DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)6. For loss of appetite/ untuk kurang selera makan.7. For difficulty in sleep/ bagi melegakan kesukaran untuk tidur.8. For relief of fatigue/ untuk melegakan kepenatan.9. As an aid to overcome fatigue during physical exertion/ membantumelegakan kepenatan fizikal.10. To expel wind and invigorate vital energy/ untuk membuang angin danmenambah tenaga.11. To improve appetite/ untuk menambah selera makan.12. For relieving waist ache and body weakness/ untuk melegakan sakitpinggang dan lemah anggota badan.13. For relieving dizziness, sweating, and difficulty in sleep/ untukmelegakan pening, berpeluh berlebihan dan sukar untuk tidur.14. For reducing body odour/ untuk mengurangkan bau badan.15. For reducing toothache/ untuk mengurangkan sakit gigi.16. To relieve tired eyes/ untuk melegakan kepenatan mata.17. For healthy eyes/ untuk kesihatan mata.b) Blood & Body Fluid/ Darah & Cecair Badan“Traditionally used…./ “Digunakan secara tradisional….1. For improving blood circulation/ untuk melancarkan perjalanan darah.2. To improve urination/ untuk melawaskan kencing/ buang air kecil.3. For improving bowel movement/ untuk melawaskan buang air besar.4. For relieving mild vomiting/ untuk melegakan muntah ringan.5. For reducing minor swelling/ untuk melegakan bengkak-bengkakringan.c) Bone, Muscle & Joint/ Tulang, Otot & Sendi“Traditionally used…./ “Digunakan secara tradisional….1. For strengthening muscle and bone/ untuk menguatkan otot dantulang.2. For relieving muscular ache/ untuk melegakan sakit otot.3. For relieving waist ache and backache/ untuk melegakan sakitpinggang dan sakit belakang.4. For relief of joints and muscular pain/ untuk melegakan sakit sendi danotot.5. For relieving muscles sprain/ untuk melegakan terseliuh/ terkehel.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 258
Drug Registration Guidance Document (<strong>DRGD</strong>)d) Pain & Fever/ Sakit Am & Demam“Traditionally used…./ “Digunakan secara tradisional….1. To relieve/ alleviate pain/ untuk melegakan kesakitan.2. For relieving fever/ untuk melegakan demam.3. For relieving headache/ untuk melegakan sakit kepala.4. For relieving pain and itchiness related to piles/ untuk melegakankesakitan dan rasa gatal akibat buasir.5. For symptomatic relief of body heatiness/ body heat / untuk melegakanpanas badan.e) Cough & Cold/ Batuk & Selsema“Traditionally used……/ “Digunakan secara tradisional…..1. For relief of fever, cough and cold/ untuk melegakan demam, batukdan selsema.2. For relief of sore throat/ untuk melegakan sakit tekak.3. For reducing phlegm and relief of cough, sore throat and bodyheatiness/ untuk mengurangkan kahak dan melegakan batuk, sakittekak dan panas badan.4. For relief of throat irritations and cough/ untuk melegakan sakit tekakdan batuk.5. For relief of nasal congestion/ untuk melegakan hidung tersumbat.6. For relief of sore throat and cough/ untuk melegakan sakit tekak danbatuk.7. For relief of mouth ulcers due to heatiness/ untuk melegakan sakitmulut akibat panas badan.8. To relieve sinusitis/ untuk melegakan resdung.f) Digestive System/ Sistem Pencernaan“Traditionally used…./ “Digunakan secara tradisional….1. For relief of stomach ache, mild diarrhoea/ untuk melegakan sakitperut, cirit-birit ringan.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 259
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Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 224 and 225: ATTACHMENT 2Drug Registration Guida
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Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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