HYPURIN PORCINE NEUTRAL
Active substance: INSULIN PORCINE
View full screen / Print PDF » Download PDF ⇩
Transcript
HYPURIN PORCINE RANGE OF INSULIN INJECTION
Read all of this leaet carefully before you inject your insulin. - Keep this leaflet. You may need to read it again while you are receiving your treatment. - If you have any further questions, please ask your doctor, pharmacist or diabetic nurse. - This medicine has been prescribed for you. It must not be shared with other patients. It may harm them even if their symptoms are the same as yours.
In this leaet: 1. What Hypurin is and what it is used for 2. Before you receive Hypurin 3. How to use Hypurin 4. Possible side effects 5. How to store Hypurin 6. Further information 1. WHAT HYPURIN IS AND WHAT IT IS USED FOR The name of your medicine is Hypurin Porcine Insulin. Hypurin Porcine is the brand name for a range of highly puried porcine (pig) insulin injections. Hypurin Porcine Neutral is a sterile, clear solution of porcine insulin (100 international units/ml). It is short acting. Hypurin Porcine Isophane is a sterile, white suspension of porcine insulin (100 international units/ml) with protamine sulphate and zinc chloride in water. It is longer acting than Hypurin Porcine Neutral. Hypurin Porcine 30/70 Mix is a sterile, white suspension of porcine neutral and isophane insulins (100 international units/ml). It is intermediate acting. What Hypurin is used for Hypurin contains insulin which is a natural hormone, made by a gland called the pancreas. Insulin plays a key role in the way the body uses carbohydrate, fat and protein. Hypurin Porcine is used for the treatment of insulindependent diabetes mellitus. In this type of diabetes, your pancreas does not make enough insulin to control the level of sugar in your blood. It can be treated by controlling your diet and taking insulin. Hypurin Porcine has been prescribed for you as a substitute for your own insulin. 2. BEFORE YOU RECEIVE HYPURIN You should not inject Hypurin Porcine insulin if: you have symptoms of hypoglycaemia (low blood sugar or hypo - see the section on hypoglycaemia in section 4 Possible side effects) you have ever had an allergic reaction to insulin or any of the other ingredients in Hypurin Porcine (see What Hypurin contains in section 6 Further information). If any of the above applies to you, should not inject Hypurin. Talk to your doctor before taking this medicine if you are taking pioglitazone, as your risk of heart failure may be increased. Taking other medicines Taking another medicine while you are using insulin can affect how it or the other medicine works. Tell your doctor or pharmacist if you are taking any other medicine before you start taking insulin. This includes medicines you may have bought yourself without a prescription. Medicines that can affect the way insulin works are; Steroids, both corticosteroids, used to treat a range of allergic conditions, and anabolic steroids, used to treat various metabolic disorders. Levothyroxine, used for an underactive thyroid gland. Anti-inflammatory drugs such as aspirin and NSAIDs such as ibuprofen. Cyclophosphamide, used to treat a wide range of tumours. Isoniazid, used to treat tuberculosis (TB). Some drugs used to treat high blood pressure such as beta blockers, ACE inhibitors, nifedipine, clonidine or guanethidine. Some drugs such as adrenaline, which are used to treat shock. Some drugs used to treat mental illness such as chlorpromazine, amitriptyline, uoxetine and MAOIs such as phenelzine. Thiazide diuretics or loop diuretics, used to control excess water. Oral contraceptives (birth control pills). Octreotide, an anti-hormone preparation. Antimalarial drugs, such as chloroquine or quinine. Diazoxide, used to treat high blood pressure or low blood sugar. Disopyramide or quinidine, used to treat an irregular heartbeat. Fenuramine, used to treat obesity. Fibrates or gembrozil, used to regulate lipids. Mebendazole, used to treat threadworm. Oxytetracycline, an antibiotic. Pentoxifylline, used to treat leg ulcers and problems with blood circulation in the legs. Testosterone.
Alcohol and smoking can also affect the way insulin works. If you have any doubts about your medicine then discuss things more fully with your doctor, pharmacist or diabetes nurse. Pregnancy and breast-feeding Before using this medicine you should let your doctor know if you are pregnant or wish to become pregnant or start breast-feeding. Particularly careful control of your diabetes and prevention of hypoglycaemia is important for your health and the health of your baby. Insulin requirements should be assessed frequently by an experienced diabetes physician during pregnancy, after delivery and whilst breast-feeding. Driving and using machines Your ability to concentrate or react may be reduced if you have hypoglycaemia. This might put yourself and others at risk when you are driving a car or operating machinery. You should contact your doctor about the advisability of driving if you have: frequent episodes of hypoglycaemia reduced or lack of warning signs of hypoglycaemia. Important information about some of the ingredients of Hypurin Zinc, protamine and the preservatives m-cresol and phenol may cause allergic reactions. 3. HOW TO USE HYPURIN What dose is needed? There is no standard dose of insulin. Each person with diabetes has their own dose calculated according to their needs. Your doctor will decide which dose is best for you and which insulin to use. Always follow your doctors instructions exactly and also follow any special instructions or warnings that appear on the label that the pharmacist has put on the package. Dosage adjustments Patients with disease of the liver, kidneys, adrenal, pituitary or thyroid glands, or coeliac disease (symptoms may include severe diarrhoea and unintentional weight loss) may need lower doses. This dose may alter during illness (including infection and surgery), injury, emotional stress, during puberty, around the time of a menstrual period, and during pregnancy and after delivery. Lactating women may also require dosage adjustments. It may also change with your diet and lifestyle, particularly if you are exercising more. Patients transferred to Hypurin Porcine Insulins from other types of insulin may require dosage adjustments. Newly diagnosed diabetic patients may require dosage adjustments during the rst weeks, months or years of treatment. If you do not understand or are in any doubt ask your doctor, pharmacist or diabetes nurse. Advice and checks to be made when using Hypurin Porcine Insulin You must keep a close watch on your blood sugar by testing your glucose levels regularly in your blood or urine. Your urine should be tested for ketones at regular intervals. Be aware that insulin resistance can occur, particularly in patients who have lipid disorders (usually this will be diagnosed by blood tests), hypertension (high blood pressure) or heart disease. Stress can also contribute to insulin resistance. If your doctor has asked you to increase the frequency or dose of your insulin treatment in order to improve your sugar levels, you may at some point lose some of the warning symptoms that usually occur when your blood sugar is falling too low (hypoglycaemia). These symptoms include shakiness, pounding heartbeat, sweating and feeling anxious. You may also lose some of the warning symptoms of hypoglycaemia if you have had repeated attacks of hypoglycaemia, if control of your blood sugar is greatly improved, if you have a long history of diabetes, or if you are also taking certain other medicines, such as beta blockers (used to treat high blood pressure and angina) or clonidine (used to treat high blood pressure). If you are elderly, you may have more severe episodes of hypoglycaemia and some of the warning symptoms may change, be weaker or be missing. Be aware that activities such as taking a hot bath, sunbathing, or using a sunbed or sauna can increase the rate at which insulin is absorbed and increase the risk of hypoglycaemia. Injection sites Recommended injection sites include the upper arms, thighs, buttocks and lower abdomen. It may be preferable to use those areas that are less visible. Each time you inject your insulin you should use a different spot in the same general area. Change to a different injection area each week. Hypurin Porcine Isophane or Hypurin Porcine 30/70 Mix should not be injected into a vein. Hypurin Porcine Neutral may be injected into a vein, but only by a doctor in an emergency.
Injecting Hypurin Your doctor or diabetes nurse will advise you on how to inject your insulin. Check that the cartridge in the carton has the same label as on the carton and that different types of Hypurin Porcine have not been mixed up. Do not use Hypurin Porcine that has been frozen or contains lumps that do not disappear on mixing. Wash and dry your hands. If you are using a new cartridge of Hypurin Porcine Isophane or Hypurin Porcine 30/70 Mix or one that has been used before but now looks clear, roll the cartridge down, with a bell ringing action at least ten times until the insulin appears white and cloudy. The cartridge contains a glass bead to help mix the suspension. Hypurin Porcine Neutral does not need to be mixed. It should be a clear, colourless solution and not contain any particles. Put the cartridge into the pen following the pen manufacturers written instructions. Before using the pen to inject Hypurin Porcine Isophane or Hypurin Porcine 30/70 Mix, the insulin must be mixed again by turning the pen up and down at least ten times on each occasion. Always check that your pen is working before each injection by performing an air shot. Hold the pen vertically, needle up. Dial two units, press the release button and check for a drop of insulin at the end of the needle (repeat until insulin is seen). Dial your dose to the number of units required. You are now ready to inject your insulin. Pinch up the skin at the injection site. Inject the Hypurin Porcine Insulin under the skin as you have been taught, keeping the pen in place for a count of ve seconds. Release the pinched up skin and remove the pen. Remove the needle from the pen. There is no need to massage the area. Your doctor may prescribe more than one type of Hypurin Porcine cartridge injection for you. A separate pen must be used for each type of insulin. If you think you have received too much Hypurin If you think you have received too much Hypurin, contact your doctor or diabetes nurse immediately. Symptoms of an overdose include weakness, sweating, trembling, nervousness, excitement and irritability which, if untreated, could lead to collapse and coma. 4. POSSIBLE SIDE EFFECTS Like all medicines, insulin may cause side effects in some patients when treatment is rst started or if there is a change in the type of insulin used. These include: hypoglycaemia (see section Treating Hypoglycaemia below) swelling (oedema) redness, itching or swelling around the area of injection stinging, or sensations of warmth or burning at the site of injection thickening or pitting of the skin in the areas used for injection (lipodystrophy). rash pain caused by nerve damage shortness of breath or wheezing low levels of potassium, which can cause muscle weakness, twitching or abnormal heart rhythm (hypokalaemia) weight gain nausea. Rarely the following side effects may occur: allergic reactions and generalised swelling (oedema). severe allergic reactions that cause difficulty in breathing or dizziness. If you experience any other side effects or feel that your insulin is affecting you badly please contact your doctor, pharmacist or diabetes nurse. Hypoglycaemia (hypo or insulin reaction) symptoms Hypoglycaemia means low blood sugar. The symptoms of a hypo are: pale face, sweating palpitations, rapid heartbeat, heart disease (symptoms may include chest pain and shortness of breath) hunger cramps deep breathing weakness, drowsiness, yawning, fatigue, reduced consciousness altered behaviour, aggression, confusion, irritability, anxiety, nervousness, restlessness, excitement, trembling difficulty in finding words, difficulty in concentration fits blurred vision and/or double vision, slurred speech tingling or numbness of the nose, mouth, fingers or toes, paralysis headache, excess fluid in the brain (symptons may include headache, loss of co-ordination), brain damage (symptoms may include forgetfulness, learning difculties).
Why might hypoglycaemia occur? Hypoglycaemia may occur for the following reasons (or occasionally for no apparent reason): missing or postponing a meal or eating less than the correct dietary allowance taking more exercise than usual injecting the wrong dose of insulin Episodic heavy alcohol intake binge drinking. Untreated hypos can have serious consequences. It is important to recognise the symptoms and treat hypoglycaemia early. Treating hypoglycaemia Always carry glucose tablets or sugar lumps with you wherever you go. At the first warning sign of hypoglycaemia, stop what you are doing and take ve glucose tablets or three sugar lumps, preferably with water. You should begin to feel better almost immediately. If you do not feel better in ten minutes repeat the glucose tablets or sugar lumps. If the hypo happens shortly before a meal or snack, treat the hypo and have your meal as soon as you can. If a meal is not due, take the quick-acting glucose tablets or sugar lumps and follow them with some longer-acting carbohydrate food like a sandwich or biscuits. Because of the risk of a hypo you should carry an identication card or wear an identity bracelet or necklace carrying details of your name, address, doctor and insulin treatment. It is also important that relatives, friends and colleagues know that you have diabetes. 5. HOW TO STORE HYPURIN Keep all cartridges, needles and pens out of the reach and sight of children. Hypurin Porcine cartridges should be stored in a refrigerator between 2C - 8C. Once in use, the cartridge can be kept at room temperature (up to 25C) for 28 days after which it should be discarded. Do not use this medicine if the expiry date on the label has passed or if the insulin has been frozen. The expiry date refers to the last day of the month. The cartridge should be changed once the plunger has reached the coloured band at the bottom of the cartridge. The empty cartridge should be disposed of immediately. Do not attempt to rell it. Fit a new needle to your pen every time you inject your insulin; do not leave a used needle on your pen between injections as this can cause the cartridge to leak and become non-sterile. Do not share needles. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Hypurin Porcine Contains Hypurin Porcine Neutral is a sterile, clear solution of porcine insulin (100 international units/ml). It also contains m-cresol, phenol, glycerol and sodium phosphate. Hypurin Porcine Isophane is a sterile, white suspension of porcine insulin (100 international units/ml) with protamine sulphate and zinc chloride in water. It also contains m-cresol, phenol, glycerol and sodium phosphate. Hypurin Porcine 30/70 Mix is a sterile, white suspension of porcine neutral and isophane insulins (100 international units/ml). It also contains m-cresol, phenol, glycerol and sodium phosphate. What Hypurin Porcine looks like and contents of the pack Hypurin Porcine is available in packs of ve glass cartridges, which contain 3ml of solution or suspension for use in pen injectors and glass vials, which contain 10ml of solution or suspension. Other formats To listen to or request a copy of this information in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information:
Product Name Hypurin Porcine Neutral 100iu/ml Insulin Injection Hypurin Porcine Isophane 100iu/ml Insulin Injection Hypurin Porcine 30/70 Mix 100iu/ml Insulin Injection Reference Number 29831/0124 29831/0122 29831/0119
Marketing Authorisation holder Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK Leaet prepared: October 2011
101972/5
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

