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ROCEPHIN 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CEFTRIAXONE DISODIUM SALT / CEFTRIAXONE DISODIUM SALT

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Genisys-No.
Printing Colour:
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10179201
Pantone Black
148x840 mm
148x210 mm

Type Size
Drawing Norm
make-up code

Date

Version

19.06.17

4

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NP9345
GB

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11.08.10

Date

97.4.3525
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Package leaflet: Information for the Patient

Rocephin® 2 g

Powder for solution for injection or 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.

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.
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.

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

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).

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.
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.
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.

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.
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.

3. How Rocephin is given
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

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

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.

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.

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.

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.

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.

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.
●● 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.

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 need a blood or urine test

If you are given Rocephin for a long time, you
may need to have regular blood tests.

Please turn over

1



The following information is intended for healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Rocephin® 2 g Powder for solution for injection or 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

National or local guidance should be taken
into consideration.
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.

250 mg and 1g vial: Type 1 Ph. Eur 15 ml
glass vial with fluorobutyl rubber stopper and
aluminium cap, containing a sterile powder,
equivalent to 250 mg or 1g ceftriaxone.
2g vial: Type II Ph. Eur 50 ml glass bottle with
fluorobutyl rubber stopper and aluminium cap,
containing a sterile powder, equivalent to 2 g
ceftriaxone.

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.

Ceftriaxone
dosage*
50‑80 mg/kg

Treatment Indications
frequency**
Once daily Intra-abdominal
infections
Complicated
urinary tract
infections
(including
pyelonephritis)
Community
acquired
pneumonia
Hospital
acquired
pneumonia
50‑100 mg/kg Once daily Complicated
(Max 4 g)
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 Bacterial
(max 4 g)
meningitis
100 mg/kg
Once daily Bacterial
(max 4 g)
endocarditis

Supplied in packs of 1 vial or bottle.

Posology

The dose depends on the severity, susceptibility,
site and type of infection and on the age and
hepato-renal function of the patient.
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.
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)
2g
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

* 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.
10179201_NP9345.indd 1

Neonates 0‑14 days
Rocephin is contraindicated in
premature neonates up to a postmenstrual
age of 41 weeks (gestational age +
chronological age).
1

Please turn over
10179201 GB

19.06.2017 12:18:13

Genisys-No.
Printing Colour:
Format:
Folding Format:
Creator

10179201
Pantone Black
148x840 mm
148x210 mm
Date

Type Size
Drawing Norm
make-up code

Version

Degen

Signature

10 pt
NP9345
GB

Proofreader

11.08.10

Date

97.4.3525
Signature

4

If you are given more Rocephin than
you should

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 accidentally receive more than your
prescribed dose, contact your doctor or nearest
hospital straight away.

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.

Malta

ADR Reporting
Website:
http://www.medicinesauthority.gov.mt/adrportal

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.

United Kingdom

4. Possible side effects

5. How to store Rocephin

Like all medicines, this medicine can cause
side effects, although not everybody gets them.
The following side effects may happen with
this medicine:

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 on the vial or
bottle label after EXP. The expiry date refers
to the last day of that month.
Do not store above 30°C, keep vial or bottle in
the outer carton in order to protect from light.
Chemical and physical in-use stability of the
reconstituted product has been demonstrated
for at least 6 hours at or below 25°C or
24 hours at 2-8°C.
From a microbiological point of view, 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 not be longer than the
times stated above for the chemical and
physical in-use stability.Do not throw away
any medicines via wastewater. Ask your
pharmacist to throw away medicines you no
longer use. These measures will help protect
the environment.

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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.

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.
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.

6. Contents of the pack and other
information
What Rocephin contains

Rocephin 2 g powder for solution for injection
or infusion
The active substance is
ceftriaxone.
Each bottle contains 2 g
(grams) ceftriaxone as
ceftriaxone sodium.
Rocephin 1 g powder for
solution for injection
or infusion
The active substance is ceftriaxone.
Each vial contains 1 g (grams) ceftriaxone as
ceftriaxone sodium.
Rocephin 250 mg powder for solution
for injection
The active substance is ceftriaxone.
Each vial contains 250 mg (milligrams)
ceftriaxone as ceftriaxone sodium.Rocephin
should not be mixed in the same syringe with
any drug.
The infusion line should be flushed after each
administration.

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).

What Rocephin looks like and contents
of the pack

Rocephin 2 g powder for solution for injection
or infusion
Rocephin 1 g powder for solution for injection
or infusion
Rocephin consists of a powder for solution for
injection or infusion
Rocephin 250 mg powder for solution
for injection
Rocephin consists of a powder for solution
for injection.
The powder is white to yellowish-orange.
Rocephin is available in packs of 1 vial
or bottle.

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.

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.

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:
Rocephin 2 g Powder for Solution for
Injection or Infusion
Malta, United Kingdom: Rocephin
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 June 2017

2

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
* 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.

Indications for neonates 0‑14 days that require
specific dosage schedules:
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.
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.
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.
Older people
The dosages recommended for adults require
no modification in older people provided that
renal and hepatic function is satisfactory.
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.
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.
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.
As the solvent used is lidocaine,
the resulting solution should never
be administered intravenously. The information
in the Summary of Product Characteristics of
2
lidocaine should be considered.
10179201_NP9345.indd 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.
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.
For pre-operative prophylaxis of surgical site
infections, ceftriaxone should be administered
30‑90 minutes prior to surgery.

Instructions for use

The use of freshly prepared solutions is
recommended. These maintain potency for at
least 6 hours at or below 25°C or 24 hours at
2-8°C. Protect from light.
Rocephin should not be mixed in the same
syringe with any drug other than 1% Lidocaine
Hydrochloride solution (for intramuscular
injection only).
Intramuscular injection: 250 mg Rocephin is
dissolved in 2 ml of 1% Lidocaine
Hydrochloride solution, or 1 g in 3.5ml of 1%
Lidocaine Hydrochloride 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 is
dissolved in 2.5 ml of Water for Injections or
1 g in 10 ml of Water for Injections. The
injection should be administered over
5 minutes, directly into the vein or via the
tubing of an intravenous infusion.
Intravenous infusion: 2 g of Rocephin is
dissolved in 40 ml of one of the following
calcium-free solutions: sodium chloride 0.9%,
sodium chloride 0.45% + dextrose 2.5%,
dextrose 5%, dextrose 10%, dextran 6% in
dextrose 5%, hydroxyethly-starch 6 – 10%,
water for injections. The infusion should be
administered over at least 30 minutes.
Refer to ‘Posology’ and ‘Method of
administration’ for further information.

Incompatibilities

Based on literature reports, ceftriaxone is not
compatible with amsacrine, vancomycin,
fluconazole and aminoglycosides.
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 or
bottle for intravenous administration because a
precipitate can form. Ceftriaxone must not be
mixed or administered simultaneously with
calcium containing solutions including total
parenteral nutrition.

Shelf life

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

Special precautions for storage

Do not store above 30°C, keep vial or bottle in
the outer carton in order to protect from light.
This leaflet was last revised in June 2017
10179201 GB

19.06.2017 12:18:13

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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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