CLEXANE. 60 mg. 0.6 ml. 1

CLEXANE. 60 mg.  0.6 ml. 1
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This product is anticoagulant drug (antithrombotic agent) of the so-called group of low molecular weight heparins. It prevents the formation of blood clots in the veins or arteries (thrombosis) and also prevents re-formation. 

CLEXANE. 60 mg. / 0.6 ml. 1

 
 
CLEXANE WHAT IS AND WHAT IT IS USED
What Clexane
This product is anticoagulant drug ( antithrombotic agent ) of the so-called group of low molecular weight heparins. It prevents the formation of blood clots in the veins or arteries ( thrombosis) and also prevents re- formation .

What is it used Clexane
Low molecular weight heparin may be prescribed :
as a prophylactic treatment to prevent blood clots ;
as curative therapy when blood clots already formed.
This medicine is used in surgery and medicine :
in patients at risk of disease of veins ( blood clot in a vein ), or in patients who have the disease with or without pulmonary embolism ;
in patients with certain types of coronary artery disease .

2 . BEFORE YOU TAKE CLEXANE
Do not take Kleksan and tell your doctor if:

The use of this drug is contraindicated DEPRECATED
In any case - if you are known to have an allergy to the drug , heparin or its derivatives , including other low molecular weight heparins ;
- If you have a serious drop in platelets for heparin ( platelets play an important role in blood clotting) ;
- If you found bleeding disorder ;
- If you have a disability ( internal or external ) that could bleed ;
- If you are prone to excessive bleeding .
As a healing therapy - bleeding in the brain ;
- If you have severe renal insufficiency (except dialysis ) ;
- Spinal / epidural anesthesia are contraindicated during medical therapy . - Regardless of age, in combination with aspirin (at doses used for analgesia , and for lowering the temperature ) , or with non-steroidal anti-inflammatory drugs (NSAIDs ) or dextran ( a drug used in intensive care ) ;
- During the first few days after stroke hemorrhage ;
- In most species endocarditis ( heart infection ) ;
with mild or moderate renal impairment
As prophylactic therapy
- If you have severe kidney disease ;
- In 24 hours after cerebral hemorrhage ;
- If you are over the age of 65, in combination with aspirin (at doses used to relieve pain and lower fever ) or nonsteroidal anti-inflammatory drugs (NSAIDs) or dextran.
SPECIAL WARNINGS
To avoid bleeding , be sure not to exceed the dose and duration of treatment prescribed by your doctor (see section 2. Take special care with Kleksan ) .
Treatment requires multiple blood tests regularly platelet counts you (usually twice a week).
During treatment with heparin, in very rare cases can occur a significant fall in the number of platelets. This discontinuation of heparin and the hard track , since they can lead to serious complications , in particular , paradoxical thrombosis .
In general, this product is not recommended for children.
The use of this drug for the prevention of thromboembolic events is not recommended for patients with a mechanical heart valve prosthesis , especially pregnant women.
NOT injected intramuscularly . The injection should be strictly enforced.

Take special care with Kleksan
As with all anticoagulants, bleeding can occur . In the event of bleeding , the cause must be found and should be an appropriate treatment .
In some cases, especially in therapeutics , there is a risk of hemorrhage in the following situations:
the elderly ;
weighing less than 40 kg;
renal failure ;
if the treatment has more than the normal period of 10 days ;
in combination with certain medications (see section 2 . Taking other medicines ) ;
in combination with certain medications that increase the risk of bleeding (see section 2 . Taking other medicines).
These situations may require special monitoring : possible medical examinations and blood tests .
Epidural and spinal anesthesia is not contraindicated when the drug is administered prophylactically. Some precautions , however , must be observed : interval between injection and anesthesia specific follow .
If you currently have , or have severe liver or kidney disease , ulcers or other damage that might bleed , tell your doctor.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Because of the likelihood of the occurrence of bleeding, always tell your doctor if you are taking any of the following :
aspirin ;
nonsteroidal anti-inflammatory drugs (NSAIDs) ;
platelet aggregation inhibitors (abciximab, eptifibatide, iloprost, ticlopidine, tirofiban);
dextran (a medicine used in intensive care units ) ;
oral anticoagulants ( that block vitamin K).
Your doctor may adjust your treatment accordingly .

Pregnancy and lactation
Tell your doctor if you are pregnant or think you may be pregnant or plan to become pregnant .

pregnancy
Curative therapy:
Preferably, this product can not be used during the entire pregnancy .

Prophylactic therapy:
Preferably, this product can not be used during the first trimester of pregnancy. During the second trimester , the drug can be used only if your doctor thinks it is necessary.
If during treatment you find that you are pregnant, consult your doctor as only he / she can assess the need for continued treatment.

breastfeeding
This drug is contraindicated in nursing mothers .
As a general rule , you should always inform your doctor or pharmacist if you are pregnant or breastfeeding before using any medicine.

Driving and using machines
Enoxaparin did not affect the ability to drive and use machines.

3 . HOW TO TAKE CLEXANE
Always take Kleksan exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.

How to take this medicine
Subcutaneous (except when used for dialysis) .
Not to be injected intramuscularly.
How much to take
The dose depends on the testimony and the patient :
Prophylactic therapy:
Operations with moderate risk : one injection per day 2000 anti-Xa IU / 0,2 ml ( 20 mg / 0,2 ml);
Operations at high risk (hip and knee) : one injection per day 4000 anti-Xa IU / 0,4 ml ( 40 mg / 0,4 ml).
hemodialysis :
100 anti- Xa IU / kg (lmg / kg) as a single dose .
Curative therapy:
Dose and duration of treatment is determined by your doctor according to your body weight and therapeutic indications.
In general , the dose is 100 anti- Xa IU / kg ( 1 mg / kg) every 12 hours.
In patients treated for certain types of angina Kleksan combined with aspirin oral dose which is administered once daily .
1 ml of the injection solution is the equivalent of about 10, 000 anti- Xa IU enoxaparin ( 100 mg / ml).
If this drug should be replaced with oral anticoagulant injections will stop after a few days , during which time you will receive both drugs . This corresponds to the time required for the second drug to be active and the blood coagulation to reach adequate levels determined by your doctor.

When and how often you use Kleksan
Prophylaxis in surgery : 1 injection per day.
Curative treatment : Two daily injections with an interval 12 hours.
Hemodialysis : the drug is injected directly into the arterial line of the dialysis tubes at the beginning of the dialysis session.

How long should I use Kleksan
Prevention of venous thrombosis in general surgery : treatment generally appointed for 7 to 10 days , except in certain hip operations.
Treatment of venous thrombosis : in general, the treatment should not exceed 10 days.
Treat certain types of angina : treatment lasts 2 to 8 days to stabilization.

If you take more dose Kleksan
Due to the risk of bleeding quickly contact a doctor .

If you forget to take Kleksan
Nothing special.

If you stop taking Kleksan
Nothing special.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4 . POSSIBLE SIDE EFFECTS
Like all medicines, Kleksan can cause side effects, although not everybody gets them .
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common ( affects 1 to 10 users in 100) uncommon ( affects 1 to 10 users 1 000 ), rare (affects 1 to 10 users in 10,000 ) very rare ( affects less than 1 user in 10,000 ) not known ( from the available data can not be estimated ) .

When Kleksan used for prophylactic treatment to prevent blood clots were observed following side effects:
Very common:
bleeding of varying severity , externally or internally . You should immediately notify your doctor or nurse. Bleeding can be increased from damage with bleeding, renal failure, or certain medicines taken at the same time;
temporarily increasing the number of platelets.
Common:
decrease the number of platelets in the blood, which in some cases can be dangerous , and you should immediately be reported to your doctor. Therefore, should regularly examine the platelet count .
rare:
retroperitoneal hemorrhage.
When Kleksan used as a healing therapy when blood clots already formed were observed following side effects:

Common:
bleeding of varying severity , externally or internally .
Uncommon:
decrease the number of platelets in the blood.
When Kleksan used in patients at risk of disease of veins ( blood clot in a vein ), or in patients who have the disease with or without pulmonary embolism :

Very common:
bleeding of varying severity , externally or internally ;
temporarily increasing the number of platelets.
Common:
decrease the number of platelets in the blood.
Uncommon:
intracranial haemorrhage ;
retroperitoneal hemorrhage.
When Kleksan be used in patients with certain types of coronary artery disease (unstable angina and myocardial infarction without Q bell ) were reported the following adverse reactions :
Common:
bleeding of varying severity , externally or internally .
Uncommon:
decrease the number of platelets in the blood.
rare:
retroperitoneal hemorrhage.
When Kleksan be used in patients with certain types of coronary artery disease (acute myocardial infarction with ST segment elevation ) were reported the following adverse reactions :
Common:
bleeding of varying severity , externally or internally ;
temporarily increasing the number of platelets ;
decrease the number of platelets in the blood.
Uncommon:
intracranial haemorrhage ;
retroperitoneal hemorrhage.
Very rare:
immuno- allergic thrombocytopenia.
Regardless of indication for use were observed following clinically significant side effects:

Very common:
elevated levels of some liver enzymes in the blood.
Common:
Allergic reactions;
hives , itching, redness ;
bruising , pain and other reactions at the injection site .
Uncommon:
bullous dermatitis;
local irritation , skin necrosis at the injection site .
rare:
local or generalized allergic reactions;
increased levels of potassium in the blood ;
severe skin reactions at the injection site ;
occurrence of nodules (small bumps) on the injection site , which are then spread on naturally and are not a reason for cessation of treatment ;
in rare cases of neurological disorders of varying severity after application of this type of medicine during certain types of anesthesia ;
immuno- allergic thrombocytopenia.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.

5 . HOW TO STORE CLEXANE
Keep out of reach of children.
Kleksan not use after the expiry date stated on the pack .
The expiry date refers to the last day of that month.
Store at temperatures below 25 ° C in the original package .
Do not freeze .

6 . ADDITIONAL INFORMATION
What does Clexane
The active substance is enoxaparin sodium (enoxaparin sodium). Each pre-filled syringe contains enoxaparin sodium 60 mg, corresponding to the 6000 anti-Xa IU / 0.8 ml.
Other ingredients include water for injection.

Clexane looks like and contents of pack
Clexane is a clear, sterile , non-pyrogenic solution for injection in pre-filled syringe.
Packs of 2 or 10 pre-filled syringes.
Not all pack sizes may be marketed.
 
 
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