qanastek/EMEA-V3 huggingface dataset:
In case of shock, standard medical treatment should be administered.
Šoka gadijuma jaordine standarta terapija.
Patients treated with ATryn should be monitored for possible clinical immunological reactions.
Pacientus, kuri ir arsteti ar Atryn, ir jakontrole attieciba uz iespejamam kliniskam imunologiskam reakcijam.
Antibody status should be monitored and reported.
Ir jakontrole antivielu stavoklis un jazino par kontroles rezultatiem.
The experience from repeated treatment with ATryn is very limited.
Pieredze par atkartotu arstešanu ar ATryn ir loti ierobežota.
Close surveillance with regard to immunological reactions is especially important in such situations.
Šadas situacijas arkartigi nozimiga ir stingra imunologisko reakciju uzraudziba.
Due to differences in pharmacokinetic characteristics of ATryn in pregnant versus non- pregnant patients, recommendations for dosing in pregnancy or in the peripartum period cannot be given.
Sakara ar ATryn farmakokinetikas atškiribam grutniecibas perioda, salidzinot ar pacientiem, kuriem nav grutniecibas, nav dotas devu rekomendacijas grutniecibas perioda, ka ari pirms - un pecdzemdibu perioda.
Clinical and biological surveillance when antithrombin is used together with heparin, low molecular weight heparin or other anticoagulants which potentiate the anticoagulant activity of antithrombin:
Kliniska un biologiska uzraudziba gadijuma, ja antitrombinu lieto kopa ar heparinu, mazmolekularu heparinu vai citiem antikoagulantiem, kuri potence antitrombina antikoagulejošo aktivitati:
- In order to adjust dosage of the anticoagulant and to avoid excessive hypocoagulability,
- lai korigetu antikoagulanta devu un noverstu parmerigu hipokoagulaciju, regulari, ar isiem
controls of the extent of anticoagulation (APTT, and where appropriate anti-Factor Xa activity) should be performed regularly, at close intervals and in particular in the first minutes/ hours following the start of antithr ombin use.
intervaliem, jo ipaši pirmajas minutes/ stundas pec antitrombina lietošanas sakuma jakontrole antikoagulacijas speja (APL un, kad iespejams, antifaktora Xa aktivitate);
- Measure antithrombin levels daily, in order to adjust the individual dose.
- lai korigetu individualo devu, reizi diena janosaka antitrombina koncentracija.
The risk of
Jaievero antitrombina
diminution of antithrombin levels by prolonged treatment with a non-fractionated heparin should be taken into account.
koncentracijas samazinajuma risks, kas saistits ar ilgstošu terapiju ar nefrakcionetu heparinu.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Mijiedarbiba ar citam zalem un citi mijiedarbibas veidi
Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e. g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Antitrombina aizvietošana laika, kad ordineti antikoagulanti, kuri potence antitrombina antikoagulejošo aktivitati (piemeram, heparins vai mazmolekulars heparins), var palielinat asinošanas risku.
The half-life of recombinant antithrombin may be altered with concomitant treatment with these anticoagulants due to an altered antithrombin turnover.
Rekombineta antitrombina pusperiodu var ietekmet vienlaiciga terapija ar šiem antikoagulantiem, kas saistita ar antitrombina aprites izmainam.
Thus, concurrent administration of antithrombin with heparin, low molecular weight heparin, or other anticoagulants that potentiate the anticoagulant activity of antithrombin to a patient with increased risk of bleeding must be monitored clinically and biologically.
Tadejadi pacienti, kuriem paaugstinata asinošanas riska apstaklos vienlaicigi ievada antitrombinu un heparinu, mazmolekularu heparinu vai citus antikoagulantus, kas potence antitrombina antikoagulejošo aktivitati, ir kliniski un biologiski jakontrole.
4 No interaction studies have been performed.
Mijiedarbibas petijumi nav veikti.
4.6 Pregnancy and lactation
4. 6 Grutnieciba un zidišana
Limited clinical data are available on the use of ATryn in pregnant women.
Ir pieejami ierobežoti dati par ATryn lietošanu grutniecem.
Available data do not suggest harmful effects to the mother or infant.
Pieejamie dati neliecina par kaitigu ietekmi uz mati vai jaundzimušo.
However due to the difference in pharmacokinetic characteristics of ATryn in pregnant vs. non-pregnant patients no recommendation for dosing in pregnancy can be given at this time (see section 4.4).
Tomer, sakara ar to, ka ATryn farmakokinetikas raksturojums, salidzinot grutnieces un sievietes, kuram grutnieciba nav iestajusies, atškiras, pašlaik nekadus devu ieteikumus grutniecem sniegt nav iespejams (skatit apakšpunktu 4. 4).
Animal studies performed in rats did not indicate harmful effects on parturition, embryonal/ foetal and post-natal development.
Petijumi ar dzivniekiem (žurkam) neliecina par kaitigu ietekmi uz dzemdibam, embrionalo/ augla un postnatalo attistibu.
4.7 Effects on ability to drive and use machines
4 4. 7 Ietekme uz speju vadit transportlidzeklus un apkalpot mehanismus
Not relevant.
Nav piemerojams.
4.8 Undesirable effects
4. 8 Nevelamas blakusparadibas
In clinical trials involving congenital antithrombin deficient patients (n=35) one mild undesirable effect of “ Application site pruritis” was reported as related to treatment with ATryn.
Kliniskajos petijumos, kuros tika ieklauti pacienti ar iedzimtu antitrombina deficitu (n=35), ir aprakstita viena ar ATryn terapiju saistita nevelama blakusparadiba — “ Nieze ievades vieta ”.
In other clinical trials with acquired antithrombin deficient cardiac surgery patients (n=118) and healthy volunteers (n=102), undesirable effects reported to be related to treatment with ATryn that were observed more than once are listed by System Organ Class in the table below.
Citos kliniskos petijumos ar kirurgiskiem sirds slimniekiem ar iegutu antitrombina deficitu (n=118) un veseliem brivpratigajiem (n=102), aprakstitas nevelamas blakusparadibas, kas saistitas ar ATryn terapiju un ir noverotas vairak ka vienu reizi, sistematizejot pec organu grupas, ir uzskaititas turpmakaja tabula.
Common (1-10% of subje cts) Nervous system disorders dizziness headache Vascular disorders haemorrhage Gastrointestinal disorders nausea General disorders and administration site conditions venipuncture site haemorrhage Injury and poisoning post procedural haemorrhage wound secretion
Bieži (1– 10% pacientu) Nervu sistemas traucejumi reiboni galvassapes Asinsvadu sistemas traucejumi asinošana Kunga- zarnu trakta traucejumi škebinašana Vispareji traucejumi un reakcijas ievadišanas vieta asinošana venas punkcijas vieta Traumas, saindešanas un komplikacijas pec manipulacijam asinošana pec proceduras sekrecija no bruces
Uncommon (0.1-1% of subjects) General disorders and administration site conditions Feeling hot Infusion site erythema Infusion site pain Infusion site rash Venipuncture site bruise
Retak (0, 1– 1% pacientu) Vispareji traucejumi un reakcijas ievadišanas vieta karstuma sajuta apsartums infuzijas vieta sapes infuzijas vieta izsitumi infuzijas vieta hematoma venas punkcijas vieta
No antibodies to antithrombin alfa have been detected up to 90 days following treatment with ATryn.
Lidz pat 90 dienas pec terapijas ar ATryn antivielas pret alfa antitrombinu nav atrastas.
5 4.9 Overdose
4. 9 Pardozešana
No case of overdose has been reported.
Pardozešanas gadijumi nav aprakstiti.
PHARMACOLOGICAL PROPERTIES
FARMAKOLOGISKAS IPAŠIBAS
5.1 Pharmacodynamic properties
5. 1 Farmakodinamiskas ipašibas
Pharmacotherapeutic Group:
Farmakoterapeitiska grupa:
Antithrombotic agents: heparin group.
Heparina grupas antitrombotiskie preparati.
ATC code:
ATK kods:
Antithrombin, a 58 kD, 432 amino-acid glycoprotein, belongs to the serpin (serine protease inhibitor) superfamily.
Antitrombins, 58 kD, 432 aminoskabju glikoproteins, pieder serpinu (serina proteazes inhibitoru) klasei.
It is one of the most important natural inhibitors of blood coagulation.
Tas ir viens no nozimigakajiem dabigajiem asins koagulacijas inhibitoriem.
The factors most strongly inhibited are thrombin and Factor Xa, but also factors of contact activation, intrinsic system and the Factor VIIa/ tissue factor complex.
Faktori, kas tiek inhibeti visspecigak, ir trombins un faktors Xa Inhibeti tiek ari kontakta aktivacijas faktori, iekšeja sistema un faktora VIIa/ audu faktora komplekss.
Antithrombin activity is greatly enhanced by heparin and the anticoagulant effects of heparin depend on the presence of antithrombin.
Antitrombina aktivitati ieverojami pastiprina heparins, bet heparina antikoagulejoša iedarbiba ir atkariga no antitrombina klatbutnes.
Antithrombin contains two functionally important domains.
5 Antitrombins ietver divas funkcionali nozimigas strukturvienibas.
The first contains the reactive centre and provides a cleavage site for proteinases such as thrombin, a prerequisite for forming a stable proteinase-inhibitor complex.
Tas ir stabila proteinazes inhibitorkompleksa veidošanas priekšnoteikums.
The second is a glycosaminoglycan binding domain responsible for the interaction with heparin and related substances, which accelerates the inhibition of thrombin.
Otra strukturvieniba saista glikozaminoglikanu, ta ir atbildiga par mijiedarbibu ar heparinu un tam radniecigam vielam, kas paatrina trombina inhibiciju.
The inhibitor-coagulation enzyme complexes are removed by the reticulo-endothelial system.
Inhibitora- koagulacijas enzima kompleksus škel retikuloendoteliala sistema.
Normal antithrombin activity in adults is 80 - 120% (0.8-1.2 IU/ ml) and levels in neonates are about 40 - 60% (0.4-0.6 IU/ ml).
Normala antitrombina aktivitate pieaugušajiem ir 80– 120% (0, 8– 1, 2 SV/ ml), bet jaundzimušajiem tas ir aptuveni 40– 60% (0, 4– 0, 6 SV/ ml).
In a formal clinical trial employing serial Duplex ultrasound examinations, antithrombin alfa was shown to be effective in the prevention of thromboembolic events in fourteen congenital antithrombin deficient patients in clinical high risk situations.
Formala kliniska petijuma, izmantojot serijveida “ Duplex ” ultraskanas izmeklejumus, ir pieradits, ka cetrpadsmit pacientiem ar iedzimtu antitrombina deficitu augsta kliniska riska situacijas alfa antitrombins ir efektivs tromboembolijas gadijumu profilaksei.
Some additional data have been obtained from a number of patients in a compassionate use programme.
Tika ieguti daži papildus dati no vairakiem pacientiem, izmantojot šis zales reti sastopamo slimibu arstešanai paredzeto zalu lietošanas programma.
This medicinal product has been authorized under “ Exceptional Circumstances”.
Šis zales ir registretas “ Iznemuma apstaklos ”.
This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Tas nozime, ka, sakara ar to, ka slimiba ir loti reta, pilnigu informaciju par šim zalem nav iespejams iegut.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
Eiropas Zalu agentura katru gadu izskatis visu jauno informaciju, kas varetu klut pieejama, un šis zalu apraksts tiks papildinats pec vajadzibas.
5.2 Pharmacokinetic properties
5. 2 Farmakokinetiskas ipašibas
After intravenous administration of ATryn (IV bolus dose of 50 IU/ kg or 100 IU/ kg body weight) to congenital antithrombin deficient patients without clinical symptoms of thrombosis, and not using heparin, the incremental recovery was 2.07 ± 1.54 %/ IU/ kg body weight (mean ± SD).
Pec ATryn intravenozas ievades (50 SV/ kg vai 100 SV/ kg IV bolus deva) pacientiem ar iedzimtu antitrombina deficitu un bez kliniskiem trombozes simptomiem, neizmantojot heparinu, pakapeniskais pieaugums bija 2, 07 ± 1, 54% / SV/ kg kermena masas (videji ± SD).
Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD): • Area under the curve:
Šai paša petijuma pacientu grupa noverotie ATryn farmakokinetikas parametri (videji ± SD): • Laukums zem liknes:
587.88 ± 1.63 (% x h) • Distribution half-life:
587, 88 ± 1, 63 (% x st) • Izkliedes pusperiods:
1.74 ± 1.28 h, elimination half-life:
1, 74 ± 1, 28 h, eliminacijas pusperiods:
10.16 ± 1.28 h. • Mean residence time (MRT):
10, 16 ± 1, 28 h • Videjais rezidences laiks (MRT):
8.57 ± 1.24 h • Clearance:
8, 57 ± 1, 24 h • Klirenss:
0.665 ± 0.0493 l/ h (Mean ± SE)
0, 665 ± 0, 0493 l/ h (Videji ± SE)
6 5.3 Preclinical safety data
5. 3 Prekliniskie dati par drošibu
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Ne- kliniskajos standartpetijumos iegutie dati par farmakologisko drošibu, atkartotu devu toksicitati, genotoksicitati, iespejamu kancerogenitati un toksisku ietekmi uz reproduktivitati neliecina par ipašu risku cilvekam.
PHARMACEUTICAL PARTICULARS
FARMACEITISKA INFORMACIJA
6.1 List of excipients
6. 1 Paligvielu saraksts
Glycine Sodium citrate Sodium chloride
Glicins Natrija citrats Natrija hlorids
6.2 Incompatibilities
6. 2 Nesaderiba
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Saderibas petijumu trukuma del zales nedrikst sajaukt (lietot maisijuma) ar citiem produktiem.
6.3 Shelf life
6. 3 Uzglabašanas laiks
Unopened vials:
Neatverti flakoni:
It is recommended to reconstitute the product immediately prior to use.
Preparatu atškaidit ieteicams tieši pirms lietošanas.
Reconstituted product should be used immediately after preparation.
Atškaidits preparats jaizlieto tulit pec sagatavošanas.
6.4 Special precautions for storage
6 6. 4 Ipaši uzglabašanas nosacijumi
Store in a refrigerator (2°C – 8°C).
Uzglabat ledusskapi (2 °C– 8 °C).
Powder containing 1750 IU antithrombin alfa in a clear vial (type I glass) with a stopper (siliconised bromobutyl rubber) and capped with a band (aluminium) and flip-off cap (plastic).
1750 SV alfa antitrombinu saturošs pulveris caurspidiga I tipa stikla flakona ar silikonizetas brombutilgumijas aizbazni, kas aizvakots ar aluminija lenti un noraujamu plastmasas vacinu.
Pack sizes:
Iepakojumu lielums:
1, 10 or 25 vials.
1, 10 vai 25 flakoni.
Not all pack sizes may be marketed.
Visi iepakojuma lielumi tirgu var nebut pieejami.
6.6 Special precautions for disposal and other handling
6. 6 Ipaši noradijumi atkritumu likvidešanai un noradijumi par sagatavošanu lietošanai
Each vial of ATryn contains a lyophilised powder of 1750 IU antithrombin alfa and is intended for single use only.
Flakons ir paredzets tikai vienreizejai lietošanai.
Vials should be brought to room temperature prior to reconstitution and kept no longer than 3 hours.
Pirms atškaidišanas flakoniem jasasilst lidz istabas temperaturai (istabas temperatura tas nedrikst atrasties ilgak par 3 stundam).
The powder should be reconstituted with 10 ml of Sterile Water for Injection (WFI) injected along the side wall of the vial and g swirled (not shaken) to prevent foaming.
Pulveri atškaida ar 10 ml sterila udens injekcijam, ko injice gar flakona sienu.
The reconstituted product should be inspected
Lai noverstu putošanos, flakonu viegli pagroza (nekrata).
visually for particulate matter and discolouration prior to administration.
Pirms ievades atškaiditais preparats ir vizuali japarbauda attieciba uz dalinu klatbutni un krasas mainu.
The solution should be clear or slightly opalescent.
Škidumam jabut dzidram vai viegli lasmojošam.
Do not use solutions that are cloudy or have deposits.
Nelietot škidumus, kas ir dulkaini vai ar nogulsnem.
Upon complete dissolution, the reconstituted product may be drawn up into a sterile disposable syringe.
Pec tam, kad produkts ir pilnigi izškidis, atškaidito preparatu var panemt sterila, vienreizejai lietošanai paredzeta šlirce.
The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag wit h a 0.22 micron pore size in-line filter.
Atškaiditais produkts jaievada intravenozas infuzijas veida, izmantojot sterilu, vienreizejai lietošanai paredzetu šlirci vai infuzijas maisu ar 0, 22 mikronu filtru ievades caurule.
Normal sodium chloride solution 9 mg/ ml (0.9%) may be added to dilute to a concentration convenient for administration.
Lai preparatu atškaiditu lidz ievadei ertai koncentracijai, var pievienot fiziologisko natrija hlorida 9 mg/ ml (0, 9%) škidumu.
The contents of infusion syringes or diluted solution prepared in infusion bags should be administered within 8 hours of preparation.
Infuzijas šlirces saturs vai atškaidits škidums, kas sagatavots infuzijas maisa, ir jaievada 8 stundu laika pec sagatavošanas.
Compatibility with PVC infusion lines with in-line filters has been established.
Neizlietotas zales vai izlietotie materiali jaiznicina atbilstoši vietejam prasibam.
MARKETING AUTHORISATION HOLDER
REGISTRACIJAS APLIECIBAS IPAŠNIEKS
MARKETING AUTHORISATION NUMBER(S)
REGISTRACIJAS NUMURS( I)
DATE OF FIRST AUTHORISATION
REGISTRACIJAS
DATE OF REVISION OF THE TEXT
TEKSTA PEDEJAS PARSKATIŠANAS DATUMS
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
BIOLOGISKI AKTIVAS VIELAS RAŽOTAJS UN RAŽOŠANAS LICENCES IPAŠNIEKS, KURŠ ATBILD PAR SERIJAS IZLAIDI
CONDITIONS OF THE MARKETING AUTHORISATION
REGISTRACIJAS APLIECIBAS NOSACIJUMI
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
IPAŠAS SAISTIBAS, KAS JAIZPILDA REGISTRACIJAS APLIECIBAS IPAŠNIEKAM
Name and address of the manufacturer of the biological active substance
Biologiski aktivas vielas ražotaja nosaukums un adrese
97 South Street Hopkinton, MA 01748-2204 USA
97 South Street Hopkinton, MA 01748- 2204 ASV
Name and address of the manufacturer responsible for batch release
Ražotaja, kas atbild par serijas izlaidi, nosaukums un adrese
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• NOSACIJUMI UN IEROBEŽOJUMI ATTIECIBA UZ PIEGADI UN LIETOŠANU, KAS UZLIKTI REGISTRACIJAS APLIECIBAS IPAŠNIEKAM
Medicinal product subject to restricted medical prescription (See Annex I:
Ierobežotu recepšu zales (Skatit Pielikumu I:
Summary of Product Characteristics, section 4.2).
Zalu apraksts, apakšpunkts 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
NOSACIJUMI VAI IEROBEŽOJUMI EFEKTIVU ŠO ZALU LIETOŠANU
Not applicable
Nav piemerojami.
• OTHER CONDITIONS
• CITI NOSACIJUMI
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Registracijas apliecibas ipašnieks nodrošina farmakovigilances sistemas ieviešanu un funkcionešanu pirms produkta nonakšanas tirgu.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Registracijas apliecibas ipašnieks apnemas veikt petijumus, ka ari papildus farmakovigilances pasakumus, noraditos farmakovigilances plana.
An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use.
Atbilstoši Humano zalu lietošanas komitejas zalu pielietošanas cilvekiem riska menedžmenta sistemu noradijumiem, nepieciešams nodrošinat precizetu riska menedžmenta planu.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Registracijas apliecibas ipašniekam ir jaizpilda sekojoša petijumu programma noteiktaja laika posma, un tas rezultati bus par pamatu ikgadejai ieguvumu/ riska profila novertešanai.
10 Clinical aspects
Kliniskie aspekti
1. Protocol GTC AT HD 012-04:
1.
A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin alfa in Hereditary Antithrombin (AT) Deficient Patients in High- Risk Situations for Thrombosis.
Protokols GTC AT HD 012- 04: vairakcentru, daudznacionalie petijumi drošibas un efektivitates noteikšanai antitrombina alfa un iedzimta antitrombina (AT) deficita pacientiem ieverojama riska trombozes situaciju gadijumos.
The results of ongoing study GTC AT HD 012-04 and in particular the results of investigations in pregnant women treated during the peri-partum period will be submitted when enrollment is completed (total of 17 patients, a mix of surgical and pregnant women).
Notiekoša petijuma GTC AT HD 012- 04 rezultati un ipaši grutniecem, arstetam pirms - un pecdzemdibu perioda, veikto petijumu rezultati tiks nodrošinati pec pacientu nokomplektešanas (kopuma 17 pacienti,
An update on the status of the trial will be submitted on an annual basis until such time as the study is completed.
9 grutnieces un kirurgijas pacienti).
2. Post-marketing surveillance a) Prior to launch in any EU Member State, the MAH will set up a post-marketing surveillance programme to collect the following information about congenital AT deficient patients treated with ATryn
Izvertejot pozitivos petijuma rezultatus, tiks nodrošinatas nepieciešamas registracijas variacijas dozešanas un indikaciju paplašinašanai grutniecem.
• • • • • • • •
Tiks nodrošinata ikgadeja petijuma statusa precizešana lidz petijuma pabeigšanai.
Demographics Indication Posology Length of treatment Prior treatment with ATryn Use of anti-coagulants Adverse drug reactions including lack of efficacy Development of antibodies
Pectirdzniecibas uzraudziba a) Pirms produkta ieviešanas jebkura ES dalibvalsti registracijas apliecibas ipašnieks ieviesis pectirdzniecibas uzraudzibas programmu informacijas apkopošanai par pacientiem ar antitrombina deficitu, arstetiem ar Atryn, ieklaujot: • demografiskos datus; • indikacijas; • dozešanas datus; • arstešanas ilgumu; • pirmsarstešanas datus ar ATryn; • datus par antikoagulantu lietošanu; • datus par zalu blakusefektiem, t. sk. neefektivitati; • antivielu veidošanas datus.
Physicians should be encouraged to enrol patients in the surveillance programme and results of the surveillance should be provided in the update to the EU-RMP or at the time of the annual reassessment, whichever comes first.
Arstiem jaiedrošina pacienti piedalities uzraudzibas programma, un uzraudzibas rezultati janodrošina precizetaja ES Riska vadibas programma vai ari ikgadeja parvertešana, atkariba no ta, kurš pasakums tiek organizets atrak.
b) Prior to launch in any EU Member State, the MAH will set up an immunosurveillance programme and provide antibody testing for anti-ATryn antibodies to physicians.
b) Pirms produkta ieviešanas jebkura ES dalibvalsti registracijas apliecibas ipašnieks ieviesis imunologiskas uzraudzibas programmu, ka ari nodrošinas arstiem antivielu pret anti- ATryn parbaudes iespejas.
This antibody testing should be provided upon request of a physi cian and when the MAH receives a report suggestive of a possible immune reaction or lack of efficacy.
Antivielu parbaude javeic pec arsta pieprasijuma, ka ari tad, kad registracijas apliecibas ipašnieks ir sanemis zinojumu, kas varetu liecinat par iespejamam imunologiskam reakcijam vai medikamenta neefektivitati.
c) The MAH will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.
c) Registracijas apliecibas ipašnieks nodrošinas, ka arstiem izsniegtajos materialos ir sniegta informacija par pectirdzniecibas uzraudzibas programmu un imunologisko reakciju uzraudzibas programmu.
LABELLING AND PACKAGE LEAFLET
MARKEJUMA TEKSTS
LABELLING
12 INFORMACIJA, KAS JANORADA UZ AREJA IEPAKOJUMA
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
AREJAIS KARTONA IEPAKOJUMS (1 FLAKONS)
ATryn 1750 IU powder for solution for infusion Antithrombin alfa
ATryn 1750 SV pulveris infuziju škiduma pagatavošanai Antithrombin alfa
STATEMENT OF ACTIVE SUBSTANCE(S)
AKTIVAS VIELAS NOSAUKUMS UN DAUDZUMS
Approximately 175 IU/ml antithrombin alfa when reconstituted with 10 ml of WFI.
Aptuveni 175 SV/ ml alfa antitrombina pec atškaidišanas ar 10 ml udens injekcijam.
LIST OF EXCIPIENTS
PALIGVIELU SARAKSTS
Excipients:
Paligvielas:
Glycine Sodium chloride Sodium citrate
Glicins Natrija hlorids Natrija citrats
METHOD AND ROUTE(S) OF ADMINISTRATION
LIETOŠANAS METODE UN IEVADIŠANAS VEIDS
Read the package leaflet before use.
Pirms lietošanas izlasit lietošanas instrukciju.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
IPAŠI BRIDINAJUMI PAR ZALU UZGLABAŠANU BERNIEM NEPIEEJAMA UN NEREDZAMA VIETA
Keep out of the reach and sight of children.
Uzglabat berniem nepieejama un neredzama vieta.
OTHER SPECIAL WARNING(S), IF NECESSARY
CITI IPAŠI BRIDINAJUMI, JA NEPIECIEŠAMS
EXP IRY DATE
DERIGUMA TERMINŠ
EXP {MM/YYYY)
Derigs lidz {MM/ GGGG)
SPECIAL STORAGE CONDITIONS
IPAŠI UZGLABAŠANAS NOSACIJUMI
Store in a refrigerator.
13 Uzglabat ledusskapi.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
IPAŠI PIESARDZIBAS PASAKUMI, IZNICINOT NEIZLIETOTO PREPARATU VAI IZMANTOTOS MATERIALUS, KAS BIJUŠI SASKARE AR ŠO PREPARATU (JA PIEMEROJAMS)
For single use only.
Tikai vienreizejai lietošanai.
Any unused solution should be discarded.
Visi neizlietotie škidumi jaiznicina.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
REGISTRACIJAS APLIECIBAS IPAŠNIEKA NOSAUKUMS UN ADRESE
LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
LEO Pharma A/ S Inudstriparken 55 DK- 2750 Ballerup Danija
MARKETING AUTHORISATION NUMBER(S)
REGISTRACIJAS NUMURS
BATCH NUMBER
SERIJAS NUMURS
Batch {number}
Serija{ numurs}
GENERAL CLASSIFICATION FOR SUPPLY
IZSNIEGŠANAS KARTIBA
Medicinal product subject to medical prescription.
Recepšu zales.
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
NORADIJUMI PAR LIETOŠANU
OUTER CARTON (10 VIALS)
14 INFORMACIJA, KAS JANORADA UZ AREJA IEPAKOJUMA UN UZ TIEŠA IEPAKOJUMA
ATryn 1750 IU powder for solution for infusion Antithrombin alfa
ATryn 1750 SV pulveris infuzijas škiduma pagatavošanai Antithrombin alfa
Approximately 175 IU/ml antithrombin alfa when reconstituted with 10 ml of WFI.
Aptuveni 175 SV/ ml antitrombina alfa, pec atškaidišanas ar 10 ml udens injekcijam.
10 Vials
10 flakoni
Read the package leaflet before use.
Intravenozai lietošanai Pirms lietošanas izlasiet lietošanas instrukciju
EXPIRY DATE
DERIGUMA TERMINŠ
EXP {MM/YYYY)
Der. lidz {MM/ GGGG}
Store in a refrigerator.
15 Uzglabat ledusskapi.
Any unused solution should be discarded.
Parpalikušais škidums jalikvide.
LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
LEO Pharma Industriparken 55 DK- 2750 Ballerup Danija
Batch {number}
Serija {numurs}
INSTRUCTIONS ON USE
NORADIJUMI PAR LIETOŠANU
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
16 INFORMACIJA, KAS JANORADA UZ AREJA IEPAKOJUMA UN UZ TIEŠA IEPAKOJUMA
OUTER CARTON (25 VIALS)
AREJAIS IEPAKOJUMS (25 FLAKONI)
25 Vials
25 flakoni.
Store in a refrigerator.
17 Uzglabat ledusskapi
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 MINIMALA INFORMACIJA IZVIETOJAMA UZ MAZA IZMERA TIEŠA IEPAKOJUMA
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
ZALU NOSAUKUMS UN IEVADIŠANAS VEIDS
ATryn 1750 IU powder for solution for infusion Antithrombin alfa For intravenous use.
ATryn 1750 SV pulveris infuzijas škiduma pagatavošanai Antithrombin alfa Intravenozai lietošanai
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
SATURA SVARS, TILPUMS VAI VIENIBU DAUDZUMS
Approximately 175 IU/ml antithrombin alfa when reconstituted with 10 ml of WFI
Aptuveni 175 SV/ ml antitrombina alfa, pec atškaidišanas ar 10 ml udens injekcijam.
Store in a refrigerator.
Uzglabat ledusskapi.
INFORMATION FOR THE USER
INFORMACIJA ZALU LIETOTAJAM
ATryn 1750 IU powder for solution for infusion Antithrombin alfa.
Atryn 1750 SV pulveris infuziju škiduma pagatavošanai Antithrombin alfa
Read all of this leaflet carefully before you start using this medicine.
Pirms zalu lietošanas uzmanigi izlasiet visu instrukciju.
- Keep this leaflet.
- Saglabajiet šo instrukciju!
You may need to read it again.
Iespejams, ka velak to vajadzes parlasit.
- If you have any further questions, ask your doctor.
- Ja Jums rodas jebkadi jautajumi, vaicajiet savam arstam.
- If any of the side effects get serious or if you notice any side effects not listed in the
- Ja Jus noverojat jebkadas blakusparadibas, kas šaja instrukcija nav minetas, vai kada no
leaflet, please tell your doctor.
minetajam blakusparadibam Jums izpaužas smagi, ludzu izstastiet to savam arstam.
In this leaflet:
Šaja instrukcija varat uzzinat:
What ATryn is and what it is used for 2.
Kas ir ATryn un kadam nolukam to lieto 2.
Before you use ATryn 3.
Pirms ATryn lietošanas 3.
How to use ATryn 4.
Ka lietot ATryn 4.
Possible side effects 5 How to store ATryn 6.
Iespejamas blakusparadibas 5 Ka uzglabat ATryn 6.
Further information
Sikaka informacija
WHAT ATryn IS AND WHAT IT IS USED FOR
KAS IR ATryn UN KADAM NOLUKAM TO LIETO
ATryn is an anti-clotting agent and contains antithrombin alfa which is similar to human antithrombin.
Alfa antitrombins ir lidzigs cilveka antitrombinam.
Antithrombin alfa is produced by recombinant DNA technology from the milk of goats.
Alfa antitrombinu iegust no kazas piena, izmantojot DNS rekombinacijas tehnologiju.
If you have congenital antithrombin deficiency, your blood level of antithrombin is lower than normal, which may result in a reduced anti-clotting capacity of your blood.
Ja Jums ir iedzimts antitrombina deficits, antitrombina koncentracija Jusu asinis ir zemaka par normalo, ka rezultata var samazinaties Jusu asins antitrombotiska speja.
If your anti-clotting capacity is reduced, there is an increased risk of the formation of clots in the vessels of your legs (deep vein thrombosis) or in other vessels of your body (thromboembolism) during major surgery.
Ja Jusu antitrombotiska speja ir samazinata, palielinas iespeja, ka augsta riska situacijas (piemeram, nozimigu kirurgisku operaciju gadijuma) veidosies trombi Jusu kaju asinsvados (dzilo venu tromboze) vai citos kermena asinsvados (tromboembolija).
Therefore, it is important that your antithrombin blood level be maintained at sufficient levels in these situations.
Tadejadi ir butiski, ka šadas situacijas antitrombina koncentracija Jusu asinis tiek uztureta pietiekami augsta limeni.
BEFORE YOU USE ATryn
PIRMS ATryn LIETOŠANAS
Do not use ATryn If you are allergic (hypersensitive) to antithrombin alfa or any of the other ingredients of ATryn.
Ja Jums ir alergija (paaugstinata jutiba) pret alfa antitrombinu vai jebkuru no ATryn paligvielam.
Take special care with ATryn If you are allergic to goat products, please tell your treating physician since you should not use ATryn.
Ipaša piesardziba, lietojot ATryn, nepieciešama šados gadijumos:
As with any intravenous protein product, allergic reactions are possible.
Ja Jums ir alergija pret kazu izcelsmes produktiem, ludzu, pastastiet to savam arstejošajam arstam, jo Jums ATryn ievadit nav atlauts.
If you experience hives, itchy welts or wheals all over the skin, tightness of the chest, wheezing (difficulty breathing), you should immediately contact your physician since these might be symptoms of a severe allergic reaction.
Ja Jums ir natrene, niez pedas vai visu adu parklaj natrene, ir spiediena sajuta krušu kurvi, aizsmakums (apgrutinata elpošana), Jums nekavejoties jasazinas ar savu arstu, jo minetas paradibas var but smagas alergiskas reakcijas simptomi.
To test for the occurrence of an allergic reaction, blood will be collected and tested before and some time after you have been treated with ATryn.
Lai noskaidrotu alergisku reakciju iespeju, pirms, ATryn lietošanas, ka ari kadu laiku pec tam Jums tiks veiktas asins analizes.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pastastiet arstam vai farmaceitam par visam zalem, kuras lietojat vai pedeja laika esat lietojis, ieskaitot zales, ko var iegadaties bez receptes.
When ATryn is used together with heparin (an anti-clotting drug), or some other anti-clotting drugs, this may increase the risk of bleeding.
Ja ATryn lieto kopa ar heparinu (antitrombotisks lidzeklis) vai citam antitrombotiskam zalem, var pieaugt asinošanas risks.
Therefore your doctor will carefully monitor the use of ATryn when administered together with these anti-clotting drugs.
Tadejadi, ja preparats tiks ievadits kopa ar minetajam antitrombotiskajam zalem, Jusu arsts rupigi kontroles ATryn lietošanu.
22 Using ATryn with food and drink No special precautions should be taken while eating or drinking.
21 ATryn lietošana kopa ar partiku un dzerieniem Nav nepieciešami ipaši piesardzibas pasakumi. lietojot edienus vai dzerienus.
Pregnancy ATryn is not indicated for use in pregnant patients.
Grutnieciba Grutniecem ATryn nav indicets.
Breast-feeding It is unknown whether ATryn is present in breast milk.
Zidišanas periods Nav zinams, vai ATryn izdalas ar mates pienu.
Therefore it is not recommended to breastfeed whilst being treated with ATryn.
Tadejadi ATryn terapijas laika barot ar kruti nav ieteicams.
Driving and using machines Not relevant.
Transportlidzeklu vadišana un mehanismu apkalpošana Nav piemerojams.
Important information about some of the ingredients of ATryn Not relevant.
Svariga informacija par kadu no ATryn sastavdalam Nav piemerojams.
HOW TO USE ATryn
KA LIETOT ATryn
Your health care provider will prepare a solution of ATryn to be administered through an infusion directly into a blood vessel.
Jusu veselibas aprupes specialists sagatavos ATryn škidumu, kas infuzijas veida jaievada tieši asinsvada.
Blood levels of antithrombin will be regularly checked in the blood and a change of dose may be necessary.
Var but nepieciešams mainit preparata devu.
If you use more ATryn than you should
Ja esat lietojis ATryn vairak neka noteikts
The doctor will treat you, as appropriate, if you have any particular ill effects.
Ja Jums paradisies kadas noteiktas blakusparadibas, arsts Jums nozimes piemerotu terapiju.
If you stop using ATryn
Ja Jus partraucat lietot ATryn
Please discuss possibility of stopping the treatment with your doctor.
Iespeja terapiju partraukt Jums jaapspriež ar savu arstu.
If you have any further questions on the use of this product, ask your doctor.
Ja Jums ir vel kadi jautajumi par ši produkta lietošanu, jautajiet savam arstam.
POSSIBLE SIDE EFFECTS
IESPEJAMAS BLAKUSPARADIBAS
Like all medicines, ATryn may cause side effects, although not everybody gets them.
Tapat ka citas zales, ATryn var izraisit blakusparadibas, kaut ari ne visiem tas izpaužas.
Some side effects such as bleeding, bruises, redness, or pain at the site of injection, nausea, headache, feeling hot, dizziness, bruising and increased bleeding may occur during treatment with ATryn.
ATryn terapijas laika ir iespejamas dažas tadas blakusparadibas ka asinošana, hematomas, apsartums vai sapes injekcijas vieta, škebinašana, galvassapes, karstuma sajuta, reiboni, hematomu veidošanas un pastiprinata asinošana.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Ja noverojat jebkadas blakusparadibas, kas šaja instrukcija nav minetas vai kada no minetajam blakusparadibam Jums izpaužas smagi, ludzam par tam izstastit arstam.
HOW TO STORE ATryn
KA UZGLABAT ATryn
Store in a refrigerator (2°C – 8°C).
Uzglabat ledusskapi (2°C – 8°C).
Do not use ATryn after the expiry date stated on the labelling after the letters EXP.
Nelietot ATryn pec uz iepakojuma noradita deriguma termina, kas uz iepakojuma noradits aiz markejuma Derigs lidz.
Diluted solutions:
Atškaiditi škidumi:
The product should be used immediately.
22 Preparats jaizlieto nekavejoties.
FURTHER INFORMATION
SIKAKA INFORMACIJA
What ATryn contains
Ko ATryn satur
- The active substance is antithrombin alfa
- Aktiva viela ir alfa antitrombins
- The other ingredients are: glycine, sodium chloride, sodium citrate
- Paligvielas: glicins, natrija hlorids, natrija citrats
What ATryn looks like and contents of the pack
ATryn arejais izskats un iepakojuma saturs
White to off-white powder.
Balts vai peleki balts pulveris.
1, 10 or 25 vials per carton.
Iepakojuma lielums: iepakojuma 1, 10 vai 25 flakoni.
Each vial of ATryn contains a nominal value of 1750 IU of recombinant antithrombin alfa.
Viena iepakojuma nominalais saturs ir 1750 SV rekombineta alfa antitrombina.
The powder will be dissolved before it can be infused.
Pirms infuzijas pulveris ir jaizškidina.
Marketing Authorisation Holder and Manufacturer
Registracijas apliecibas ipašnieks un ražotajs
Marketing authorisation Holder LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
Registracijas apliecibas ipašnieks LEO Pharma A/ S, Industriparken 55, DK- 2750 Ballerup, Danija.
Manufacturer authorisation holder responsible for batch release LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
Ražošanas licences ipašnieks, kas atbild par serijas izlaidi LEO Pharma A/ S, Industriparken 55, DK- 2750 Ballerup, Danija.
This leaflet was last approved in
Ši lietošanas instrukcija akcepteta
This medicinal product has been authorized under “Exceptional Circumstances”.
Šis zales ir registretas “ Iznemuma apstaklos ”.
This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Tas nozime, ka sakara ar to, ka slimiba ir loti reta, pilnigu informaciju par šim zalem nav iespejams iegut.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this leaflet will be updated as necessary.
Eiropas Zalu agentura katru gadu izskatis visu jauno informaciju, kas varetu klut pieejama un ši lietošanas instrukcija tiks papildinata pec vajadzibas.
Detailed information is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu --------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Detalizeta informacija ir pieejama Eiropas Zalu agenturas (EMEA) majas lapa: http: // www. emea. europa. eu / ------------------------------------------------------------------------------------------------------------------------------ Talak sniegta informacija paredzeta tikai medicinas vai veselibas aprupes profesionaliem:
Vials should be brought to room temperature prior to reconstitution and kept no longer than 3 hours.
Pirms atškaidišanas flakoniem jasasilst lidz istabas temperaturai, tomer istabas temperatura tie nedrikst atrasties ilgak ka 3 stundas.
The powder should be reconstituted with 10 ml of Sterile Water for Injection (WFI) injected along the side wall of the vial and gently swirled (not shaken) to prevent foaming.
Lai noverstu putošanos, flakonu viegli pagroza (nekrata).
The reconstituted product should be inspected visually for particulate matter and discolouration prior to administration.
Pirms ievades atškaiditais preparats ir vizuali japarbauda attieciba uz dalinu klatbutni un krasas mainu.
The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag with an in-line filter e.g. a methylcellulose filter with a 0.2 micron pore size.
Atškaiditais produkts jaievada intravenozas infuzijas veida, izmantojot sterilu, vienreizejai lietošanai paredzetu šlirci vai infuzijas maisu ar filtru (piemeram, metilcelulozes filtru ar 0, 22 mikronu poram) ievades caurule.
Normal sodium chloride solution 9 mg/ml (0.9%) may be added to dilute to a concentration convenient for administration.
Lai preparatu atškaiditu lidz ievadei ertai koncentracijai, var pievienot fiziologisko natrija hlorida 9 mg/ ml (0, 9%) škidumu.
The contents of infusion syringes on diluted solution prepared in infusion bags should be administered within 8 hours of preparation.
Injekciju šlircu saturs un atškaidits škidums, kas sagatavots infuzijas maisa, pec pagatavošanas ir jaizlieto 8 stundu laika.
Compatibility with PVC infusion lines with in-line filters has been established.
Ir pieradita saderiba ar PVH infuzijas caurulem ar iekšejo filtru.
24 Any unused product or waste material should be disposed of in accordance with local requirements.
23 Neizlietotas zales vai izlietotie materiali jaiznicina atbilstoši vietejam prasibam.
The therapeutic goal of treatment with ATryn is to increase to, and maintain antithrombin activity between 80 – 120% (0.8 – 1.2 IU/ml) for the duration of treatment.
ATryn terapijas merkis ir paaugstinat antitrombina aktivitati lidz 80– 120% (0, 8– 1, 2 SV/ ml) un uzturet to terapijas laika.
This initial loading dose is based on body weight and on the pretreatment antithrombin activity level.
Šis sakotnejas piesatinošas devas lielumu pamato kermena masa un antitrombina aktivitate pirms terapijas.
Loading Dose (IU) = [(100 – patient’s pre -treatment AT activity level in%) /2.28] x Body Weight in kg
Piesatinoša deva (SV) = [(100 – pacienta AT aktivitate% pirms terapijas) / 2, 28] x Kermena masa kg
The usual loading dose in surgical patients (baseline AT activity 50%, bodyweight 75 kg) with congenital antithrombin deficiency in clinical risk situations is 20-25 IU/kg bodyweight.
Parasta kirurgisko pacientu ar iedzimtu antitrombina deficitu (sakotneja AT aktivitate — 50%, kermena masa — 75 kg) piesatinoša deva kliniska riska situacijas ir 20- 25 SV/ kg kermena masas.
The required maintenance dose for surgical patients is given as a continuous infusion and is determined using the following formula:
Kirurgiskiem pacientiem nepieciešamas uzturošas devas, ko ievada nepartrauktas infuzijas veida, lielumu nosaka pec šadas formulas:
Maintenance Dose (IU/hour) = [(100 – patient’s pre -treatment AT activity level in%) /10.22] x Body Weight in kg
Uzturoša deva (SV/ stunda) = [(100 – pacienta AT aktivitate% pirms terapijas) / 10, 22] x Kermena masa kg
The usual maintenance dose in surgical patients with congenital antithrombin deficiency in clinical risk situations is 4-5 IU/kg/h.
Parasta kirurgisko pacientu ar iedzimtu antitrombina deficitu uzturoša deva kliniska riska situacijas ir 4 – 5 SV/ kg kermena masas stunda.
During consumptive states (e.g. major surgery, concomitant use of heparin) the actual dose may be higher.
Konsumptivos stavoklos (piemeram, nozimigas kirurgiskas manipulacijas, vienlaiciga heparina lietošana) faktiska deva var but lielaka.
Frequent antithrombin activity assessments and dosing adjustments may be necessary when starting treatment and just after surgery.
Terapijas sakuma un tulit pec kirurgiskam manipulacijam var but nepieciešama bieža antitrombina aktivitates novertešana un devu korigešana.
In case the AT activity level is between 80% and 120% (0.8- 1.2 IU/ml), no dose adjustment is needed.
Ja AT aktivitate ir robežas starp 80% un 120% (0, 8– 1, 2 SV/ ml), deva nav jakorige.
Subsequently, antithrombin activity should be checked 1 times a day and dose -2 adjustments made accordingly.
Turpmak antitrombina aktivitate jakontrole 1– 2 reizes diena un javeic atbilstošas devas korekcijas.
The dose can be calculated utilizing the p loading dose formula above.
Devu iespejams aprekinat, izmantojot AT aktivitates lielumu pec kirurgiskas iejaukšanas un iepriekš noradito formulu, pec kuras aprekina piesatinošo devu.
ost-surgical AT activity in the
Nav pieredzes lietošana berniem.
Strength
Es numurs
Film-coated tablet
Ievadīšanas veids
112 tablets
Iepakojums
Film-coated tablet
Iepakojuma lielumi
EU/ 1/ 06/ 349/ 006
EU/ 1/ 06/ 349/ 001 EU/ 1/ 06/ 349/ 002 EU/ 1/ 06/ 349/ 003 EU/ 1/ 06/ 349/ 004 EU/ 1/ 06/ 349/ 005 EU/ 1/ 06/ 349/ 006 EU/ 1/ 06/ 349/ 007 EU/ 1/ 06/ 349/ 008 EU/ 1/ 06/ 349/ 009 EU/ 1/ 06/ 349/ 010
Film-coated tablet
Apvalkotās tabletes Apvalkotās tabletes Apvalkotās tabletes Apvalkotās tabletes Apvalkotās tabletes Apvalkotās tabletes Apvalkotās tabletes Apvalkotās tabletes Apvalkotās tabletes Apvalkotās tabletes
Oral use
Iekšķīgai lietošanai Iekšķīgai lietošanai Iekšķīgai lietošanai Iekšķīgai lietošanai Iekšķīgai lietošanai Iekšķīgai lietošanai Iekšķīgai lietošanai Iekšķīgai lietošanai Iekšķīgai lietošanai Iekšķīgai lietošanai
blister (PVC/ PVdC/ alu)
blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu) blisters (PVH/ PVDH/ alu)
What is Avaglim?
Kas ir Avaglim?
Avaglim is a medicine containing two active substances, rosiglitazone and glimepiride.
Avaglim ir zāles, kas satur divas aktīvās vielas – roziglitazonu un glimepirīdu.
It is available as triangular tablets (pink:
Tās ir pieejamas kā trīsstūrainas tabletes (rozā krāsā:
4 mg rosiglitazone and 4 mg glimepiride; red:
4 mg roziglitazona un 4 mg glimepirīda; sarkanā krāsā:
8 mg rosiglitazone and 4 mg glimepiride).
8 mg roziglitazona un 4 mg glimepirīda).
What is Avaglim used for?
Kāpēc lieto Avaglim?
Avaglim is used to treat adult patients who have type 2 diabetes (non-insulin-dependent diabetes).
Avaglim lieto pieauguši 2. tipa diabēta (insulīnneatkarīga cukura diabēta) slimnieki.
Avaglim is used in patients who cannot satisfactorily control their blood glucose (sugar) when using an adequate dose of a sulphonylurea (a type of antidiabetes medicine) on its own, and for whom metformin (another antidiabetes medicine) is not suitable.
Avaglim lieto slimnieki, kas nespēj pietiekami labi kontrolēt glikozes (cukura) līmeni asinīs, lietojot tikai attiecīgo sulfonilurīnvielas (pretdiabēta zāļu) devu, un kuriem metformīns (citas pretdiabēta zāles) nav ieteicams.
How is Avaglim used?
Kā lieto Avaglim?
Avaglim is taken once a day, just before or during a meal, generally breakfast.
Avaglim lieto vienreiz dienā pirms ēšanas vai ēšanas laikā, parasti brokastīs.
Doctors must be careful when switching patients who are at risk of developing hypoglycaemia (low blood sugar) to Avaglim, such as elderly patients, patients with low weight or those who have been taking certain other medicines.
Ārstiem jābūt piesardzīgiem, ordinējot Avaglim slimniekiem, kam var attīstīties glikēmija (pazemināts cukura līmenis asinīs), t. i., gados veciem slimniekiem, slimniekiem ar mazu ķermeņa masu vai slimniekiem, kuri lieto noteiktas citas zāles.
The patient can start with separate tablets containing only rosiglitazone or a sulphonylurea, before switching to the combination tablet once control is achieved.
Pacients var sākt lietot tabletes, kas satur tikai roziglitazonu vai sulfonilurīnvielu, pirms pāriet uz kombinācijas tabletēm, kad jau ir panākts efekts.
The dose should start with the 4 mg/ 4 mg tablet.
Sākuma deva ir 4 mg/ 4 mg.
The dose can be increased to the 8 mg/ 4 mg tablets after eight weeks if needed, but this should be done with caution, due to the risk of fluid retention.
Devu, ja nepieciešams, var palielināt līdz 8 mg/ 4 mg pēc astoņām nedēļām, bet jāievēro zināma piesardzība, jo pastāv šķidruma aizturēšanas risks.
If the patient develops hypoglycaemia, then a return to separate tablets will be needed so that the dose of glimepiride can be adjusted.
Attīstoties hipoglikēmijai, jāsāk atkal lietot parastās tabletes, lai pielāgotu glimepirīda devu.
How does Avaglim work?
Kā Avaglim darbojas?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
2. tipa diabēts ir slimība, kad aizkuņģa dziedzeris neizdala pietiekamu daudzumu insulīna, kas regulē glikozes līmeni asinīs, vai stāvoklis, kad organisms nespēj efektīvi izmantot insulīnu.
Avaglim contains two active substances, which have different modes of action.
Avaglim satur divas aktīvās vielas, kuras darbojas atšķirīgi.
Rosiglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Roziglitazons padara šūnas (taukaudu, muskuļaudu un aknu šūnas) jutīgākas pret insulīnu, līdz ar to ļaujot organismam labāk izmantot paša veidoto insulīnu.
Glimepiride is a sulphonylurea.
Glimepirīds ir sulfonilurīnviela.
It stimulates the pancreas to produce more insulin.
Tā liek aizkuņģa dziedzerim ražot vairāk insulīna.
As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Abas aktīvās vielas samazina glikozes līmeni asinīs un tādējādi palīdz kontrolēt 2. tipa diabētu.
How has Avaglim been studied?
Reproduction is authorised provided the source is acknowledged Kā noritēja Avaglim izpēte?