Urografin 150 solution for infusion 250ml bottles

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Meglumine amidotrizoate; Sodium amidotrizoate

Available from:

Bayer Plc

INN (International Name):

Meglumine amidotrizoate; Sodium amidotrizoate

Dosage:

260mg/1ml ; 40mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5016703000013

Summary of Product characteristics

OBJECT 1
UROGRAFIN 150 FOR INFUSION
Summary of Product Characteristics Updated 09-Oct-2017 | Bayer plc
1. Name of the medicinal product
Urografin® 150 for infusion
2. Qualitative and quantitative composition
1ml contains 40 mg sodium amidotrizoate (sodium diatrizoate) and 260
mg 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
deco