natgillin/translations-raw huggingface dataset:
In these patients, careful clinical monitoring is advised, and biological monitoring by anti-Xa activity measurement might be considered (see section 5.2).
Pri teh bolnikih je priporočljiv natančen klinični nadzor in v poštev pride biološko spremljanje z meritvijo aktivnosti anti-Xa (glejte poglavjie 5.2).
• Stop blood clots from forming in your blood in the following situations: o Before and after an operation o When you have an acute illness and face period of limited mobility o When you have unstable angina (a condition when not enough blood gets to your heart) o After a heart attack
o Pred operacijami in po njih o Če imate akutno bolezen in vas čaka obdobje omejene možnosti gibanja (mobilnosti) o Če imate nestabilno angino pektoris (motnjo, pri kateri v srce ne pride dovolj krvi) o Po srčnem infarktu
The occurrence of total and major bleeding were respectively 8.6% and 1.1% in the placebo group, 11.7% and 0.3% in the enoxaparin sodium 2,000 IU (20 mg) group and 12.6% and 1.7% in the enoxaparin sodium 4,000 IU (40 mg) group.
Pojavljanje vseh krvavitev je bilo v skupini s placebom 8,6 %, v skupini z 2.000 i.e. (20 mg) natrijevega enoksaparinata 11,7 % in v skupini s 4.000 i.e. (40 mg) natrijevega enoksaparinata 12,6 %,
The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting haemostasis such as NonSteroidal-Anti Inflammatory Drugs (NSAIDs), with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity.
Tveganje za te učinke je večje v primeru pooperacijske uporabe stalnih epiduralnih katetrov, med sočasno uporabo dodatnih zdravil, ki vplivajo na hemostazo, npr. nesteroidnih protivnetnih zdravil (NSAID), v primeru travmatske ali ponavljajoče se epiduralne ali spinalne punkcije, ali pri bolnikih z anamnezo spinalne operacije ali spinalno deformacijo.
You should tell your doctor straight away • If you have any sign of blockage of a blood vessel by a blood clot such as :
• Če imate kakršen koli znak zamašitve žile s krvnim strdkom, na primer:
LOVENOX (and associated names) should not be used interchangeably with other medicines belonging to the group of low molecular weight heparins.
Zdravila LOVENOX (in povezana imena) se ne sme uporabljati medsebojno zamenljivo z drugimi zdravili iz skupine nizkomolekularnih heparinov.
Musculoskeletal, connective tissue and bone disorders • Rare: Osteoporosis* following long term therapy (greater than 3 months)
• Redki: Osteoporoza* po dolgotrajnem zdravljenju (več kot 3 mesece)
• Spinal/Epidural anaesthesia or lumbar puncture Spinal/epidural anaesthesia or lumbar puncture must not be performed within 24 hours of administration of enoxaparin at therapeutic doses (see also section 4.3).
• Spinalna/epiduralna anestezija ali lumbalna punkcija Spinalne/epiduralne anestezije ali lumbalne punkcije se ne sme opraviti v 24 urah po uporabi terapevtskih odmerkov natrijevega enoksaparinata (glejte poglavje 4.3).
o For patients with a high venous thromboembolism (VTE) risk who undergo abdominal or pelvic surgery for cancer an extended thromboprophylaxis up to 4 weeks is recommended.
o Pri bolnikih z velikim tveganjem za vensko trombembolijo (VTE) s trebušno ali medenično operacijo zaradi raka je priporočljiva podaljšana tromboprofilaksa do
It may cause toxic and allergic reactions in infants up to 3 years old.
Pri otrocih do 3. leta starosti lahko benzilakohol povzroči toksične in alergijske reakcije.
Intracranial haemorrhage,
- huda arterijska hipertenzija,
If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 30 IU/kg (0.3 mg/kg) enoxaparin sodium should be administered.
Če je bil zadnji subkutani odmerek uporabljen več kot 8 ur pred balonskim širjenjem, je treba dati intravenski bolus 30 i.e./kg (0,3 mg/kg) natrijevega enoksaparinata.
- cramping pain, redness, warmth, or swelling in one of your legs - these are symptoms of deep vein thrombosis - breathlessness, chest pain, fainting or coughing up blood - these are symptoms of a pulmonary embolism
- krčevite bolečine, pordelost, toploto ali oteklost ene noge - to so simptomi globoke venske tromboze, - težko dihanje, bolečino v prsih, omedlevico ali izkašljevanje krvi - to so simptomi pljučne embolije.
• Switch between enoxaparin sodium and vitamin K antagonists (VKA) Clinical monitoring and laboratory tests [prothrombin time expressed as the International Normalized Ratio (INR)] must be intensified to monitor the effect of VKA.
Za nadzor nad učinkom VKA je treba poostriti klinični nadzor in laboratorijske preiskave (protrombinski čas, izražen kot internacionalno normalizirano razmerje [INR]).
• At the same time you will also be given LOVENOX (and associated names) as an injection underneath your skin (subcutaneous injection).
• Obenem boste dobili zdravilo LOVENOX (in povezana imena) tudi v injekciji pod kožo
What LOVENOX (and associated names) is and what it is used for
Kaj je zdravilo LOVENOX (in povezana imena) in za kaj ga uporabljamo
LOVENOX (and associated names) can be used to:
Zdravilo LOVENOX (in povezana imena) se uporablja za:
After you have had a heart attack
o Po srčnem infarktu
No pharmacokinetic interactions were observed between enoxaparin sodium and thrombolytics when administered concomitantly.
Farmakokinetično medsebojno delovanje Med sočasno uporabljenim natrijevim enoksaparinatom in trombolitiki niso opazili farmakokinetičnih medsebojnih delovanj.
50,000 IU (500 mg)/5 mL
50.000 i.e. (500 mg)/5 ml
LOVENOX (and associated names) is indicated in adults for:
4.1 Terapevtske indikacije Zdravilo LOVENOX (in povezana imena) je indicirano pri odraslih za:
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming
• Acetilsalicilno kislino, klopidogrel ali druga zdravila, ki se uporabljajo za preprečevanje nastajanja krvnih strdkov
• you have high level of potassium in your blood (this may be checked with a blood test)
• če imate v krvi visoko koncentracijo kalija (to je mogoče preveriti s preiskavo krvi) • če trenutno uporabljate zdravila, ki vplivajo na strjevanje krvi (glejte spodaj - poglavje
(≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data).
< 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov) Pri vsakem organskem sistemu so neželeni učinki navedeni po padajoči resnosti.
30,000 IU (300 mg) /3 mL
30.000 i.e. (300 mg)/3 ml
To obtain a 300 IU/mL (3 mg/mL) solution, using a 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe, it is recommended to use a 50 mL infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) as follows:
(60 mg) natrijevega enoksaparinata je priporočljivo uporabiti 50-ml infuzijsko vrečko (tj. z uporabo fiziološke raztopine (0,9 % raztopine natrijevega klorida) ali 5 % raztopine glukoze v vodi) takole:
Immuno-allergic thrombocytopeni a
Trombocitozaβ Trombocitopenij a
Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4).
opaženega pri nosečnicah s protetičnimi srčnimi zaklopkami, podatki v celoti pri nosečnicah ne kažejo večjega tveganja za krvavitve, trombocitopenijo ali osteoporozo v primerjavi s tveganjem, zabeleženim pri nenosečih ženskah (glejte poglavje 4.4).
4,000 IU (40 mg) /0.4 mL
4.000 i.e. (40 mg) /0,4 ml
In patients with severe renal impairment (creatinine clearance 15-30 mL/min), since exposure of enoxaparin sodium is significantly increased, a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges.
Ker so bolniki s hudo okvaro ledvic (očistek kreatinina < 15-30 ml/min) pomembno bolj izpostavljeni natrijevemu enoksaparinatu, jim je priporočljivo prilagoditi terapevtske in profilaktične odmerke.
15,000 IU (150 mg) /1 mL
15.000 i.e. (150 mg)/1 ml
As with other anticoagulants, haemorrhage may occur in the presence of associated risk factors such as: organic lesions liable to bleed, invasive procedures or the concomitant use of medications affecting haemostasis (see sections 4.4 and 4.5).
Tako kot pri drugih antikoagulansih se krvavitev lahko pojavi v prisotnosti spremljajočih dejavnikov tveganja, npr.: organskih lezij, nagnjenih h krvavitvi, invazivnih posegov ali sočasne uporabe zdravil,
One 3.0 mL pen contains enoxaparin sodium 40,000 IU anti-Xa activity (equivalent to 400 mg), equivalent to 10 single doses of 4,000 IU (40 mg) enoxaparin sodium, + 45 mg benzyl alcohol in 3.0 mL water for injections
En 3,0 ml peresnik vsebuje 40.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 400 mg), kar ustreza 10 enkratnim odmerkom 4.000 i.e. (40 mg) natrijevega enoksaparinata, + 45 mg benzilalkohola v 3,0 ml vode za injekcije
In patients with severe renal impairment (creatinine clearance <30 mL/min), the AUC at steady state is significantly increased on average by 65% after repeated SC 4,000 IU (40 mg) once daily doses (see section 4.4).
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je AUC v stanju dinamičnega ravnovesja bistveno večja, povprečno za 65 % po večkratni subkutani uporabi odmerkov 4.000 i.e. (40
One vial (3.0 mL) contains 30,000 IU (300 mg) enoxaparin sodium One vial (5.0 mL) contains 50,000 IU (500 mg) enoxaparin sodium One vial (10.0 mL) contains 100,000 IU (1,000 mg) enoxaparin sodium
Ena viala (3,0 ml) vsebuje 30,000 i.e. (300 mg) natrijevega enoksaparinata Ena viala (5,0 ml) vsebuje 50,000 i.e. (500 mg) natrijevega enoksaparinata Ena viala (10,0 ml) vsebuje 100,000 i.e. (1.000 mg) natrijevega enoksaparinata
• Medicinal products affecting haemostasis (see section 4.4) It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated.
Pred začetkom zdravljenja z natrijevim enoksaparinatom je priporočljivo opustiti nekatera zdravila, ki vplivajo na hemostazo, če niso strogo indicirana.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX 10,000 IU/10 mL (100 mg/10 mL) VIAL
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 10.000 i.e./10 mL (100 mg/10 mL) VIALO
6,000 IU (60 mg) /0.6 mL
6.000 i.e. (60 mg) /0,6 ml
OUTER BOX PRE FILLED SYRINGE
ŠKATLA ZA NAPOLNJENO INJEKCIJSKO BRIZGO
VTE = venous thromboembolic event (DVT and/or PE) *The 95% Confidence Intervals for the treatment differences for total VTE were: - Enoxaparin sodium once a day versus heparin (-3.0 to 3.5) - enoxaparin sodium every 12 hours versus heparin (-4.2 to 1.7).
*95-odstotna intervala zaupanja za razliko med zdravljenji za vse VTE sta bila: - natrijev enoksaparinat enkrat na dan v primerjavi s heparinom (-3,0 do 3,5) - natrijev enoksaparinat na 12 ur v primerjavi s heparinom (-4,2 do 1,7)
• LOVENOX (and associated names) is added to the tube leaving the body (arterial line) at the start of the dialysis session.
• Zdravilo LOVENOX (in povezana imena) se na začetku dialize da v cevko, ki vodi iz telesa (v arterijsko linijo).
For patients with creatinine clearance [15-30 mL/minute], additional considerations are necessary because elimination of enoxaparin sodium is more prolonged.
Pri bolnikih z očistkom kreatinina od 15 do 30 ml/min je potreben dodaten preudarek, ker je odstranjevanje natrijevega enoksaparinata dolgotrajnejše.
100,000 IU (1000 mg)/10 mL
100.000 i.e. (1000 mg)/10 ml
However, since renal function is known to decline with age, elderly patients may show reduced elimination of enoxaparin sodium (see section 4.4).
Ker pa je znano, da se delovanje ledvic s starostjo zmanjšuje, je odstranjevanje natrijevega enoksaparinata pri starejših bolnikih lahko upočasnjeno (glejte poglavje 4.4).
• If you are bleeding heavily or have a condition with a high risk of bleeding (such as stomach ulcer, recent surgery of the brain or eyes), including recent bleeding stroke.
(npr. razjedo na želodcu, nedavno operacijo na možganih ali očeh), vključno z nedavno možgansko kapjo zaradi možganske krvavitve.
• Percutaneous coronary revascularization procedures To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, NSTEMI and acute STEMI, adhere precisely to the intervals recommended between enoxaparin sodium injection doses.
• Postopki za perkutano koronarno revaskularizacijo Za zmanjšanje nevarnost krvavitve po žilnih posegih med zdravljenjem nestabilne angine pektoris,
10,000 IU (100 mg) /1.0 mL
10.000 i.e. (100 mg) /1,0 ml
• Common: Urticaria, pruritus, erythema
Bolezni kože in podkožja • Pogosti: Urtikarija, srbenje, eritem
The mean maximum anti-IIa activity level is observed approximately 3 to 4 hours following SC 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
Very common: Thrombocytosis β
Zelo pogosti: Trombocitoza β
12,000 IU (120 mg) / 0.8 mL
12.000 i.e. (120 mg)/0,8 ml
• you have had a heart valve fitted
• če imate umetno srčno zaklopko
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen enoxaparin
IME ZDRAVILA IN POT(I) UPORABE LOVENOX 10 x 4.000 i.e. (10 x 40 mg) peresnik enoksaparin
Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients Individual thromboembolic risk for patients can be estimated using validated risk stratification model.
Tveganje za trombembolijo je mogoče pri posameznem bolniku oceniti z validiranim modelom stratifikacije tveganja.
All patients also received warfarin sodium (dose adjusted according to prothrombin time to achieve an INR of 2.0 to 3.0), commencing within 72 hours of initiation of enoxaparin sodium or standard heparin therapy, and continuing for 90 days.
(odmerek prilagojen protrombinskemu času, tako da je bilo doseženo INR od 2,0 do 3,0), z začetkom v 72 urah po uvedbi natrijevega enoksaparinata ali običajnega heparinskega zdravljenja in z nadaljevanjem 90 dni.
15,000 IU/mL (150 mg/mL) solution for injection
15.000 i.e./ml (150 mg/ml) raztopina za injiciranje
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3.0 mL OTHER 1. taking on …………… at ……….. ….
DRUGI PODATKI 1. vzeti na …………… ob ……….. ….
Retroperitoneal haemorrhage : such as haematoma, ecchymosis other than at injection site, wound haematoma, haematuria, epistaxis and gastro-intestinal haemorrhage.
Intrakranialna krvavitev, retroperitonealn a krvavitev : npr. hematom, ekhimoze drugje kot na mestu injiciranja, hematom rane, hematurija, epistaksa in gastrointestinalna krvavitev.
2,000 IU (20 mg) /0.2 mL
2.000 i.e. (20 mg) /0,2 ml
In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day.
(40 mg) subkutano enkrat na dan. Za zdravljenje GVT s PE ali brez nje so bili bolniki, ki so prejemali natrijev enoksaparinat, zdravljeni z odmerkom 100 i.e./kg (1 mg/kg) subkutano na 12 ur ali z odmerkom 150 i.e./kg (1,5 mg/kg) subkutano enkrat na dan.
This helps your body to break them down and stops them from causing you harm2) Stopping blood clots from forming in your blood.
Tako telesu pomaga, da jih razgradi, in prepreči, da bi povzročili škodo
10,000 IU/mL (100 mg/mL) solution for injection:
10.000 i.e./ml (100 mg/ml) raztopina za injiciranje:
Therefore, careful clinical monitoring is advised in these patients (see section
Zato je treba te bolnike priporočljivo klinično nadzorovati (glejte poglavje 5.2).
8,000 IU (80 mg) /0.8 mL
8.000 i.e. (80 mg) /0,8 ml
R
D L
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
• If you are using LOVENOX (and associated names) to treat blood clots in your body and going to receive spinal or epidural anaesthesia or lumbar puncture within 24 hours.
• Če uporabljate LOVENOX (in povezana imena) za zdravljenje krvnih strdkov in imate v
Retroperitoneal haemorrhage
Retroperitonealn a krvavitev
What LOVENOX (and associated names) looks like and contents of the pack
Izgled zdravila LOVENOX (in povezana imena) in vsebina pakiranja
Method of administration LOVENOX (and associated names) should not be administered by the intramuscular route.
Zdravila LOVENOX (in povezana imena) se ne sme injicirati intramuskularno.
Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin-induced thrombocytopenia without circulating antibodies.
Natrijev enoksaparinat je treba skrajno previdno uporabljati pri bolnikih z anamnezo (> 100 dni)
The usual dose is 100 IU (1 mg) for every kilogram of your weight.
Običajen odmerek je 100 i.e. (1 mg) na kilogram telesne mase.
Your doctor will decide how much LOVENOX (and associated names) to give you.
Zdravnik bo določil, koliko zdravila LOVENOX (in povezana imena) boste dobili.
o Initial 3,000 IU (30 mg) bolus
o Začetni bolus 3.000 i.e. (30 mg)
Your doctor will request you perform blood tests called INR and tell you when to start LOVENOX (and associated names) accordingly.
imenovano INR, in vam bo glede na to povedal, kdaj začnite uporabljati zdravilo LOVENOX (in povezana imena).
• For treatment of acute STEMI, the recommended dose of enoxaparin sodium is a single intravenous (IV) bolus of 3,000 IU (30 mg) plus a 100 IU/kg (1 mg/kg) SC dose followed by 100 IU/kg (1 mg/kg) administered SC every 12 hours (maximum 10,000 IU (100 mg) for each of the first two SC 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
One vial contains enoxaparin sodium 50,000 IU anti-Xa activity (equivalent to 500 mg) + 75 mg benzyl alcohol in 5.0 mL water for injections.
Ena viala vsebuje 50.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 500 mg) in 75 mg benzilalkohola v 5,0 ml vode za injekcije.
Multiple dose vials containing benzyl alcohol
Večodmerne viale, ki vsebujejo benzilalkohol
Extracorporeal use (in the dialysis circuit).
izventelesna uporaba (v dializnem obtoku)
At doses used for prophylaxis of venous thromboembolism, enoxaparin sodium does not influence bleeding time and global blood coagulation tests significantly, nor does it affect platelet aggregation or binding of fibrinogen to platelets.
• Laboratorijske preiskave V odmerkih, uporabljanih za profilakso venske trombembolije, natrijev enoksaparinat ne vpliva pomembno na čas krvavitve in preiskave celotne koagulacije krvi.
If you get any side effects, talk to your doctor orpharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
What you need to know before you use LOVENOX (and associated names)
Kaj morate vedeti, preden boste uporabili zdravilo LOVENOX (in povezana imena) Ne uporabljajte zdravila LOVENOX (in povezana imena)
When given at a dose of 4,000 IU (40 mg) once a day SC, enoxaparin sodium significantly reduced the incidence of VTE as compared to placebo.
(40 mg) enkrat na dan subkutano je zmanjšal incidenco VTE značilno bolj kot placebo.
Treatment of unstable angina and non ST elevation myocardial infarction In a large multicenter study, 3,171 patients enrolled at the acute phase of unstable angina or non-Qwave myocardial infarction were randomized to receive in association with acetylsalicylic acid (100 to 325 mg once daily), either SC enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours or IV unfractionated heparin adjusted based on aPTT.
V veliki multicentrični študiji so 3.171 bolnikov, vključenih v akutni fazi nestabilne angine pektoris ali miokardnega infarkta brez zobca Q, randomizirali na prejemanje natrijevega enoksaparinata 100 i.e./kg (1 mg/kg) subkutano na 12 ur ali nefrakcioniranega heparina intravensko s prilagoditvijo glede na aPTČ.
• Your doctor will decide how much LOVENOX (and associated names) to give you.
• Zdravnik bo določil, koliko zdravila LOVENOX (in povezana imena) boste dobili.
{MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
{Ime in naslov} {tel.} {faks}
A puncture-free interval of at least 12 hours shall be kept between the last injection of enoxaparin sodium at prophylactic doses and the needle or catheter placement.
Med zadnjo injekcijo natrijevega enoksaparinata v profilaktičnih odmerkih in vstavitvijo igle ali katetra mora miniti vsaj 12 ur brez punkcij.
One vial contains enoxaparin sodium 100,000 IU anti-Xa activity (equivalent to 1000 mg) + 150 mg benzyl alcohol in 10.0 mL water for injections.
Ena viala vsebuje 100.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 1000 mg) in 150 mg benzilalkohola v 10,0 ml vode za injekcije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX AMPOULE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA AMPULO
STATEMENT OF ACTIVE SUBSTANCE(S) One vial (10.0 mL) contains 10,000 IU (100 mg) enoxaparin sodium.
Ena viala (10,0 ml) vsebuje 10.000 i.e. (100 mg) natrijevega enoksaparinata SEZNAM POMOŽNIH SNOVI
The incidence of major bleeding at 30 days was significantly higher (p<0.0001) in the enoxaparin sodium group (2.1%) versus the heparin group (1.4%).
(2,1 %, p < 0,0001) kot v skupini s heparinom (1,4 %).
Initiate dosing with 75 IU/kg (0.75 mg/kg) SC every 12 hours (maximum 7,500 IU (75 mg) for each of the first two SC doses only, followed by 75 IU/kg (0.75 mg/kg) SC dosing for the remaining doses).
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).
• LOVENOX (and associated names) can be added to the tube leaving the body (arterial line) at the start of the dialysis session.
• Zdravilo LOVENOX (in povezana imena) se lahko na začetku dialize da v cevko, ki vodi iz telesa
Major bleeding were respectively 1.7% in the enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day group, 1.3% in the enoxaparin sodium 100 IU/kg (1 mg/kg) twice a day group and 2.1% in the heparin group.
1,7 %, v skupini s 100 i.e./kg (1 mg/kg) natrijevega enoksaparinata dvakrat na dan 1,3 % in v skupini s heparinom 2,1 %.
What LOVENOX (and associated names) contains
LOVENOX (in povezana imena).
A 3,000 IU (30 mg) IV bolus immediately followed by a 100 IU/kg (1 mg/kg) SC 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.
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.
Renal impairment (see sections 4.4 and 5.2)
ki vplivajo na hemostazo (glejte poglavji 4.4 in 4.5).
These agents include medicinal products such as:
• Druga zdravila, ki vplivajo na hemostazo, na primer:
Rare:
Krvavitevα Redki:
- Changing from treatment with direct oral anticoagulant to LOVENOX (and associated names) Stop taking direct oral anticoagulant.
- Prehod z zdravljenja z neposrednim peroralnim antikoagulansom na zdravilo LOVENOX (in povezana imena)
• Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
prisotnostjo maligne novotvorbe z velikim tveganjem za krvavitev, nedavno operacijo na možganih, hrbtnem mozgu ali očeh, znanimi varicami požiralnika ali sumom nanje,