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ROCEPHIN 250 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFTRIAXONE DISODIUM SALT

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Package leaflet: Information for the Patient

10163974 GB

Rocephin® 2 g

Powder for solution for injection/infusion
®

Rocephin 1 g

Powder for solution for injection or infusion
®

Rocephin 250 mg

Powder for solution for injection
Ceftriaxone (as Ceftriaxone Sodium)
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.

● You have other illnesses, such as
haemolytic anaemia (a reduction in your red
blood cells that may make your skin pale
yellow and cause weakness or
breathlessness).
● You are on a low sodium diet.
If you need a blood or urine test
If you are given Rocephin for a long time, you
may need to have regular blood tests.
Rocephin can affect the results of urine tests
for sugar and a blood test known as the
Coombs test. If you are having tests:
● Tell the person taking the sample that you
have been given Rocephin.

What is in this leaflet
1. What Rocephin is and what it is used for
2. What you need to know before you are
given Rocephin
3. How Rocephin is given
4. Possible side effects
5. How to store Rocephin
6. Contents of the pack and other information

If you are diabetic or need to have your blood
glucose level monitored you should not use
certain blood glucose monitoring systems
which may estimate blood glucose incorrectly
while you are receiving ceftriaxone. If you use
such systems check the instructions for use
and tell your doctor, pharmacist or nurse.
Alternative testing methods should be used if
necessary.
Children
Talk to your doctor or pharmacist or nurse
before your child is administered Rocephin if:
● He/She has recently been given or is to be
given a product that contains calcium into
their vein.

1. What Rocephin is and what it is
used for
Rocephin is an antibiotic given to adults and
children (including newborn babies). It works
by killing bacteria that cause infections. It
belongs to a group of medicines called
cephalosporins.

Other medicines and Rocephin
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
In particular, tell your doctor or pharmacist if
you are taking any of the following medicines:
● A type of antibiotic
called an
aminoglycoside.
● An antibiotic called
chloramphenicol (used
to treat infections,
particularly of the eyes).

Rocephin is used to treat infections of
● the brain (meningitis).
● the lungs.
● the middle ear.
● the abdomen and
abdominal wall
(peritonitis).
● the urinary tract and
kidneys.
● bones and joints.
● the skin or soft tissues.
● the blood.
● the heart.

Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.

It can be given:
● to treat specific sexually transmitted
infections (gonorrhoea and syphilis).
● to treat patients with low white blood cell
counts (neutropenia) who have fever due to
bacterial infection.
● to treat infections of the chest in adults with
chronic bronchitis.
● to treat Lyme disease (caused by tick bites)
in adults and children including newborn
babies from 15 days of age.
● to prevent infections during surgery.

The doctor will consider the benefit of treating
you with Rocephin against the risk to your
baby.
Driving and using machines
Rocephin can cause dizziness. If you feel dizzy,
do not drive or use any tools or machines.
Talk to your doctor if you experience these
symptoms.

2. What you need to know before
you are given Rocephin

3. How Rocephin is given

You must not be given Rocephin if:
● You are allergic to ceftriaxone or any of the
other ingredients of this medicine (listed in
section 6).
● You have had a sudden or severe allergic
reaction to penicillin or similar antibiotics
(such as cephalosporins, carbapenems or
monobactams). The signs include sudden
swelling of the throat or face which might
make it difficult to breath 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.

Rocephin is usually given by a doctor or nurse.
It can be given as
● a drip (intravenous infusion) or as an
injection directly into a vein or
● into a muscle.
Rocephin is made up by the doctor, pharmacist
or nurse and will not be mixed with or given to
you at the same time as calcium-containing
injections.
The usual dose
Your doctor will decide the correct dose of
Rocephin for you. The dose will depend on the
severity and type of infection; whether you are
on any other antibiotics; your weight and age;
how well your kidneys and liver are working.
The number of days or weeks that you are
given Rocephin depends on what sort of
infection you have.

Rocephin must not be given to babies if:
● The baby is premature.
● The baby is newborn (up to 28 days of age)
and has certain blood problems or jaundice
(yellowing of the skin or the whites of the
eyes) or is to be given a product that
contains calcium into their vein.

Adults, older people and children aged
12 years and over with a body weight
greater than or equal to 50 kilograms (kg):
● 1 to 2 g once a day depending on the
severity and type of infection. If you have a
severe infection, your doctor will give you a
higher dose (up to 4 g once a day). If your
daily dose is higher than 2 g, you may
receive it as a single dose once a day or as
two separate doses.

Warnings and precautions
Talk to your doctor or pharmacist or nurse
before you are given Rocephin if:
● You have recently received or are about to
receive products that contain calcium.
● You have recently had diarrhoea after
having an antibiotic medicine. You have
ever had problems with your gut,
in particular colitis (inflammation of the
bowel).
● You have liver or kidney problems.
● You have gall stones or kidney stones.
1

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The following information is intended for healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Rocephin® 2 g Powder for solution for injection/infusion
Rocephin® 1 g Powder for solution for injection or infusion
Rocephin® 250 mg Powder for solution for injection
Ceftriaxone (as Ceftriaxone Sodium)
Please refer to the Summary of Product Characteristics for full prescribing information.
Presentation
250 mg and 1g vial: Clear glass 15 ml vial
with rubber stopper and aluminium cap.

Disseminated Lyme borreliosis
(early [Stage II] and late [Stage III])
2 g once daily for 14‑21 days. The
recommended treatment durations vary and
national or local guidelines should be taken
into consideration.

2g vial: Clear glass 50 ml vial with rubber
stopper and aluminium cap.

Paediatric population
Neonates, infants and children 15 days to
12 years of age (< 50 kg)
For children with bodyweight of 50 kg or
more, the usual adult dosage should be given.

Vials contain a sterile, white to yellowishorange crystalline powder. There are no
excipients. Each gram of Rocephin contains
approximately 3.6 mmol sodium.
Supplied in packs of 1 vial.

Ceftriaxone Treatment Indications
dosage*
frequency**

Posology
The dose depends on the severity, susceptibility,
site and type of infection and on the age and
hepato-renal function of the patient.

50‑80 mg/kg Once daily

Intra-abdominal
infections
Complicated
urinary tract
infections
(including
pyelonephritis)

The doses recommended in the tables below
are the generally recommended doses in these
indications. In particularly severe cases, doses
at the higher end of the recommended range
should be considered.

Community
acquired
pneumonia

Adults and children over 12 years of age
(≥ 50 kg)
Ceftriaxone Treatment Indications
Dosage*
frequency**
1‑2 g
Once daily Community
acquired
pneumonia
Acute
exacerbations of
chronic
obstructive
pulmonary
disease
Intra-abdominal
infections
Complicated
urinary tract
infections
(including
pyelonephritis)
2 g
Once daily Hospital acquired
pneumonia
Complicated skin
and soft tissue
infections
Infections of
bones and joints
2‑4 g
Once daily Management of
neutropenic
patients with fever
that is suspected
to be due to a
bacterial infection
Bacterial
endocarditis
Bacterial
meningitis

Hospital
acquired
pneumonia
50‑100 mg/kg Once daily
(Max 4 g)

Complicated
skin and soft
tissue infections
Infections of
bones and joints
Management of
neutropenic
patients with
fever that is
suspected to be
due to a
bacterial
infection

80‑100 mg/kg Once daily
(max 4 g)

Bacterial
meningitis

100 mg/kg
(max 4 g)

Bacterial
endocarditis

Once daily

* In documented bacteraemia, the higher end
of the recommended dose range should be
considered.
** Twice daily (12 hourly) administration may
be considered where doses greater than 2 g
daily are administered.
Indications for neonates, infants and children
15 days to 12 years (< 50 kg) that require
specific dosage schedules:

* In documented bacteraemia, the higher end
of the recommended dose range should be
considered.
** Twice daily (12 hourly) administration may
be considered where doses greater than 2 g
daily are administered.

Acute otitis media
For initial treatment of acute otitis media,
a single intramuscular dose of Rocephin
50 mg/kg can be given. Limited data suggest
that in cases where the child is severely ill or
initial therapy has failed, Rocephin may be
effective when given as an intramuscular dose
of 50 mg/kg daily for 3 days.

Indications for adults and children over
12 years of age (≥ 50 kg) that require specific
dosage schedules:

Pre-operative prophylaxis of surgical site
infections
50‑80 mg/kg as a single pre-operative dose.

Acute otitis media
A single intramuscular dose of Rocephin 1‑2 g
can be given.
Limited data suggest that in cases where the
patient is severely ill or previous therapy has
failed, Rocephin may be effective when given
as an intramuscular dose of 1‑2 g daily for
3 days.

Syphilis
The generally recommended doses are
75‑100 mg/kg (max 4 g) once daily for
10‑14 days. The dose recommendations in
syphilis, including neurosyphilis, are based on
very limited data. National or local guidance
should be taken into consideration.
Disseminated Lyme borreliosis
(early [Stage II] and late [Stage III])
50–80 mg/kg once daily for 14‑21 days.
The recommended treatment durations vary
and national or local guidelines should be
taken into consideration.

Pre-operative prophylaxis of surgical site
infections
2 g as a single pre-operative dose.
Gonorrhoea
500 mg as a single intramuscular dose.
Syphilis
The generally recommended doses are
500 mg‑1 g once daily increased to 2 g once
daily for neurosyphilis for 10‑14 days. The
dose recommendations in syphilis, including
neurosyphilis, are based on limited data.
National or local guidance should be taken
into consideration.
10163974.indd 1

Neonates 0‑14 days
Rocephin is contraindicated in premature
neonates up to a postmenstrual age of 41 weeks
(gestational age + chronological age).
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Newborn babies, infants and children aged
15 days to 12 years with a body weight of
less than 50 kg:
● 50‑80 mg Rocephin for each kg of the
child’s body weight once a day depending
on the severity and type of infection. If you
have a severe infection, your doctor will
give you a higher dose up to 100 mg for
each kg of body weight to a maximum of
4 g once a day. If your daily dose is higher
than 2 g, you may receive it as a single dose
once a day or as two separate doses.
● Children with a body weight of 50 kg or
more should be given the usual adult dose.

Not known (Frequency cannot be estimated
from the available data)
● A secondary infection that may not respond
to the antibiotic previously prescribed
● Form of anaemia where red blood cells are
destroyed (haemolytic anaemia).
● Severe decrease in white blood cells
(agranulocytosis).
● Convulsions.
● Vertigo (spinning sensation).
● Inflammation of the pancreas (pancreatitis).
The signs include severe pain in the
stomach which spreads to your back.
● Inflammation of the mucus lining of the
mouth (stomatitis).
● Inflammation of the tongue (glossitis). The
signs include swelling, redness and soreness
of the tongue.
● Problems with your gallbladder, which may
cause pain, feeling sick and being sick.
● A neurological condition that may occur in
neonates with severe jaundice (kernicterus).
● Kidney problems caused by deposits of
calcium ceftriaxone. There may be pain when
passing water (urine) or low output of urine.
● A false positive result in a Coombs’ test
(a test for some blood problems).
● A false positive result for galactosaemia
(an abnormal build up of the sugar galactose).
● Rocephin may interfere with some types of
blood glucose tests - please check with your
doctor.

Newborn babies (0‑14 days)
● 20 – 50 mg Rocephin for each kg of the
child’s body weight once a day depending
on the severity and type of infection.
● The maximum daily dose is not to be more
than 50 mg for each kg of the baby’s weight.
People with liver and kidney problems
You may be given a different dose to the usual
dose. Your doctor will decide how much
Rocephin you will need and will check you
closely depending on the severity of the liver
and kidney disease.
If you are given more Rocephin than you
should
If you accidentally receive more than your
prescribed dose, contact your doctor or nearest
hospital straight away.

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
(see details below). By reporting side effects,
you can help provide more information on the
safety of this medicine.

If you forget to use Rocephin
If you miss an injection, you should have it as
soon as possible. However, if it is almost time
for your next injection, skip the missed
injection. Do not take a double dose
(two injections at the same time) to make up
for a missed dose.
If you stop using Rocephin
Do not stop taking Rocephin unless your doctor
tells you to. If you have any further questions
on the use of this medicine, ask your doctor or
nurse.

Malta
ADR Reporting
Website:
http://www.medicinesauthority.gov.mt/adrportal
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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
(not known, frequency
cannot be estimated from
the available data)
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.

5. How to store Rocephin
● 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.

6. Contents of the pack and other
information

Severe skin rashes (not known, frequency
cannot be estimated from the available data)
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.

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.
There are no other ingredients in Rocephin.

Other possible side effects:
Common (may affect up to 1 in 10 people)
● Abnormalities with your white blood cells
(such as a decrease of leucocytes and an
increase of eosinophils) and platelets
(decrease of thrombocytes).
● Loose stools or diarrhoea.
● Changes in the results of blood tests for liver
functions.
● Rash.

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.

Uncommon (may affect up to 1 in 100 people)
● Fungal infections (for example, thrush).
● A decrease in the number of white blood
cells (granulocytopenia).
● Reduction in number of red blood cells
(anaemia).
● Problems with the way your blood clots.
The signs may include bruising easily and
pain and swelling of your joints.
● Headache.
● Dizziness.
● Feeling sick or being sick.
● Pruritis (itching).
● Pain or a burning feeling along the vein
where Rocephin has been given. Pain where
the injection was given.
● A high temperature (fever).
● Abnormal kidney function test
(blood creatinine increased).
Rare (may affect up to 1 in 1,000 people)
● Inflammation of the large bowel (colon).
The signs include diarrhoea, usually with
blood and mucus, stomach pain and fever.
● Difficulty in breathing (bronchospasm).
● A lumpy rash (hives) that may cover a lot of
your body, feeling itchy and swelling.
● Blood or sugar in your urine.
● Oedema (fluid build-up).
● Shivering.

Marketing Authorisation Holder and
Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
2 g Powder for Solution for Injection/Infusion
Malta, United Kingdom: Rocephin
1 g Powder for Solution for Injection or Infusion
Ireland, Latvia, Malta, United Kingdom:
Rocephin
Rocephin 250 mg Powder for Solution for
Injection
Malta, United Kingdom: Rocephin
This leaflet was last revised in
February 2015
2


Intravenous administration
Rocephin can be administered by intravenous
infusion over at least 30 minutes (preferred
route) or by slow intravenous injection over
5 minutes. Intravenous intermittent injection
should be given over 5 minutes preferably in
larger veins. Intravenous doses of 50 mg/kg or
more in infants and children up to 12 years of
age should be given by infusion. In neonates,
intravenous doses should be given over
60 minutes to reduce the potential risk of
bilirubin encephalopathy. Intramuscular
administration should be considered when the
intravenous route is not possible or less
appropriate for the patient. For doses greater than
2 g intravenous administration should be used.
Ceftriaxone is contraindicated in neonates
(≤ 28 days) if they require (or are expected to
require) treatment with calcium-containing
intravenous solutions, including continuous
calcium-containing infusions such as parenteral
nutrition, because of the risk of precipitation
of ceftriaxone-calcium.

Ceftriaxone Treatment Indications
dosage*
frequency
20‑50 mg/kg Once daily Intra-abdominal
infections
Complicated skin
and soft tissue
infections
Complicated
urinary tract
infections
(including
pyelonephritis)
Community
acquired
pneumonia
Hospital acquired
pneumonia
Infections of bones
and joints
Management of
neutropenic
patients with fever
that is suspected to
be due to a
bacterial infection
50 mg/kg
Once daily Bacterial
meningitis
Bacterial
endocarditis

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 intravenous
administration because a precipitate can form.
Precipitation of ceftriaxone-calcium can also
occur when ceftriaxone is mixed with calciumcontaining solutions in the same intravenous
administration line. Therefore, ceftriaxone and
calcium-containing solutions must not be
mixed or administered simultaneously.

* In documented bacteraemia, the higher end
of the recommended dose range should be
considered.
A maximum daily dose of 50 mg/kg should
not be exceeded.

For pre-operative prophylaxis of surgical site
infections, ceftriaxone should be administered
30‑90 minutes prior to surgery.

Indications for neonates 0‑14 days that require
specific dosage schedules:

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.

Acute otitis media
For initial treatment of acute otitis media,
a single intramuscular dose of Rocephin
50 mg/kg can be given.
Pre-operative prophylaxis of surgical site
infections
20‑50 mg/kg as a single pre-operative dose.

Rocephin should not be mixed in the same
syringe with any drug other than 1.06%
Lidocaine Hydrochloride BP solution (for
intramuscular injection only).

Syphilis
The generally recommended dose is 50 mg/kg
once daily for 10‑14 days. The dose
recommendations in syphilis, including
neurosyphilis, are based on very limited data.
National or local guidance should be taken
into consideration.

Intramuscular injection: 250 mg Rocephin
should be dissolved in 1 ml of 1.06%
Lidocaine Hydrochloride BP solution, or 1 g in
3.5ml 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.

Duration of therapy
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
48 - 72 hours after the patient has become
afebrile or evidence of bacterial eradication
has been achieved.

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
5 minutes, directly into the vein or via the
tubing of an intravenous infusion.

Older people
The dosages recommended for adults require
no modification in older people provided that
renal and hepatic function is satisfactory.

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.

Patients with hepatic impairment
Available data do not indicate the need for
dose adjustment in mild or moderate liver
function impairment provided renal function is
not impaired.
There are no study data in patients with severe
hepatic impairment.

Refer to ‘Posology’ and ‘Method of
administration’ for further information.

Patients with renal impairment
In patients with impaired renal function, there
is no need to reduce the dosage of ceftriaxone
provided hepatic function is not impaired.
Only in cases of preterminal renal failure
(creatinine clearance < 10 ml/min) should the
ceftriaxone dosage not exceed 2 g daily.
In patients undergoing dialysis no additional
supplementary dosing is required following
the dialysis. Ceftriaxone is not removed by
peritoneal- or haemodialysis. Close clinical
monitoring for safety and efficacy is advised.

The displacement value of 250 mg of Rocephin
is 0.194 ml.
Incompatibilities
Based on literature reports, ceftriaxone is not
compatible with amsacrine, vancomycin,
fluconazole, aminoglycosides and labetalol.
Solutions containing ceftriaxone should not be
mixed with or added to other agents except
those mentioned in ‘Instructions for use’. 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
intravenous administration because a
precipitate can form. Ceftriaxone must not be
mixed or administered simultaneously with
calcium containing solutions including total
parenteral nutrition.

Patients with severe hepatic and renal
impairment
In patients with both severe renal and hepatic
dysfunction, close clinical monitoring for
safety and efficacy is advised.
Method of administration
Intramuscular administration
Rocephin can be administered by deep
intramuscular injection. Intramuscular
injections should be injected well within the
bulk of a relatively large muscle and not more
than 1 g should be injected at one site.

Shelf life
3 years.
For shelf life of diluted product see
‘Instructions for use’.

As the solvent used is lidocaine, the resulting
solution should never be administered
intravenously. The information in the
Summary of Product Characteristics of
lidocaine should be considered.

This leaflet was last revised in June 2014

10163974.indd 2

Special precautions for storage
Do not store above 25°C.

2

10163974 GB

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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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