C13 - UREA

Israel - English - Ministry of Health

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Active ingredient:
UREA- C 13
Available from:
EXALENZ BIOSCIENCE LTD
Pharmaceutical form:
TABLETS
Composition:
UREA- C 13 75 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
EXALENZ BIOSCIENCE LTD
Therapeutic indications:
Intended for use in the qualitative detection of urease associated with H. Pylory in the human stomach and as an aid in the initial diagnosis and post treatment monitoring of H. Pylory infection in adult patients.
Authorization number:
130 45 30942 02
Authorization date:
2015-02-28

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

26-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

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صخم لولحملا

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كأتلل رركتملا صحفلا نإف ،يروليپ ريتكابوكيليهلا ةموثرج جلاع دعب .1 صيخشتلا

مت اذإ .جلاعلا اذه دعب

لقلأا ىلع عيباسأ ةعبرأ ذ

فنتي نأ بجي اهدوجو .ةئطاخ ةجيتنلا نوكت دقف دعوملا اذه لبق نم ةنس 18 نود ىضرم ىدل صحفلا مايق نامأو ةعاجن نع ةمئاقلا تامولعملا

.ةخسار ريغ تلاز ام رمعلا ةيحارج ةيلمعب او

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يئزج وأ ا

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ت مل

.صحفلا ةجيتن يف ر

يغت أرط اذإ وأ ،ةيبناج ضارعأب ،ةلاح ةيأ يف ،ترعش اذإ :ةيبناج ضارعأ

روف بيبطلا ةراشتسا كيلعف ،ماعلا كروعش .ةيوئم ةرارح ةجرد 25 تحت ،ةفرغلا ةرارح ةجرد يف :نيزختلا دعوملا اذه .ةوبعلا ىلع عوبطملا هتيحلاص ءاهتنا دعوم دعب ءاودلا لامعتسا زوجي لا .هيف روكذملا رهشلا موي رخآ ىلا بستني 130 45 30942 02 :ءاودلا ليجست مقر ،.ض.م ةينلاديص ةعانص ورات :جاتنلإا عقوم .افيح جيلخ ،10347، .ب.ص ،14 روتيكه عراش ،.ض.م سنيياسويب سنيلاسكإ :ليجستلا بحاصو جتنملا .ليئارسا ،71700 نيعيدوم ،4 نايعمه عراش اهيلع قدوصو اهنومضم صح

فو ةحصلا ةرازو لبق نم ةرشنلا هذه ةغيص تد

2011 لوليأ يف اهلبق نم

Patient package insert in accordance with the

pharmacists’ regulations (Preparations, 1986)

The dispensing of this medicine requires a physician’s prescription.

Read this package insert carefully in its entirety

before using this medicine

13

C UREA Tablet

Description: UREA Tablet, enriched with

C, 75 mg.

Indication: For the diagnosis of Helicobacter pylori (H. pylori)

presence in the human stomach by breath test, as an aid in the initial

diagnosis and post treatment monitoring of H. pylori infection.

For use with a suitable kit (according to the instructions for use in

the leaflet provided with the kit).

Content: Each tablet contains 75 mg of

C-Urea

Inactive ingredients:

Sodium Benzoate, NF, Pvidone, USP (Kollidon 90F),

Microcrystalline Cellulose, NF (Avicel 102), Colloidal Silicon

Dioxide, NF (Aerosil 200).

Instructions for Use:

Preparation of the drink:

Dissolve the

C-Urea tablet in 150 to 200 mL of tap water

together with citric acid (“Citrica“) supplied in a separate sealed

pouch in a single drinking cup.

Stir thoroughly with the provided straw for 2 to 3 minutes until

the Citrica powder and the urea tablet are completely dissolved.

However, tiny particles might still be seen in the solution after stirring.

Alternatively, the tablet may be dissolved in 150 to 200 mL of

tap water with 1.4 g of citric acid or in a glass of orange juice

without Citric acid.

Drink the content of the drinking solution from the glass with a

straw.

Drink the content of the drinking solution within two minutes.

Note:

If substantial particulate matter is still present after 5 minutes

of stirring, discard the solution and repeat the procedure with

a new tablet.

Administer the test drink within two hours of preparation, as this

is the maximal time to maintain solution stability.

Recommendations before the use:

- The patient should have fasted at least 1 hour before

administering the solution.

- The patient should not have taken proton pump inhibitors,

antimicrobials and bismuth containing preparations within two

weeks prior to administering the test, since these medicines

suppress the Helicobacter pylori organism, and may give a false

negative result.

Recommendations at the time of use:

The breath test should be performed within 30 minutes after

drinking the solution.

During these 30 minutes no eating, drinking, or smoking is allowed.

Warnings:

For diagnostic use only.

The dissolved solution is taken orally as part of the diagnostic

procedure.

In the case of accidental overdose, drink water and immediately

contact the poison control emergency center.

A negative result does not rule out the possibility of H. pylori

infection. False negative results can occur with this procedure.

A false positive test may occur due to presence of other

microorganisms like Helicobacter heilmanni (rare).

A false positive test could occur in patients who have

achlorhydria (lack of Hydrochloric acid).

If clinical signs suggest H. pylori infection, retest with a new sample

or an alternate method.

Limitations of the test:

1. Post treatment monitoring of H. pylori should be performed

after at least four weeks of treatment for H. pylori infection.

2. Safety and effectiveness in patients under the age of 18 years

have not yet been established.

3. Data is insufficient for recommending the use of this test on

patients with total or partial gastrectomy.

4. Data is insufficient to recommend the use of this test on

pregnant and lactating women.

5. A correlation between the number of H. pylori organisms in the

stomach and the BreathID

results has not been established.

Side effects:

In the event that you experience side effects, or if there is a change

in your general health, consult with your doctor immediately.

Storage: At room temperature, below 25°C.

Do not use the medicine beyond the expiry date mentioned on the

package. The expiry date refers to the last day of that month.

Registration number: 130 45 30942 02

Manufacturing site:

Taro Pharmaceutical Industries Ltd.,

14 Hakitor St., P.O.B. 10347, Haifa Bay.

Manufacturer and registration holder: Exalenz Bioscience Ltd.,

4 Hamaayan St. Modiin 71700.

The format of this leaflet was determined by the Ministry of Health

and its content was checked and approved by it in September 2011.

LB00064 Rev. 03

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