Gemapaxane injeksi 4000/0.4ml trombosis vena Italfarmaco (6 jarum suntik)

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Spesifikasi Natrium Enoxaparin

Komposisi

Thành phần cho 0.4ml

Informasi komposisi	Isi
Natrium Enoxaparin	4000iu

Migunakake

indikasi

Obat injeksi subkutan Gemapaxane dituduhake ing kasus ing ngisor iki:

Tromboembolisme vena lan trombosis ing pasien kanthi operasi rata-rata lan risiko dhuwur, utamane kasus operasi ortopedi lan operasi sintetik, kalebu operasi kanker. hiperglikemia vena. Steering myocardial infarction (Stemi) kalebu kasus | Pasien diobati karo obat hemolitik utawa sawise intervensi koroner.

Kode ATC: b01ab05.

Enoxaparin minangka turunan heparin molekul rendah kanthi molekul molekul rata-rata udakara 4500 Dalton, kanthi aktivitas anti-trombotik lan aktivitas anti-dinamis saka heparin. Bahan aktif saka persiapan kasebut yaiku uyah natrium.

Riset In vitro babagan organisasi murni, sodium enoxaparin nduweni aktivitas anti-aktif sing dhuwur (udakara 100 IU/mg) lan aktivitas anti-colla utawa aktivitas trombotik sing kurang (udakara 28 IU/mg), kanthi rasio loro zat kasebut yaiku 3,6. Antikoagulan iki dinetralake liwat anti-trombin III (ATIII) kanggo nggawe aktivitas anti-trombotik kanggo awak. Saliyane aktivitas anti-lla/lla, sifat anti-inflamasi lan anti-inflamasi Enoxaparin uga ditemtokake kanggo wong sing sehat lan pasien, uga ing model non-klinis.

Ciri-ciri kasebut kalebu efek inhibisi faktor koagulasi liyane sing gumantung marang ATIII, unsur Vlla, pelepasan inhibitor jaringan (TFPI - Faktor Tissue Pathway Inhitor) saka VWF, minangka faktor penghambat jalur VWF, pembuluh getih endothelial ing sirkulasi. Faktor iki dikenal kanggo kontribusi kanggo efek anti-trombotik sakabèhé saka sodium Enoxaparin. Nalika digunakake ing dosis cadangan, Enoxaparin Sodium ora mengaruhi APTT. Nalika digunakake ing dosis perawatan, ing puncak aktif, APPT bisa tahan udakara 1,5 nganti 2,2 kaping wektu kontrol.

Farmakokinetik dinamis

Karakteristik umum

Parameter farmakokinetik sodium enoxaparin wis diteliti utamane sajrone wektu aktivitas anti-slant ing serum, uga aktivitas anti-colla, ing dosis sing disaranake sawise dosis siji dosis siji utawa injeksi subkutan, uga sawise dosis intravena tunggal. Ngukur aktivitas farmakokinetik Anti-ALA lan Anti-Ca wis ditindakake kanthi metode penilaian amidolitik.

panyerepan

Bioavailability mutlak sodium enoxaparin, adhedhasar aktivitas anti-xa, meh tekan 100% sawise injeksi subkutan. Obat kasebut bisa digunakake miturut indikasi sing beda, rumus lan mode dosis sing beda. Aktivitas Anti-Xa sing diamati yaiku entuk nilai rata-rata maksimal sawise udakara 3-5 jam sawise injeksi subkutan ing dosis 2000 IU, 4000 IU, 100 IU/kg lan 150 IU/kg (setara karo 20 mg, 40 mg, 1 mg/kg lan 1.5 mg/kg).

Nalika ngobati 1 dosis bolus intravena cepet 3000 IU (setara karo 30 mg) disusul 1 dosis 100 IU/kg setara karo 1 mg/kg ing kulit saben 12 jam kanthi asumsi konsentrasi maksimum awal aktivitas anti-xa 1,16 IU/kg (N-16 rata-rata wektu) 88%. Status stabil diraih ing tanggal perawatan kaping 2.

Sawise injeksi, dosis injeksi ing kulit yaiku 4000 IU (40 mg) 1 wektu / dina lan 150 IU / kg (1.5mg / kg) 1 wektu saben dina ing sukarelawan sehat, kahanan stabil stabilitas diraih ing dina kapindho perawatan kanthi rata-rata periode medis 15% luwih dhuwur tinimbang nalika njupuk 1 dosis tunggal. Sawise dosis 100 IU / kg, padha karo 1 mg / kg injeksi subkutan, dielingake kanthi 2 dosis / dina, kondisi stabil konsentrasi obat kasebut diraih sawise 3 nganti 4 dina kanthi wektu kontak medium | Botol kasebut 65% luwih dhuwur tinimbang nggunakake dosis siji lan nilai konsentrasi maksimal maksimal lan nilai ngisor kurva konsentrasi aktivitas anti-xa yaiku 1,2 lan 0,52 IU/mL.

Volume injeksi lan konsentrasi obat antarane 100 - 200 mg/ml ora mengaruhi parameter farmakokinetik ing sukarelawan sehat.

Farmakokinetik Enoxaparin Sodium dianggep linier ing dosis sing disaranake. Bedane farmakokinetik saben pasien lan antarane pasien sithik. Nalika diobati kanthi dosis sing diulang kanthi injeksi subkutan, aja mirsani akumulasi obat kasebut.

Aktivitas anti-colla ing serum sawise injeksi subkutan kira-kira 10 kaping luwih murah tinimbang aktivitas anti-xa. Konsentrasi rata-rata aktivitas anti-lill diamati sawise kira-kira 3 nganti 4 sawise injeksi subkutan lan tekan tingkat konsentrasi 0,13 IU / mL lan 0,19 IU / mL sawise injeksi 100 IU / kg dosis ing kulit 2 kali / dina lan 150 IU / kg dosis 1 wektu / dina.

Distribusi

Volume distribusi enoxaparin natrì diitung kanthi aktivitas anti-xa kira-kira 4,3 l lan cedhak karo volume getih. Metabolisme biologis enoxaparin utamane dimetabolisme ing ati kanthi nyuda sulfat lan/utawa nyuda polimer dadi molekul massa sing luwih murah kanthi nyuda aktivitas biologis sing signifikan.

Eliminasi

Enoxaparin minangka reresik kurang kanthi reresik rata-rata aktivitas anti-xa kira-kira 0,74 l / h sawise 6 jam injeksi intravena 1 dosis 150 IU / kg padha karo 1,5 mg / kg.

Eliminasi obat kasebut ditindakake 1 fase kanthi ekskresi setengah umur kira-kira 5 jam sawise dosis injeksi subkutan lan udakara 7 jam sawise pangeling.

Ekskresi ginjel saka jinis animasi kira-kira 10% saka tingkat perawatan lan total emisi ing ginjel saka aktivitas lan non-aktivitas kira-kira 40% saka dosis perawatan.

Farmakokinetik ing pasien khusus

Sepuh

Adhedhasar asil analisis farmakokinetik ing klompok pasien, cathetan metabolisme Enoxaparin ora nuduhake bedane ing wong tuwa yen dibandhingake karo pasien sing luwih enom ing kahanan fungsi ginjel normal. Nanging, amarga fungsi kelemahane sing dikenal ing wong tuwa, pasien kasebut bisa nyuda ekskresi sodium enoxaparin.

Pasien gagal ati

Ing panaliten sing ditindakake ing pasien sirosis progresif sing diobati karo sodium enoxaparin dosis 4000 IU (padha karo 40 mg), sapisan dina, ana pangurangan maksimal ing kegiatan anti-xa babagan keruwetan karusakan ati (liwat penilaian klasifikasi Child-Pugh). Penurunan fungsi ati iki utamane dituduhake kanthi nyuda konten ATIII sekunder amarga nyuda sintesis ATIII ing pasien gagal ati.

Pasien gagal ginjal

Wong sing diamati duwe korélasi linier antara anti-xa ing plasma lan reresik creatinin ing tingkat keseimbangan konsentrasi, sing nuduhake pangurangan reresik natrium enoxaparin ing pasien kanthi insufisiensi ginjel. Nindakake konsentrasi Anti-Xa dening area ing sangisore kurva, ing negara sing stabil, nuduhake paningkatan cilik banget ing pasien kanthi gangguan ginjel entheng (clearance bun saka 50 - 80 ml / min) lan pasien gangguan ginjel medium (eliminasi bun saka 30 - 50 ml / min) sawise perawatan karo dosis 4000 mg saben dina (4000 mg saben dina), Ing pasien kanthi gangguan ginjel sing abot (reresik

Divisi

Farmakokinetik Enoxaparin Sodium meh padha karo klompok bukti, sawise injeksi intravena tingkat dosis tunggal 25 IU, 50 IU utawa 100 IU/kg (padha karo 0,25mg, 0,5 utawa 1 mg/kg). Nanging, wilayah ing kurva AUC tambah 2 kaping luwih dhuwur tinimbang klompok kontrol.

Bobot pasien

Sawise dosis subkutan 150 IU / kg (setara karo 1,5 mg / kg) 1 wektu / dina, area ing kurva rata-rata aktivitas anti-xa meh mung luwih dhuwur ing negara stabil ing sukarelawan obesitas sehat (BMI 30-48 kg / m2) tinimbang wong sing ora obesitas, dene konsentrasi maksimal Ani-Xa ora nambah. Ana koreksi dosis sing luwih murah gumantung saka bobot reresik ing pasien lemu nalika ngobati injeksi subkutan karo natrium Enoxaparin.

Nalika nuduhake dosis sing ora cocog kanggo pasien, diamati yen sawise injeksi bahan kulit siji 4000 IU (padha karo 40 mg), wektu kontak karo Enoxaparin kurang saka 5 kg tinimbang 5 kg sodium (kurang saka 2% sodium) luwih dhuwur tinimbang natrium. ing wong lanang bobot entheng ( Interaksi farmakokinetik

Ora ana pengamatan interaksi farmakokinetik antarane sodium enoxaparin lan obat sing larut ing getih sajrone perawatan kombinasi.

Sadurunge njupuk Gemapaxane injeksi 4000/0.4ml trombosis vena Italfarmaco (6 jarum suntik)

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: Severe 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): Dosage Dosage mg/kg weight), subcutaneous injection 1 time/day Patients under 75 years of age: Patients over 75 years old: 1 x 3000 IU (30 mg) Fast intravenous bolus + 100 IU/kg (1 mg/kg of weight) injected subcutaneously, repeat the dose of 100 IU/kg (1 mg/kg) injected subcutaneously every 24 hours. Do not conduct fast intravenous bolus + 100 IU/kg (1 mg/kg of weight) injected under the skin, repeating 100 IU/kg (1 mg/kg) injected under the skin every 24 hours. medium and mild kidney failure: Although there is no need to adjust the dose for patients with medium renal impairment (30-50 ml/minute clearance) and bared (50 - 80 ml/min), still need to monitor patients closely during treatment. switch between Enoxaparin sodium and oral anticoagulant The conversion between Enoxaparin Sodium and antifinal anticoagulant drugs (VKA): Need to strengthen monitoring of clinical manifestations and clinical tests in time prothrombin manifest as international index (INR)] Due to the time weighing time for vitamin K anticoagulant drugs to achieve optimal effects, sodium enoxaparin treatment therapy should be maintained at a constant dose as long as possible to maintain the Inr index in the expected treatment between two tests. In patients currently treated with anti -anticoagulant drugs, it is necessary to stop using anticoagulants and indicated the first sodium enoxaparin dose as soon as the INR index is lowered below treatment. The conversion between Enoxaparin Sodium and oral anticoagulants has a direct effect: In patients currently prescribed Enoxaparin sodium, need to stop treating with Enoxaparin sodium and start switching to oral anticoagulant with direct effect (DEAC) in the range of 0 - 2 hours before starting the process with enoxaparin sodium instructions Write on the labels of oral anticoagulants. In patients being treated with direct oral anticoagulant, the first sodium enoxaparin dose should be indicated at the time of starting the next direct anticoagulant dosage. Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? Symptoms Missing overdose after intravenous injection, gastrointestinal or subcutaneous injection, which can cause hemorrhage complications. Using Enoxaparin sodium by oral even in large doses, nor does it have the risk of absorbed drugs. Handling The effectiveness of anticoagulants can be neutralized in large parts through slow intravenous infusion with protamine. The dose of protamine in this case depends on the dose of Enoxaparin sodium injected; Anti-colla activity of 100 IU is equivalent to 1 mg of Enoxaparin is neutralized by 1 mg of protamine if Enoxaparin sodium has been injected earlier 8 hours earlier; A 0.5 mg intravenous inferiority is indicated on 100 IU equivalent to 1 mg of Enoxaparin sodium if Enoxaparin sodium has been injected for more than 8 hours, or in the second dose of protamine is necessary. If Enoxaparin sodium has been injected more than 12 hours earlier, there may be no need to specify protamine. However, even in the case of high doses of protamine, anti-xa activity is also only neutralized up to 60% of the dose. In an emergency, call the 115 emergency center immediately or go to the nearest local health station. What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Efek sisih

Ringkesan sakabèhé keamanan obat

Natrium enoxaparin wis dievaluasi kanggo perawatan luwih saka 150000 pasien liwat uji klinis, ditindakake ing obat referensi. Saka jumlah kasebut, 1776 kasus pencegahan vena jero, diikuti pasien karo pasien bedah ortopedi, operasi abdomen ana ing risiko komplikasi thrombotic; 169 kasus trombosis vena jero ing pasien medis provinsi lan gerakan sing winates banget, 559 kasus perawatan vena jero kanthi utawa tanpa embolisme paru; 1578 Kasus perawatan angina sing ora stabil lan infark miokard gelombang non-Q, lan 10176 kasus perawatan infark miokard provinsi kanthi gelombang ST.

Terapi perawatan natrium enoxaparin ditrapake ing studi klinis iki beda-beda gumantung saka indikasi. Tingkat dosis Enoxaparin sing digunakake yaiku injeksi subkutan 4000 IU, padha karo 40 mg / 1 wektu dina kanggo indikasi kanggo vena jero sawise operasi utawa ing pasien sing ngrangkul perawatan medis sing abot lan larangan motorik sing serius. Ing indikasi kanggo perawatan trombosis vena jero kanthi utawa tanpa embolisme paru, pasien digunakake karo sodium enoxaparin kanthi tingkat 100 IU / kg (setara karo 1 mg / kg) injeksi subkutan saben 12 jam utawa 150 IU / kg, padha karo 1,5 mg / kg injeksi subkutan saben dina. Ing studi klinis babagan perawatan infark miokard akut, ana bedane ST, dosis natrium Enoxaparin digunakake minangka bolus intravena cepet 3000 IU, padha karo 30 mg sabanjure 100 IU / kg, padha karo 1 mg / kg injeksi subkutan saben 12 jam.

Ing studi klinis kasebut ing ndhuwur, thrombocytopenia, thrombosis minangka efek sing ora dikarepake sing dilapurake.

Ringkesan efek sing ora dikarepake

Efek sing ora dikarepake liyane diamati ing studi klinis lan laporan sawise sirkulasi obat (* yaiku efek sing ora dikarepake dilaporake sawise sirkulasi) sing diterangake ing ngisor iki. Frekuensi efek efektif banget populer (≥1/10), populer (≥1/100 nganti

Gangguan getih lan sistem limfatik limfatik:

Popular: Perdarahan, anemia hemoragik*, trombositopenia, trombosit Obat).

gangguan sistem imun:

Populer: Reaksi alergi

Populer: sirah*.

kelainan sirkuit:

Populer: Hematoma ing sumsum tulang belakang ", utawa hematoma ing wilayah saraf. Efek kasebut nyebabake owah-owahan ing tingkat karusakan sistem saraf kalebu mbatesi gerakan utawa kelumpuhan permanen.

Populer banget: Nambah enzim ati (utamane transaminase mundhak luwih saka 3 kaping tingkat kira-kira ing wates normal, eczema, itching) *. (tumor inflamasi, ora ana hubungane karo kista kistik sing disebabake dening natrium Enoxaparin). hyperpass.

Pendarahan

Ana laporan babagan pendarahan, kalebu pendarahan serius, luwih saka 4,2% pasien (pasien bedah). Sawetara kasus bisa nyebabake pati.

Ing pasien bedah, komplikasi pendarahan dianggep gedhe: (1) Yen getihen nyebabake kedadeyan klinis, utawa (2) yen diiringi penurunan hemoglobin getih ≥ 2 g/dl utawa kudu ditularake saka 2 utawa luwih unit produk getih. Pendarahan sawise peritoneal utawa intrakranial dianggep minangka komplikasi gedhe.

Kaya antikoagulan liyane, pendarahan bisa kedadeyan amarga ana faktor risiko gabungan kayata lesi ing lembaga sing bisa nyebabake pendarahan, prosedur perawatan invasif utawa perawatan bebarengan karo obat sing mengaruhi hemostasis.

Efek sing ora dikarepake kanggo bocah cilik

Ora ana data babagan safety lan panggunaan obat kanggo bocah cilik.

Laporan babagan efek sing ora dikarepake

Nglaporake efek sing ora dikarepake sawise sirkulasi obat kasebut penting banget, iki ngidini kanggo terus ngawasi lan ngawasi keseimbangan keuntungan / risiko obat sajrone perawatan. Pakar kesehatan kudu nglaporake efek sing curiga ing sistem pelaporan nasional.

Kabar dhokter babagan efek sing ora dikarepake nalika nggunakake obat kasebut.

Pènget

Sadurunge nggunakake obat kasebut, sampeyan kudu maca instruksi kasebut kanthi teliti lan deleng informasi ing ngisor iki.

kontraindikasi

Injeksi Gemapaxane dikontraindikasi ing kasus ing ngisor iki:

Riwayat alergi marang natrium Enoxaparin, heparin uga heparin bobot molekul rendah liyane. Tumor ganas beresiko dhuwur pendarahan, ngalami operasi otak/utomo/mripat, ana utawa dicurigai vena varikos esophagus, deformitas dinamis vena, aneurisma utawa aneurisma arteri spinalis utawa aneurisma intrakranial.

Ati-ati nalika nggunakake

Peringatan umum

Sodium enoxaparin ora bisa digunakake tinimbang siji liyane (unit liwat unit) amarga beda-beda gumantung saka proses produksi, molekul, aktivitas spesifik anti-xa lan anti-II, dosis lan unit kemasan, efisiensi klinis lan safety. Iki ndadékaké prabédan ing farmakokinetik lan aktivitas biologi sing cocog. Tindakake pandhuan pangguna saben obat tartamtu.

Riwayat pendarahan heparin karo heparin sajrone 100 dina sadurunge.

Contraindicated Enoxaparin ing kasus pasien kanthi riwayat pendarahan thrombocytopenic amarga heparin sajrone 100 dina sadurunge, utawa duwe antibodi ing sirkulasi getih. Antibodi ing sirkulasi getih bisa urip sawetara taun.

Jumlah trombosit

Ana risiko antibodi hemorrhage heparin nalika diobati karo heparin heparin molekul rendah. Ing kasus pendarahan platelet, biasane kedadeyan ing Kamis lan 21 sawise perawatan karo sodium Enoxaparin.

Resiko thrombocytopenia sing disebabake dening heparin luwih dhuwur ing pasien sawise operasi, utamane sawise operasi jantung lan pasien kanker:

Mula, perlu kanggo ngawasi jumlah trombosit pasien sadurunge perawatan karo Enoxaparin uga ngawasi sajrone perawatan.

Yen ana pratandha klinis sing dicurigai nyuda pendarahan hemarin amarga heparin (tahap anyar trombosis arteri lan/utawa vena, lesi sing nyeri ing area kulit, reaksi alergi utawa reaksi anafilaksis sing kedadeyan sajrone perawatan), jumlah trombosit dibutuhake. Pasien uga kudu digatekake babagan risiko gejala ing ndhuwur, lan yen ditemoni, kudu langsung ngandhani dhokter sing nambani.

Kasunyatane, yen ana pratandha yen jumlah trombosit mudhun, mula kudu mandheg ngobati obat kasebut lan ngganti cara perawatan liyane kanthi antikoagulan tanpa heparin.

Pendarahan

Kaya antikoagulan liyane, perawatan sodium enoxaparin uga ana risiko pendarahan. Yen getihen ana, perlu kanggo netepake panyebab pendarahan lan perawatan sing cocog. Natrium enoxaparin, kaya antikoagulan liyane, kudu diobati kanthi ati-ati yen ana risiko pendarahan, utamane:

Masalah hemostatik;

duwe riwayat ulkus lambung;
Tes subklinis
Ing dosis perawatan trombosis vena, Enoxaparin ora mengaruhi wektu getihen lan tes klinis umum babagan fungsi pembekuan getih, uga ora mengaruhi koleksi trombosit utawa kohesi serat fibrin karo trombosit. Ing dosis dhuwur, kahanan nambah wektu aktivasi thromboplastin (wektu APTT) lan wektu aktivasi nggawe gumpalan getih (ACT). Nambah wektu APTT lan wektu pembekuan getih tanpa korélasi linier kanthi paningkatan aktivitas anti-trombotik sodium Enoxaparin lan mulane ora cocog lan ora cocog kanggo ngawasi aktivitas perawatan Enoxaparin.
Anestesi spinal/anesthesia epidural utawa anestesi spinal
Aja nindakake anestesi anestesi spinal utawa deteksi sumsum tulang belakang sajrone 24 jam natrium enozaparin ing tingkat dosis perawatan (deleng bagean panggunaan). Ana laporan babagan komplikasi hematoma subkutan nalika ngobati sodium Snoxaparin sajrone anestesi spinal / anestesi epidural / spinal poking, sing nyebabake watesan gerakan jangka panjang utawa lumpuh. Efek ala iki jarang kedadeyan nalika diobati karo sodium enoxaparin kanthi dosis 4000 IU (padha karo 40 mg) 1 wektu / dina, utawa dosis sing luwih murah. Risiko efek salabetipun luwih dhuwur nalika nempatake pipa njaba ing njero awak lan ngobati obat liya kanthi obat liya sing mengaruhi hemostasis kayata NSAID, karusakan utawa anestesi epidural sing terus-terusan, utawa ngilangi spinal, utawa ing pasien sing duwe riwayat operasi sumsum tulang belakang utawa malformasi balung mburi.
Kanggo nyilikake risiko pendarahan amarga perawatan simultan saka sodium enoxaparin lan teknik anestesi spinal / anestesi epidural utawa nggodha sumsum tulang belakang, farmakokinetik kudu dianggep kanggo farmakokinetik sodium enoxaparin. Panggonan sing paling apik utawa mbusak kateter epidural utawa kateter spinal mung kudu ditindakake nalika efek antikoagulan saka sisa sodium enoxaparin kurang, nanging wektu sing tepat kanggo nggayuh efek antikoagulan ing saben pasien angel ditemtokake. Kanggo pasien kanthi reresik 15 - 30 ml / min, perlu kanggo ngawasi kanthi teliti sajrone perawatan amarga ngilangi obat-obatan ing pasien kasebut.
Nalika nindakake perawatan antikoagulan kanggo pasien karo anestesi spinal, anestesi epidural utawa deteksi sumsum tulang belakang, ngawasi kanthi teliti sajrone proses perawatan kanggo ndeteksi dini pratandha lan gejala karusakan syaraf lan nyeri punggung (kayata nyeri punggung, nyeri punggung, nyeri punggung), perangan awak, kelainan turu, etc perawatan Sy nalika ngalami pratandha ndhuwur. Yen pratandha utawa gejala hematoma ing sumsum balung mburi dicurigai, perlu kanggo langsung diagnosa lan nambani, kalebu pertimbangan kanggo ngurangi tekanan ing sumsum tulang belakang, sanajan perawatan iki ora bisa nyegah utawa mbantu mbalikke cacat neurologis.
Nekrosis kulit/inflamasi kapiler
Ana laporan babagan kasus nekrosis kulit lan inflamasi kapiler nalika diobati karo heparin bobot molekul sing sithik, sing kudu cepet mungkasi perawatan ing kasus kasebut.
Intervensi arteri koroner
Kanggo nyilikake risiko pendarahan nalika intervensi arteri koroner ing perawatan sindrom arteri koroner akut kayata angina ora stabil, infark miokard akut sing bedane tingkat ST utawa ora, kudu ngetutake wektu antarane dosis sodium Enoxaparin. Penting kanggo nggayuh negara keseimbangan ing posisi tusukan sawise nempatake kateter. Yen sampeyan nggunakake tutup kateter, tutup alat timbang dicopot sanalika bisa. Yen nggunakake teknik pencet biasa, cangkang alat kasebut kudu dicopot sajrone 6 jam sawise injeksi sodium Lieu Enoxaparin pungkasan. Yen sampeyan terus ngobati sodium enoxaparin, dosis sabanjure kudu ora luwih saka 6-8 jam sawise ngilangi kasus kasebut. Ngawasi penempatan kateter kanggo mirsani pratandha lan gejala pendarahan utawa trombosis.
Endokarditis akut
Pangobatan heparin ora dianjurake kanggo pasien endokarditis amarga infeksi bakteri akut amarga risiko pendarahan serebral. Yen perlu kanggo milih heparin kanggo pasien kasebut, keputusan perawatan mung ditindakake sawise evaluasi kanthi ati-ati babagan keuntungan - risiko ing saben pasien.
Katup jantung buatan
Panggunaan sodium enoxapain kanggo nyegah trombosis ing pasien karo kardiovaskular buatan durung diteliti kanthi lengkap. Ana laporan babagan sawetara kasus trombosis ing katup jantung buatan ing pasien karo katup buatan sing wis diobati karo sodium enoxaparin kanggo nyegah trombosis. Faktor infus, kalebu patologi sing diiringi utawa kekurangan data klinis, mbatesi evaluasi kasus kasebut. Sawetara kasus dilapurake yen wanita ngandhut minangka subyek sing trombosis bisa nyebabake meteng utawa mati ing bayi anyar.
Njupuk obat kanggo wanita ngandhut sing duwe katup jantung buatan
Saiki ora ana studi lengkap babagan panggunaan sodium enoxaparin kanggo wanita ngandhut kanthi katup jantung buatan kanggo nyegah trombosis. Ing panaliten klinis sing ditindakake ing wanita ngandhut kanthi katup jantung buatan, natrium Enoxaparin 100 IU / kg padha karo 1 mg / kg, 2 kali / dina kanggo ngurangi risiko trombosis, 2 saka 8 subyek isih mbentuk gumpalan getih menyang katup jantung sing clogged lan nyebabake meteng, pati ing bayi. Ana laporan sing kapisah sawise nyebarake obat babagan trombosis ing katup jantung ing wanita ngandhut kanthi katup jantung buatan nalika dituduhake kanggo natrium Enoxaparin kanggo nyegah trombosis. Wanita ngandhut kanthi katup jantung buatan bisa uga dadi klompok trombosis kanthi risiko dhuwur.
Sepuh
Ora ana kecenderungan kanggo nyumbang getihen ing pasien tuwa nalika dikirim | Upacara karo tingkat dosis serep. Pasien tuwa (utamane pasien umur 80 lan luwih lawas, bisa nambah risiko komplikasi pendarahan nalika nggunakake tingkat perawatan. Sampeyan kudu ngawasi awak kanthi klinis lan nyuda bobot bobot kanggo pasien sing umure luwih saka 75 taun kanthi indikasi kanggo infark miokard akut kanthi beda ST.
gagal ginjel
Pasien sing duwe fungsi ginjel cacat duwe kemampuan kanggo nambah wektu ngilangi sodium Enoxaparin, saéngga nambah risiko pendarahan.
Ing pasien kasebut, perlu kanggo ngawasi rapet lan ngawasi fisiologis adhedhasar evaluasi aktivitas anti-xa. Sodium Enoxaparin ora kudu dituduhake kanggo pasien kanthi gagal ginjal tahap pungkasan (reresik
Gagal ati
Ati-ati nalika nuduhake sodium Enoxaparin kanggo pasien gagal ati amarga tambah risiko pendarahan. Penyesuaian dosis adhedhasar tingkat anti-xa ora cukup dipercaya ing pasien sirosis, lan uga ora dianjurake.
Enteng
Ngamati risiko nambah wektu paparan Enoxaparin Sodium nalika diobati kanthi dosis prophylactic (ora dikalibrasi miturut bobot) ing wanita entheng (kurang saka 45 kg) lan lanang bobot entheng (ing 57 kg), bisa nyebabake risiko pendarahan. Mula, kudu dipantau kanthi tliti nalika diobati pasien kasebut.
pasien obesitas
Pasien obesitas yaiku trombosis dhuwur. Riset lan data babagan safety lan efektifitas perawatan pencegahan ing pasien obesitas (BMI> 30 kg / m2) durung disetel kanthi lengkap lan mulane ora cukup otot kanggo nyetel dosis. Ngawasi kanthi rapet kanthi klinis nalika nambani pasien kasebut.
Kalium getih dhuwur
Heparin bisa nyuda penghapusan testoteron adrenal saka kelenjar adrenal, sing nyebabake hiperkalemia ing pasien diabetes, gagal ginjal kronis kanthi asam lambung metabolik, lan pasien sing njupuk obat sing duwe pengaruh marang kalium. Perlu ngawasi konsentrasi kalium getih kanthi rutin nalika diobati, utamane ing pasien sing duwe risiko dhuwur.
Traceability
Preparasi heparin molekul rendah dianggep minangka produk biologis, kanggo nambah traceability sumber heparin heparin molekul rendah, menehi saran marang dokter kanggo nyathet jeneng jeneng Farmasi lan nomer lot saka lot biologis.
Isi sodium
Obat iki ngandhut kandungan sodium kurang saka 1 mmol, padha karo 23 mg/dosis, tegese bisa dianggep ora ana sodium. ”
Efek obat ing nyopir lan ngoperasikake mesin

Obat kasebut ora mengaruhi kemampuan nyopir lan ngoperasikake mesin.
Gunakake obat kanggo wanita nalika meteng lan laktasi

Wanita ngandhut
Ing manungsa, ora ana bukti kanggo ngatasi plasenta obat kasebut ing trimester kapindho lan katelu. Ora ana informasi babagan panggunaan obat kasebut sajrone trimester pisanan. Kéwan eksperimen ora nuduhaké bukti keracunan ing janin, utawa keracunan gen.
Nanging, mung obat kanggo wanita ngandhut nalika dhokter nambani kabutuhan nyata.
Perlu ngawasi perawatan natrium Enoxaparin kanggo wanita ngandhut kanthi ati-ati banget kanggo nyegah pendarahan utawa sensitif marang antikoagulan, wanita ngandhut uga kudu dielingake babagan risiko pendarahan nalika diobati. Umumé, data nganti saiki durung nuduhaké bukti nambah risiko pendarahan, trombositopenia utawa osteoporosis dibandhingake karo risiko pengamatan ing wanita sing ora ngandhut, uga yen dibandhingake karo risiko pengamatan ing wanita ngandhut kanthi katup jantung buatan.
Yen ana anestesi epidural, perlu kanggo mungkasi perawatan miturut sodium regixaparin.
wanita sing nyusoni
Isih ora jelas manawa Enoxaparin minangka ekskresi konstan ing susu manungsa. Ing tikus sing nyusoni, transportasi Enoxaparin lan metabolit menyang susu sithik banget. Penyerapan lisan saka Enoxaparin meh diabaikan. Gemapaxane bisa digunakake nalika nyusoni.
Obat interaktif

Obat sing ora dianjurake
Kanthi obat sing mengaruhi hemostasis sajrone perawatan:
Mungkasi perawatan karo obatan sing mengaruhi hemostasis sadurunge perawatan karo Enoxaparin sodium, kajaba dipeksa kanggo perawatan. Ing kasus perawatan koordinasi, perlu kanggo ngawasi kanthi rapet perawatan karo sodium enoxaparin lan nindakake tes subklinis yen cocog. Efek saka hemostasis kalebu:
Salisilat sistemik, asam acetylsalicylic ing tingkat perawatan anti-inflamasi, NSAID kalebu ketorolac.
Kombinasi obat kudu digunakake kanthi ati-ati
Obat-obatan ing ngisor iki kudu digunakake kanthi ati-ati nalika diobati kanthi kombinasi natrium Enoxaparin:
Inhibitor trombosit, kalebu asam acetylsalicylic nalika digunakake ing tingkat agregasi anti-platelet (tingkat dosis perlindungan jantung), clopidogel, TyClopidine lan antagonis Glycoprotein ILB/LLA digunakake ing perawatan sindrom koroner akut amarga risiko pendarahan. Efek awak glukokortikoid.

Obat sing nambah kalium getih

Perlu ngawasi kanthi teliti nalika ngobati obat-obatan sing nambah kalium getih kanthi kombinasi karo sodium Enoxaparin.

Tyeum obat

injeksi subkutan. Aja nyampur karo persiapan liyane. Dosis intravena cepet bolus (kanggo indikasi infark miokard akut).

Natrium enoxaparin bisa aman yen diobati nganggo larutan garam fisiologis (0,9%) utawa larutan dekstrosa 5% ing banyu.

Panyimpenan

Ing suhu ora ngluwihi 30 ° C, aja nganti beku.

Obat liyane

Disclaimer

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