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XIMARACT 50 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFUROXIME SODIUM

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Package leaflet: Information for the patient

Ximaract 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, 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Ximaract is and what it is used for
2. What you need to know before you are
given Ximaract
3. How Ximaract is administered
4. Possible side effects
5. How to store Ximaract
6. Contents of the pack and other information

1. What Ximaract is and
what it is used for
Ximaract contains the 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
a 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
Ximaract

If you have any further questions on the use
of this medicine, ask your doctor, pharmacist
or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Speak to a doctor or nurse
immediately if you get any of
these symptoms.
-- Serious allergic reaction which
causes a raised itchy skin rash
(urticaria or ‘hives’), difficulty in
breathing, or dizziness. The
side effect is very rare (may affect
up to 1 in 10,000 people).
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via:
United Kingdom
Yellow Card Scheme;
Website: 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 Ximaract
Keep this medicine out of the sight and reach
of children.
Do not use this medicine 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.
Do not store above 25°C. 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 use Ximaract if you are
allergic to cefuroxime or to any of the
cephalosporin type antibiotics or any of
the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before you are given Ximaract:
-- if you have had a reaction to other
antibiotics such as penicillin;
-- if you have previously had an antibiotic
resistant infection e.g. Methicillin-resistant
Staphylococcus aureus;
-- if you are at risk of a severe infection;
-- if you have been diagnosed with a
complicated cataract;
-- if combined eye surgery is planned;
-- if you have severe thyroid disease.

Any remaining reconstituted solution must be
discarded.

Ximaract should be administered in aseptic
conditions (meaning clean and germ free) of
cataract surgery.

To prepare the product for intracameral
administration, a sterile needle (18G x
1½”, 1.2 mm x 40 mm) with 5-micron
filter (acrylic co-polymer membrane)
must be used.

One vial of Ximaract must be used for one
patient only.
Other medicines and Ximaract
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 breast-feeding, 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 Ximaract if your doctor
thinks it is clearly necessary.

3. How Ximaract is
administered
Ximaract injections will be administered, as
an injection into the eye, by an ophthalmic
surgeon at the end of cataract surgery.
Ximaract 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
Ximaract
Your medication will usually be given by the
health professional. If you think you may have
received too little or too much medicine,
please tell your doctor or nurse.

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
protect the environment.

6. Contents of the pack and
other information
What Ximaract 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.
-- There are no other ingredients.

The filter needle and any other equipment
required for preparation of Ximaract are
NOT enclosed in the package.
For details on the required medical devices and
solvent, please refer to “How to prepare and
administer Ximaract”.
What Ximaract looks like and contents
of the pack
Ximaract is a white to almost white powder
for solution for injection, supplied in a clear,
transparent glass vial.
Each box contains 1 or 10 or 25 vials. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2, 170 00 Praha 7,
Czech Republic
Manufacturer
GlaxoSmithKline Manufacturing S.p.A.
Via Alessandro Fleming 2
37135 Verona
Italy
This leaflet was last revised in May 2016.

The following information is intended for healthcare
professionals only:

How to prepare and administer
Ximaract
Single-use vial for intracameral use only.
Ximaract 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 clear, colourless to yellowish solution free
from visible particles.
The product should be used
immediately after reconstitution and
not reused. The medicinal product should
be discarded if particles are visible in the
solution.
The recommended dose for
cefuroxime is 1 mg in 0.1 ml sodium
chloride 9 mg/ml (0.9 %) solution for
injection.
THE RECOMMENDED DOSE MUST
NOT BE EXCEEDED.
Vial is for single use only.
Each vial should only be used for the
treatment of a single eye. The flag
label of the vial should be stuck on the
patient’s file, as applicable.
P1UK01_Ximaract 50mgINJ_UK.indd 1

To prepare Ximaract for intracameral
administration, please adhere to the
following instructions:
1. Check the integrity of the flip-off cap before
withdrawing it.
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 clear,
colourless to yellowish and free from visible
particles.
5. Assemble a sterile needle (18G x 1½”,
1.2 mm x 40 mm) with 5-micron filter (acrylic
co-polymer membrane) 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.
6. Aseptically withdraw at least 0.1 ml of the
solution. Discard the remaining reconstituted
solution (4.9 ml) in the vial.
7. Disconnect 5-micron filter needle from the
syringe and attach a sterile anterior chamber
cannula to the syringe.
8. Carefully expel the air from the syringe and
expel excess drug by slowly depressing the
plunger so that the plunger tip aligns with
the line that marks 0.1 ml on the syringe.
The syringe is ready for injection.
After use, discard the remaining
reconstituted solution. Do not keep it for
subsequent use.
Any unused product or waste material
should be disposed of in accordance
with local requirements.
2016-06-02 09:06:53

P1UK01

Incompatibilities
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).

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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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