Aprok 50mg powder for solution for injection

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Cefuroxime Sodium

Beschikbaar vanaf:

Laboratoires Thea

ATC-code:

S01AA; S01AA27

INN (Algemene Internationale Benaming):

Cefuroxime Sodium

Dosering:

50 milligram(s)

farmaceutische vorm:

Powder for solution for injection

Prescription-type:

Product subject to prescription which may not be renewed (A)

Therapeutisch gebied:

Antibiotics; cefuroxime

Autorisatie-status:

Marketed

Autorisatie datum:

2012-09-07

Bijsluiter

1
APROK 50 MG POWDER FOR SOLUTION FOR INJECTION
Cefuroxime
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 your doctor, or pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What APROK is and what it is used for
2. What you need to know before you are given APROK
3. How APROK is used
4. Possible side effects
5. How to store APROK
6. Contents of the pack and other information
1. WHAT APROK IS AND WHAT IT IS USED FOR
The full name of your medicine is Aprok 50 mg, powder for solution for
injection. It is called Aprok
in this leaflet.
This medicine contains cefuroxime (as cefuroxime sodium) which belongs
to a group of antibiotics
called cephalosporins. Antibiotics are used to kill the bacteria or
germs that cause infections.
You will be given this medicine if you are having eye surgery because
of cataract (cloudy lens).
Your ophthalmic surgeon will give you this medicine by injection into
the eye at the end of the
surgery to prevent eye infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN APROK
DO NOT USE APROK
•
If you are allergic (hypersensitive) to cefuroxime or to any of the
cephalosporin type of
antibiotics.
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse before you are given
APROK:
•
if you are allergic to other antibiotics such as penicillin,
•
if
you
are
at
risk
of
an
infection
due
to
bacteria
called
MRSA
(Methicillin-resistant
_Staphylococcus aureus_),
•
if you have a high risk of infection,
•
if you have been told you have a complicated cataract,
•
if a combined eye surgery is planned,
•
if you

Productkenmerken

Health Products Regulatory Authority
09 October 2019
CRN0092JK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aprok 50mg powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of cefuroxime (as 52.6 mg of cefuroxime
sodium).
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 the
antibiotic prophylaxis on 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.
DO NOT INJECT MORE THAN THE RECOMMENDED DOSE (see section 4.9).
_Paediatric population:_
The optimal dose and the safety of APROK 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 APROK, no dose adjustment is
necessary.
_METHOD OF ADMINISTRATION_
APROK 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 APROK (see
section 6.6).
After reconstitution, APROK should be inspected visually for
particulate matter and discoloration prior to administration.
Slowly inject 0.1 ml of the reconstituted solution into the anter