Urografin 150 solution for injection 20ml ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium amidotrizoate; Meglumine amidotrizoate

Available from:

Bayer Plc

INN (International Name):

Sodium amidotrizoate; Meglumine amidotrizoate

Dosage:

40mg/1ml ; 260mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5016703000976

Patient Information leaflet

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
UROGRAFIN®
SODIUM AMIDOTRIZOATE (SODIUM DIATRIZOATE) AND MEGLUMINE AMIDOTRIZOATE
(MEGLUMINE
DIATRIZOATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask the doctor giving you Urografin
(the
radiologist) or the X-ray department staff.
-
If you get any side effects, talk to your doctor or the X-ray
department
staff/radiologist. This includes any possible side effects not listed
in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Urografin is and what it is used for
2.
What you need to know before you are given Urografin
3.
How you will be given Urografin
4.
Possible side effects
5.
How to store Urografin
6.
Contents of the pack and other information
1. WHAT UROGRAFIN IS AND WHAT IT IS USED FOR
Urografin is an injectable contrast medium (a dye) which contains
iodine. It is used to clearly
show on X-rays the area of your body that your doctor wants to
investigate.
X-rays, like radio waves, can pass through objects and can be focused
to make a picture.
When you have an X-ray, the beam of rays goes through your body where
it is absorbed to
differing degrees by different tissues such as bones, muscles and
organs. When the rays
come out on the other side they make a pattern of light and shade on a
film. Urografin helps
to make this pattern clearer. The film is then examined by a
specialist who will make a
diagnosis.
This medicine is for diagnostic use only.
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2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN UROGRAFIN
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Summary of Product characteristics

OBJECT 1
UROGRAFIN 150
Summary of Product Characteristics Updated 09-Oct-2017 | Bayer plc
1. Name of the medicinal product
Urografin® 150
2. Qualitative and quantitative composition
1ml contains 40mg sodium amidotrizoate (sodium diatrizoate) and 260mg
meglumine amidotrizoate
(meglumine diatrizoate).
Excipient with known effect
Sodium calcium edetate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Aqueous solution for injection
4. Clinical particulars
4.1 Therapeutic indications
X-ray contrast medium for the delineation of the vascular and renal
systems.
4.2 Posology and method of administration
1. Adults only
The table below shows the medium the licence holder suggests for each
investigation. This medium may
be used at the discretion of the radiologist for other established
permutations of medium and examination
which, for the sake of simplicity, have been omitted from the table.
Examination
Dose regimen
Drip-infusion urography
2-4 ml/kg body
wt up to 250 ml
Retrograde urography
5-10 ml
Cystography
Up to 500 ml
(Other indications include: high dose urography, pelvic venography,
venacavography, arthrography,
selective visceral angiography, limb venography, jugular venography,
vesiculography, sialography,
sinusography, amniography, lymphangiography, intramuscular urography,
operative
cholangiography,percutaneous cholangiography, fistulography,
oesophageal and anal atresia).
_Urografin medium is not suitable for myelography_
2. Children and neonates
_Drip-infusion urography:_ Dosage of Urografin 150 should not exceed 4
ml/kg body weight.
• General Information
The patient should be recumbent during the administration of Urografin
and kept under close observation
for at least 30 minutes (see Special warnings and special precautions
for use),
Experience shows that contrast medium is tolerated better if it is
warmed to body temperature.
4.3 Contraindications
Proven or suspected hypersensitivity to iodine-containing contrast
media, uncontrolled thyrotoxicosis and
decompensated cardiac insuffic