Ximaract 50 mg Pulver till injektionsvätska, lösning

Land: Svíþjóð

Tungumál: sænska

Heimild: Läkemedelsverket (Medical Products Agency)

Virkt innihaldsefni:

cefuroximnatrium

Fáanlegur frá:

Bausch & Lomb Ireland Limited

ATC númer:

S01AA27

INN (Alþjóðlegt nafn):

Cefuroxime sodium

Skammtar:

50 mg

Lyfjaform:

Pulver till injektionsvätska, lösning

Samsetning:

cefuroximnatrium 52,6 mg Aktiv substans

Gerð lyfseðils:

Receptbelagt

Vörulýsing:

Förpacknings: Injektionsflaska, 1 st (med 1 filternål); Injektionsflaska, 10 st (med 10 filternålar); Injektionsflaska, 25 st (med 25 filternålar); Injektionsflaska, 1 st (utan filternål); Injektionsflaska, 10 st (utan filternålar); Injektionsflaska, 25 st (utan filternålar)

Leyfisstaða:

Godkänd

Leyfisdagur:

2016-08-24

Vara einkenni

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Ximaract 50 mg powder for solution for injection
[Name of the medicinal product in the RMS.]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefuroxime sodium corresponding to 50 mg of
cefuroxime.
After reconstitution with 5 ml of solvent (see section 6.6), 0.1 ml
solution contains 1 mg of
cefuroxime.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection [Powder for injection].
White to almost white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antibiotic prophylaxis of postoperative endophthalmitis after cataract
surgery (see section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents,
including guidance on antibiotic prophylaxis in eye surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Intracameral use. One vial for single-use only.
Posology
_Adults:_
The recommended dose is 0.1 ml of reconstituted solution (see section
6.6), i.e. 1 mg of cefuroxime.
THE RECOMMENDED DOSE MUST NOT BE EXCEEDED (see section 4.9).
Page 3 of 10
_Paediatric population_
The optimal dose and the safety of Ximaract have not been established
in the paediatric population.
_Elderly:_
No dose adjustment is necessary.
_Patients with hepatic and renal impairment:_
Considering
the
low
dose
and
the
expected
negligible
systemic
exposure
to
cefuroxime
using
Ximaract, no dose adjustment is necessary.
Method of administration
Ximaract must be administered after reconstitution by intraocular
injection in the anterior chamber of
the eye (intracameral use), by an ophthalmic surgeon, in the
recommended aseptic conditions of
cataract surgery. Only sodium chloride 9 mg/ml (0.9 %) solution for
injection must be used when
reconstituting Ximaract (see section 6.6).
After reconstitution, Ximaract should be inspected visually for
particulate matter and discoloration
prior to administration.
At the end of the cataract surgery, 0.1 ml of