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10115955 GB 0912.10 78

Package Leaflet – Information for the Patient

Rocephin
Rocephin
Rocephin

®

250 mg vials
1 g vials
®
2 g vials
Powder for solution for injection or infusion

r

®

Ceftriaxone (as hydrated disodium ceftriaxone)

Take special care with Rocephin
Check with your doctor or nurse before
having Rocephin 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 Rocephin.

Please read all of this leaflet
carefully before you start having
this medicine.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions,
ask your doctor or nurse.
• If any of the side effects become serious
or troublesome, or if you notice any
side effects not listed in this leaflet,
please tell your doctor or nurse.
In this leaflet:
1. What Rocephin is and what it is used
for
2. Before you are given Rocephin
3. How Rocephin will be given
4. Possible side effects
5. How Rocephin is stored
6. Further information

1. What Rocephin is and what
it is used for

Taking other medicines
Please tell your doctor or nurse if you are
taking or have recently taken any other
medicines. This includes medicines
that you buy without a prescription
and herbal medicines. This is because
Rocephin can affect the way some
medicines work. Also some medicines
can affect the way Rocephin works.

Rocephin contains a medicine called
ceftriaxone. This belongs to a group of
medicines called antibiotics.
• Rocephin is used to treat infections
caused by bacteria.
• It can be used to treat
infections in different
parts of the body
including the lungs
(pneumonia), blood
(septicaemia), skin,
other soft body parts
(tissues), bone,
and for infections
such as meningitis
and gonorrhoea
(a sexually
transmitted
infection).
• It can be used to treat 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.

In particular, tell your
doctor or nurse
if you are taking any of
the following medicines:
• Oral contraceptives
(the pill). Rocephin can stop the pill
from working, so you should use extra
barrier contraception methods (such as
condoms) while you are taking Rocephin
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).

It works by stopping the bacteria
from growing properly. This causes
the bacteria to die.

Pregnancy and breast-feeding
Talk to your doctor before taking this
medicine if you are pregnant, might
become pregnant, or are breast-feeding.

2. Before you are given Rocephin

Driving and using machines
Rocephin can cause dizziness. Talk to
your doctor if this happens to you and do
not drive or use any tools or machines.

You must not be given Rocephin if:
• You are allergic (hypersensitive)
to ceftriaxone (the only ingredient
in Rocephin).
• You are allergic to antibiotics called
‘cephalosporins’. These include
cefalexin, cefaclor and cefuroxime.
• You have had a sudden or severe
allergic reaction to 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 Rocephin as an
injection into a muscle.
You must not be given Rocephin if any
of the above apply to you. If you are
not sure, talk to your doctor or nurse
before having Rocephin.

3. How Rocephin will be given
Rocephin will be given to you by a doctor
or nurse. It will be given to you in one
of the following ways:
• 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 Rocephin for depends on
what sort of infection you have. You will
usually continue to be given Rocephin
for 2 to 3 days after you have started to
recover from your illness.

Rocephin must not be given
to babies if:
• 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.

Adults, the elderly and children
aged 12 years and over
• 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 250 mg (milligrams), given as
an injection into a muscle.
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This information is intended for medical or healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Rocephin® 250 mg vials
Rocephin® 1 g vials
Rocephin® 2 g vials
Ceftriaxone (as hydrated disodium ceftriaxone)
Powder for solution for injection or infusion
Please refer to the Summary of Product Characteristics for full prescribing
information.
Presentation
250 mg and 1 g vial: Clear glass 15 ml
vial with rubber stopper and aluminium
cap.

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.

2 g vial: Clear glass 50 ml vial with
rubber stopper and aluminium cap.
Vials contain a sterile, white to
yellowish-orange crystalline powder.
There are no excipients. Each gram
of Rocephin contains approximately
3.6 mmol sodium.

Elderly
These dosages do not require modification
in elderly patients provided that renal
and hepatic function are satisfactory
(‘Renal and hepatic impairment’ below).

Supplied in packs of 1 vial.
Posology and method
of administration
Rocephin may be administered by deep
intramuscular injection, slow intravenous
injection, or as a slow intravenous
infusion, after reconstitution of the
solution according to the Instructions
for use section.
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.

Neonates
Recommended for once daily
administration of 20–50 mg/kg body
weight, not to exceed 50 mg/kg.
In the neonate, 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 of the Summary of Product
Characteristics).
Infants and children of up to 12 years
The following dosage schedules are
recommended for once daily
administration:
Standard therapeutic dosage:
20–50 mg/kg body weight.
In severe infections up to 80 mg/kg body
weight 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.

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 Rocephin 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.

Renal and hepatic impairment
In patients with impaired renal function,
there is no need to reduce the dosage
of Rocephin provided liver function is
intact. 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.

Acute, uncomplicated gonorrhoea:
A single dose of 250 mg intramuscularly
should be administered. Simultaneous
administration of probenecid is not
indicated.

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 Rocephin should be
determined at regular intervals
and dosage adjusted.
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Very rare
(affect less than 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.
• Inflammation of the large bowel (colon).
The signs include diarrhoea, usually
with blood and mucus, stomach pain
and fever.

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 any of the side effects become serious
or troublesome, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or nurse.

If you are given too much Rocephin
• If you think you have been given
too much Rocephin, tell your doctor
or nurse.

5. How Rocephin is stored
• Your doctor or pharmacist is
responsible for storing Rocephin.
They are also responsible for disposing
of any unused Rocephin correctly.
• Keep out of the reach and sight
of children.
• Do not store Rocephin above 25 °C.
• Do not use Rocephin after the expiry
date printed on the pack.

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

4. Possible side effects
Like all medicines, Rocephin can cause
side effects, although not everyone
will get them. The following side effects
may happen with this medicine.

6. Further information
What Rocephin contains
The active substance in Rocephin
powder for solution for injection
or infusion is ceftriaxone. Rocephin is
supplied in glass vials containing either
250 mg (milligrams), 1 g (gram) or 2 g
of ceftriaxone.

Severe allergic reactions
(uncommon, affect less than 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.

There are no other
ingredients in Rocephin.
What Rocephin looks like
and contents of the pack
• Rocephin is a powder. It is white
to yellowish-orange in colour.
It is supplied in a glass vial.
• Before it is given to the patient,
Rocephin 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.
• Rocephin is supplied in packs of 1 vial.

Severe skin rashes
(very rare, affect less than 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.
Other possible side effects:
Common (affect less than 1 in
10 people)
• Loose stools or diarrhoea.
• Feeling sick or being sick.

Marketing Authorisation Holder
and Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom.

Uncommon
(affect less than 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.

This leaflet was last approved
in July 2010

Rare (affect less than 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 Rocephin has been given.
• Pain where the injection was given.
• A high temperature (fever)
or shivering.

Rocephin is a registered trademark.

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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.

Special precautions for storage
Do not store above 25 °C.
This leaflet was last approved
in October 2009

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.
Rocephin should not be mixed in the
same syringe with any drug other than
1.06% Lidocaine Hydrochloride BP
solution (for intramuscular injection
only).
Intramuscular injection: 250 mg
Rocephin should be dissolved in 1 ml
of 1.06% Lidocaine Hydrochloride
BP solution, or 1 g in 3.5 ml of 1.06%
Lidocaine Hydrochloride BP solution.
The solution should be administered by
deep intramuscular injection. Dosages
greater than 1 g should be divided and
injected at more than one site.
Solutions in Lidocaine should not be
administered intravenously.
Intravenous injection: 250 mg Rocephin
should be dissolved in 5 ml of Water
for Injections BP or 1 g in 10 ml of Water
for Injections BP. The injection should be
administered over at least 2–4 minutes,
directly into the vein or via the tubing
of an intravenous infusion.
Intravenous infusion: 2 g of Rocephin
should be dissolved in 40 ml of one of the
following calcium-free solutions: Dextrose
Injection BP 5% or 10%, Sodium Chloride
Injection BP, Sodium Chloride and
Dextrose Injection BP (0.45% Sodium
Chloride and 2.5% Dextrose), Dextran 6%
in Dextrose Injection BP 5%,
Hydroxyethyl Starch 6–10% infusions.
The infusion should be administered over
at least 30 minutes.
The displacement value of 250 mg
of Rocephin is 0.194 ml.
Incompatibilities
Solutions containing Rocephin should not
be mixed with or added to 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
3 years.
For shelf life of diluted product see
Instructions for use.

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10115955 GB 0912.10 78

Expand Transcript

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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