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CEFTRIAXONE IG POWDER FOR SOLUTION FOR INJECTION (IM. IV)

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• pneumonia
• meningitis (infection in the brain)
• Infections of the bone, skin or other
soft body parts (tissues)
• Gonorrhoea, (a sexually transmitted
infection)
• Infections in people with low numbers
of white blood cells (neutropenia)
• It can also be given before and after
operations to stop infections from
happening
The treatment may sometimes need to
be started before knowing if the bacteria
are sensitive to ceftriaxone or not.

Package leaflet:
Information for the patient
Ceftriaxone 500 mg Powder for
Solution for Injection (IM, IV)
Ceftriaxone 1 g Powder for
Solution for Injection (IM, IV)
Ceftriaxone 2 g Powder for
Solution for Infusion (IV)
Ceftriaxone

2. What you need to know before you
are given Ceftriaxone
You must not be given Ceftriaxone if:
• You are allergic to ceftriaxone or
any of the other ingredients of this
medicine (listed in section 6).
• You are allergic to antibiotics called
‘cephalosporins’. These include
cefalexin, cefaclor and cefuroxime.
• You have had a sudden or severe
allergic reaction to antibiotics called
‘beta-lactams’. These include
penicillin or similar antibiotics (such as
amoxicillin or flucloxacillin). The signs
include sudden swelling of the throat
or face which might make it difficult to
breathe or swallow, sudden swelling
of the hands, feet and ankles, and a
severe rash that develops quickly.
• You are allergic to lidocaine and you
are to be given Ceftriaxone as an
injection into a muscle.
Intramuscular injection of the medicinal
product is contraindicated:
• in infants < 2 years of age
• during pregnancy and breast-feeding
You must not be given Ceftriaxone if any
of the above apply to you. If you are not
sure, talk to your doctor or nurse before
having Ceftriaxone.

Read all of this leaflet carefully
before you start using 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.
• If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1. What Ceftriaxone is and what it is
used for
2. What you need to know before you are
given Ceftriaxone
3. How Ceftriaxone will be given
4. Possible side effects
5. How to store Ceftriaxone
6. Contents of the pack and other
information

1. What Ceftriaxone is and what it is
used for

Ceftriaxone must not be given to
babies if:

Ceftriaxone belongs to a group
of antibacterial agents called
cephalosporins, which act by killing the
bacteria.
Ceftriaxone is used when an infection
is known to be or likely to be caused by
bacteria that are sensitive to ceftriaxone.
It is used for the treatment of the
following infections:

The following information is intended for
healthcare professionals only:

Ceftriaxone 500 mg Powder for
Solution for Injection (IM, IV)
Ceftriaxone 1 g Powder for
Solution for Injection (IM, IV)
Ceftriaxone 2 g Powder for
Solution for Infusion (IV)
Ceftriaxone
Please refer to the Summary of Product
Characteristics for full prescribing
information.

Presentation
< 500 mg:> 10 ml Type I clear glass vial
closed with bromobutyl rubber stoppers and
aluminium caps.
<1 g:> 20 ml Type I clear glass vial closed
with bromobutyl rubber stoppers and
aluminium caps.
<2 g:> 100 ml Type I clear glass vial closed
with bromobutyl rubber stoppers and
aluminium caps.
Vials contain a sterile, almost white or
yellowish, slightly hygroscopic, crystalline
powder. There are no excipients. Each
gram of Ceftriaxone contains approximately
3.6 mmol (82.8 mg) sodium.
Supplied in packs of 1, 5, 10 or 25 vials per
carton. Not all pack sizes may be marketed.

Posology and method of administration
Route and Method of administration:
Ceftriaxone may be administered by deep
intramuscular injection, slow intravenous
injection, or as a slow intravenous infusion,
after reconstitution of the solution according
to the directions given below.

• The baby is premature.
• The baby is newborn (up to 28 days)
and has certain blood problems or
jaundice (yellowing of the skin or the
whites of the eyes) or is about to be
given another injection that contains
calcium.

The intramuscular method of administration
should only be used in exceptional clinical
situations (see section 4.3) and should
undergo a risk-benefit assessment.
Diluents containing calcium, (e.g. Ringer’s
solution or Hartmann’s solution), should not
be used to reconstitute ceftriaxone vials or
to further dilute a reconstituted vial for IV
administration because a precipitate can
form. Precipitation of ceftriaxone-calcium can
also occur when ceftriaxone is mixed with
calcium-containing solutions in the same IV
administration line. Therefore, ceftriaxone
and calcium-containing solutions must not be
mixed or administered simultaneously (see
sections 4.3, 4.4 and 6.2).
For instructions on reconstitution of the
medicinal product before administration, see
section 6.6.Posology.
Dosage and mode of administration should
be determined by the severity of the infection,
susceptibility of the causative organism
and the patient’s condition. Under most
circumstances a once-daily dose - or, in the
specified indications, a single dose - will give
satisfactory therapeutic results.
Adults and children 12 years and over
Standard therapeutic dosage: 1 g once daily.
Severe infections: 2 - 4 g daily, normally as a
single dose every 24 hours.
The duration of therapy varies according
to the course of the disease. As with
antibiotic therapy in general, administration
of Ceftriaxone should be continued for a
minimum of 48 to 72 hours after the patient
has become afebrile or evidence of bacterial
eradication has been obtained.
Acute, uncomplicated gonorrhoea: A single
dose of 250 mg intramuscularly should be
administered. Simultaneous administration of
probenecid is not indicated.

Warnings and precautions

Pregnancy and breast-feeding

Talk to your doctor or nurse before using
Ceftriaxone if:
• You have had a mild allergic reaction
to penicillin or similar antibiotics (such
as a skin rash which may have been
itchy).
• You are allergic to anything not
already mentioned in this leaflet.
• You have asthma.
• You have recently received or are
about to receive calcium.
• You have ever had problems with your
gut, in particular colitis (inflammation
of the bowel).
• You have liver or kidney problems.
• You have other illnesses, such as
blood problems.
• You are on a low sodium diet.
If any of the above apply to you, or if you
are not sure, talk to your doctor or nurse
before you have Ceftriaxone

If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, tell your doctor
or nurse before using this medicine.

Driving and using machines
Ceftriaxone can cause dizziness. Talk
to your doctor if any of these happen to
you and do not drive or use any tools or
machines.

Ceftriaxone contains sodium
Each gram of Ceftriaxone contains
approximately 3.6 mmol (82.8 mg)
sodium. To be taken into consideration by
patients on a controlled sodium diet.

3. How Ceftriaxone will be given
Ceftriaxone will be given to you by a
doctor or nurse. It will be given to you in
one of the following ways:
• Before it is given to the patient,
Ceftriaxone is made into a solution by
adding sterile liquid to the vial.
• The correct dose is then taken out of
the vial. It can be given to the patient
either as an injection or added to a
bag of infusion solution which is given
through a small tube into one of your
veins.
• As an injection into a muscle (such as
the muscle in your arm).
• By slow injection into one of your
veins. This may take between 2 and
4 minutes.
• Through a small tube into one of your
veins. This is called an ‘intravenous
infusion’. It may take at least
30 minutes.
The number of days or weeks that you
are given Ceftriaxone for depends on
what sort of infection you have. You will
usually continue to be given Ceftriaxone
for 2 to 3 days after you have started to
recover from your illness.

Other medicines and Ceftriaxone
Tell your doctor or nurse if you are taking,
have recently taken or might use any
other medicines. This includes medicines
that you buy without a prescription
and herbal medicines. This is because
Ceftriaxone can affect the way some
medicines work. Also some medicines
can affect the way Ceftriaxone works.
In particular, tell your doctor or nurse
if you are taking any of the following
medicines:
• Oral contraceptives (the pill).
Ceftriaxone can stop the pill from
working, so you should use extra
barrier contraception methods (such
as condoms) while you are taking
Ceftriaxone and for one month
afterwards.
• Chloramphenicol (used to treat
infections, particularly of the eyes).
• Anticoagulants (medicines used to thin
the blood).
• Probenecid (used to treat gout).
• Amsacrine (an anti-cancer medicine).
• Fluconazole (an anti-fungal medicine).
• Vancomycin or other antibiotics (used
to treat infections).
You should also tell your doctor or nurse
if you are doing urine tests for glucose or
having blood tests.

Peri-operative prophylaxis: Usually 1 g as
a single intramuscular or slow intravenous
dose. In colorectal surgery, 2 g should be
given intramuscularly (dosages greater
than 1 g should be divided and injected at
more than one site), or by slow intravenous
infusion, in conjunction with a suitable agent
against anaerobic bacteria.
Elderly
These dosages do not require modification
in elderly patients provided that renal and
hepatic function are satisfactory (see below).
Neonates, infants and children up to
12 years
The following dosage schedules are
recommended for once daily administration:
Neonates
A daily dose of 20 - 50 mg/kg body weight,
not to exceed 50 mg/kg. In neonates, the
intravenous dose should be given over
60 minutes to reduce the displacement of
bilirubin from albumin, thereby reducing the
potential risk of bilirubin encephalopathy (see
section 4.4).
Infants and children of up to 12 years
Standard therapeutic dosage: 20 - 50 mg/kg
body weight once daily.
In severe infections up to 80 mg/kg body
weight daily may be given. For children with
body weights of 50 kg or more, the usual
adult dosage should be used. Doses of
50 mg/kg or over should be given by slow
intravenous infusion over at least 30 minutes.
Doses greater than 80 mg/kg body weight
should be avoided because of the increased
risk of biliary precipitates.
Renal and hepatic impairment
In patients with impaired renal function,
there is no need to reduce the dosage of
Ceftriaxone provided liver function is intact.

Component Specification
Q73863

Request number:

AS2152

• The usual dose is 1 g (gram) once a
day. If you have a severe infection,
your doctor may give you a higher
dose (between 2 g and 4 g once a
day).
• If you are going to have an operation
you may be given between 1 g and 2 g
in one or two injections.
• The usual treatment for an infection
called ‘gonorrhoea’ is one dose of
Only in cases of pre-terminal renal failure
(creatinine clearance < 10 ml per minute)
should the daily dosage be limited to 2 g or
less.
In patients with liver damage there is no need
for the dosage to be reduced provided renal
function is intact.
In severe renal impairment accompanied
by hepatic insufficiency, the plasma
concentration of Ceftriaxone should be
determined at regular intervals and dosage
adjusted.
In patients undergoing dialysis, no additional
supplementary dosing is required following
the dialysis. Serum concentrations should be
monitored, however, to determine whether
dosage adjustments are necessary, since
the elimination rate in these patients may be
reduced.

Instructions for use
The use of freshly prepared solutions is
recommended. These maintain potency for at
least 6 hours at or below 25°C in daylight, or
24 hours at 2 – 8°C.
When reconstituted in water for injections,
ceftriaxone powder gives a light yellow to
amber coloured clear solution.
Ceftriaxone Powder for Solution for Injection
or Infusion should not be mixed in the same
syringe with any drug other than 1.0%
Lidocaine Hydrochloride BP solution (for
intramuscular injection only).

Q73863
TN/DRUGS/763

Requester

Item number:

Adults, the elderly and children aged
12 years and over

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Country:

United Kingdom

Inventory code(s):

1 pk, 5 pk,
10 pk, 25 pk

OI template:
Amalia version:
Mulgrave version:

OCI006
1
n/a

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

250 x 320 mm
10 and 20 ml vials
Hospira India
N/A
tbc mm
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

n/a
n/a
n/a

Colours
Black:

Previous Item Number:

N/A

Signed:
Date:
Version 1
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15/Aug/12

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250 mg (0.25 g), given as an injection
into a muscle.

Other possible side effects:
Common (may affect up to 1 in
10 people)
• Loose stools or diarrhoea.
• Feeling sick or being sick.
Uncommon (may affect up to 1 in
100 people)
• Other skin reactions. These include
a rash which may cover a lot of your
body, a lumpy rash (hives), feeling
itchy and swelling.
Rare (may affect up to 1 in 1,000 people)
• Other types of infection, such as
those caused by fungi and yeasts (for
example, thrush).
• Blood problems. The signs include
feeling tired, bruising easily, being
short of breath and nosebleeds.
• Headache.
• Feeling dizzy.
• A sore mouth.
• Inflammation of the tongue (glossitis).
The signs include swelling, redness
and soreness of the tongue.
• Liver problems (shown in a blood test).
• Problems with your gallbladder which
may cause pain, feeling sick and being
sick.
• Kidney problems. These may affect
the amount of water (urine) that you
pass. Some people pass less water
than usual. Very rarely, people stop
passing water altogether.
• Blood or sugar in your urine.
• Pain or a burning feeling along the
vein where Ceftriaxone has been
given.
• Pain where the injection was given.
• A high temperature (fever) or
shivering.
Very rare (may affect up to 1 in
10,000 people)
• Positive results in a Coombs’ test (a
test for some blood problems).
• Problems with the way your blood
clots. The signs include bruising easily
and pain and swelling of your joints.
• Changes in the numbers of white
cells in your blood. The signs include
a sudden high temperature (fever),
shivering and a sore throat.
• Inflammation of the pancreas
(pancreatitis). The signs include
severe pain in the stomach which
spreads to your back.

Children up to 12 years
• The dose is worked out by the doctor
based on the child’s weight. The
medicine is usually given to the child
once a day through a small tube into
a vein (intravenous infusion). This
usually takes at least 30 minutes.

Newborn babies
• The dose is worked out by the doctor
based on the baby’s weight. The
medicine is usually given to the baby
once a day through a small tube into
a vein (intravenous infusion). This
usually takes 1 hour.

People with liver and kidney problems
• If you have problems with your liver
and kidneys, you may be given a
lower dose. You may need to have
blood tests to check that you are
getting the dose you need.

If you are given too much Ceftriaxone
• If you think you have been given too
much Ceftriaxone, tell your doctor or
nurse.
If you have any further questions on the
use of this medicine, ask your doctor or
nurse.

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them. The following side
effects may happen with this medicine.
Severe allergic reactions (uncommon,
may affect up to 1 in 100 people)
If you have a severe allergic reaction, tell
a doctor straight away.
The signs may include:
• Sudden swelling of the face, throat,
lips or mouth. This can make it difficult
to breathe or swallow.
• Sudden swelling of the hands, feet
and ankles.
Severe skin rashes (very rare, may
affect up to 1 in 10,000 people)
If you get a severe skin rash, tell a
doctor straight away.
• The signs may include a severe rash
that develops quickly, with blisters
or peeling of the skin and possibly
blisters in the mouth.

• Inflammation of the large bowel
(colon). The signs include diarrhoea,
usually with blood and mucus,
stomach pain and fever.
If you get any side effects, talk to your
doctor or nurse. This includes any side
effects not listed in this leaflet.

Reporting of side effects

Powder Concentration
of Solution
250 mg 250 mg/ml
500 mg 250 mg/ml
1g
250 mg/ml

Volume of
Diluent
1 ml
2 ml
3.5 ml

Displacement Volume/Rise in
volume upon reconstitution
0.193 ml
0.447 ml
0.726 ml

Displacement Volume/Rise in
volume upon reconstitution
0.218 ml
0.327 ml
0.807 ml

Total volume in vial
after reconstitution
1.193 ml
2.447 ml
4.226 ml

Total volume in vial
after reconstitution
5.218 ml
5.327 ml
10.807 ml

Approx. concentration of solution
based on displacement volume
210 mg/ml
204 mg/ml
237 mg/ml

Approx. concentration of solution
based on displacement volume
48 mg/ml
94 mg/ml
93 mg/ml

Intravenous infusion:
Powder Volume of Diluent Quantity of Displacement
(approximately)
Solution
Volume/Rise in volume
upon reconstitution

Total volume
in vial after
reconstitution

Approx. concentration
of solution based on
displacement volume

41.170 ml

49 mg/ml

Glucose Injection 5% or 10%
Sodium Chloride Injection
Sodium Chloride and Glucose
2g
Injection (0.45% sodium
chloride and 2.5% glucose)
Dextran 6% in Glucose
Injection 5%

50 mg/ml

40 ml

1.170 ml

• Ceftriaxone is a powder. It is almost
white to yellowish in colour. It is
supplied in a glass vial.
• Ceftriaxone is supplied in packs of 1,
5, 10 or 25 vials per carton. Not all
pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom
Alternate Batch release site:
Hospira Enterprises B.V.
Randstad 22-11,
1316 BN ALMERE
The Netherlands

This medicinal product is authorised in
the Member States of the EEA under
the following names:
Ceftriaxone 0.5 g Powder for Solution for
Injection
Ceftriaxone 1 g Powder for Solution for
Injection
Ceftriaxone 2 g Powder for Solution for
Injection or Infusion
This leaflet was last revised in 01/2014.

The injection should be administered over at least 2 - 4 minutes, directly into the vein or via the tubing of an intravenous infusion.
Solution for Reconstitution

What Ceftriaxone looks like and
contents of the pack

• Your doctor or pharmacist is
responsible for storing this medicine.
• This medicine does not require
any special temperature storage
conditions. Keep the vial in the outer
carton in order to protect from light.
• 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 after EXP.

Intravenous injection:
Volume of
Diluent
5 ml
5 ml
10 ml

The active substance in Ceftriaxone is
ceftriaxone disodium 3,5 hydrate.
Each vial contains 500 mg ceftriaxone as
596 mg ceftriaxone sodium.
Each vial contains 1 g ceftriaxone as
1.193 g ceftriaxone sodium.
Each vial contains 2 g ceftriaxone as
2.386 g ceftriaxone sodium.
There are no other ingredients in
Ceftriaxone.

5. How to store Ceftriaxone

The solution should be administered by deep intramuscular injection. Dosages greater than 1g should be divided and injected at more than one
site. Not more than 1 g of ceftriaxone should be injected on either side of the body (see section 4.2).
Solutions in Lidocaine should not be administered intravenously.
Solution for
Powder Concentration
Reconstitution
of Solution
Water for
250 mg 50 mg/ml
Injections
500 mg 100 mg/ml
1g
100 mg/ml

What Ceftriaxone contains

If you get any side effects, talk to your
doctor. This includes any possible side
effects not listed in this leaflet. You can
also report side effects directly via the
national reporting for
United Kingdom
Yellow Card Scheme
Website:
http://www.mhra.gov.uk/yellowcard
or
Ireland
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: http://www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
or
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website:
http://www.medicinesauthority.gov.mt
e-mail: postlicensing.
medicinesauthority@gov.mt.
By reporting side effects you can help
provide more information on the safety of
this medicine.

Intramuscular injection:
Solution for
Reconstitution
1.0%
Lidocaine
Hydrochloride
solution

6. Contents of the pack and other
information

The infusion should be administered over at least 30 minutes.
Add the recommended volume of reconstitution solution and shake well until the contents of the vial have dissolved completely. The solution
should be visually inspected prior to use. Only clear solutions practically free from particles should be used.
For single use only. Discard any unused solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

It is necessary to rinse the tubing between
each administration.

Incompatibilities
Solutions containing ceftriaxone should
not be mixed with or added to solutions
containing other agents. In particular, diluents
containing calcium, (e.g. Ringer’s solution,
Hartmann’s solution) should not be used to
reconstitute ceftriaxone vials or to further
dilute a reconstituted vial for IV administration
because a precipitate can form. Ceftriaxone
must not be mixed or administered
simultaneously with calcium-containing
solutions. Based on literature reports,
ceftriaxone is not compatible with amsacrine,
vancomycin, fluconazole, aminoglycosides
and labetalol.

Shelf life
Unopened: 2 years
Opened & After reconstitution: Chemical
and physical in-use stability has been
demonstrated for 6 hours at or below 25°C or
24 hours at 2°C to 8°C.
From a microbiological point of view, unless
the method of reconstitution precludes the
risk of microbial contamination, the product
should be used immediately. If not used
immediately, in-use storage times and
conditions prior to use are the responsibility
of the user and would normally not be longer
than the times stated above for the chemical
and physical in-use stability.
Unused solution should be discarded.

Special precautions for storage
This medicinal product does not require any
special temperature storage conditions.
Keep the vial in the outer carton in
order to protect from light.
Q73863
TN/DRUGS/763

#########

Component Specification

Requester

Item number:

Q73863

Request number:

AS2152

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Country:

United Kingdom

Inventory code(s):

1 pk, 5 pk,
10 pk, 25 pk

OI template:
Amalia version:
Mulgrave version:

OCI006
1
n/a

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

250 x 320 mm
10 and 20 ml vials
Hospira India
N/A
tbc mm
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

n/a
n/a
n/a

Colours
Black:

Previous Item Number:

N/A

Signed:
Date:
Version 1
Technician:
Date:

JL
15/Aug/12

Version 2
Technician:
Date:

SE
17/Aug/12

Version 15
Technician:
Date:

DM
28/Jan/14

Version 16
Technician:
Date:

NC
21/Feb/14

Version 3
Technician:
Date:

JL
07/Sep/12

Version 4
Technician:
Date:

SE
13/Sep/12

Version 17
Technician:
Date:

LB
03/Mar/14

Version 18
Technician:
Date:

KN
04/Mar/14

Version 5
Technician:
Date:

JL
20/Sep/12

Version 6
Technician:
Date:

BE
05/Jun/13

Version 19
Technician:
Date:

XX
dd/mmm/yy

Version 20
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

BE
12/Jun/13

Version 8
Technician:
Date:

BJ
19/Jun/13

Version 21
Technician:
Date:

XX
dd/mmm/yy

Version 22
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

BJ
20/Jun/13

Version 10
Technician:
Date:

BJ
21/Jun/13

Version 23
Technician:
Date:

XX
dd/mmm/yy

Version 24
Technician:
Date:

XX
dd/mmm/yy

Version 11
Technician:
Date:

BJ
28/Jun/13

Version 12
Technician:
Date:

DM
22/Jan/14

Version 25
Technician:
Date:

XX
dd/mmm/yy

Version 26
Technician:
Date:

XX
dd/mmm/yy

Version 13
Technician:
Date:

DM
23/Jan/14

Version 14
Technician:
Date:

DM
27/Jan/14

Version 27
Technician:
Date:

XX
dd/mmm/yy

Version 28
Technician:
Date:

XX
dd/mmm/yy

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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