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WHAT HEPARINOL IS AND WHAT IT IS USED FOR
HEPARINOL belongs to a group of medicines called anticoagulants. There are two strength of HEPARINOL HEPARINOL 1000 IU/mL containing 1000 IU of heparin sodium in each mL and HEPARINOL 5000 IU/mL containing 5000 IU of heparin sodium in each mL. Heparin changes the way your blood clots. This means your blood keeps flowing smoothly inside your blood vessels. These are the tubes that carry blood around your body and are called arteries and veins. HEPARINOL is used: to help stop harmful blood clots in your veins growing bigger (treatment). to help stop harmful blood clots forming in your (prevention). to help stop hanmful blood clots forming in the tubing of an artificial kidney machine dunng kidney dialysis (haemodialysis)
An example is a harmful blood clot in a vein deep inside your body. This is usually in your leg (deep vein thrombosis or DVT for short). Another example is a clot which blocks the blood supply to your lungs (pulmonary embolism). It is more likely these clots will form if you are either over weight, pregnant, have certain blood disorders or have already had a pulmonary embolism, DVT, heart attack or stroke. It can also happen if you do not move around for long periods of time. This could be because you have had surgery or you have another illness.
BEFORE YOU USE HEPARINOL
Do not use HEPARINOL
• If you are allergic (hypersensitive) to heparin or any of the other ingredients in your medicine.
• If you know that you have, or have ever had, a big drop in the clotting cells (platelets) in your blood, caused by having any type of heparin (reaction thrombocytopenia).
• If you have any condition which makes you bleed severely, such as haemophilia.
• If you have very high blood pressure. called heparin-induced
• If you have severe liver problems.
• If you have a stomach ulcer.
• If you know that you have a condition called endocarditis (an inflammation of the lining of the heart and heart valves).
• If you have had a brain haemorrhage (bleeding inside your brain).
• If you have an injury to your spine, head, eyes or ears.
• If you have recently had, or are about to have an operation involving your spine, head, eyes or cars.
• If you may be having a miscarriage.
Important: If you are having an epidural or spinal anaesthetic
You must remind your doctor that you are having HEPARINOL before you receive any anaesthetic.
If you are pregnant please also read the section of this leaflet "Pregnancy and breast-feeding".
After you have the anaesthetic your doctor or nurse will make regular checks. This is to check if you are getting any major bleeding or bruising around your spine. This may cause paralysis that could be permanent. Any signs this may be happening to you include tingling, weakness or mumbness in your lower legs or body, back pain or problems in going to the toilet, This happens very rarely.
After you have the anacsthetic your doctor will tell you when you can take your medicine again.
Take special care with HEPARINOL
Before treatment with HEPARINOL tell your doctor.
If you have any condition which makes you more likely to bleed more easily.
Ask your doctor if you are unsure.
• If you are allergic (hypersensitive) to heparins
• If you have kidney problems.
• If you have liver problems.
• If you have problems with your blood pressure (hypertension).
• If you know you have a condition called diabetes mellitus.
• If you know you have a condition called metabolic acidosis.
• If you know you have any medical condition which may cause high levels of potassium in your blood (hyperkalaemia). Ask your doctor if you are unsure.
• If you are taking a medicine from the group called potassium-sparing diuretics, such as amiloride or spironolactone.
• If this medicine is for a child who is between one month and two years old.
• If you are taking another medicine that may affect your blood clotting. For a list of these medicines see the section "Taking other medicines".
• If you are pregnant, or think you are pregnant. Read the infornmation about benzyl alcohol in the section "Important information about some of the ingredients of heparin".
Your doctor may take a blood test before you start having this mcdicine, and while you are having it.
This is so the doctor can chcck you are having the right dose. This is also to check the level of the clotting cells (platelets) and potassium in your blood.
This medicine may make you bleed more easily.
The doctor or nurse should take care when giving you any other injections or procedures.
This medicine must not be injected into your muscles.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.
You must tell your doctor or pharmacist if you are taking any of the following medicines:
• ACE inhibitors or angiotensin Il antagonists, such as enalapril, losartan or valsartan: for treating high blood pressure or heart problems. You may get too much potassium in your blood.
• Non-steroidal anti-inflammatory drugs, such as ibuprofen or diclofenac: for arthritis or aches or pains. You may be likely to bleed more easily.
• Salicylates, such as aspirin: for reducing pain and inflammation, or for stopping harmful blood clots forming. You may be likely to bleed more easily.
• Platelet aggregation inhibitors, such as clopidogrel: for stopping harmful blood clots forming. You may be likely to bleed more easily.
• Thrombolytic agents, such as streptokinase: for dissolving blood clots. i
You may be likely to bloed more casily.
• Vitamin K antagonists, such as warfarin: for stopping harmful blood clots. You may be likely to bleed more easily.
• Glyceryl trinitrate infusion: for treating angina. This may reduce the effect of HEPARINOL
• Activated protein C: for getting rid of blood clots. You may be likely to bleed more easily.
• Dextrans: for increasing your blood volume. You may be likely to bleed more easily.
Your doctor may carry out check-ups on you, including blood tests, if you take any of these medicines at the same time as HEPARINOL.
Pregnancy and breast-feeding
Unless your doctor has told you it is essential, you must not have heparin if you are pregnant, or think you are pregnant. Read the information about benzyl alcohol in the section "Important information about some of the ingredients of HEPARINOL".
If you become pregnant while having this medicine, tell your doctor. If you are pregnant and are going to have an epidural anaesthetic, you should stop having your medicine. Ask your doctor for advice.
If you are breast-feeding, ask your doctor for advice before having HEPARINOL.
Driving and using machines
Usually your medicine may have little effect on your ability to drive or use machines. However, you should check with your doctor if you feel any side effect that may stop you from driving or using machines.
HOW TO USE HEPARINOL
HEPARINOL will be given to you by a doctor or nurse. HEPARINOL should not be mixed with any other injection. Ikt may be given under your skin or into your vein.
How much HEPARINOL to have
Your doctor will prescribe the right dose for you.
If you have more HEPARINOL than you should
Your doctor or nurse will give you this medicine.
If you think you may have been given too much, tell your doctor or nurse straight away.
you may have been given too much, You may start to haemorrhage (bleed severely).
You may be given another injection of a medicine called protamine sulphate.
If you have missed a dose of HEPARINOL
Your doctor or nursc will givc you this medicine. If you think that you have missed a dose thecn tell your doctor or nurse.
If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
SERIOUS SIDE EFFECTS
Like all medicines, HEPARINOL can cause side effects, although not everybody gets them.
You must get urgent medical help if you have any of the following symptoms. You may having an allergic reaction:
• You have difficulty breathing
• Your face or throat swell
• Your skin develops a severe rash
• Your skin develops blisters at the site of your injection.
You must get urgent medical help if you have any of the following symptoms after having an epidural or spinal anaesthetic. You may be developing paralysis:
• Tingling, weakness or numbness in your legs or lower body
• Back pain
• Problems in going to the toilet.
You should tell your doctor straight away If you spot any of the following signs which mean you may be starting to bleed severely:
• Red or brown urine
• Black tarry stools
• Unusual bruising Bleeding from your nose, mouth or any operation wound that will not stop.
5. OTHER POSSIBLE SIDE EFFECT
• Bruising at the site of the injection
• Irritation at the site of the injection
• Bleeding (haemorrhage). This may be more likely if you are taking a high dose of HEPARINOL OTHER POSSIBLE SIDE EFFECT
• Changes in your blood test results. Your doctor can explain this more.
• Rash
• Itchy raised rash (hives)
• Osteoporosis. Your boncs bccome less strong and can break more easily. This has been seen in patients taking heparin for a long time.
• Bruising or bleecding more casily. Your blood may also form morc harmful clots. A big drop in clotting cells (platelets) in your blood may give you these symptoms. Your doctor can explain this more.
• Changes in your blood tecst results. The amount of potassium may be increased. This is more likely to happen if you have severe kidney problems or diabetes. Your doctor can explain this more.
• Prolonged, painful erections in men.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
HOW TO STORE HEPARINOL
• Keep out of the reach and the sight of children.
• Do not use HEPARINOL after the expiry date on the label.
• The expiry date is the last day of that month.
• Do not store above 30°C. Do not refrigerate.
Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.
What HEPARINOL contains
• The active ingredient is heparin sodium. There are two strengths of this product containing either 1,000 or 5,000 IU of heparin sodium in each millilitre (mL).
• The other ingredients are benzyl alcohol, sodium hydroxide solution and water for injections.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
AIN MEDICARE SDN. BHD.,
Jalan 6/44, Kaw. Perindustrian Pengkalan Chepa 2, 16100 Kota Bharu, Kelantan, MALAYSIA..
Tel : +609-7743388, 7741239
Fax : +609-7742205
Email : info@ainmedicare.com.my
Website : www.ainmedicare.com.my
Manufacturer:
AIN MEDICARE SDN. BHD.,
Jalan 6/44, Kaw. Perindustrian Pengkalan Chepa 2, 16100 Kota Bharu, Kelantan, MALAYSIA..
Tel : +609-7743388, 7741239
Fax : +609-7742205
Email : info@ainmedicare.com.my
Website : www.ainmedicare.com.my
تعريف هيبارينول وداوعي الاستعمال :
هيبارينول يتبع مجموعة مضادات تجلط الدم يوجد منه ترکیزین 5000 و.د / مل و 1000 و.د / مل صوديوم هيبارين .
هيبارين يغير طريقة تجلط الدم ، مما يحافظ على انسياب الدم في الأوردة والشرايين
دواعي الاستعمال :
• منع تجلط الدم .
• منع تجلط الدم في الأوردة .
• منع تجلط الدم في الأنابيب والأجهزة خلال الغسيل الكلوي
مثال لخطورة تجلط الدم ، مثل م يحدث في الأوردة العميقة للساقين او في أجهزة الجسم الرئيسية مثل ما يحدث في منع مرور الدم للرئتين .
غالبا يكون تجلط الدم في وجود السمنة أو الدوالي أو مشاكل الدورة الدموية .
قبل استعمال هيبارينول :
• لا تستعمل هيبارينول في الحالات التالية :
حساسية من المستحضر مشاكل في تجلط الدم .
نزيف شديد
ضغط الدم المرتفع
قصور في وضائف الكبد .
قرحة المعدة .
التهاب بطانة القلب أو الصمام .
نزيف بالمخ .
جروح بالحبل الشوكي أو الراس او العين أو الأذن .
بعد أو عند اجراء عمليات جراحية بالحبل الشوكي أو الراس او العين أو الأذن .
الاجهاض.
• هام :
عند التخدير يجب ابلاغ الطبيب انك تستعمل هيبارينول قبل التخدير .
ويجب بعد التخدير قياس سيولة الدم ومرعاة عدم وجود نزيف داخلي ربما يودي الى الشلل غالبا يشعر المريض بالتنميل والضعف بالارجل بعد التخدير .
الطبيب يحدد موعد استعمال هيبارينول ثانية .
• عناية خاصة مع هيبارينول :
قبل استعمال هيبارينول ابلغ الطبيب عن :
اذا كان لديك أي حالة نزيف أو احتمال لنزيف
اذا كان لديك حساسية للهيبارين
اذا كان عندك قصور في وظائف الكلية الكبد ارتفاع ضغط الدم أو السكري أو حموضة .
زيادة البوتاسيوم في الدم .
أدوية أدرار البول الموفرة البوتاسيوم مثل امیلورید او سبيرنولکتون .
العمر ( 1 ) شهر - ( 2 ) سنة .
تناول أدوية أخري تؤثر على تجلط الدم .
الحمل راعی تأثیر بنزيل الكحول .
يجب على الطبيب أن يجري فحص الدم قبل استعمال هيبارينول وبعده لتحديد الجرعة المناسبة.
• التداخلات الدوائية :
مثبطات انزيم أنجيوتنسين ترفع تركيز البوتاسيوم بالدم .
الأدوية غير الستيرويدية وهي مضاد للالتهابات مثل ابديوبرفين او دیکلوفینال تزید مسيولة الدم
الساليسلات مثل الأسبيرين تزيد سيولة الدم .
مثبطات التجلط مثل ستربتوكينز تزيد سيولة الدم .
مثبطات فيتامين K تزيد سيولة الدم
محلول جیلسريل تراي نيترات الوريدي يضعف مفعول هيبارينول
بروتين سي النشط يزيد سيولة الدم .
ديكستران يزيد سيولة الدم
يلزم عمل تحليل للدم قبل استعمال هيبارينول عند وجود الحالات الاتية :
• الحمل والرضاعة :
لا يستعمل هيبارينول في حالات الحمل أو الرضاعة يجب استشارة الطبيب
• قيادة السيارة و المعدات :
يجب استشارة الطبيب قبل استعمال هيبارين .
• معلومات مهمة :
يحتوي هيبارينول على بنزيل كحول لهذا لا يستعمل على للأطفال حديثي الولادة الى عمر سنتان . يجب استشارة الطبيب مع الحمل و الرضاعة
يجب استشارة الطبيب بخصوص وجود الصوديوم بالمستحضر
طريقة استعمال الهيبارينول
يحقن بالوريد أو تحت الجلد بواسطة الطبيب او الممرضة .
يجب عدم خلط هيبارينول مع ادوية اخرى
الطبيب يحدد الجرعة المناسبة
في حالة زيادة الجرعة وزيادة النزيف يعطي دواء بروتامین سلفيت
يجب التأكيد على الطبيب بعدم نسيان جرعة هيبارينول
الآثار الجانبية الخطيرة :
كما باقي الادوية هيبارينول يسبب بعض الأعراض الجانبية يجب سرعة العلاج في حالات :
ظهور حساسية مع صعوبة التنفس واحتقان الحلق أو بثور في الجلد أو تقرحات مكان الحقن
اعراض نزيف حاد مثل ظهور البول بلون بني أو البراز الاسود او نزيف من الأنف أو الفم .
اثار جانبية محتملة :
احتقان مكان الحقنة
نزيف خاصة مع الجرعات العالية
تغيرات في تحاليل الدم
ظهور بثور بالجلد
حكة
هشاشة عظام خاصة مع الاستعمال الطويل للمستحضر
زيادة البوتاسيوم بالدم خاصة اذا كان يوجد قصور في وظائف الكلية .
زيادة الانتصاب المؤلم عند الرجال .
عند حدوث مثل هذه الأعراض يجب استشارة الطبيب
طريقة التخزين :
يجب حفظه بعيدا عن متناول الأطفال
لا يستعمل بعد نهاية تاريخ الصلاحية
يحفظ عند درجة حرارة اقل من 30 م ولا يحفظ بالثلاجة .
حافظ على البيئة ولا تلقى الدواء مع الفضلات راجع الصيدلي عند التخلص من الدواء
7- معلومات اخرى :
يتكون هيبارينول من هيبارين صوديوم تركيز 5000 و.د / مل و 1000 و.د / مل
المكونات الأخرى : بنزيل الكحول و صوديوم هیدروکسید وماء للحقن . هيبارينول شفاف مع اصفرار خفيف بدون ترسيبات أو عوالق .
العبوة :
علبة 10 فيال كل فيال 5 مل .
توزيع وصناعة شركة عين ميديكير
العنوان : جالان 44/6 کاوا براندسترین بنگلان شيبا 2
16100 كوتا بهارو . كيلانتان ماليزيا
ت . 7743388 ( 609 ) - 7741239 ( 609 )
ف . 7742205 ( 609 )
ایمیل : info@ainmedicare.com.my
الموقع : www.ainmedicare.my
Indication :
Heparin is indicated for prophylaxis and treatment of thrombo-embolic disorders such as thrombophlebitis, pulmonary embolism, myocardial infarction, arterial embolism and other occlusive vascular disease. It is also used to prevent thrombo-embolic complication from cardiac and vascular surgery, dialysis, frostbite and other perfusion procedures. Heparin is also used as anticoagulant in blood transfusions and for laboratory purposes.
Recommended Dosage :
Express dose in units only; dose must be individually titrated to desired effect (usually 1.5 - 2.5 times control clotting test used).
1. Treatment of venous thrombosis or pulmonary embolus. Duration of therapy is 7-10 days, then followed by oral anticoagulation.
i. Continuous IV solution : 50-100 units/kg initially: then 10-15 units/kg/hr (venous thrombosis) or 20 units/kg/hr (pulmonary embolus).
ii. Intermittent IV : 75-125 units/kg q 4 hr.
iii. Subcutaneous : 10,000-20,000 units initially (proceeded by a 5000 units IV loading dose), then 8000-10,000 units q 8 hr or 15,000-20,000 units q 12 hr.
2. SC for prophylaxis of deep vein thrombosis (low-dose) 5000 units 2 hr before surgery, repeated q 8-12 hr until patient is ambulatory.
3. IV for heparin lock flush inject sufficient solution (of 10-100 units/ml) into injection hub to fill the entire after each heparin lock use.
4. Haemodialysis : 7,500-12,500 IU is normally required per dialysis.
5. Myocardial infarction : 5,000 IU s.c. every 12 hours beginning during the 12 hours following the first sign of myocardial infarction.
Route of Administration: IV/SC
Warnings and Precautions:
Warnings
Heparinol contains benzyl alcohol, its use should be avoided in children below 2 years old and should not be used in neonates.
Precautions
Heparin therapy should be monitored carefully to reduce the risk of overdosage, haemorrhage and serious adverse reactions such as delayed onset thrombocytopenia.
Risk factors for haemorrhage may include IM injections, trauma, recent surgery, women over 60 years, malignancy, peptic ulcer disease, potential bleeding sites and acquired or congenital homeostatic defects.
As heparin is derived from animal tissue (bovine mucous), it should be used with caution in patients with a history of allergy. Before a therapeutic dose is given to such a patient, a trial dose of 1,000 units may be advisable.
Interactions with Other Medicaments:
Aspirin effects on platelet adhesiveness might leave the heparin treated patient more prone haemorrhage. Non steroidal anti-inflammatory agents, dextran, dypyridamole and thrombolytic agents such as streptokinase or urokinase may also increase the risk of haemorrhage.
Pregnancy
Category C (FDA)
Safety for use during pregnancy has not been established. Use only when clearly needed and when the potential benefits overweigh the potential hazards to the fetus. Osteoporosis and thrombocytopenia are the usual risks for mother. Although heparin dose not cause malformations, an increased incidence of human foetal loss and prematurity associated with haemorrhage has been reported.
Caution is recommended when heparin is used during the last trimester of pregnancy or during the postpartum period because of the increased risk of maternal bleeding.
Lactation
Heparin is not distributed in milk.
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Adverse Effects / Undesirable Effects:
Haemorrhage (bleeding) is a major risk of heparin therapy and may range from minor local ecchymoses to major haemorrhagic complications. Skin necrosis, transient alopecia, diarrhoea and allergic reactions to heparin occur rarely. Delayed onset thrombocytopenia is also a possible complication of therapy. Osteoporosis may occur with doses of 15,000 units/day or more for 6 months or longer.
Overdose and Treatment:
Slight haemorrhage due to overdosage can usually be treated by withdrawing the drug. Severe bleeding may be reduced by the administration of protamine sulfate. Protamine sulfate should be administered intravenously. The dose of protamine required to antagonise heparin can be estimated; 1mg of protamine should be administered for every 100 units of heparin remaining in the patient.
Alternatively the requirement for protamine can be determine directly invitro by titration of the patient’s blood with the protein. To avoid circulatory side effects, injection protamine should be given slowly at rate of 5mL/10 minutes and maximum dose at one time
in 50 mg.
Parameter to monitor:
Baseline values for APPT or ACT, PT, haematocrit and platelet count. Obtain APPT or ACT (Therapeutic range 1.5-2.5 times
control) 3-4 times (or until therapeutic range is achieved) on 1 day, and at least daily thereafter. Platelets and haematocrit every
other day; sign of bleeding (melena, haematuria, ecchymosis, haematemesis, epistaxis) daily.
Pharmacodynamics :
Heparin is an anticoagulant which prevent the coagulant of blood in vivo or in vitro. The whole blood clotting time, the thrombin time and the one stage prothrombin time are prolonged following therapeutic doses of Heparin. After injection, Heparin is extensively bound to Plasma Proteins. It does not cross the placenta or appear in the milk of nursing mothers.
A heterogeneous group of mucopolysaccharides derived from the mast cells of animal tissues. It binds with antithrombin III, accelerating the rate at which antithrombin III neutralizes activated forms of factors XII, XI, IX, VII and II.
Pharmacokinetics :
Heparin is not absorbed through the gastrointestinal tract and must be administered parenterally. Its onset of action is immediately following I.V administration. There may be considerable variation among patients in the extent of absorbtion following deep subcutaneous injection of heparin; however, the onset of activity usually occurs within 20-60 minutes.
The metabolic rate of heparin is not fully understood. No biotransformation in plasma or liver, nor any renal excretory mechanism has been identified as primarily responsible for elimination of the drug. It has been suggested that transfer and storage in the reticuloendothelial system may play a role, or that heparin may be partially metabolised in the liver. After administration of large doses intravenously, a small fraction of unchanged drug is excreted in the urine.
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Benzyl Alcohol 1%
Incompatibilities:
Heparin is incompatible with certain substances in aqueous solution. The following incompatibilities have been reported : hydrocortisone, hyaluronidase, hydroxyzine, some antihistamine, narcotic analgesics, phenothiazines and antibiotics.
Storage Conditions:
Do not store above 30C. Do not refrigerate.
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