natgillin/translations-raw huggingface dataset:
Initiate dosing with 75 IU/kg (0.75 mg/kg) subcutaneously every 12 hours (maximum 7,500 IU (75 mg) for each of the first two subcutaneous doses only, followed by 75 IU/kg (0.75 mg/kg) subcutaneous dosing for the remaining doses).
Odmerjanje začnite s 75 i.e./kg (0,75 mg/kg) subkutano na 12 ur (največ 7.500 i.e. (75 mg) za vsakega od prvih dveh subkutanih odmerkov, nato pa 75 i.e./kg (0,75 mg/kg) subkutano za preostale odmerke).
• For treatment of unstable angina and NSTEMI, the recommended dose of enoxaparin sodium is 100 IU/kg (1 mg/kg) every 12 hours by subcutaneous injection administered in combination with antiplatelet therapy.
• Za zdravljenje nestabilne angine pektoris in NSTEMI je priporočeni odmerek natrijevega enoksaparinata 100 i.e./kg (1 mg/kg) na 12 ur v subkutani injekciji, dani v kombinaciji z antiagregacijskim zdravljenjem.
• In patients at moderate risk of thromboembolism, the recommended dose of enoxaparin sodium is 2,000 IU (20 mg) once daily by subcutaneous injection.
• Za bolnike z zmernim tveganjem za trombembolijo je priporočeni odmerek natrijevega enoksaparinata 2.000 i.e. (20 mg) enkrat na dan v subkutani injekciji.
To avoid the possible mixture of enoxaparin sodium with other drugs, the intravenous access chosen should be flushed with a sufficient amount of sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose solution prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug.
Da boste preprečili možno mešanje natrijevega enoksaparinata z drugimi zdravili, morate intravenski dostop sprati z zadostno količino raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze, in sicer pred dajanjem intravenskega bolusa natrijevega enoksaparinata in po njem, da boste nastavek očistili zdravila.
90 pre-filled syringes
90 napolnjenih injekcijskih brizg
The Inhixa pre-filled syringes are for single dose use only.
Napolnjene injekcijske brizge zdravila Inhixa vsebujejo en sam odmerek.
Prophylaxis of venous thromboembolism in medical patients The recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily by subcutaneous injection.
Profilaksa venske trombembolije pri nekirurških bolnikih Priporočeni odmerek natrijevega enoksaparinata je 4.000 i.e. (40 mg) enkrat na dan v subkutani injekciji.
Inhixa 50,000 IU (500 mg)/5 mL
Inhixa 50.000 i.e. (500 mg)/5 ml
Following repeated subcutaneous administration no accumulation takes place.
Po ponavljajoči se subkutani uporabi se zdravilo ne kopiči.
Inhixa 30,000 IU (300 mg)/3 mL solution for injection in multidose vial Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose vial Inhixa 100,000 IU (1000 mg)/10 mL solution for injection in multidose vial enoxaparin sodium
Inhixa 30.000 i.e. (300 mg)/3 ml raztopina za injiciranje v večodmerni viali Inhixa 50.000 i.e. (500 mg)/5 ml raztopina za injiciranje v večodmerni viali Inhixa 100.000 i.e. (1000 mg)/10 ml raztopina za injiciranje v večodmerni viali natrijev enoksaparinat
10) Drop the used syringe into the sharps container.
10) Uporabljene injekcijske brizge odložite v zabojnik za ostre predmete.
• Acetylsalicylic acid is recommended for all patients without contraindications at an initial oral loading dose of 150-300 mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75-325 mg/day long-term regardless of treatment strategy.
• Acetilsalicilna kislina je priporočljiva za vse bolnike brez kontraindikacij, in sicer v začetnem peroralnem polnilnem odmerku od 150 do 300 mg (pri bolnikih, ki še niso prejemali acetilsalicilne kisline) in v vzdrževalnem odmerku od 75 - 325 mg/dan dolgoročno, ne glede na strategijo zdravljenja.
*p value versus placebo =0.008 #p value versus placebo =0.537
*Vrednost p v primerjavi s placebom = 0,008 #Vrednost p v primerjavi s placebom = 0,537
Obese Patients
Debeli bolniki
Pregnant women with mechanical prosthetic heart valves The use of enoxaparin sodium for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied.
Nosečnice z mehaničnimi protetičnimi srčnimi zaklopkami Uporaba natrijevega enoksaparinata za tromboprofilakso pri nosečnicah z mehaničnimi protetičnimi srčnimi zaklopkami ni ustrezno raziskana.
Monitoring of platelet counts
Nadziranje števila trombocitov
• Proximal DVT
Proksimalne GVT
Inhixa 15,000 IU (150 mg)/ mL
Inhixa 15.000 i.e. (150 mg)/ ml
In a double blind multicentre, parallel group study, enoxaparin sodium 2,000 IU (20 mg) or 4,000 IU (40 mg) once a day subcutaneously was compared to placebo in the prophylaxis of DVT in medical patients with severely restricted mobility during acute illness (defined as walking distance of <10 meters for ≤3 days).
V dvojno slepi, multicentrični študiji vzporednih skupin so natrijev enoksaparinat v odmerkih 2.000 i.e. (20 mg) ali 4.000 i.e. (40 mg) enkrat na dan subkutano primerjali s placebom za profilakso GVT pri nekirurških bolnikih z zelo omejeno mobilnostjo med akutno boleznijo (opredeljeno kot prehojena razdalja < 10 metrov ≤ 3 dni).
At doses used for prophylaxis
V odmerkih, ki se uporabljajo za profilakso
Solution for injection in multidose vial Clear, colourless to pale yellow solution.
raztopina za injiciranje v večodmerni viali Bistra, brezbarvna do bledo rumena raztopina.
• Headache.
• Glavobol
When the quantity of drug to be injected requires to be adjusted based on the patient's body weight, the graduated pre-filled syringes should be use to reach the required volume by discarding the excess before injection.
Če potrebna količina zdravila za injiciranje zahteva prilagoditev glede na bolnikovo telesno maso, je treba uporabiti graduirano napolnjeno injekcijsko brizgo, s katero boste potrebno količino dosegli tako, da boste pred injiciranjem zavrgli odvečno količino.
Inhixa 4,000 IU (40 mg)/0.4 mL
Inhixa 4.000 i.e. (40 mg)/0,4 ml
Acetylsalicylic acid is recommended for all patients without contraindications at an initial oral loading dose of 150-300 mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75-325 mg/day long-term regardless of treatment strategy.
Acetilsalicilna kislina je priporočljiva za vse bolnike brez kontraindikacij, in sicer v začetnem peroralnem polnilnem odmerku od 150 do 300 mg (pri bolnikih, ki še niso prejemali acetilsalicilne kisline) in v vzdrževalnem odmerku od 75 - 325 mg/dan dolgoročno, ne glede na strategijo zdravljenja.
Do not use Inhixa - if you are allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na natrijev enoksaparinat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Inhixa can be added to the tube leaving the body (arterial line) at the start of the dialysis session.
• Zdravilo Inhixa se lahko na začetku dialize da v cevko, ki vodi iz telesa (v arterijsko linijo).
Your pre-filled syringe has a needle guard attached to it in order to protect you from needle stick injury.
Vaša napolnjena injekcijska igla je opremljena s spripomočkom za zaščito igle, ki služi za zaščito pred vbodom z iglo.
Inhixa 30,000 IU (300 mg)/3 mL
Inhixa 30.000 i.e. (300 mg)/3 ml
For the prophylaxis of venous thromboembolic disease following surgery, treatment of DVT and PE, treatment of unstable angina and NSTEMI, enoxaparin sodium should be administered by subcutaneous injection.
Za profilakso venske trombembolične bolezni po operaciji, za zdravljenje GVT in PE ter za zdravljenje nestabilne angine pektoris in NSTEMI je treba natrijev enoksaparinat injicirati subkutano.
CARTON (Packs of 2, 10 or 30)
ŠKATLA (pakiranja po 2, 10 ali 30)
Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, careful clinical monitoring is advised.
Čeprav pri bolnikih z zmerno (očistek kreatinina 30-50 ml/min) ali blago (očistek kreatinina 50-80 ml/min) okvaro ledvic odmerka ni treba prilagoditi, je priporočljivo natančno klinično spremljanje.
• For treatment of acute STEMI, the recommended dose of enoxaparin sodium is a single intravenous bolus of 3,000 IU (30 mg) plus a 100 IU/kg (1 mg/kg) subcutaneous dose followed by 100 IU/kg (1 mg/kg) administered subcutaneously every 12 hours (maximum 10,000 IU (100 mg) for each of the first two subcutaneous doses).
• Za zdravljenje akutnega STEMI je priporočeni odmerek natrijevega enoksaparinata enkraten intravenski bolus 3.000 i.e. (30 mg) in 100 i.e./kg (1 mg/kg) subkutano, nato pa 100 i.e./kg (1 mg/kg) subkutano na 12 ur (največ 10.000 i.e. (100 mg) za vsakega od prvih dveh subkutanih odmerkov).
• In patients at high risk of thromboembolism, the recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily given by subcutaneous injection preferably started 12 hours before surgery.
• Če ima bolnik veliko tveganje za trombembolijo, je priporočeni odmerek natrijevega enoksaparinata 4.000 i.e. (40 mg) enkrat na dan v subkutani injekciji; uporaba naj se po možnosti začne 12 ur pred operacijo.
Each mL contains 150 mg enoxaparin sodium.
En ml vsebuje 150 mg natrijevega enoksaparinata.
For all indications except STEMI, no dose reduction is necessary in the elderly patients, unless kidney function is impaired (see below paragraph “Renal impairment” and section 4.4).
Starejšim bolnikom odmerka ni treba zmanjšati za nobeno indikacijo razen za STEMI; izjema so bolniki, ki imajo okvarjeno delovanje ledvic (glejte spodnji odstavek "Okvara ledvic" in poglavje 4.4).
In moderate risk patients, enoxaparin sodium treatment should be maintained for a minimal period of 7-10 days whatever the recovery status (e.g. mobility).
Pri bolnikih z zmernim tveganjem je treba zdravljenje z natrijevim enoksaparinatom nadaljevati vsaj še 7 do 10 dni, ne glede na stanje okrevanja (npr. mobilnost).
Inhixa 6,000 IU (60 mg)/0.6 mL
Inhixa 6.000 i.e. (60 mg)/0,6 ml
Enoxaparin sodium can be administered subcutaneously either as a once daily injection of 150 IU/kg (1.5 mg/kg) or as twice daily injections of 100 IU/kg (1 mg/kg).
Natrijev enoksaparinat je mogoče uporabiti v subkutani injekciji 150 i.e./kg (1,5 mg/kg) enkrat na dan ali v dveh injekcijah po 100 i.e./kg (1 mg/kg) na dan.
Inhixa should not be administered by the intramuscular route.
Zdravila Inhixa se ne sme injicirati intramuskularno.
Treatment of deep vein thrombosis with or without pulmonary embolism In a multicentre, parallel group study, 900 patients with acute lower extremity DVT with or without PE were randomized to an inpatient (hospital) treatment of either (i) enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day subcutaneously, (ii) enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours subcutaneously, or (iii) heparin intravenous bolus (5,000 IU) followed by a continuous infusion (administered to achieve an aPTT of 55 to 85 seconds).
Zdravljenje globoke venske tromboze, s pljučno embolijo ali brez nje V multicentrični študiji vzporednih skupin so 900 bolnikov z akutno GVT spodnje okončine, s PE ali brez nje, randomizirali na bolnišnično zdravljenje (i) z natrijevim enoksaparinatom 150 i.e./kg (1,5 mg/kg) enkrat na dan subkutano, (ii) z natrijevim enoksaparinatom 100 i.e./kg (1 mg/kg) na 12 ur subkutano ali (iii) z intravenskim bolusom heparina (5.000 i.e.), ki mu je sledilo stalno infundiranje (uporabljeno tako, da je bil dosežen aPTČ od 55 do 85 sekund).
Wash your hands and the area that you will inject with soap and water.
1) Roke in mesto injiciranja dobro umijte z milom in vodo ter jih posušite.
Inhixa 8,000 IU (80 mg)/0.8 mL
Inhixa 8.000 i.e. (80 mg)/0,8 ml
When given at a dose of 4,000 IU (40 mg) once a day subcutaneously, enoxaparin sodium significantly reduced the incidence of VTE as compared to placebo.
Natrijev enoksaparinat v odmerku 4.000 i.e. (40 mg) enkrat na dan subkutano je zmanjšal incidenco VTE značilno bolj kot placebo.
When non-weight adjusted dosing was administered, it was found after a single-subcutaneous 4,000 IU (40 mg) dose, that anti-Xa exposure is 52% higher in low-weight women (< 45 kg) and 27% higher in low-weight men (< 57 kg) when compared to normal weight control subjects (see section 4.4).
Če so uporabili odmerjanje, ki ni bilo korigirano za telesno maso, so po enkratnem subkutanem odmerku 4.000 i.e. (40 mg) ugotovili izpostavljenost anti-Xa, ki je bila pri ženskah z majhno telesno maso (< 45 kg) 52 % večja in pri moških z majhno telesno maso (< 57 kg) 27 % večja kot pri kontrolnih osebah z normalno telesno maso (glejte poglavje 4.4).
Enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day subcutaneously n (%)
Natrijev enoksaparinat 150 i.e./kg (1,5 mg/kg) enkrat na dan subkutano n (%)
Inhixa 2,000 IU (20 mg)/0.2 mL
Inhixa 2.000 i.e. (20 mg)/0,2 ml
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči, domnevate, da ste noseči ali nameravate zanositi, se posvetujte z zdravnikom, preden vzamete to zdravilo.
o Additional bolus for PCI when last SC administration was given more than 8 hours before balloon inflation For patients being managed with PCI, an additional IV bolus of 30 IU/kg (0.3 mg/kg) is to be administered if last SC administration was given more than 8 hours before balloon inflation.
o Dodaten bolus za PKI, če je bil zadnji subkutani odmerek uporabljen več kot 8 ur pred balonskim širjenjem Bolniki, zdravljeni s PKI, morajo dobiti dodaten intravenski odmerek 30 i.e./kg (0,3 mg/kg), če je bil zadnji subkutani odmerek uporabljen več kot 8 ur pred balonskim širjenjem.
Method of administration Inhixa should not be administered by the intramuscular route.
Način uporabe Zdravila Inhixa se ne sme injicirati intramuskularno.
In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) subcutaneously every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) intravenous bolus followed by 100 IU/kg (1 mg/kg) subcutaneously every 12 hours.
V kliničnih študijah za zdravljenje nestabilne angine pektoris in miokardnega infarkta brez zobca Q so bili odmerki 100 i.e./kg (1 mg/kg) subkutano na 12 ur, v klinični študij za zdravljenje akutnega STEMI pa je bila shema natrijevega enoksaparinata 3.000 i.e. (30 mg) v intravenskem bolusu, ki mu je sledila uporaba 100 i.e./kg (1 mg/kg) subkutano na 12 ur.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Če ste noseči, domnevate, da ste noseči ali nameravate zanositi, se posvetujte z zdravnikom, preden uporabite to zdravilo.
Inhixa 12,000 IU (120 mg)/0.8 mL solution for injection Inhixa 15,000 IU (150 mg)/1 mL solution for injection enoxaparin sodium
Inhixa 12.000 i.e. (120 mg)/0,8 ml raztopina za injiciranje Inhixa 15.000 i.e. (150 mg)/1 mL raztopina za injiciranje natrijev enoksaparinat
Inhixa 12,000 IU (120 mg)/0.8 mL
Inhixa 12.000 i.e. (120 mg)/0,8 ml
Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
Inhixa 100,000 IU (1000 mg)/10 mL
Inhixa 100.000 i.e. (1000 mg)/10 ml
• Inhixa is added to the tube leaving the body (arterial line) at the start of the dialysis session.
• Zdravilo Inhixa se na začetku dialize da v cevko, ki vodi iz telesa (v arterijsko linijo).
Accidental overdose with enoxaparin sodium after intravenous, extracorporeal or subcutaneous administration may lead to haemorrhagic complications.
Naključno preveliko odmerjanje intravensko, izventelesno ali subkutano uporabljenega natrijevega enoksaparinata lahko povzroči krvavitvene zaplete.
All Treated DVT Patients with or without PE Total VTE (%)
Vsi zdravljeni bolniki z GVT, s PE ali brez nje Vse VTE (%) Samo GVT (%) Proksimalne GVT
A puncture-free interval of at least 24 hours shall be kept between the last injection of enoxaparin sodium at curative doses and the needle or catheter placement (see also section 4.3).
Med zadnjo injekcijo natrijevega enoksaparinata v kurativnih odmerkih in vstavitvijo igle ali katetra mora miniti vsaj 24 ur brez punkcij (glejte tudi poglavje 4.3).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VEČODMERNE VIALE
How to give yourself an injection of Inhixa
Kako si sami injicirate zdravilo Inhixa
Inhixa 10,000 IU (100 mg)/1 mL
Inhixa 10.000 i.e. (100 mg)/1 ml
- Changing from treatment with direct oral anticoagulant to Inhixa Stop taking direct oral anticoagulant.
- Prehod z zdravljenja z neposrednim peroralnim antikoagulansom na zdravilo Inhixa Nehajte jemati neposredni peroralni antikoagulans.
6 pre-filled syringes
6 napolnjenih injekcijskih brizg
This medicine contains less than 1 mmol sodium (23 mg) per dose within the recommended dose range, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, v priporočenem razponu odmerkov to v bistvu pomeni, da je »brez natrija«.
A 3,000 IU (30 mg) intravenous bolus immediately followed by a 100 IU/kg (1 mg/kg) subcutaneous every 12 hours provided initial maximum anti-Xa activity level of 1.16 IU/mL (n=16) and average exposure corresponding to 88% of steady-state levels.
Intravenski bolus 3.000 i.e. (30 mg), ki mu je takoj sledila subkutana uporaba 100 i.e./kg (1 mg/kg) na 12 ur, je dosegel uvodno največjo raven aktivnosti anti-Xa 1,16 i.e./ml (n = 16) in povprečno izpostavljenost, ki je ustrezala 88 % tiste v stanju dinamičnega ravnovesja.
In clinical studies, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see sections 4.4 and “Description of selected adverse reactions” below).
V kliničnih študijah so bili najpogosteje zabeleženi neželeni učinki krvavitve, trombocitopenija in trombocitoza (glejte poglavje 4.4 in "Opis izbranih neželenih učinkov", spodaj).
Enoxaparin sodium 100 IU/kg (1 mg/kg) twice a day subcutaneously n (%)
Natrijev enoksaparinat 100 i.e./kg (1 mg/kg) dvakrat na dan subkutano n (%)
To avoid the possible mixture of enoxaparin sodium with other drugs, the intravenous access chosen should be flushed with a sufficient amount of sodium chloride or dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug.
Da boste preprečili možno mešanje natrijevega enoksaparinata z drugimi zdravili, morate intravenski dostop sprati z zadostno količino raztopine natrijevega klorida ali raztopine glukoze, in sicer pred dajanjem intravenskega bolusa natrijevega enoksaparinata in po njem, da boste nastavek očistili zdravila.
SC injection.
Raztopina za injiciranje.
Very common: Thrombocytosisβ Common:
Zelo pogosti: Trombocitozaβ Pogosti:
50 pre-filled syringes
50 napolnjenih injekcijskih brizg
30 pre-filled syringes
30 napolnjenih injekcijskih brizg
What Inhixa looks like and contents of the pack Inhixa 12,000 IU (120 mg)/0.8 mL is 0.8 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a purple polypropylene plunger rod.
Izgled zdravila Inhixa in vsebina pakiranja 12.000 i.e. (120 mg)/0,8 ml je 0,8 ml raztopine v: - injekcijski brizgi iz prozornega, brezbarvnega, nevtralnega stekla tipa I, opremljeni z injekcijsko iglo in ščitnikom igle, z gumijasto zaporko iz klorobutila in z vijoličnim polipropilenskim batom.
• if you have any sign of blockage of a blood vessel by a blood clot such as: o cramping pain, redness, warmth, or swelling in one of your legs - these are symptoms of deep vein thrombosis o breathlessness, chest pain, fainting or coughing up blood - these are symptoms of a pulmonary embolism
- če imate kakršen koli znak zamašitve žile s krvnim strdkom, na primer: o krčevite bolečine, pordelost, toploto ali oteklost ene noge - to so simptomi globoke venske tromboze, o težko dihanje, bolečino v prsih, omedlevico ali izkašljevanje krvi - to so simptomi pljučne embolije, - če imate boleč izpuščaj s temno rdečimi podkožnimi pegami, ki ne izginejo, če nanje pritisnete.
Solution for injection 2 pre-filled syringes 10 pre-filled syringes 30 pre-filled syringes 10 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard
10 napolnjenih injekcijskih brizg 30 napolnjenih injekcijskih brizg 10 napolnjenih injekcijskih brizg z varnostno zaščito za iglo 30 napolnjenih injekcijskih brizg z varnostno zaščito za iglo
Changing from Inhixa to treatment with direct oral anticoagulant Stop using Inhixa.
- Prehod z zdravila Inhixa na zdravljenje z neposrednim peroralnim antikoagulansom Nehajte uporabljati zdravilo Inhixa.
One vial (5 mL) contains 50,000 IU (500 mg) enoxaparin sodium.
Ena viala (5 ml) vsebuje 50.000 i.e. (500 mg) natrijevega enoksaparinata.
Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose vial
Inhixa 50.000 i.e. (500 mg)/ 5 ml raztopina za injiciranje v večodmerni viali
Mechanical prosthetic heart valves
Mehanične protetične srčne zaklopke
Enoxaparin sodium was found to have no effect on fertility or reproductive performance of male and female rats at subcutaneous doses up to 20 mg/kg/day.
Ugotovljeno je bilo, da natrijev enoksaparinat v subkutanih odmerkih do 20 mg/kg/dan ne vpliva na plodnost ali sposobnost razmnoževanja podganjih samcev in samic.
One vial (5.0 mL) contains 50,000 IU (500 mg) enoxaparin sodium.
Ena viala (5,0 ml) vsebuje 50.000 i.e. (500 mg) natrijevega enoksaparinata.
The mean maximum anti-IIa activity level is observed approximately 3 to 4 hours following subcutaneous injection and reaches 0.13 IU/mL and 0.19 IU/mL following repeated administration of 100 IU/kg (1 mg/kg) twice daily and 150 IU/kg (1.5 mg/kg) once daily, respectively.
Povprečna največja raven aktivnosti anti-IIa se pojavi približno 3 do 4 ure po subkutanem injiciranju in doseže po večkratni uporabi 100 i.e./kg (1 mg/kg) dvakrat na dan 0,13 i.e./ml in po uporabi 150 i.e./kg (1,5 mg/kg) enkrat na dan 0,19 i.e./ml.
One vial contains enoxaparin sodium 50,000 IU anti-Xa activity (equivalent to 500 mg) in 5.0 mL water for injections.
Ena viala vsebuje 50.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 500 mg) v 5,0 ml vode za injekcije.
Skin and subcutaneous tissue disorders o Common: Urticaria, pruritus, erythema o Uncommon: Bullous dermatitis o Rare: Alopecia* o Rare: Cutaneous vasculitis*, skin necrosis* usually occurring at the injection site (these phenomena have been usually preceded by purpura or erythematous plaques, infiltrated and painful).
• Redki: Alopecija* o Redki: Kožni vaskulitis*, nekroza kože*, ki se po navadi pojavi na mestu injiciranja (pred temi pojavi so se po navadi razvili purpura ali infiltrirani in boleči eritematozni plaki).
Volume to be injected through intravenous line after dilution is completed at a concentration of 300 IU (3 mg)/mL.
Količina, ki jo je treba injicirati v intravensko linijo po dokončanem razredčenju na koncentracijo 300 i.e. (3 mg)/ml.
• Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids.
• Druga zdravila, ki vplivajo na hemostazo, na primer: - zaviralci agregacije trombocitov, vključno z acetilsalicilno kislino v antiagregacijskih odmerkih (zaščita srca), klopidogrel, tiklopidin in antagonisti glikoproteina IIb/IIIa, ki so indicirani pri akutnem koronarnem sindromu, zaradi tveganja za krvavitve, - dekstran 40, - sistemski glukokortikoidi.
Inhixa 30,000 IU (300 mg)/3 mL solution for injection in multidose vial
Inhixa 30.000 i.e. (300 mg)/3 ml raztopina za injiciranje v večodmerni viali