Obat Epclusa 400mg/100mg gilead perawatan kanggo hepatitis C kronis (28 tablet)

Bentuk sediaan Kothak 28 tablet
Spesifikasi Sofosbuvir, velpatasvir

Komposisi

Informasi komposisi	Isi
Sofosbuvir	400 mg
Velpatasvir	100 mg

Migunakake

indications Epclusa drugs are indicated in the following cases: Treatment of chronic hepatitis C virus infection (HCV) in adults. ATC code: Jo5AP55. Mechanism of action Sofosbuvir is an inhibitor of all genotypes of RNA polymerase dependent NSSB of HCV, an essential enzyme to copy the virus. Sofosbuvir is a nucleotide fee, undergoing intracellular metabolism to form triphosphate Uridine derivatives with pharmacological activity (GS-461203), which can be combined into the RNA of HCV with NS5B Polymerase and act as a string disconnect component. GS-461203 (Sofosbuvir's active metabolites) are not inhibitors of DNA and RNA polymerase in humans or RNA polymerase inhibitors in mitochondria. Velpatasvir is a HCV inhibitor with the target of the NS5A protein of HCV, a protein needed to copy RNA and create HCV virus particles. The studies selected in vitro and cross -drug resistance show that the mechanism of action of Velpatasvir is the effect on the target NS5A. Viral anti -virus activity Please see more information about drugs in the instructions for the use of drugs attached. drug resistance In cell culture Symptomatic claims copying units with Sofosbuvir have been selected in cell culture for multiple genotypes, including 1B, 2A, 2B, 3A, 4A, 5A and 6A. The reduction of sensitivity to Sofosbuvir is associated with mutations instead of NS5B is the S282T in all genotypes of copying units that are checked. Creating S282T replacement spot mutations in genotype copying units from 1 to 6 reduces sensitivity to Sofosbuvir from 2 to 18 times and reduces the ability to copy viruses from 89% to 99% compared to the corresponding wild strain. In biochemical trials, the possibility of triphosphate metabolites has the activity of Sofosbuvir (GS-461203) inhibiting the NS5B polymerase re-combination from the genotypes of 1B, 2A, 3A and 4A that the S282T replacement mutation manifests itself reduced compared to the ability to inhibit polymerase NS5B re-organized from the wild strain, as expected by the increase from 8.5 to 24% (IC50). Selective In vitro the HCV copy units with reduced sensitivity to Velpatasvir has been performed in cell culture for multiple genotypes, including 1A, 1B, 2A, 3A, 4A, 5A and 6A. The variants are selected in positions related to NS5A resistance are 24, 28, 30, 31, 32, 58, 92 and 93. Variants related to drug resistance (RAV) are selected in 2 or more genotypes, F28S, L31I/V and Y93H. The point -oriented mutation with NS5A RAV has shown that replacement mutations reduce the sensitivity to Velpatasvir over 100 times, M28G, A92K and Y93H/N/R/W in genotype 1A, A92K in genotype 1B, C92T and Y93H/N in genotypes 2B, Y93H in genotypes 3, and L31V and P32A/L/Q/R in genotypes 6. The odd test is tested for the 2A, 4A or 5A genotypes that reduce the sensitivity of Velpatasvir more than 100 times. Combining these variants often shows a higher level of reduction in velpatasvir than when only the single radio. In clinical studies Research in patients without cirrhosis and patients with cirrhosis are still compensated In a blistering analysis for patients without cirrhosis or cirrhosis, the use of EPCLusa for 12 weeks in three phase 3, 12 patients (2 patients with genotypes 1 and 10 patients with genotypes 3) eligible for drug resistance analysis due to virus failure. Another patient infected with genotype 3 genotype 3 at the beginning re -infection of genotype medal in a genotype when the virus failure and is excluded from the virus analysis. No patient infected with HCV genotype 2, 4, 5 or 6 encountered a virus failure. Of the two patients with genotype failure, one patient with viruses with NS5A RAV Y93N has just appeared and the other patient carries viruses with NS5A RAV L31i/V and Y93H when the virus failure. Both patients carry the virus at the beginning containing NS5A RAV. No observations of nucleoside inhibitors (Ni) NS5B at the time of failure in 2 patients. Of the 10 patients with genotypic viruses 3, Y93H observed in all 10 patients at the time of failure (6 patients with Y93H appeared after treatment and 4 patients with Y93H at the beginning and after treatment). No observation shows NS5B Ni Rav at the time of failure in 10 patients. Research in patients with unsatisfactory cirrhosis In a phase 3 study in patients with unprocessed cirrhosis using Epclusa + RBV for 12 weeks, 3 patients (1 patient infected with genotype 1 and 2 patients infected with genotype 3) are eligible for anti -drug analysis due to viral failures. No patient infected with HCV genotype 2 or 4 encountered a virus failure in the EpClusa + RBV treatment group for 12 weeks. 1 patient infected with genotype 1 genotype 1 failed viruses without RAV NS5A or NS5B at the time of failure. Among 2 patients infected with genotypes of genotypes 3 failed viruses, a patient with NS5A RAV Y93H appeared at the time of failure. Another patient infected with the virus had Y93H at the beginning and when the virus failed and also appeared a low level (less than 5%) of NS5B Ni Rav N142T and E237G at the time of failure. Pharmacokinetic data in this patient is suitable for not adhering to treatment. In this study, two patients were treated with Epclusa for 12 or 24 weeks without Ribavirin with NS5B S282T that appeared at a low level (less than 5%) and L159F. The effect of variants related to medical anti -medication at the beginning for the results of treatment Please see more information about drugs in the instructions for the use of drugs attached. Cross resistance In vitro test data shows that most NS5A RAVs are resistant to Ledipasvir and Daclatasvir are still sensitive to Velpatasvir. Velpatasvir is a full -active drug for S282T replacement mutations related to Sofosbuvir resistance in NS5B chain while all mutations are replaced related to Velpatasvir resistance in NS5A chain completely sensitive to Sofosbir. Both Sofosbuvir and Velpatasvir are fully active against replacement mutations related to resistance to other direct impact anti -virus drugs with other mechanisms, such as NS5B inhibitors without nucleoside structure and Protease NS3 inhibitors. The effectiveness of EPCLusa has not been evaluated in patients who have failed when treated with other regimens containing an NS5A inhibitor. Clinical efficiency and safety Efficiency of EPCLusa is evaluated in three phase 3 studies in patients infected with genotype from 1 to 6 with or without compensation cirrhosis, a 3rd stage study in patients infected with genotype from 1 to 6 suffered from compensated cirrhosis and a third -stage study in the medium -infected patient with HCV/HIV infection with genotype from 1 to 6 is summarized in Group 1. TN and TE, without cirrhosis or cirrhosis still compensated Epclusa for 12 weeks (624) Parolysis for 12 weeks (116) TN and TE, without cirrhosis or cirrhosis still compensated Epclusa for 12 weeks (134) SOFD + RBV for 12 weeks (132) TN and TE, without cirrhosis or cirrhosis still compensated Epclusa for 12 weeks (277) SOFD + RBV for 12 weeks (275) TN and TE, suffering from cirrhosis of CPT type B Epclusa for 12 weeks (90) Epclusa + RBV for 12 weeks (87) Epclusa for 24 weeks (90) TN and TE, without cirrhosis or compensation, there are co -infections of HCV/HIV EPCLusA for 12 weeks (106) Te = patients who had been treated (including patients who were unsuccessfully treated with the regimen containing peginterferon alfa + ribavirin, with or without protease inhibitors) Ribavirin dose is based on weight (1,000 mg daily, divided into two times for patients

Sadurunge njupuk Obat Epclusa 400mg/100mg gilead perawatan kanggo hepatitis C kronis (28 tablet)

How to use Used by oral. Instruct patients to swallow both tablets with or without food (see pharmacokinetics). Because the drug has a bitter taste, it is recommended not to chew or crush film tablets. Dosage The recommended dose of Epclusa is 1 tablet/day, drinking or not with food (see more pharmacokinetics). Patient group

Efek sisih

Nalika nggunakake EPCLUsa sampeyan bisa ngalami efek sing ora dikarepake (ADR):

Cathetan keamanan

Assessment safety saka Epclusa adhedhasar data riset klinis fase 3 disintesis saka pasien sing kena infeksi HCV genotipe 1, 2, 3, 4, 5 utawa 6 (kanthi utawa tanpa sirosis kompensasi) kalebu 1.035 pasien sing nggunakake Epclusa sajrone 12 minggu.

Persentase pasien mandheg perawatan amarga reaksi mbebayani yaiku 0,2% lan proporsi pasien kanthi reaksi serius yaiku 3,2% kanggo pasien sing nggunakake EPCLusA sajrone 12 minggu. Ing studi klinis, sirah, lemes lan mual minangka reaksi sing paling umum sing katon sajrone perawatan (tingkat insidensi ≥ 10%) dilaporake ing pasien sing diobati sajrone 12 minggu karo Epclusa. Reaksi mbebayani lan reaksi mbebayani liyane dilaporake kanthi frekuensi sing padha ing pasien sing diobati plasebo dibandhingake karo pasien sing diobati karo EPCLusA.

Pasien sirosis sing ora puas

Profil safety Epclusa wis dievaluasi ing studi label terbuka ing ngendi pasien sirosis CPT CPT nggunakake Epclusa sajrone 12 minggu (n = 90), Epclusa + RBV sajrone 12 minggu (n = 87) utawa Epclusa sajrone 24 minggu (n = 90). Kedadeyan sing mbebayani cocog karo akibat klinis sing diarepake saka penyakit ati, utawa cathetan keracunan Ribavirin sing dikenal kanggo pasien sing nggunakake EPCLusa kanthi kombinasi karo Ribavirin.

Saka 87 pasien sing diobati karo EPCLusA + RBV sajrone 12 minggu, jumlah kasus pengurangan hemoglobin kurang saka 10 g / dl lan 8,5 g / dl sajrone perawatan 23% lan 7%. Mungkasi nggunakake Ribavirin ing 15% pasien sing diobati nganggo Epclusa + RBV sajrone 12 minggu amarga kedadeyan sing mbebayani.

Nerangake sawetara reaksi mbebayani sing selektif

aritmia

Kasus sing diamati saka detak jantung sing alon lan blok jantung sing serius nalika nggunakake Sofosbuvir ing kombinasi karo obat anti-virus sing duwe pengaruh langsung (DAA), digunakake karo amiodarone lan/utawa obat liya sing nyuda denyut jantung (ndeleng kanthi teliti nalika digunakake lan sesambungan karo obat).

Laporan kasus sing dicurigai ana reaksi mbebayani

Nglaporake kasus sing dicurigai ana reaksi mbebayani sawise lisensi sirkulasi obat penting. Iki ngidini terus ngawasi keseimbangan antarane keuntungan / risiko obat kasebut. Petugas kesehatan diwajibake nglaporake kasus sing dicurigai ana reaksi mbebayani liwat sistem pelaporan nasional.

Pandhuan kanggo nangani ADR:

Takon dhokter babagan efek sing ora dikarepake nalika njupuk obat.

Pènget

Sadurunge nggunakake obat sampeyan kudu maca instruksi kasebut kanthi teliti lan deleng informasi ing ngisor iki.

Kontraindikasi

Obat Epclusa dikontraindikasi ing kasus ing ngisor iki:

Hipersensitivitas kanggo bahan aktif utawa eksipien apa wae ing obat kasebut.

Gunakake kanthi induksi P-GP sing kuwat lan induksi CYP sing kuwat:

Obat-obatan yaiku induksi Plycoprotein (P-GP) kuwat (P-GP) utawa Cytochrome P450 (CYP) kuwat (Rifampicin, Rifabutin, St. John's Wort [Ban Hypericum Perforatum], Carbamazepine, Phenobarbital VA Phenytoin). Panggunaan simultan bakal nyuda konsentrasi plasma Sofosbuvir utawa Velpatasvir kanthi signifikan lan bisa nyebabake efektifitas Epclusa (deleng interaksi obat).

Ati-ati nalika nggunakake

kudu ati-ati banget nalika njupuk obat kanggo pasien ing kasus ing ngisor iki:

Aja nggunakake epclusa bebarengan karo obat liyane sing ngemot Sofosbuvir.

Detak jantung serius alon lan jantung jantung

Kasus detak jantung serius alon lan blok jantung nalika nggunakake Sofosbuvir kanthi kombinasi karo obat-obatan anti-dampak langsung (DAA) liyane, bebarengan digunakake karo amiodarone kanthi utawa tanpa obat liya sing nyuda denyut jantung. Mekanisme kasebut durung dingerteni.

Panggunaan Amiodarone bebarengan diwatesi ing program pangembangan klinis Sofosbuvir lan DAA. Kasus kasebut bisa ngancam nyawa, mula mung amiodarone sing kudu digunakake kanggo pasien sing diobati karo Epclusa nalika ora toleran utawa kontraindikasi kanggo perawatan anti-arrhythmic alternatif liyane.

Nalika nggunakake Amiodarone simultan dianggep perlu, nyaranake kanggo ngawasi kanthi teliti kondisi pasien nalika miwiti nggunakake EPCLusA. Pasien ditemtokake duwe risiko dhuwur detak jantung alon sing kudu dipantau terus-terusan sajrone 48 jam ing kahanan klinis sing cocog.

Amarga Amiodarone duwe wektu sade dawa, perlu kanggo ngetutake pemantauan sing cocog kanggo pasien sing wis mandheg nggunakake Amiodarone sajrone sawetara sasi lan wiwit nggunakake EPCLusA.

Kabeh pasien sing diobati karo Epclusa sing digabungake karo amiodarone duwe utawa tanpa obat liyane sing nyuda denyut jantung uga kudu dielingake babagan gejala detak jantung sing alon lan gejala deg-degan sing alon lan menehi saran medis yen ana gejala darurat.

Pasien sing sadurunge gagal perawatan karo regimen sing ngemot NS5A

Ora ana data klinis sing mbuktekake efektifitas Sofosbuvir/Velpatasvir ing perawatan pasien sing gagal karo regimen sing ngemot inhibitor NS5A. Nanging, adhedhasar varian sing ana gandhengane karo resistensi obat (RAV) NS5A sing umum ditemokake ing pasien sing gagal diobati karo regimen liyane sing ngemot inhibitor NS5A, farmakologi Vitro Velpatasvir lan asil perawatan karo Sofosbuvir / Velpatasvir ing pasien sing durung nate nggunakake NS5A NS5A ing wiwitan kanggo didaftarake kanggo melu ing Astral. Gunakake EPCLusA + RBV sajrone 24 minggu kanggo pasien sing wis diobati gagal karo NS5A lan pasien sing dikandhakake duwe risiko ngembangake penyakit klinis lan pasien sing ora duwe pilihan perawatan alternatif.

gagal ginjel

Ora perlu nyetel dosis Epclusa kanggo pasien kanthi gagal ginjel entheng utawa medium. Iki durung ditaksir safety Epclusa ing pasien kanthi gagal ginjal sing abot (EGFR

Gunakake bebarengan karo zat induksi P-GP rata-rata utawa zat induksi CYP rata-rata

Rata-rata obat induksi P-G-GP utawa CYP (kayata Oxcarbazepine, Modafinil utawa Efavirenz) bisa nyuda konsentrasi plasma Sofosbuvir utawa Velpatasvir, sing nyebabake nyuda perawatan perawatan Epcluseda. Ora dianjurake kanggo nggunakake obat kasebut bebarengan karo Epclusa (deleng interaksi obat).

Gunakake karo sawetara regimen resistensi HIV Retrovirus

Epclusa wis ditampilake nambah kemampuan kanggo mbukak Tenofovir, utamane yen digunakake karo regimen perawatan HIV sing ngemot Tenofovir disoprocil Fumarate lan paningkatan farmakokinetik (ritonavir utawa cobicistat). Keamanan Tenofovir Disoproxil Fumarate Potensi risiko lan mupangat ana hubungane karo panggunaan EPCLusA simultan kanthi tablet kombinasi tetep kanthi dosis sing ngemot Elvitegravir / Cobicistat / Emtricitabine / Tenofovir disoproxil fumarate utawa Tenofovir disoproxil Fumarate sing digabungake karo inhibitor protease ing Darinevir, utamane ing pasien sing duwe risiko pharmacotic HIV. disfungsi. Pasien diobati karo Epclusa kanthi kombinasi Elvitegravir / CoBicistat / Emtricitabine / Tenofovir Disoproxil Fumarate utawa Tenofovir Disoproxil Fumarate lan Inhibitor HIV Protease sing ditingkatake farmakokinetik, kudu dipantau kanthi reaksi mbebayani sing ana hubungane karo Tenofovir. Delengen ringkesan karakteristik produk Tenofovir disoproxil fumarate, Emtricitabine/Tenofovir disoproxil fumarate, utawa elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate kanggo rekomendasi kanggo ngawasi fungsi ginjel.

ko-infeksi HCV/HBV (virus hepatitis B)

Ana laporan babagan kasus sing nyebabake virus hepatitis B (HBV), sawetara kasus wis mati, sajrone utawa sawise perawatan karo obat antivirus sing langsung tumindak. Skrining HBV kudu ditindakake kanggo kabeh pasien sadurunge miwiti perawatan. Amarga pasien sing kena infeksi HBV/HCV beresiko nyebabake HBV maneh, mula kudu dipantau lan dikontrol miturut instruksi klinis sing saiki.

sirosis c

Ora dievaluasi keamanan lan efektifitas EPCLusa ing pasien sirosis CPT tipe C (deleng efek samping lan efek farmakologis).

Pasien transplantasi ati

Ora dievaluasi keamanan lan efektifitas EPCLusa ing perawatan infeksi HCV ing pasien sawise transplantasi ati. Pangobatan karo Epclusa ing dosis sing disaranake (ndeleng dosis, panggunaan) kudu diatur liwat evaluasi keuntungan lan risiko potensial kanggo saben pasien.

Efek obat-obatan ing nyopir lan ngoperasikake mesin

Epclusa ora duwe pengaruh utawa pengaruh sing bisa diabaikan ing nyopir lan ngoperasikake mesin.

Gunakake obat kanggo wanita nalika meteng lan laktasi

Wanita ngandhut

Ora ana data utawa data sing sithik banget (kurang saka 300 kasus meteng) nggunakake Sofosbuvir, Velpatasvir utawa Epclusa ing wanita ngandhut.

Sofosbuvir

Riset kewan ora nuduhake efek langsung utawa ora langsung sing ana hubungane karo keracunan reproduksi (deleng informasi tambahan babagan obat-obatan ing lembar instruksi panggunaan obat sing dilampirake).

Ora bisa ngira kanthi lengkap amplitudo paparan Sofosbuvir ing tikus dibandhingake karo tingkat pajanan ing manungsa ing dosis sing disaranake klinis (ndeleng informasi babagan obat ing lembar instruksi obat sing digandhengake karo obat).

velpatasvir

Riset kewan nuduhake manawa bisa dadi beracun kanggo kesuburan (deleng informasi obat ing lembar instruksi nggunakake obat sing dilampirake).

Minangka langkah pencegahan, rekomendasi ora nggunakake EPCLusA nalika meteng.

Periode nyusoni

Ora jelas apa Sofosbuvir, metabolit Sofosbuvir utawa Velpatasvir apa ASI diekskresi utawa ora.

Farmakokinetik kewan sing ana ing kewan nuduhake yen ekskresi Velpatasvir lan metabolit Sofosbuvir liwat susu.

ora bisa ngilangi risiko bayi/bocah cilik. Mula, aja nganggo epclusa nalika nyusoni.

kesuburan

Ora ana data riset ing wong babagan pengaruh EPCLusa ing kesuburan.

Riset kewan ora nuduhake efek mbebayani Sofosbuvir utawa Velpatasvir kanggo kesuburan.

Yen Ribavirin digunakake bebarengan karo Epclusa, waca informasi obat ing pandhuan kanggo nggunakake obat sing dilampirake kanggo ngerti rekomendasi rinci babagan meteng, kontrasepsi lan laktasi.

Interaksi obat

Amarga Epclusa ngandhut Sofosbuvir lan Velpatasvir, interaksi apa wae wis ditemtokake karo saben bahan aktif bisa kedadeyan karo Epclusa.

Kemampuan Epclusa mengaruhi obat liyane

Velpatasvir minangka inhibitor protein obat P-GP, protein anti-kanker payudara (polipeptida grathporting anion organik (BCRP), polipeptida pengiriman anion organik (polipeptida-OATP gedporting anion organik) 1B1 lan OATP1B3. Panggunaan simultan EPCLUsa karo obat-obatan sing bisa ngirim obat-obatan sing bisa dadi substrat kanggo eksposur ing tabel3. interaksi karo substrat sensitif P-GP (Digoxin), BCRP (Rosuvastatin) lan OATP (Pravastatin).

Kemungkinan obat liya mengaruhi Epclusa

Sofosbuvir lan Velpatasvir minangka substrat transportasi obat P-GP lan BCRP. Velpatasvir uga minangka substrat polipeptida sing ngangkut obat OATP1B. Ing tes In Vitro, metabolisme alon Velpatasvir diamati dening CYP2B6, CYP2C8 lan CYP3A4. Obat kasebut minangka zat induksi P-GP sing kuwat utawa agen sentuhan sing kuat CYP2B6, CYP2C8 utawa CYP3A4 (umpamane Rifampicin, Rifabutin, St. John's Wort, Carbamazepine, Phenobarbital lan Phenytoin) bisa nyuda konsentrasi plasma Sofosbir utawa VelpatasVIR, sing ndadékaké reduksi SoVelfospatavir sing efektif. Kontraindikasi nggunakake obat kasebut karo Epclusa (pirsani bagean kontrol). Obat kasebut minangka zat induksi P-GP rata-rata utawa zat induksi CYP rata-rata (kayata Oxcarbazepine, Modafinil utawa Efavirenz) sing bisa nyuda plasma Sofosbuvir utawa plasma Velpatasvir sing nyebabake nyuda efektifitas perawatan Epclusa. Ora dianjurake kanggo nggunakake obat kasebut bebarengan karo Epclusa (deleng bagean sing ati-ati nalika digunakake). Panggunaan simultan inhibitor P-GP utawa BCRP bisa nambah plasma Sofosbuvir utawa Velpatasvir. Inhibitor Oatp, CYP2B6, CYP2C8 utawa CYP3A4 bisa nyandhet konsentrasi plasma Velpatasvir.

Ora ana interaksi obat sing dikarepake kanthi signifikan klinis karo Epclusa karo inhibitor P-GP, BCRP, OATP utawa CYP450; Epclusa bisa digunakake bebarengan karo inhibitor P-GP, BCRP, OATP lan CYP.

Pasien diobati karo antagonis vitamin K

Amarga fungsi ati bisa owah sajrone perawatan karo EPCLusa, dianjurake kanggo ngawasi kanthi teliti nilai indeks standar internasional (INR).

Interaksi antarane epclusa lan obat liyane

Mangga deleng informasi luwih lengkap babagan obat-obatan ing pandhuan kanggo nggunakake obat sing dilampirake.

Panyimpenan

Ninggalake papan sing adhem, aja nganti cahya, suhu ngisor 30⁰C.

Supaya ora bisa digayuh bocah-bocah, waca instruksi kasebut kanthi teliti sadurunge digunakake.

Obat liyane

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