Indium [111In] DTPA 37 MBq/ ml

Država: Norveška

Jezik: norveščina

Source: Statens legemiddelverk

Aktivna sestavina:

Indium (111In) pentetat

Dostopno od:

Curium Netherlands B.V.

Koda artikla:

V09AX01

INN (mednarodno ime):

Indium (111In) pentetate

Odmerek:

37 MBq/ ml

Farmacevtska oblika:

Injeksjonsvæske, oppløsning

Enote v paketu:

Hetteglass 1 ml

Tip zastaranja:

C

Status dovoljenje:

Markedsført

Datum dovoljenje:

1999-11-01

Lastnosti izdelka

1.
NAME OF THE MEDICINAL PRODUCT
Indium (
111
In) DTPA Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per ml at activity reference time and date:
-
Indium (
111
In) pentetate 37 MBq
-
Pentetic acid
0.1 mg
Summary of the physical characteristics of the radioactive isotope in
the active substance:
111
In.
Physical half-life 2.8 days.
Most important radiation emitted
Energy level
Abundance (%)
171 keV
90.9%
245 keV
94 %
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
pH: 7.0-7.6.
Osmolality: 280-320 mosmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Cisternoscintigraphy:
Detection of obstructions in cerebrospinal flow. Differentiation
between normal pressure hydrocephalus and
other forms of hydrocephalus.
Detection of leaks of cerebrospinal fluid (rhinorrhoea or otorrhoea).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly population:
9-20 MBq (250-500

Ci)
Paediatric population:
0.4-0.6 MBq/kg body weight (10-15

Ci/kg)
Method of administration
Indium (
111
In) pentetate is administered by intrathecal injection (lumbar or
suboccipital).
Image acquisition
A first visualisation of the skull area should preferably be done 1 to
1.5 hrs after injection. Further imaging is
done at 3, 6 and 24 hrs and sometimes 48 or 72 hours after
administration, depending on the diagnostic
information required.
Ten to 15 minutes after lumbar puncture a control scan should be
performed at the puncture level to exclude
extra-arachnoidal activity, which might cause false-negative results.
STYLE DEFINITION: Footer: Font: 8 pt, English (United
Kingdom), Widow/Orphan control, Tab stops: 1 cm, Left + 8
cm, Centered + 15,75 cm, Centered + Not at 7,32 cm +
14,65 cm
STYLE DEFINITION: Header: Font: 10 pt, English (United
Kingdom), Widow/Orphan control, Tab stops: 1 cm, Left
STYLE DEFINITION: Normal: Font: Times New Roman, 11 pt,
English (United Kingdom), Line spacing: Exactly 13 pt,
Widow/Orph