Apo-Warfarin

Maklumat utama

  • Nama dagangan:
  • Apo-Warfarin Tablet
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Apo-Warfarin Tablet
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL 2002139
  • Kemaskini terakhir:
  • 31-08-2017

Risalah Maklumat Pesakit: ciri produk - komposisi, petunjuk, kesan sampingan, dos, interaksi, tindak balas buruk, kehamilan, penyusuan

APO-WARFARIN

Warfarin Sodium (1mg, 2mg, 5mg)

1

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Apakah yang ada pada risalah ini

Apakah kegunaan Apo-Warfarin

Bagaimana Apo-Warfarin berfungsi

Sebelum menggunakan Apo-

Warfarin

Cara menggunakan Apo-Warfarin

Semasa menggunakan Apo-Warfarin

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Apo-Warfarin

Maklumat lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan Apo-Warfarin

Apo-warfarin membantu mencegah

darah dari pembekuan secara berlebihan

atau membentuk gumpalan yang

berbahaya. Jika pembekuan secara

berlebihan tidak dirawat, ia boleh

membawa kepada masalah kesihatan

yang serius seperti strok atau serangan

jantung.

Bagaimana Apo-Warfarin berfungsi

Apo-Warfarin ialah sejenis ubat

antikoagulan. “Anti” bermaksud

menentang, dan “koagulan” merujuk

kepada penggumpalan darah.

Antikoagulan membantu mengurangkan

berlakunya penggumpalan dalam darah.

Apo-Warfarin

menghalang

sebahagian

daripada penggunaan semula vitamin K

oleh

hati

anda.

Vitamin

diperlukan

untuk membina faktor penggumpal yang

membantu

menggumpal

darah

menghentikan

pendarahan.

Vitamin

boleh didapati secara semula jadi dalam

makanan

seperti

sayur-sayuran

yang

hijau dan berdaun dan juga sesetengan

minyak sayuran.

Apo-Warfarin mula mengurangkan

penggumpalan darah dalam masa 24 jam

selepas pengambilan ubat ini. Kesan

penuh boleh mengambil selama 72 ke 96

jam untuk berlaku.

Sebelum menggunakan Apo-Warfarin

Bila tidak boleh menggunakan

Jangan guna Apo-Warfarin jika anda

alah kepada Warfarin Sodium, atau

sebarang isi kandungan dalam ubatan

ini.

Mengandung dan menyusukan anak

Jangan ambil Apo-Warfarin jika anda

mengandung, sedang merancang untuk

mengandung atau mungkin

mengandung.

Jangan ambil Apo-Warfarin jika anda

sedang menyusukan anak. Dapatkan

nasihat doktor atau ahli farmasi

sebelum mengambil sebarang ubat.

Sebelum mula menggunakan Apo-

Warfarin

Maklumkan

kepada

pengamal

perubatan

anda

tentang

keadaaan

kesihatan anda, termasuklah jika anda:

Mempunyai masalah pendarahan

Kerap jatuh

Mempunyai

masalah

pada

hati

atau buah pinggang

Mempunyai tekanan darah tinggi

Mempunyai kencing manis

Mengambil

alkohol

atau

mempunyai masalah pengambilan

alkohol berlebihan

Telah merancang untuk menjalani

sebarang

operasi/

pembedahan

pada masa terdekat

Jika mengambil ubat-ubat lain

Beritahu doktor jika anda

menggunakan sebarang ubat lain,

termasuk ubat yang dibeli tanpa

preskripsi dari farmasi, pasaraya, atau

kedai makanan kesihatan.

Sesetengah ubat mungkin

menyebabkan komplikasi apabila

diambil bersama-sama dengan Apo-

Warfarin, sebagai contoh:

Acetalminophen, Allopurinol, aspirin,

azithromycin, capecitabine, cefoxitin,

Clarithromycin, Dekstran, diclofenac

(masa pendarahan dipanjangkan)

Atorvastatin, azathioprine,

chlordiazepoxide, phenytoin,

Ranitidine,

vitamin K (boleh

mengurangkan kesan Apo-Warfarin)

Non Steroidal anti-inflammatory

drugs

(NSAIDs)

Cara menggunakan Apo-Warfarin

Berapa banyak harus digunakan

Cara mengambil atau dos Apo-

warfarin adalah berdasarkan reaksi

individu kepada ubat ini.

Ikut arahan doktor atau ahli farmasi

anda dengan teliti. Ia mungkin berbeza

dari maklumat di dalam risalah ini.

Jika anda tidak memahami arahan pada

label ubat anda, sila rujuk kepada

doktor atau ahli farmasi.

Bila perlu digunakan

Ikut arahan doktor atau ahli farmasi

anda.

Berapa lama perlu digunakan

Teruskan penggunaan ubat ini untuk

tempoh masa yang ditetapkan oleh

doktor anda.

Jika terlupa menggunakan

Rujuk kepada doktor atau ahli farmasi

anda tentang apa yang perlu dilakukan

jika anda terlupa menggunakan ubat

ini.

Ambil dos yang terlepas sebaik sahaja

anda teringat. Sekiranya sudah hampir

masa untuk dos seterusnya, abaikan

dos terlepas dan tunggu untuk

mengambil dos seterusnya pada masa

biasa. Jangan ambil dos berganda

untuk menggantikan dos yang

tertinggal.

Jika mengambil berlebihan (terlebih

dos)

Hubungi doktor anda dengan segera

atau pergi ke Jabatan Kecemasan

hospital terdekat, jika terambil dos

berlebihan. Ini perlu dilakukan

walaupun tiada sebarang kesan

keracunan atau rasa tidak selesa. Anda

mungkin memerlukan perhatian

perubatan segera.

2

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Semasa menggunakan Apo-Warfarin

Perkara yang perlu dilakukan

Ambil ubat anda mengikut arahan

doktor.

Maklumkan kepada semua doktor,

doktor gigi dan ahli farmasi yang

merawat anda bahawa anda sedang

menggunakan Apo-Warfarin.

Beritahu doktor anda dengan segera

jika anda menjadi hamil semasa

menggunakan ubat ini.

Perkara yang tidak boleh dilakukan

Jangan berhenti menggunakan ubat ini

kecuali diarahkan oleh doktor anda.

Jangan mula mengambil sebarang ubat

baru tanpa berbincang dengan doktor

atau ahli farmasi anda.

Jangan berkongsi Apo-Warfarin

dengan sesiapa, walaupun mereka

mempunyai simptom atau penyakit

yang sama.

Perkara yang perlu diberi perhatian

Memandu dan menggunakan jentera

Ubat ini mungkin mengganggu

keupayaan anda untuk memandu atau

mengendalikan jentera, Jika ubat ini

menyebabkan anda terasa loya, pening,

letih, atau sakit kepala, jangan

memandu atau mengendalikan jentera

dan hubungi doktor anda dengan

segera.

Kesan-kesan sampingan

Seperti ubat-ubatan lain,Apo-Warfarin

boleh menyebabkan kesan sampingan,

walaupun bukan semua orang

mengalaminya.

Kesan sampingan mungkin termasuk

pendarahan secara berlebihan di mana-

mana tisu atau organ. Tanda dan gejala

akan berbeza-beza mengikut di mana ia

berlaku. Komplikasi boleh hadir sebagai

sakit kepala, sakitdada / perut / otot

sendi, mudah pening, perasaan menjadi

lemah.

Kesan sampingan yang lain termasuk:

sakit, hipersensitiviti, demam, sakit

kepala, pening, tidak dapat bertoleransi

dengan keadaan sejuk, mual muntah,

ruam.

Kesan sampingan yang lebih serius

termasuk:

- Masalah pada saluran pernafasan

(tracheal or tracheobronchial

calcification) jika mengambil rawatan ini

secara berpanjangan.

- nekrosis kulit (kematian tisu kulit)

Jumpa doktor atau ahli farmasi anda

dengan segera jika anda mengalami

sebarang kesan sampingan selepas

menggunakan ubat ini.

Anda boleh melaporkan sebarang kesan

sampingan atau kesan advers ubat

kepada Pusat Pemantauan Kesan Advers

Ubat Kebangsaan melalui No. Tel: 03-

78835550, atau laman

web portal.bpfk.gov.my

Consumers

Reporting

Cara penyimpanan dan pelupusan

Apo-Warfarin

Penyimpanan

Jauhi semua ubat daripada kanak-

kanak.

Simpan di bawah suhu 25°C.

Pelupusan

Ubat-ubatan tidak harus dilupuskan

melalui air buangan atau sisa isi

rumah. Sila rujuk kepada ahli farmasi

anda mengenai cara yang betul untuk

melupuskan ubat yang tidak

diperlukan lagi. Langkah-langkah ini

dapat membantu melindungi alam

sekitar.

Maklumat lanjut

Rupa dan warna produk

Apo-Warfarin 1mg: Tablet berwarna

merah jambu dan berbentuk

dwicembung bulat dan diukir dengan

perkataan ‘WAR’ di atas 1 pada satu

permukaan, ‘APO’ pada satu lagi.

Apo-Warfarin 2mg: Tablet

berwarna lavender dan berbentuk

dwicembung bulat berukir ‘WAR’ di

atas 2 pada satu permukaan, ‘APO’

pada satu lagi.

Apo-Warfarin 5mg: Tablet berwarna

kuning kemerah-merahan dan

berbentuk dwicembung bulat

berukir ‘WAR’ di atas 5 pada satu

permukaan, ‘APO’ pada satu lagi.

Bahan-bahan kandungan

Bahan aktif

Warfarin Sodium

-Bahan tidak aktif

Laktos monohidrat, microcrystalline

cellulose, magnesium stearate dan

kanji.

Apo-Warfarin 1mg mengandungi

kuning senja & merah D&C #30.

Apo-Warfarin 2mg mengandungi

ferric ferrous oxide dan merah D&C

Apo-Warfarin 5mg mengandungi

mengandungi kuning senja & dan

kuning D&C #10.

Nombor MAL

Apo-Warfarin 1mg:

(MAL 20021394AZ)

Apo-Warfarin 2mg:

(MAL 20021395AZ)

Apo-Warfarin 5mg:

(MAL 20021396AZ)

Pengilang

Apotex Inc.

150 Signet Drive

Weston Toronto Ontario

M9L 1T9 Canada

Pemegang Pendaftaran Produk

Pharmaforte (M) Sdn Bhd

2, Jalan PJU 3/49

Sunway Damansara

47810 Petaling Jaya

Tarikh kemaskini RiMUP

12/8/2015

Nombor Siri

BPFK(R4/1)080615/00148

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13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

FDA - U.S. Food and Drug Administration

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

CVM Update describing FDA Dear Veterinarian Letter about the differences between FDA-approved Mirataz (mirtazapine transdermal ointment), an animal drug with demonstrated safety and effectiveness to manage undesired weight loss in cats, and compounded formulations of transdermal mirtazapine.

FDA - U.S. Food and Drug Administration

7-8-2018

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of four sizes of El Guapo Jamaica Hibiscus Flower packages in flexible packaging due to an unlabeled peanut allergen

FDA - U.S. Food and Drug Administration

24-7-2018

Orphan designation:  Itraconazole,  for the: Prevention of invasive aspergillosis

Orphan designation: Itraconazole, for the: Prevention of invasive aspergillosis

Europe - EMA - European Medicines Agency

20-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

FDA - U.S. Food and Drug Administration

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

20-2-2019


Nimesulide (systemic formulations): List of nationally authorised medicinal products - PSUSA/00009236/201806

Nimesulide (systemic formulations): List of nationally authorised medicinal products - PSUSA/00009236/201806

Nimesulide (systemic formulations): List of nationally authorised medicinal products - PSUSA/00009236/201806

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Europe - EMA - European Medicines Agency

15-2-2019

tacrolimus (systemic formulations)

tacrolimus (systemic formulations)

tacrolimus (systemic formulations) (Active substance: tacrolimus) - Centralised - Art 28 - (PSUR - Commission Decision (2019)1437 of Fri, 15 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00002839/201803

Europe -DG Health and Food Safety

4-2-2019

On February 1st, @US_FDA classified a Class I Recall, the most serious   type of recall: Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS  PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate  Test Results. Find out more here:  h

On February 1st, @US_FDA classified a Class I Recall, the most serious type of recall: Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results. Find out more here: h

On February 1st, @US_FDA classified a Class I Recall, the most serious type of recall: Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results. Find out more here: https://go.usa.gov/xEX7Y  pic.twitter.com/MeFubksqsa

FDA - U.S. Food and Drug Administration

22-1-2019


Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805

Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805

Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805

Europe - EMA - European Medicines Agency

22-1-2019


Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Europe - EMA - European Medicines Agency

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

18-5-2018

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (Active substance: A highly purified formulation of Staphylococcus aureus protein A) - Transfer of orphan designation - Commission Decision (2018)3144 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/111/15/T/01

Europe -DG Health and Food Safety