Gemapaxane injection 4000/0.4ml Italfarmaco venous thrombosis (6 syringe)
Dosage form Box of 6 pieces
Specifications Enoxaparin sodium
Ingredient
Thành phần cho 0.4ml
| Composition information | Content |
| Enoxaparin sodium | 4000iu |
Uses
indications
Gemapaxane's subcutaneous injection drug indicated in the following cases:
Enoxaparin is a low molecular heparin derivative with an average molecular molecule of about 4500 Dalton, with anti -thrombotic activity and anti -dynamic activity of heparin. The active ingredient of the preparation is in the form of sodium salt.
In In vitro research on pure organizations, sodium enoxaparin has high anti-active activity (about 100 IU/mg) and anti-colla activity or low thrombotic activity (about 28 IU/mg), with the ratio of these two substances is 3.6. These anticoagulants are neutralized through anti-thrombin III (ATIII) to create anti-thrombotic activity for the body. In addition to the anti-lla/lla activity, Enoxaparin's anti-inflammatory and anti-inflammatory properties are also determined on healthy people and patients, as well as on the non-clinical model.
These characteristics include the inhibitory effects of other coagulation factors dependent ATIII, the Vlla element, the release of the tissue inhibitors (TFPI - Tissue Factor Pathway Inhitor), as well as reduce the release of the VWF (Von Willebrand) factor from the endothelial blood vessel in the circulation. These factors are known to contribute to the overall anti -thrombotic effect of Enoxaparine sodium. When used in backup dose, Enoxaparine Sodium does not significantly affect APTT. When used at the treatment dose, at the active peak, APPT can last about 1.5 to 2.2 times the control time.
Dynamic pharmacokinetics
General characteristics
Sodium enoxaparin pharmacokinetics parameters have been studied mainly over the time of anti-slant activity in serum, as well as anti-colla activity, at the recommended doses after a single dose of single-dose or subcutaneous injections, as well as after single intravenous doses. Quantifying pharmacokinetic activity of Anti-ALA and Anti-Ca has been carried out by amidolytic assessment method.
absorption
The absolute bioavailability of sodium enoxaparin, based on the activity of anti-xa, almost reaches 100% after subcutaneous injection. The drug can be used according to different indications, different dose formulas and modes. The activity of Anti -Xa observed is to achieve the maximum average value after about 3-5 hours after subcutaneous injection at the doses of 2000 IU, 4000 IU, 100 IU/kg and 150 IU/kg (equivalent to 20 mg, 40 mg, 1 mg/kg and 1.5 mg/kg).
When treating 1 dose of rapid intravenous bolus 3000 IU (equivalent to 30 mg) followed by 1 dose of 100 IU/kg equivalent to 1 mg/kg under the skin every 12 hours with the assumption of the initial maximum concentration of anti-xa activity of 1.16 IU/kg (N-16) and the average time of the stable concentration levels is | 88%. Stable state achieved at the 2nd treatment date.
After the injection, the injection dose under the skin is 4000 IU (40 mg) 1 time/day and 150 IU/kg (1.5mg/kg) 1 time per day on a healthy volunteer, the stable state of the stability is achieved at the second day of treatment with the average medical period of 15% higher than when taking 1 single dose. After a dose of 100 IU/kg, equivalent to 1 mg/kg of subcutaneous injection, it is reminded by 2 doses/day, the stable state of the drug concentration is achieved after 3 to 4 days with medium contact time | The bottle accounts for 65% higher than using a single dose and the maximum maximum concentration value and the bottom value of the curve of anti-xa activity concentration is 1.2 and 0.52 IU/mL.
The volume of injection and drug concentration between 100 - 200 mg/ml does not affect the pharmacokinetic parameters on healthy volunteers.
The pharmacokinetics of Enoxaparin Sodium are considered linear in recommended doses. The difference in pharmacokinetics per patient and between patients is low. When treated with doses repeated by subcutaneous injection, do not observe the accumulation of drugs.
Anti-colla activity in serum after subcutaneous injection is about 10 times lower than the activity of anti-xa. The average concentration of the anti-lill activity is observed after about 3 to 4 after subcutaneous injection and reaches the concentration levels of 0.13 IU/mL and 0.19 IU/mL after the injection of 100 IU/kg doses under the skin 2 times/day and 150 IU/kg doses 1 time/day.
Distribution
The distribution volume of enoxaparin natrì is calculated by anti-xa activity at about 4.3 l and close to the blood volume. Enoxaparin biological metabolism is mainly metabolized in the liver by reducing sulfate and/or reducing polymer into a lower mass molecule with a significant decrease in biological activity.
Elimination
Enoxaparin is a low clearance with the average clearance of anti-xa activity at about 0.74 l/h after 6 hours of intravenous injection 1 dose of 150 IU/kg equivalent to 1.5 mg/kg.
The elimination of the drug takes place 1 phase with half a lifetime excretion is about 5 hours after a dose of subcutaneous injection and about 7 hours after a reminder of.
The renal excretion of animated types accounts for about 10% of the treatment level and the total emissions in the kidneys of both activity and non -activity are about 40% of the dose of treatment.
Pharmacokinetics on special patients
Elderly
Based on the results of pharmacokinetics analysis on a group of patients, Enoxaparin's metabolism records do not show the difference in the elderly when compared to younger patients under normal renal function conditions. However, due to the known function of weakening in the elderly, these patients may have a reduction in sodium enoxaparin excretion.
Patients with liver failure
In a study conducted in patients with progressive cirrhosis treated with sodium enoxaparin dose of 4000 IU (equivalent to 40 mg), once a day, there is a maximum reduction in the anti-xa-related activity regarding the severity of liver damage (through the Child-Pugh classification assessment). This liver function decrease is mainly shown in reducing secondary ATIII content due to the reduction of ATIII synthesis in patients with liver failure.
Patients with renal failure
Observed people have a linear correlation between anti-xa in plasma and creatinin's clearance at the equilibrium level of concentration, which shows the reduction of the clearance of enoxaparin sodium in patients with renal insufficiency. Performing the concentration of Anti -Xa by the area under the curve, in a stable state, shows a very small increase in patients with mild renal impairment (creatinine clearance from 50 - 80 ml/min) and medium renal impairment patients (creatinine elimination from 30 - 50 ml/min) after treatment with 4000iu doses (equivalent to 40 mg), once a day. In patients with severe renal impairment (clearance
Division
The pharmacokinetics of Enoxaparin Sodium are almost similar to the evidence group, after intravenous injection of single dose levels 25 IU, 50 IU or 100 IU/kg (equivalent to 0.25mg, 0.5 or 1 mg/kg). However, the area under the AUC curve increased 2 times higher than the control group.
Patient weight
After the subcutaneous dose of 150 IU/kg (equivalent to 1.5 mg/kg) 1 time/day, the area under the average curve of the anti-xa activity is almost only higher in stable state in healthy obesity volunteers (BMI 30-48 kg/m2) than non-obese people, while the maximum concentration of the Ani-Xa activity does not increase. There is a lower dose correction depend on the weight of the clearance on obese patients when treating subcutaneous injection with Enoxaparin sodium.
When indicating unproperable doses for patients, it is observed that after an injection of a single -skinned material 4000 IU (equivalent to 40 mg), the time of contact with Enoxaparin sodium in lightweight women (less than 45 kg) increases higher than 52% and in mild weight men ( Pharmacokinetic interaction
There has been no observation of pharmacokinetic interaction between sodium enoxaparin and blood soluble drugs during combination treatment.
Before taking Gemapaxane injection 4000/0.4ml Italfarmaco venous thrombosis (6 syringe)
How to use
Gemapaxane subcutaneous injection is injected deep under the skin in treatment and prophylaxis, intravenous injection (in patients with myocardial infarction, the initial venous dosage is used), and injected into the blood vessel (into the tube of the fertilizer system connected to the artery in artificial dialysis).
Gemapaxane subcutaneous injection is not used in intriguing.
Injection technique
Should take medication under the skin in the skin in preventing the formation of blood clots after surgery, treatment of deep vein thrombosis and pulmonary embolism, unstable angina treatment and no difference.
In the treatment of ST -acute coronary syndrome, starting with a venous bolus injection, and followed by a subcutaneous dose of subcutaneous injection. In the provision for forming blood clots during the body's circulation, injecting into the blood vessels (into the tube of the system of the fertilizer connected to the artery in dialysis).
The type of syringe is closed to use immediately.
Injection technique:
Should be injected when the patient is lying. Epoxaparin sodium drugs are indicated for deep skin injection.
If there is no excess volume, do not push air bubbles before the injection to avoid losing data when using the pre -closed syringe. In case of adjusting the dose according to the weight of the patient, using the division lines on the pre -closed syringe and removing the excess solution before proceeding with the injection. Note, in some cases, the exact volume may not be counted based on the degrees of the pre -closed syringe, in these cases, round the volume in the syringe to the nearest division line.
The normal injection site is the front and rear of the waist area, rotating on the left and right. Pinch and hold the abdominal wall with the thumb and index finger, put the perpendicular needle, not to be tilted and stabbed along the length of the needle into the skin. Still pinching skin until the injection is complete. Do not rub on the injection site after injection.
In case of self -treatment, patients should be recommended closely follow the instructions in the instruction sheet with the accompanying product.
Dosage
Preventive treatment of venous thrombosis on patients with average or high surgery:
In patients at risk of medium thrombosis, the recommended dose of Enoxaparin Sodium is 2000 IU (equivalent to 20 mg) or 4000 IU (equivalent to 40 mg), once a day. In case of surgery, the starting dose of enoxaparin sodium 2 hours before surgery has been shown to be effective and safe in patients with average surgical risk.
In patients with high risk of thrombosis or thrombosis (eg orthopedic surgery), the recommendations of Enoxaparin sodium are 4000 IU (equivalent to 40 mg)/time, once a day with the first dose of starting before surgery 12 hours.
In case of an enoxaparin sodium injection before surgery than 12 hours earlier (for example, high risk patients are waiting for orthopedic surgery), the last dose must be performed no later than 12 hours before surgery and a 12 -hour surgical dose.
In patients who have large orthopedic surgery, prolonging the prophylaxis for up to 5 weeks is necessary.
On patients at risk of large vein thrombosis undergoing abdominal surgery or pelvic area in the case of cancer, prolonging prophylaxis after 4 weeks is necessary.
Venous thrombosis in medical patients:
The indicated dose is the sodium enoxaparin is 4000 IU (equivalent to 40 mg) once a day, according to the subcutaneous injection. The treatment period is from 6 to 14 days until the symptoms are improved (for example, motor status). There is no effect on evaluating the effectiveness of treatment for over 14 days.
Treatment of deep vein thrombosis with or without any embolism:
The treatment of Enoxaparin Sodium is 150 IU/kg body weight (1.5 mg/kg/time, once a day or 100 IU/kg body weight (1 mg/kg)/time x 2 times/day by subcutaneous injection. In the risk of low thrombosis. 100 IU/kg (1 mg/kg) x 2 times/day should be indicated for all other cases such as obesity patients, patients with symptoms
Sodium Enoxaparin treatment is indicated for an average of 10 days. The oral anticoagulant therapy can start when appropriate.
Blood prevention outside the body during dialysis:
The recommended dose is 100 IU/kg equivalent to 1 mg/kg enoxaparin sodium. In patients with high risk of bleeding, the dose should be reduced to 50 IU/kg, equivalent to 0.5 mg injected into 2 pipes of the artery line or 0.75 IU/kg equivalent to 75 mg/kg (injected into one side of the cord).During treatment, enoxaparin should be injected into the tube connected to the artery line as soon as a cycle of fertilizer. This dose is usually only enough for 4 hours. However, if the fibrin ring appears, for example, in the case of a longer than normal than usual appraisal, enoxaparin can be added at a dose of 50 - 100 IU/kg (equivalent to 0.5 - 1 mg/kg).
There is currently no data in patients using Enoxaparin for prophylaxis or treatment and during the process of mitosis.
Acute coronary disease:
Treatment of unstable angina, myocardial infarction without Q wave, myocardial infarction but St different.
Treatment of unstable angina, myocardial infarction without Q:
Recommended subcutaneous injections at a dose of 100 IU/kg body in 1 mg/kg every 12 hours, combined with anti -platelet aggregation drugs. The minimum treatment takes up to 2 days and is continued until clinical stable symptoms are achieved. The normal treatment time lasts from 2 - 8 days.
Recommendation of the use of acetylsalicylic acid for all patients without contraindications with the initial loading dose is 150 - 300 mg/kg and the maintenance dose lasts 75 - 235 mg/kg regardless of the treatment strategy.
Treatment of ST wave myocardial infarction is different: The recommended dose is the initial intake of 3000 IU venous boluses, equivalent to 30 mg, followed by the subcutaneous dose of 100 IU/kg equivalent to 1 mg/kg, and then continue subcutaneous injection after every 12 hours (maximum 100 mg for every 2 doses of subcellular). Applying anti-oral anti-plateletal drugs at the same time, for example, acetylsalicylic acid (75-325 mg once daily) unless there is contraindications. The treatment can last up to 8 days or until discharged. When treated simultaneously with a hemolysis (specific with fibrin or non -fibrin), the enoxaparin injection should be conducted in a period of 15 minutes ago and 30 minutes after starting with hemolysis.
Using drugs on special patients:
In patients who are using coronary intervention (PCI), if the end of the sodium enoxaparin dose is injected less than 8 hours before opening the coronary joke, there is no additional dose of an additional dose. If the last dose is injected subcutaneously before the ball over 8 hours, it is necessary to indicate 1 dose of fast intravenous bolus 30 IU/kg equivalent to 0.3 mg/kg.
Children: Use drugs in young children, safe and effective of using Enoxaparin sodium on children who have not been set up.
Elderly: Using drugs in the elderly for all indications except for acute myocardial infarction with stiff waves, no need to adjust the dose in the elderly, unless the kidney function is damaged.
Patients with hepatic failure: still limiting the data of drug use in patients with liver failure, need to apply caution measures in the treatment of drugs for patients with liver failure.
Patients with renal failure:
It is not recommended that the indication of Enoxaparin sodium in patients with end -stage renal impairment patients (clearance of less than 15 ml/min) due to lack of clinical data on prevention of thrombosis on these patients during blood circulation in blood vessels in the fertilizer.
Dosage indicated for severe kidney failure (clearance from 15 - 30 ml/minute):
Side Effects
Overall summary of drug safety
Enoxaparin sodium has been evaluated for treatment on more than 150000 patients through clinical trials, performed on reference drugs. Of these, 1776 cases of deep vein prevention, followed by patients with orthopedic surgery patients, abdominal surgery is at risk of thrombotic complications; 169 cases of deeply venous thrombosis in provincial medical patients and seriously limited movement, 559 cases of treatment of deep veins with or without pulmonary embolism; 1578 Cases of unstable angina treatment and non -Q wave myocardial infarction, and 10176 cases of provincial myocardial infarction treatment with ST wave.
Sodium enoxaparin treatment therapy applies in these clinical studies varies depending on indications. The level of Enoxaparin dose used is a 4000 IU subcutaneous injection, equivalent to 40 mg/1 time a day for indications for deep veins after surgery or in patients who are hugging severe medical treatment and serious motor restrictions. In the indication for treatment of deep vein thrombosis with or without pulmonary embolism, the patient is used with sodium enoxaparin with a level of 100 IU/kg (equivalent to 1 mg/kg) of subcutaneous injection every 12 hours or 150 IU/kg, equivalent to 1.5 mg/kg subcutaneous injection 1 time/day. In clinical study on the treatment of acute myocardial infarction, there is a difference of ST, the dose of Enoxaparin sodium is used as rapid intravenous bolus 3000 IU, equivalent to the next 30 mg of 100 IU/kg, equivalent to 1 mg/kg subcutaneous injection every 12 hours.
In the aforementioned clinical studies, thrombocytopenia, thrombosis are unwanted effects that are reported.
Summary of unwanted effects
Other undesirable effects are observed in clinical studies and reports after the circulation of drugs (*are unwanted effects reported after circulation) described as below. The frequency of the effective effects is very popular (≥1/10), popular (≥1/100 to
Blood disorders and lymphatic lymphatic system:
immune system disorders:
circuit disorders:
Bleeding
There have been reports on bleeding, including serious bleeding, over 4.2% of patients (surgical patients). Some cases can lead to death.
On surgical patients, hemorrhage complications are considered large: (1) If the bleeding causes clinical events, or (2) if accompanied by a decrease in blood hemoglobin ≥ 2 g/dl or need to be transmitted from 2 or more units of blood products. The hemorrhage after the peritoneal or intracranial is considered large complications.
Like other anticoagulants, hemorrhage can occur in the presence of combined risk factors such as lesions at the agency that is likely to cause bleeding, invasive treatment procedures or simultaneous treatment with drugs affecting hemostasis.
Unwanted effects on young children
There is no data on safety and use of drugs on young children.
Report on unwanted effects
Reporting unwanted effects after circulation of the drug is very important, this allows to continue monitoring and monitoring the balance of benefits/risks of the drug in treatment. Health experts are required to report any suspicious effect on the national reporting system.
Notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Gemapaxane injection is contraindicated in the following cases:
Caution when using
General warning
Sodium enoxaparin cannot be used instead of each other (units through the unit) because they vary depending on the production process, molecule, the specific activity of anti-xa and anti-II, dosage and packaging units, clinical efficiency and safety. This leads to the difference in pharmacokinetics and corresponding biological activity. Strictly follow the user guide of each specific drug.
History of heparin hemorrhage with heparin within 100 days earlier.
Contraindicated Enoxaparin in the case of patients with a history of thrombocytopenic hemorrhage due to heparin within 100 days earlier, or have antibodies in blood circulation. Antibodies in blood circulation may survive a few years.
Platelet count
There is a risk of heparin hemorrhage antibodies when treated with low molecular heparin heparin. In case of plateletal hemorrhage, usually takes place on Thursday and 21 after treatment with Enoxaparin sodium.
The risk of thrombocytopenia caused by heparin is higher in patients after surgery, mainly after heart surgery and cancer patients:
Therefore, it is necessary to monitor the number of platelets of the patient before treatment with Enoxaparin as well as monitor during treatment.
If there are clinical signs suspected of hemarin reduced hemorrhage due to heparin (new stages of arterial thrombosis and/or veins, painful lesions in the skin area, any allergic reactions or anaphylactic reactions occur during treatment), platelet count is needed. Patients should also be noted about the risk of the above symptoms, and if encountered, it is necessary to immediately notify their treating doctor.
In reality, if there are signs of affirming the number of platelets decreases, it is necessary to stop treating the drug and change to a different treatment method with heparin -free anticoagulants.
Bleeding
Like other anticoagulants, sodium enoxaparin treatment is also at risk of bleeding. If bleeding occurs, it is necessary to assess the cause of bleeding and appropriate treatment.
Enoxaparin sodium, just like other anticoagulants, should be treated carefully in cases of increased risk of bleeding, specifically:
Subclinical tests
In the dosage of venous thrombosis treatment, Enoxaparin does not significantly affect the bleeding time and general clinical tests on blood clotting function, nor does it affect the collection of platelets or the cohesion of fibrin fibers with platelets. In high doses, the situation of increasing time activation of thromboplastin (APTT time) and activation time creates blood clots (ACT). Increasing APTT time and blood clotting time without linear correlation with an increase in the anti -thrombotic activity of Enoxaparin sodium and therefore inappropriate and inappropriate enough to monitor Enoxaparin's treatment activity.
Spinal anesthesia/epidural anesthesia or spinal anesthesia
Do not perform spinal anesthesia anesthesia anesthesia or spinal cord detection within 24 hours of sodium enozaparin at the treatment dose level (see the use section). There have been reports on subcutaneous hematoma complications when treating sodium Snoxaparin during spinal anesthesia/epidural anesthesia/spinal poking, leading to long -term movement restrictions or paralysis. These adverse effects rarely occur when treated with sodium enoxaparin at a dose of 4000 IU (equivalent to 40 mg) 1 time/day, or lower dose. The risk of adverse effects occurs higher in the case of placing an outer pipe inside the body and treating other drugs with other drugs that affect the hemostasis such as NSAIDs, damage or continuing epidural anesthesia, or spinal removal, or in patients who have a history of spinal cord surgery or spinal malformation.
To minimize the risk of bleeding due to simultaneous treatment of sodium enoxaparin and spinal anesthesia techniques/epidural anesthesia or spinal cord teasing, the pharmacokinetics should be considered for the pharmacokinetics of the sodium enoxaparin. The best placement or removal of epidural catheter or spinal catheter should only be done when the anticoagulant impact of the remaining sodium enoxaparin is low, however, the exact time to reach the time of anticoagulant effect on each patient is difficult to determine. For patients with clearance of 15 - 30 ml/min, it is necessary to monitor more closely during treatment due to elimination of drugs in these patients.
When conducting the treatment of anticoagulants for patients with spinal anesthesia, epidural anesthesia or spinal cord detection, closely monitoring during the treatment process to early detect any signs and symptoms of nerve damage such as spinal pain (vertical back), sensory disorders and exercise functions such as fatigue, weak limbs, sleep disorders, etc. Sy treatment when experiencing the above signs. If the signs or symptoms of hematoma in the spinal cord are suspected, it is necessary to immediately diagnose and treat it, including a consideration of reducing pressure on the spinal cord, even if this treatment may not prevent or help reverse the neurological defects.
Skin necrosis/capillary inflammation
There have been reports on cases of skin necrosis and capillary inflammation when treated with low molecular weight heparin, which should quickly stop the treatment in these cases.
Coronary artery intervention
To minimize the risk of bleeding when intervention of coronary artery intervention in the treatment of acute coronary artery syndrome such as unstable angina, acute myocardial infarction whose difference of ST rates or not, need to closely follow the time between the doses of Enoxaparin sodium. It is important to reach the equilibrium state in the puncture position after placing the catheter. If you use a catheter closure, the cover of the weighing tool is removed as soon as possible. In case of using regular pressing techniques, the shell of the tool should be removed within 6 hours after the last Lieu Enoxaparin sodium injection. If you continue to treat with sodium enoxaparin, the next dose must not be later 6-8 hours after removing the case. Monitor the catheter placement to observe the signs and symptoms of bleeding or thrombosis.
Acute endocarditis
Heparin treatment is not recommended in patients with endocarditis due to acute bacterial infections due to the risk of cerebral hemorrhage. In case of need to appoint heparin for these patients, treatment decisions are only done after careful evaluation of benefits - risks in each patient.
Artificial heart valve
The use of sodium enoxapain to prevent thrombosis in patients with artificial cardiovascular has not been fully studied. There have been reports on some cases of thrombosis at artificial cardiac valves in patients with artificial valves that have been treated with sodium enoxaparin to prevent thrombosis. Infusion factors, including the accompanying pathologies or the lack of clinical data, limit the evaluation of these cases. Some of the cases are reported that pregnant women are subjects whose thrombosis can cause pregnancy or death in newborns.
Take drugs on pregnant women with artificial cardiac valves
There is currently no full study of the use of sodium enoxaparin for pregnant women with artificial cardiac valves to prevent thrombosis. In a clinical study conducted in pregnant women with artificial cardiac valves, received Enoxaparin sodium 100 IU/kg equivalent to 1 mg/kg, 2 times/day to reduce the risk of thrombosis, 2 of the 8 subjects still forming blood clots to the heart valve clogged and causing pregnancy, death in infants. There have been separate reports after circulating drugs about the thrombosis in the heart valve on pregnant women with artificial cardiac valves when indicated for Enoxaparin sodium in the prevention of thrombosis. Pregnant women with artificial cardiac valves may be a high -risk group of thrombosis.
Elderly
There is no tendency to donate bleeding in elderly patients when being dispatched | Ceremony with backup dose levels. Elderly patients (especially patients aged 80 and older, may increase the risk of bleeding complications when using the levels of treatment. It is necessary to monitor the body in clinical and reduce the weight of the weight for patients over 75 years old with the indication for acute myocardial infarction with the difference of ST.
kidney failure
Patients with renal impairment have the ability to increase the time of elimination of Enoxaparin sodium, thus increasing the risk of bleeding.
In these patients, it is necessary to closely monitor and physiological monitoring based on the activity evaluation of anti-xa. Sodium Enoxaparin should not be indicated for patients with end -stage renal impairment (clearance
Hepatic failure
Be cautious when indicating Enoxaparin sodium for patients with liver failure due to increased risk of bleeding. The adjustment of the dose based on the level of anti-xa is not enough reliable basis in cirrhosis patients, and also not recommended.
Lightweight
Observed the risk of extending the time of exposure to Enoxaparin Sodium when treated at a prophylactic dose (not calibrated according to weight) on lightweight women (less than 45 kg) and mild weight men (under 57 kg), can lead to the risk of increased bleeding. Therefore, it is necessary to closely monitor when treated on these patients.
obesity patients
Obese patients are high thrombosis. Research and data on safety and effectiveness in preventive treatment in obese patients (BMI> 30 kg/m2) have not been fully set and therefore not enough muscle to adjust the dose. Clinically closely monitoring when treating these patients.
High blood potassium
Heparin can slow down the elimination of the adrenal testoteron from the adrenal gland, leading to hyperkalemia in patients with diabetes, chronic renal failure with metabolic stomach acid, and patients who are taking drugs that have a effect on potassium. Need to monitor the concentration of blood potassium regularly when treated, especially on high -risk patients.
Traceability
Low molecular heparin preparations are considered as biological products, to improve the traceability of the source of low molecular heparin heparin, advising doctors to record the name of the Pharmaceutical name and the lot number of the biological lot.
Sodium content
This drug contains sodium content of less than 1 mmol, equivalent to 23 mg/dose, meaning it can be considered as no sodium. ”
The effect of the drug on driving and operating machinery
The drug does not affect the ability to drive and operate machinery.
Use drugs for women during pregnancy and lactation
Pregnant women
On humans, there is no evidence of the overcome the placenta of the drug in the second and third trimester. There is no information about the use of the drug during the first trimester. The experimental animals do not show any evidence of toxicity on the fetus, or gene toxicity.
However, only medication for pregnant women when the doctor treats the real need.
Need to monitor Enoxaparin sodium treatment for pregnant women is very careful to prevent bleeding or sensitive to anticoagulants, pregnant women also need to be warned about the risk of bleeding when treated. In general, data so far has not yet shown evidence of increasing the risk of bleeding, thrombocytopenia or osteoporosis compared to the risk of observation in non -pregnant women, as well as when compared to the risks of observation in pregnant women with artificial cardiac valves.
If an epidural anesthetic is available, it is necessary to stop treating with sodium enoxaparin according to the regimen.
breastfeeding women
It is still unclear whether the Enoxaparin is constant excretion in human milk. In breast -feeding mice, Enoxaparin's transportation and its metabolites into milk are very few. The oral absorption of Enoxaparin is almost negligible. Gemapaxane can be used during breastfeeding.
Interactive drug
Not recommended drugs
With drugs that affect hemostasis during treatment:
Stop treatment with drugs that affect hemostasis before treatment with Enoxaparin sodium, unless forced to be required for treatment. In case of coordination treatment, it is necessary to closely monitor the treatment with sodium enoxaparin and conduct subclinical tests when appropriate. The effects of hemostasis include:
Medication combination should be used with caution
The following drugs should be used carefully when treated in combination with Enoxaparin sodium:
Medications that increase blood potassium
Need to monitor closely when treating drugs that increase blood potassium in combination with Enoxaparin sodium.
Tyeum of drugs
subcutaneous injection. Do not mix with other preparations. Bolus fast intravenous dose (for acute myocardial infarction indication).
Enoxaparin sodium can be safe when treated with physiological saline solution (0.9%) or a 5% dextrose solution in water.
Storage
At a temperature not exceeding 30 ° C, avoid freezing.
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