Urografin 150 solution for infusion 500ml bottles

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Meglumine amidotrizoate; Sodium amidotrizoate

Dostupné z:

Bayer Plc

INN (Medzinárodný Name):

Meglumine amidotrizoate; Sodium amidotrizoate

Dávkovanie:

260mg/1ml ; 40mg/1ml

Forma lieku:

Solution for infusion

Spôsob podávania:

Intravenous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: ; GTIN: 5016703000983

Súhrn charakteristických

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