Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
UREA 14C
PERUSAHAAN DAGANG DAN INDUSTRI KALIROTO - Indonesia
UREA 14C
0,75 McCI
KAPSUL
DUS, 2 ALUMUNIUM POUCH @ 2 BLISTER @ 10 KAPSUL
SHENZHEN ZHONGHE HEADWAY BIO-SCI & TECH CO.,LTD - China
2019-09-22
HEADWAY UREA 14C CAPSULES [Drug name] Generic Name: Urea 14C Capsules [Ingredients] The major ingredient of this product is Urea 14C. [Half-time of radioactive nuclide] Half-time of 14 C: 5730 years [Radioactivity and indicated time] Radioactive activity: 2.78×10 -2 MBq (0.75×10 -3 mCi). Indicated time: Same as Date of Manufacture. [Indication] For the diagnosis of Helicobacter Pylori (HP) infection. [Administration and Dosage] 1. This product should be used together with the breath collecting reagent of the Urea 14C Breath Test Kit or the processed materials of breath test analyzer. 2. The test should be conducted on an empty stomach or at least two hours after eating. The patient should gargle before the test. 3. The patient takes one Urea 14C capsule with 20mL of cool water, and then sits calmly for 15~25 minutes. 4. Follow the instructions of package insert or user’s manual for medical device to collect the patient’s breath. 5. Mark on the breath sample after it is collected. 6. Test the breath sample on approved breath test analyzer for Urea 14C Breath Test. [Overdosage] In the event of overdose, the patient should drink one glass of water (150mL) every hour to hasten excretion of the radioisotope. Maximum excretion of urea achieved at a urine output of > 2.0mL/min. [Adverse reaction(s)] There were no adverse reactions reported in clinical trials at a rate >1%. All adverse reactions reported were felt by the investigators to be unrelated to the drug. [Contraindications] Unknown. [Precautions] 1. Pregnant and lactation women should not take such test. 2. The capsule should be taken orally without chewing. 3. Factors list below may affect the diagnosis from the test: Factor Result Comment Recent antibiotic or bismuth containing products False neg. Relapse of partially treated _Helicobacter pylori (Hp)_ may take 1-4 weeks Omeprazole (or other proton pump inhibitors) False neg. These agents suppress _Hp_ in 40% of patients. Discontinue for at least 1 week before performing the PYtest. Sucralfate False neg. Baca dokumen lengkapnya