Alfa-D

Maklumat utama

  • Nama dagangan:
  • Alfa-D Capsule
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Alfa-D Capsule
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL10120049, MAL09061594
  • Kemaskini terakhir:
  • 31-08-2017

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

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

ALFA-D CAPSULE

Alfacalcidol Capsule (0.25mcg, 1.00 mcg)

1

Apakah yang ada pada risalah ini

Apakah kegunaan Alfa-D

Bagaimana Alfa-D

berfungsi

Sebelum menggunakan Alfa-D

Cara menggunakan Alfa-D

Semasa menggunakan Alfa-D

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Alfa-D

Maklumat lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan Alfa-D

Alfacalcidol digunakan untuk keadaan

yang disebabkan oleh gangguan dalam

metabolisme kalsium akibat daripada

kekurangan pengeluaran Vitamin D3.

Ia juga digunakan untuk merawat syarat-

syarat berikut:

Penyakit buah pinggang kronik,

gangguan mineral dan tulang.

Gangguan kelenjar paratiroid.

Kelembutan dan kecacatan

tulang kerana kekurangan

kalsium.

kalsium darah rendah pada bayi

yang baru lahir.

Pengurangan jisim dalam tulang

dan ketumpatan

Bagaimana Alfa-D berfungsi

Ia mengandungi alfacalcidol, yang

merupakan sejenis bahan seperti vitamin

D yang merangsang penyerapan kalsium

dan fosfat di dalam makanan dari usus

dan penyerapan semula kalsium di dalam

buah pinggang.

Sebelum menggunakan Alfa-D

Bila tidak boleh menggunakan

Jangan mengambil Alfa-D jika :

Anda mempunyai terlalu

banyak kalsium dalam darah

anda (hiperkalsemia).

Anda terlalu sensitif kepada

alfacalcidol atau mana-mana

bahan-bahan aktif yang lain.

Jika anda hamil, cuba untuk hamil atau

fikir anda mungkin mengandung, rujuk

kepada doktor anda sebelum mengambil

ubat ini.

Jika anda sedang menyusukan, rujuk

kepada doktor anda sebelum mengambil

ubat ini

Sebelum menggunakan

Alfa-D

Anda perlu berunding dengan doktor

atau ahli farmasi jika anda:

Mengambil lain-lain jenis ubat

dipanggil glikosida jantung,

seperti digoxin.

Jika anda mempunyai sebarang

masalah dengan buah pinggang

anda.

Maklumkan kepada doktor anda

jika anda menggunakan

glycosides atau digitalis untuk

masalah jantung anda sebelum

mengambil Alfa-D Kapsul

Doktor anda mungkin perlu

memantau kalsium di darah dan

tahap phosphate kerap

terutamanya jika anda

mempunyai masalah buah

pinggang, menerima dos tinggi

atau ubat ini digunakan untuk

anak anda.

Jika mengambil ubat-ubat lain

Dapatkan nasihat doktor atau ahli

farmasi jika anda sedang mengambil:

Ubat-ubat lain untuk

antiepileptics, seperti

carbamazepine, phenobarbital,

phenytoin dan primidone.

Rifampicin dan isoniazid.

Corticosteroids.

Thiazide diurectics, calcium, or

phosphate

.

Cara menggunakan Alfa-D

Berapa banyak harus digunakan

Ikut semua arahan yang diberikan pada

sisip dengan teliti. Ianya mungkin

berbeza daripada maklumat yang

terkandung di dalam risalah ini. Jika

anda tidak memahami arahan pada label,

tanya doktor atau ahli farmasi anda untuk

bantuan.

Dewasa: Dos permulaan biasa adalah

1mcg sekali sehari. Dos yang mungkin

diselaraskan dengan meningkatkan

kepada 0.25-0.5mcg.It adalah penting

bahawa tahap kalsium dalam darah

dipantau. Kebanyakan orang bertindak

balas terhadap dos antara 1 hingga 3 mcg

setiap hari. Jika pesakit dengan

penyembuhan tulang, dos boleh

dikurangkan dan dos penyelenggaraan

umum adalah 0,25-1 mcg setiap hari.

Orang Tua: Dos permulaan adalah

0.5mcg sekali sehari.

Kanak-kanak antara 5 hingga 20 kg:

Dos permulaan adalah 0.05mcg/kg berat

badan sekali sehari.

Kanak-kanak 20 kg dan ke atas:

Dos permulaan adalah 1mcg setiap hari.

Bila perlu digunakan

Sentiasa telan keseluruhan kapsul dengan

segelas air.

Berapa lama perlu digunakan

Seperti dos yang telah disyorkan.

Jika terlupa menggunakan

Ambil dos yang tertinggal sebaik

sahaja anda ingat. Jika ia hampir masa

untuk dos seterusnya, tunggu sehingga

kemudian mengambil dos dan makan

dos yang tertinggal. Jangan ambil dos

yang berganda untuk membuat untuk

dos yang tertinggal itu.

Jika mengambil berlebihan (terlebih

dos)

Hubungi doktor atau ahli farmasi anda

untuk mendapatkan nasihat serta-

merta.

Mengambil terlalu banyak tablet boleh

menyebabkan tahap kalsium yang

berlebihan (hypercalcaemia).

Semasa menggunakan Alfa-D

Perkara yang perlu dilakukan

Ambil dos anda tepat seperti yang

diberikan dalam risalah.

Beritahu semua doktor, doktor gigi dan

ahli farmasi yang merawat anda

bahawa anda mengambil Alfa-D.

Dapatkan nasihat doktor dengan segera

jika anda hamil semasa mengambil

Alfa-D.

Perkara yang tidak boleh dilakukan

Jangan berikan Alfa-D untuk orang lain,

walaupun mereka mempunyai simptom

yang sama atau keadaan seperti anda.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

ALFA-D CAPSULE

Alfacalcidol Capsule (0.25mcg, 1.00 mcg)

2

Perkara yang perlu diberi perhatian

Memandu dan menggunakan mesin

Produk ini tidak memberi kesan kepada

keupayaan anda untuk memandu atau

menggunakan mesin.

Kesan-kesan sampingan

Seperti semua ubat-ubatan, Alfacalcidol

boleh menyebabkan kesan sampingan,

walaupun tidak semua orang mendapat

mereka.

Kesan sampingan yang terlalu banyak

kalsium dalam darah.

Jumpa doktor atau ahli farmasi anda

dengan segera jika anda mengalami

sebarang kesan sampingan selepas

mengambil ini Alfa-D.

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

npra.moh.gov.my

(Public

Reporting Medicinal Problems / Side

Effects / AEFI / Vaccine Safety).

Cara penyimpanan dan pelupusan

Alfa-D

Penyimpanan

Simpan dibawah suhu 30°C. Pastikan

botol ditutup dengan ketat.

Pelupusan

Produk tidak harus dilupuskan melalui

air sisa atau bahan buangan isi rumah.

Tanya ahli farmasi bagaimana untuk

melupuskan Alfa-D yang tidak lagi

diperlukan. Langkah-langkah ini akan

membantu untuk melindungi alam

sekitar.

Maklumat Lanjut

Rupa dan warna produk

Alfa-D 0.25mcg Kapsul:

Dua keping, putih, saiz ‘2’ kapsul sayur-

sayuran keras yang mengandungi jisim

separuh pepejal kekuningan.

Alfa-D Kapsul 1.00mcg:

Dua keping, bata merah, saiz ‘2’ kapsul

sayur-sayuran keras yand mengandungi

jisim separuh pepejal kekuningan.

Bahan-bahan kandungan

Bahan aktif

Alfacalcidol

Bahan tidak aktif

Colloidal Silicon dioxide

Vegetable oil

Vitamin E

Lauroyl polyoxyl-32 glycerides

Nombor MAL

Alfa-D 0.25mcg Capsules:

MAL10120049X

Alfa-D 1.00mcg Capsules:

MAL09061594X

Pengilang

PAHANG PHARMACY SDN.BHD.

Lot 5979, Jalan Teratai, 5 ½ Miles Off,

Jalan Meru,41050 Klang,

Selangor Darul Ehsan.

Pemegang Pendaftaran Produk

PAHANG PHARMACY SDN.BHD.

Lot 5979, Jalan Teratai, 5 ½ Miles Off,

Jalan Meru,41050 Klang,

Selangor Darul Ehsan.

Tarikh kemaskini RiMUP

01/04/2017

Nombor Siri

BPFK(R4/1)010417/00043

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Epoetin alfa Hexal (Hexal AG)

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Binocrit (Sandoz GmbH)

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Mepsevii (Ultragenyx Germany GmbH)

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Beromun (BELPHARMA s.a.)

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Aranesp (Amgen Europe B.V.)

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22-8-2018

Luveris (Merck Europe B.V.)

Luveris (Merck Europe B.V.)

Luveris (Active substance: Lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5631 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000292/T/0077

Europe -DG Health and Food Safety

22-8-2018

Pergoveris (Merck Europe B.V.)

Pergoveris (Merck Europe B.V.)

Pergoveris (Active substance: follitropin alfa / lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5629 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000714/T/0059

Europe -DG Health and Food Safety

8-8-2018

GONAL-f (Merck Europe B.V.)

GONAL-f (Merck Europe B.V.)

GONAL-f (Active substance: Follitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5445 of Wed, 08 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/71/T/140

Europe -DG Health and Food Safety

6-8-2018

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Active substance: Moroctocog alfa ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5374 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/232/T/146

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Active substance: Givinostat) - Orphan designation - Commission Decision (2018)5278 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/062/18

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

25-7-2018

Bemfola (Gedeon Richter Plc.)

Bemfola (Gedeon Richter Plc.)

Bemfola (Active substance: follitropin alfa) - Centralised - Yearly update - Commission Decision (2018)4989 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety