Ceftriaxone for Injection 1g, Ceftriaxone for Injection 500mg

1.Product name:Ceftriaxone for injection
2.Specification:1g
3.Package:1 vial+1 solvent/box
4.Shelf life:36 months
5.Registration dossiers are available.
If you are interested in our proudcts,ple feel free to contact us.

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.

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)

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

Ceftriaxone 2 g Powder for
Solution for Infusion (IV)

You must not be given Ceftriaxone if:

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 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.
Ceftriaxone 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.

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 Ceftriaxone.

Children
Talk to your doctor or pharmacist or
nurse before your child is administered
Ceftriaxone if:
？ He/She has recently been given or
is to be given a product that contains
calcium into their vein.

Other medicines and Ceftriaxone
Tell your doctor or pharmacist or nurse
if you are taking, have recently taken or
might take any other medicines.

？ 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 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.

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).

Ceftriaxone must not be given to
babies if:

The doctor will consider the benefit of
treating you with Ceftriaxone against the
risk to your baby.

？ 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 about
to be given a product that contains
calcium into their vein.

Warnings and precautions
Talk to your doctor or pharmacist or nurse
before you are given Ceftriaxone 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.

If you need a blood or urine test
If you are given Ceftriaxone for a long
time, you may need to have regular blood
tests. Ceftriaxone can affect the results

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)

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 advise before taking this medicine.

Driving and using machines
Ceftriaxone 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.

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 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.
Ceftriaxone 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 Ceftriaxone 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 Ceftriaxone depends on what sort
of infection you have.
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.
Newborn babies, infants and children
aged 15 days to 12 years with a body
weight of less than 50 kg:
？ 50-80 mg Ceftriaxone 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.
Newborn babies (0-14 days)
？ 20-50 mg Ceftriaxone 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 Ceftriaxone you will need and
will check you closely depending on the
severity of the liver and kidney disease.

If you are given more Ceftriaxone
than you should
If you accidently receive more than your
prescribed dose contact your doctor or
nearest hospital straight away.

If you forget to use Ceftriaxone
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 Ceftriaxone
Do not stop taking Ceftriaxone unless
your doctor tells you to. If you have
any further questions on the use of this
medicine, ask your doctor or nurse.

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.
Treatment frequency**

Indications

50-80 mg/kg

Ceftriaxone

Ceftriaxone Dosage*

Once daily

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

Please refer to the Summary of Product Characteristics for full prescribing information.

Community acquired pneumonia

Presentation
500 mg: 10 ml Type I clear glass vial closed with bromobutyl rubber stoppers and aluminium
caps.

Hospital acquired pneumonia
50-100 mg/kg (max 4 g)

Once daily

1 g: 20 ml Type I clear glass vial closed with bromobutyl rubber stoppers and aluminium caps.

Complicated skin and soft tissue
infections
Infections of bones and joints

2 g: 100 ml Type I clear glass vial closed with bromobutyl rubber stoppers and aluminium
caps.

Management of neutropenic patients
with fever that is suspected to be due
to a bacterial infection

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.

80-100 mg/kg (max 4 g)

Once daily

Bacterial meningitis

Supplied in packs of 1, 5, 10 or 25 vials per carton. Not all pack sizes may be marketed.

100 mg/kg (max 4 g)

Once daily

Bacterial endocarditis

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.

* 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:

Ceftriaxone Dosage*

Treatment frequency**

Indications

1-2 g

Once daily

Community acquired pneumonia

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

Acute exacerbations of chronic
obstructive pulmonary disease

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

Intra-abdominal infections

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.

Adults and children over 12 years of age (≥ 50 kg)

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

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.
Neonates 0-14 days
Ceftriaxone is contraindicated in premature neonates up to a postmenstrual age of 41 weeks
(gestational age + chronological age).
Ceftriaxone Dosage*

Treatment frequency**

Indications

20-50 mg/kg

Once daily

Intra-abdominal infections
Complicated skin and soft tissue
infections

* 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.

Complicated urinary tract infections
(including pyelonephritis)
Community acquired pneumonia

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

Hospital acquired pneumonia
Infections of bones and joints

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

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 ceftriaxone 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.

Q73863
TN/DRUGS/763

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.
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
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 Ceftriaxone 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.
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).
？ Ceftriaxone may interfere with some
types of blood glucose tests - please
check with your doctor.

5. How to store Ceftriaxone
？ 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.