HEADWAY

Maa: Indonesia

Kieli: indonesia

Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiivinen ainesosa:

UREA 14C

Saatavilla:

PERUSAHAAN DAGANG DAN INDUSTRI KALIROTO - Indonesia

INN (Kansainvälinen yleisnimi):

UREA 14C

Annos:

0,75 McCI

Lääkemuoto:

KAPSUL

Kpl paketissa:

DUS, 2 ALUMUNIUM POUCH @ 2 BLISTER @ 10 KAPSUL

Valmistaja:

SHENZHEN ZHONGHE HEADWAY BIO-SCI & TECH CO.,LTD - China

Valtuutus päivämäärä:

2019-09-22

Valmisteyhteenveto

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.