 PHARMACOLOGICAL PROPERTIES. 5 1 Pharmacodynamic properties, Pharmacotherapeutic group Drugs used in diabetes Insulins and analogues for injection.
intermediate acting insulin human ATC code A10AC01 or drugs used in diabetes Insulins. and analogues for injection intermediate or long acting combined with fast acting insulin. human ATC code A10AD01, 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, For PENMIX and MIXTARD the absorption profile is caused by the product being a mixture. After delivery insulin requirements normally return rapidly to pre pregnancy values Breast feeding There is no restriction on treatment with or PROTAPHANE during PENMIX MIXTARD breast feeding Insulin treatment of the nursing mother involves no risk to the baby However the insulin dosage diet or bothmay need to be adjusted Effects on

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