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APROKAM 50 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFUROXIME SODIUM

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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:
3. HOW APROKAM IS
1. What Aprokam is and what it is used
ADMINISTERED
for
2. What you need to know before you are • Aprokam injections will be administered
by an ophthalmic surgeon at the end
given Aprokam
of cataract surgery.
3. How Aprokam is administered
• Aprokam is supplied as a sterile
4. Possible side effects
powder and is dissolved in saline
5. How to store Aprokam
solution for injection before it is
6. Contents of the pack and other
administered.
information
If you are given too much, or too
1. WHAT APROKAM IS AND WHAT
little, Aprokam
IT IS USED FOR
Your medication will usually be given
• Aprokam contains an active substance, by the health professional. If you think
cefuroxime (as cefuroxime sodium) you may have missed a dose or have
which belongs to a group of antibiotics received too much medicine, please tell
called cephalosporins. Antibiotics are your doctor or nurse.
used to kill the bacteria or germs that If you have any further questions on the
use of this medicine, ask your doctor, or
cause infections.
• This medicine will be used if you are pharmacist or nurse.
undergoing eye surgery because of
4. POSSIBLE SIDE EFFECTS
cataract (cloudiness of the lens).
• Your ophthalmic surgeon will administer Like all medicines, Aprokam can cause
this medicine by injection into the eye side effects, although not everybody
at the end of cataract surgery in order gets them.
to prevent eye infection.
The following side effect is very rare
(may affect up to 1 in 10,000 people):
2. WHAT YOU NEED TO KNOW
• Serious allergic reaction which causes
BEFORE YOU ARE GIVEN
difficulty in breathing or dizziness.
APROKAM
Reporting of side effects
If you get any side effects, talk to your
Do not use Aprokam
• If you are allergic (hypersensitive) doctor or, pharmacist or nurse. This
to cefuroxime or to any of the includes any possible side effects not
listed in this leaflet. You can also report
cephalosporin type antibiotics.
side effects directly via the Yellow Card
Warnings and precautions
Scheme.
Talk to your doctor or, pharmacist or
Web site: www.mhra.gov.uk/yellowcard
nurse before using Aprokam:
By reporting side effects you can help
• if you are allergic to other antibiotics
provide more information on the safety
such as penicillin,
of this medicine.
• if you are at risk of an infection due
to bacteria called Methicillin-resistant 5. HOW TO STORE APROKAM
Staphylococcus aureus,
• if you are at risk of a severe risk of Keep this medicine out of the sight and
reach of children.
infection,
• if you have been diagnosed a Do not use Aprokam after the expiry
date which is stated on the carton and
complicated cataract,
• if a combined eye surgery is planned, vial label after EXP. The expiry date
refers to the last day of that month.
• if you have severe thyroid disease.
Aprokam is only given as an injection into Store below 25ºC. Keep the vial in the
outer carton, in order to protect from
the eye (intracameral injection).
Aprokam should be administered in light.
aseptic conditions (meaning clean and For single use only.
After reconstitution: the product should
germ free) of cataract surgery.
One vial of Aprokam must be used for be used immediately.
Do not throw away any medicines via
one patient only.
wastewater or household waste. Ask
Other medicines and Aprokam
your pharmacist how to throw away
Tell your doctor or pharmacist if you are
medicines you no longer use. These
taking, have recently taken or might take
measures will help to protect the
any other medicines.
environment.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding,
think you may be pregnant or are
Please turn
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.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 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:
Should be
disinfected

1. Check the integrity of the flip-off cap before
withdrawing it.
2. Disinfect the surface of the rubber stopper
before step 3.

5 ml

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

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. Then, push this
1 ml sterile syringe vertically into the centre of
the vial stopper, keeping the vial in an upright
position.

at least 0.1 ml

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.

0.1 ml

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.
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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. 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, Bulgaria,
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
04/2014.

N2700V10ASP/0813
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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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