PABAL 100 MCG ML

Genel Bilgiler

  • Ticaret Unvanı:
  • PABAL 100 MCG/ML IV ENJEKSIYONLUK COZELTI ICEREN 1 AMPUL
  • Reçete türü:
  • Normal
  • İçin kullanmak:
  • İnsanlar
  • İlaç türü:
  • allopatik ilaç

Belgeler

Yerelleştirme

  • Bulunduğu ülkeler::
  • PABAL 100 MCG/ML IV ENJEKSIYONLUK COZELTI ICEREN 1 AMPUL
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • carbetocin

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8697621750463
  • Yetkilendirme tarihi:
  • 03-05-2016
  • Son Güncelleme:
  • 24-05-2018

Hasta Bilgi broşürü: Ürün Özellikleri Özeti - kompozisyon, endikasyonlar, yan etkiler, dozaj, etkileşimleri, advers reaksiyonlar, gebelik, laktasyon

09.04.2015 1/5

KULLANMA TALİMATI

PABAL 100 mikrogram/ml I.V. enjeksiyonluk çözelti içeren ampul

Damar içine uygulanır.

Steril, apirojen

Etkin madde:Karbetosin……………….100 mikrogram/ml

YardımcıMaddeler:Sodyumklorür, glasiyal asetik asit, enjeksiyonluk su.

Bu ilacıkullanmayabaşlamadan önce bu KULLANMA TALİMATINI

dikkatlice okuyunuz, çünkü sizin için önemli bilgiler içermektedir.

Bu kullanma talimatınısaklayınız. Daha sonra tekrar okumaya ihtiyaç

duyabilirsiniz.

Eğer ilave sorularınız olursa, lütfen doktorunuzaveya eczacınıza danışınız.

Bu ilaç kişisel olarak siziiçin reçete edilmiştir, başkalarına vermeyiniz.

Bu ilacın kullanımısırasında, doktora veyahastaneye gittiğinizde builacı

kullandığınızıdoktorunuza söyleyiniz.

Bu talimattayazılanlara aynen uyunuz.İlaç hakkında size önerilen dozun dışında

yüksek veyadüşükdozkullanmayınız.

Bu kullanma talimatında:

1. PABAL nedir ve ne için kullanılır?

2. PABAL

ıkullanmadan önce dikkat edilmesi gerekenler

3. PABAL nasıl kullanılır?

4. Olasıyanetkiler nelerdir?

5. PABAL’ın saklanması

Başlıklarıyer almaktadır.

1. PABAL nedir ve ne için kullanılır?

PABAL, 1 ml’lik 5 veya 1 ampul içeren ambalajlarda intravenöz enjeksiyon için hazır

olarak sunulmaktadır. Her bir ampulde, 100 mikrogrametkin madde karbetosin içeren

çözelti bulunmaktadır. Karbetosin,doğumsırasında rahmin kasılmasıiçin vücut tarafından

doğal olarak üretilen oksitosin adlımaddeye benzer bir moleküldür.

PABAL sezaryen ile yeni doğumyapmışolan kadınların tedavisinde kullanılır.

Sezaryen sonrası, bazıkadınlarda rahimyeterince hızlıkasılmaz (büzülmez). Bu da rahimin

normalden daha fazla kanamasıihtimalini artırır.

PABAL rahimin kasılmasınısağlayarak kanamariskini azaltır.

09.04.2015 2/5

2. PABAL’ıkullanmadan önce dikkat edilmesi gerekenler

PABAL’ıaşağıdaki durumlarda KULLANMAYINIZ

Bebeğin doğumundan önce verilmemelidir.

Doğumindüksiyonu için kullanılmamalıdır.

Eğer:

Karbetosin veya PABAL

içerdiği maddelerden herhangi birine karşıgelişen aşırı

duyarlılık varsa (yardımcımaddeler listesine bakınız).

Ciddi bir kalp hastalığınız varsa.

Oksitosine(doğumsırasında veya sonrasında bazen damla veya enjeksiyon yoluyla

verilen) karşıolumsuz bir reaksiyon verdiyseniz.

Karaciğer ve böbrek hastalığınız varsa.

Epilepsiniz (sara hastalığı) varsa.

PABAL’ıaşağıdaki durumlarda DİKKATLİKULLANINIZ

Eğer:

Preeklampsi (gebelikte yüksek kan basıncı) veya eklampsi (gebelikte kan

zehirlenmesi) yaşadıysanız.

Migreniniz varsa.

Astımınız varsa.

Epilepsiniz varsa.

Kalp veya dolaşımsisteminizle (yüksek kan basıncıgibi) ilgili sorunlarınız varsa.

Başka bir tıbbi durumunuz varsa.

Bu uyarılar geçmişteki herhangi bir dönemde dahi olsasizin için geçerliyse lütfen

doktorunuza danışınız.

PABAL’ın yiyecek ve içecek ile kullanılması

Bildirilmemiştir.

Hamilelik

İlacıkullanmadan önce doktorunuzaveya eczacınıza danışınız.

PABAL hamilelik sırasında doğumindüksiyonu için kullanılmamalıdır.

Emzirme

İlacıkullanmadan önce doktorunuzaveya eczacınıza danışınız.

Klinik deneyler sırasında, süt verme üzerine hiçbir belirginetki bildirilmemiştir. Emziren

kadınlarda az miktarda karbetosinin, plazmadan anne sütüne geçtiği gösterilmiştir. Tek bir

karbetosin enjeksiyonundan sonra kolostruma veya anne sütüne geçen ve sonrasında bebek

tarafından yutulan küçükmiktarların bağırsakta enzimler tarafından parçalandığı

düşünülmektedir.

09.04.2015 3/5

Araç ve makine kullanımı

Bildirilmemiştir.

PABAL’ın içeriğinde bulunan bazıyardımcımaddeler hakkında önemli bilgiler

PABAL 23 mg’dan daha az sodyum(sodyum klorür) içerir. Sodyummiktarına bağlı

herhangi bir olumsuz etki beklenmez.

Diğer ilaçlar ile birlikte kullanımı

Karbetosinin oksitosine yapısal olarak benzer olmasınedeniyle, oksitosinle ilişkili olduğu

bilinen etkileşimlerin oluşumu ihtimal dahilindedir. Metilergometrin, oksitosin ve

karbetosin gibi ergot alkaloidleribirliktekullanıldığında, bu ajanların etkileriartarak kan

basıncınıartırabilir. Prostaglandinlerinoksitosinin etkisini güçlendirdiği bulunmuştur.

Bunun karbetosin ile olmasıda beklenir. Halotan ve siklopropan gibi bazıinhalasyon

anestezikleri, hipotansif etkiyiartırıp karbetosinin uterusüzerindeki etkisini zayıflatabilir.

Eğer reçeteli ya da reçetesiz herhangi bir ilacışu anda kullanıyorsanız veya son

zamanlarda kullandınız ise lütfendoktorunuzaveyaeczacınıza bunlar hakkındabilgi

veriniz.

3. PABAL nasıl kullanılır?

Uygun kullanım ve doz/uygulama sıklığıiçin talimatlar:

PABAL, epidural veyaspinal anestezi altında sezaryen ile doğumyaptıktan hemen sonra

damarlarınızdan birinden tek kez enjeksiyon yoluyla verilir. Doz bir ampuldür (100

mikrogram). Doğumdan hemen sonra mümkün olduğunca çabuk ve tercihen plasentanın

atılmasından önce verilmelidir. Sonradan ek doz uygulanmamalıdır.

Uygulama yolu ve metodu:

Damar içine intravenöz enjeksiyonla uygulanır.

Özel kullanım durumları:

Özel kullanım yoktur.

Böbrek Yetmezliği:Bildirilmemiştir.

Karaciğer Yetmezliği:Bildirilmemiştir.

Kullanmanız gerekenden dahafazla PABAL kullandıysanız:

Bir kişiye yanlışlıkla çok fazla PABAL verilmesi halinde, kişininrahmi çok fazla

kasılabilir. Vücudundaki su birikiminedeniyle uyuşukluk, halsizlik ve başağrısı

yaşayabilir. Hasta, gerekirse diğer ilaçlarla tedavi edilir.

09.04.2015 4/5

Pabal’ıkullanmayıunutursanız:

Uygulanabilir değildir.

Pabal ile tedavi sonlandırıldığında oluşabilecek etkiler:

Uygulanabilir değildir.

4. Olasıyan etkiler nelerdir?

Tümilaçlar gibi PABAL’ın içeriğinde bulunan maddelere duyarlıolan kişilerde yan etkiler

olabilir.

Çok yaygın : 10 hastadan birinde veya daha fazlasında görülebilir.

Yaygın : 10 ila 100 hastanın birinde görülebilir.

Yaygın olmayan : 100 ila 1000 hastanın birinde görülebilir.

Seyrek : 1000 ila 10.000 hastanın birinde görülebilir.

Çok seyrek :10.000hastanın birinde veya dahaseyrek olarak olarak görülebilir.

Sıklığıbilinmeyen :Eldeki verilerden hareketle tahmin edilemiyor.

Kan ve lenfsistemi bozuklukları

Yaygın: Kansızlık

Sinir sistemi bozuklukları

Çok yaygın: Başağrısı, titreme

Yaygın: Başdönmesi

Damar sistemi bozuklukları

Çok yaygın: Düşük kan basıncı, kızarma (ciltte kızarıklık)

Solunum, göğüs ve göğüs kafesi bozuklukları

Yaygın: Göğüs ağrısı, nefes darlığı

Mide barsak sistemi bozuklukları

Çok yaygın:Mide bulantısı, karın ağrısı

Yaygın: Ağızda metalik tat, kusma

Deri ve deri altıdoku bozuklukları

Çok yaygın: Kaşıntı

Kas - iskelet ve bağdokusu bozuklukları

Yaygın: Sırt ağrısı

Genel bozukluklar ve uygulama bölgesine ilişkin bozukluklar

Çok yaygın: Sıcak basması

Yaygın: Üşüme, ağrı

Nadiren bazıkadınlarda kalp atışıhızlanabilir veyaterleme görülebilir.

PABAL, vücutta su artışına neden olabilir ve bu durumuyuşukluk, halsizlik ve başağrısına

yol açabilir.

09.04.2015 5/5

Eğer bu kullanma talimatında bahsi geçmeyen herhangi bir yan etki ile karşılaşırsanız

doktorunuzuveya eczacınızıbilgilendiriniz.

Yan etkilerin raporlanması

Kullanma Talimatında yer alan veya almayan herhangi bir yan etki meydana gelmesi

durumunda hekiminiz, eczacınızveyahemşireniz ile konuşunuz. Ayrıca karşılaştığınız yan

etkileri www.titck.gov.tr sitesinde yer alan “İlaç Yan Etki Bildirimi” ikonuna tıklayarak ya

da 0 800 314 00 08 numaralıyan etki bildirimhattınıarayarak Türkiye Farmakovijilans

Merkezi (TÜFAM)’ne bildiriniz.Meydanagelen yan etkileri bildirerek kullanmakta

olduğunuz ilacın güvenliliği hakkında daha fazla bilgi edinilmesine katkısağlamış

olacaksınız.

5. PABAL

ın saklanması

PABAL’ıçocukların göremeyeceği, erişemeyeceği yerlerde ve ambalajında saklayınız.

2 °C - 8 °C arasısıcaklıklarda (buzdolabında) saklayınız.

Işıktan korumak için orijinal ambalajında saklayınız.

Dondurulmamalıdır.

Son kullanma tarihiyle uyumlu olarak kullanınız.

Ambalaj üzerindeki son kullanma tarihinden sonra PABAL’ıkullanmayınız.

Eğer üründe ve/veya ambalajında bozukluklar fark ederseniz PABAL’ıkullanmayınız.

Ferringİlaç San.ve Tic. Ltd.Şti.

Büyükdere Cad. Nurol Plaza No. 255 Kat 13

Maslak 34398Şişliİstanbul

Tel : 0212 335 62 00

Faks : 0212 285 42 74

e-posta: TR0-info@ferring.com

Üretim Yeri:

Ferring GmbH

Kiel, Almanya

Bu kullanmatalimatı06/04/2015 tarihinde onaylanmıştır.

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3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

5-7-2018

Blokhuis: jaarlijks 4 miljoen euro naar onderzoek Lifelines tot 2024

Blokhuis: jaarlijks 4 miljoen euro naar onderzoek Lifelines tot 2024

Derde onderzoeksronde Lifelines in 2019 van start Lifelines, de data- en biobank waarin informatie over de gezondheid van drie generaties inwoners in de noordelijke provincies gedurende dertig jaar wordt verzameld, start in 2019 met de derde onderzoeksronde onder alle Lifelines-deelnemers. Dit wordt mogelijk gemaakt door het Ministerie van VWS, de RUG en het UMCG en de provincies Groningen, Friesland en Drenthe. Deze gezamenlijke inzet weerspiegelt het belang van Lifelines voor zowel volksgezondheid, wet...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

27-4-2018

EpiPen 300 mcg adrenaline auto-injector

EpiPen 300 mcg adrenaline auto-injector

Medicine shortages

Therapeutic Goods Administration - Australia

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety