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APROKAM 50 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFUROXIME SODIUM / CEFUROXIME SODIUM / CEFUROXIME SODIUM

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KXXXXXX/XXXXXXXX

Aprokam 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 Aprokam is and what it is
used for
2. What you need to know before
you are given Aprokam
3. How Aprokam is administered
4. Possible side effects
5. How to store Aprokam
6. Contents of the pack and other
information
1. WHAT APROKAM IS
AND WHAT IT IS USED FOR
• Aprokam contains an active
substance, 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.
• This medicine will be used if
you are undergoing eye surgery
because of cataract (cloudiness of
the lens).
• Your ophthalmic surgeon will
administer this medicine by
injection into the eye at the end of
cataract surgery in order to prevent
eye infection.
2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN
APROKAM
Do not use Aprokam
• If you are allergic (hypersensitive)
to cefuroxime or to any of the
cephalosporin type antibiotics.
Warnings and precautions
Talk to your doctor or, pharmacist or
nurse before using Aprokam:
• if you are allergic to other
antibiotics such as penicillin,
• if you are at risk of an infection
due to bacteria called Methicillinresistant Staphylococcus aureus,
• if you are at risk of a severe risk of
infection,
• if you have been diagnosed a
complicated cataract,
• if a combined eye surgery is
planned,
• if you have severe thyroid disease.
Aprokam is only given as an injection
into the eye (intracameral injection).
Aprokam should be administered in
aseptic conditions (meaning clean
and germ free) of cataract surgery.
One vial of Aprokam must be used
for one patient only.
Other medicines and Aprokam
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.

Pregnancy and breast-feeding
• If you are pregnant or breastfeeding, think you may be
pregnant or are planning to
have a baby, ask your doctor or
pharmacist for advice before you
are given this medicine.
• You will only be given Aprokam
if the benefits outweigh the
potential risks.
3. HOW APROKAM IS
ADMINISTERED
• Aprokam injections will be
administered by an ophthalmic
surgeon at the end of cataract
surgery.
• Aprokam is supplied as a sterile
powder and is dissolved in saline
solution for injection before it is
administered.
If you are given too much, or too
little, Aprokam.
Your medication will usually be
given by the health professional. If
you think you may have missed a
dose or have received too much
medicine, please tell you doctor or
nurse.
If you have any further questions on
the use of this medicine, ask your
doctor or, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Aprokam can
cause side effects, although not
everybody gets them.
The following side effect is
very rare (may affect up to
1 in 10,000 people):
• Serious allergic reaction which
causes difficulty in breathing or
dizziness.
Reporting of side effects
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. You
can also report side effects directly
the Yellow Card Scheme.
Web site: www.mhra.gov.uk/
yellowcard
By reporting side effects you can
help provide more information on
the safety of this medicine.
5. HOW TO STORE APROKAM
Keep this medicine out of the sight
and reach of children.
Do not use Aprokam after the expiry
date which is stated on the carton
and vial label after EXP. The expiry
date refers to the last day of that
month.
Please turn

The following information is intended for medical
or healthcare professionals only:
Incompatibilities
No incompatibility with most commonly used products in cataract surgery
was reported in literature. This medicinal product must not be mixed with
other medicinal products except those mentioned below [sodium chloride
9 mg/ml (0.9%) solution for injection].
How to prepare and administer Aprokam
Single-use vial for intracameral use only.
Aprokam must be administered after reconstitution by intraocular
injection in the anterior chamber of the eye (intracameral injection), by an
ophthalmic surgeon, in the recommended aseptic conditions of cataract
surgery.
The reconstituted solution should be visually inspected and should only be
used if it is a colourless to yellowish solution free from visible particles.
The product should be used immediately after reconstitution and not
reused.
The recommended dose for cefuroxime is 1 mg in 0.1 ml
sodium chloride 9 mg/ml (0.9%) solution for injection.
DO NOT INJECT MORE THAN THE RECOMMENDED DOSE.
Vial is for single use only.
One vial for one patient only. Stick the flag label of the vial on the
patient file.
To prepare Aprokam for intracameral administration, please adhere
to the following instructions:
1. Check the integrity of the flip-off cap before
with drawing it.
Should be
disinfected

2. Disinfect the surface of the rubber stopper
before step 3.
3. Push the sterile needle vertically into the
centre of the vial stopper, keeping the vial
in an upright position. Aseptically inject into
the vial 5 ml of sodium chloride 9 mg/ml
(0.9%) solution for injection.
4. Shake gently until the solution is free from
visible particles.

5-µm filter needle

at least 0,1 ml

5. Assemble a sterile needle
(18G x 1½”, 1.2 mm x 40 mm)
with 5-micron filter (acrylic copolymer
membrane on a non-woven nylon) onto
a 1 ml sterile syringe (the sterile needle
with 5-micron filter may be provided in the
box). Then, push this 1 ml sterile syringe
vertically into the centre of the vial stopper,
keeping the vial in an upright position.
6. Aseptically withdraw at least 0.1 ml of the
solution.
7. Disconnect the needle from the syringe and
attach a sterile anterior chamber cannula to
the syringe.
8. Carefully expel the air from the syringe and
adjust the dose to the 0.1 ml mark on the
syringe. The syringe is ready for injection.

After use, discard the remaining of the reconstituted solution.
Do not keep it for subsequent use.
Any unused product or waste material should be disposed of in accordance with
local requirements. Discard used needles in a sharps container.

KXXXXXX/XXXXXXXX

Store below 25ºC. Keep the
vial in the outer carton, in order
to protect from light.
For single use only.
After reconstitution: the product
should be used immediately.
Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to throw away
medicines you no longer use.
These measures will help to
protect the environment.
6. CONTENTS OF THE PACK
AND OTHER INFORMATION
What Aprokam contains
The active substance is cefuroxime
(as cefuroxime sodium).
Each vial contains 50 mg of
cefuroxime.
After reconstitution, 0.1 ml solution
contains 1 mg of cefuroxime.
This medicinal product contains less
than 1 mmol sodium (23 mg) per
dose, i.e. essentially ‘sodium- free’.
There are no other ingredients.
What Aprokam looks like and
contents of the pack
Aprokam is a white to almost white
powder for solution for injection,
supplied in a glass vial.
Each box contains one or ten or
twenty vials, or ten vials together
with ten sterile filter needles. Not all
pack size may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder:
LABORATOIRES THEA
12 rue Louis Blériot
63017 CLERMONT-FERRAND
Cedex 2
France
Manufacturer:
BIOPHARMA S.R.L.
Via Delle Gerbere, 22/30
(loc. S. PALOMBA)
00134 ROMA (RM)
Italy
This medicinal product is
authorised in the Member States
of the EEA under the following
names:
Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany,
Italy, Iceland, Luxembourg, The
Netherlands, Norway, Poland,
Portugal, Romania, Slovak Republic,
Slovenia, Sweden,
United Kingdom ....................APROKAM
Cyprus, Greece, Spain ............PROKAM
Ireland ..............................................APROK
This leaflet was last approved in
07/2016.

N2700W10ASP/0716
KXXXXXX/XXXXXXXX

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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