RAHASIA




Formulir Keluhan Produk Farmasi
Pharmaceutical Product Complaint Form

INFORMASI PRODUK KELUHAN / INFORMATION OF PRODUCT COMPLAINT

DESKRIPSI KELUHAN PRODUK / PRODUCT COMPLAINTS DESCRIPTION
JENIS KELUHAN / TYPE OF COMPLAINT
Sample Dikirim ke / Sample Send To :
Distributor / Distributor
INFORMASI PASIEN / PATIENT INFORMATION

Tahun / Years
Kg
KESUDAHAN EFEK SAMPING OBAT / DRUG ADVERSE REACTION CONCLUSION







Riwayat Efek Samping Obat Yang Pernah Dialami / History of Drug Adverse Reaction

Apakah efek samping berkurang / sembuh setelah obat dihentikan ?
Did reaction abate after stopping drug(s) ?

Apakah efek samping timbul kembali setelah obat diberikan lagi ?
Did reaction reapper after retreatment?

No
Obat yang Dikeluhkan / Suspect Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
1
Obat yang Dikeluhkan / Suspect Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
2
Obat yang Dikeluhkan / Suspect Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
3
Obat yang Dikeluhkan / Suspect Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
4
Obat yang Dikeluhkan / Suspect Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
5
Obat yang Dikeluhkan / Suspect Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
Obat lain yang diminum pada waktu bersamaan hingga 3 bulan sebelumnya (termasuk suplemen dan obat tradisional) :
Other medicines taken at the same time up to 3 months previously (including supplements and traditional medicines) :
No
Obat Lainnya/ Other Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
1
Obat Lainnya/ Other Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
2
Obat Lainnya/ Other Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
3
Obat Lainnya/ Other Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
4
Obat Lainnya/ Other Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
No
5
Obat Lainnya/ Other Drug(s)
Dosis Harian / Daily Dose
Frekuensi Pemberian / Frequency of Administration
Rute Pemberian / Route of Administration
No. Batch / Batch No.
Tgl. Kadaluwarsa / Exp. Date
Lama Pemberian / Therapy Duration
Indikasi Penggunaan Obat / Indication for Use
Information lain yang relevan ( mis : Penyakit lain yang menyertai, diagnosis, alergi, kehamilan, hasil pemeriksaan laboratorium, dsb)
Other relevant history (e.g. disease, diagnostics, allergies, pregnancy, laboratory result, etc)

INFORMASI PELAPOR / REPORTER INFORMATION







DITERIMA OLEH / RECEIVED BY





Kepada : Yth
Penanggung Jawab Pharmacovigilance dan Customer Care
PT. QUANTUM LABORATORIS INTERNASIONAL
Jl. Stadion No. 26, Sidomukti, Kel. Pandaan, Kec. Pandaan, Pasuruan, Jawa Timur
Phone : +62 343 633432
e-mail : customercare@quantum-laboratories.com
pv@quantum-laboratories.com