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CEFTRIAXONE 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CEFTRIAXONE SODIUM

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170 mm
8
16.01.2015

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Código
Factory Code

XXXXXX/XXXX

(ceftriaxone sodium)

Sustituye a
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Producto / Product Name

Diseño realizado a escala: 100%
Image prints @ 100%

170 x 520 mm
Plegado / Folded

170 x 40 mm
N.º de Colores / No Colours

What is in this leaflet:
1. What Ceftriaxone Injection is and what it is used for
2. What you need to know before you are given
Ceftriaxone Injection
3. How Ceftriaxone Injection will be given
4. Possible side effects
5. How to store Ceftriaxone Injection
6. Contents of the pack and other information
The name of your medicine is “Ceftriaxone 1 g Powder
for Solution for Injection or Infusion” or “Ceftriaxone 2 g
Powder for Solution for Injection or Infusion” referred to as
Ceftriaxone Injection throughout this leaflet.

1/1
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Offset blanco / Offset white 40 g/m2
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1. WHAT CEFTRIAXONE INJECTION IS AND WHAT IT
IS USED FOR
Your medicine contains the active substance ceftriaxone,
which is an antibiotic. It belongs to a group of antibiotics
that are called cephalosporins. These types of antibiotic
are similar to penicillin.
Ceftriaxone kills bacteria and it can be used against
various sorts of infections.
Like all antibiotics, ceftriaxone is only effective against
some types of bacteria. Thus it is only suitable for treating
some types of infection.
Ceftriaxone can be used to treat:
• infection of the meninges (meningitis)
• serious bacterial infection of the blood (septicaemia)
• bone or joint infections
• infections of the respiratory tract (pneumonia)
• infections in the skin and soft tissues
• infections in patients having low numbers of white
blood cells
• bacterial infection of the genitals (gonorrhoea).
Ceftriaxone can also be used to help prevent infections
before, during and after surgery in patients at risk of
severe infections.
You must talk to a doctor if you do not feel better or if you
feel worse.

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Technical Leaflet Page 2:
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520 mm

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN CEFTRIAXONE INJECTION
You must not be given Ceftriaxone Injection if:
• you are allergic to ceftriaxone
• you are allergic to any other cephalosporin type
antibiotic
• you have ever had a severe or sudden allergic reaction
to any penicillin or to another beta-lactam antibiotic
because you might also be allergic to this medicine.
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.
Ceftriaxone Injection 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
whites of the eyes) or is about to be given another
injection that contains calcium.
Ceftriaxone Injection should not be given by injection into
a muscle:
• to infants under 2 years of age
• during pregnancy or breast-feeding.
If you feel uncertain, ask your doctor or nurse.
Warnings and precautions
Talk to your doctor or nurse before you are given
Ceftriaxone Injection if:
• you have ever had an allergic reaction to penicillin or a
similar antibiotic
• you have ever had an allergic reaction to anything else
or have ever had asthma, since these increase the
chance of you being allergic to ceftriaxone
• you have recently received or are about to receive
calcium
• you have ever been told that your kidneys and/or liver
do not work very well
• you have ever had bowel problems, particularly colitis
(inflammation of the bowels)

• you have other illnesses, such as blood problems
• you are on a low sodium diet.
Tell your doctor if you develop any of the following during
or after treatment with ceftriaxone:
• diarrhoea, particularly if it is severe or has blood in it
• tiredness, pale or yellowish coloured skin, shortness
of breath, dizziness, headache, cold hands and feet,
chest pain
• pain in the centre of your abdomen and possibly
spreading to your back, feeling sick or being sick
Your doctor may wish to discontinue this medicine and
give appropriate treatment.
If you develop new symptoms during the course of an
existing infection, inform your doctor as these may be due
to a second infection.
Deposits of ceftriaxone salt in the kidneys and gallbladder
have been reported (see Section 4: Possible side
effects). Small infants and children are more likely to
have this condition; however it should disappear after
completion or discontinuation of therapy.
This medicine can affect the results of some blood tests
(such as the Coombs’ test). It is important to tell the
doctor that you are using this medicine if you are to have
any blood tests.
This medicine can also affect the results of some types of
urine tests for sugar. If you have diabetes and routinely
test your urine, tell your doctor. This is because a different
type of urine test may have to be used to monitor your
diabetes while you are having this medicine.
Children
Ceftriaxone Injection should not be given to newborn
babies (especially if premature) who are at risk of
developing bilirubin encephalopathy (a disease of the
brain associated with high levels of bilirubin in blood).
As higher doses of ceftriaxone may cause problems in the
gall bladder, the doctor will avoid doses more than
80 mg/kg body weight.
Other medicines and ceftriaxone
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This medicine can be affected by other medicines that are
removed by the kidneys. This is especially if these other
medicines also affect how well the kidneys work. There
are many medicines that can do this, so you should check
with your doctor or nurse before using this medicine.
In particular, tell your doctor or nurse if you are taking:
• oral contraceptive (the pill). Ceftriaxone can stop the pill
from working. Use extra non-hormonal contraceptive
measures, such as condoms, while you are using
ceftriaxone and for one month afterwards.
• chloramphenicol (used to treat infections)
• anticoagulants (medicines 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).
This medicine should not be administered simultaneously
with intravenous (into a vein) calcium.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby you must tell
your doctor before you are given ceftriaxone.
• Although there is limited data available on use of this
medicine in pregnant women, it should only be given to
a pregnant woman if it is really necessary.
• This medicine should be given with caution to women
who are breast-feeding. This is because small amounts
of it enter the milk and thus the breast-fed infant.
• In pregnancy and breast-feeding this medicine should
not be given intramuscularly (into the muscle) with
lidocaine.
Driving and using machines
You may get dizzy when using this medicine. Talk to your
doctor if this happens to you and do not drive or use any
tools or machines.
Ceftriaxone Injection contains sodium.
Each gram ceftriaxone contains 3.6 mmol (83 mg)
sodium. To be taken into consideration by patients on a
controlled sodium diet.
3. HOW CEFTRIAXONE INJECTION WILL BE GIVEN
Ceftriaxone will be given to you by a doctor or nurse in
one of the following ways:
• as a slow injection into a vein
• as an injection into a large muscle (such as the muscle
in your arm)
• as an infusion through a small tube into one of your
veins

The following information is intended for healthcare professionals only
Ceftriaxone 1 g Powder for Solution for Injection or
Infusion
Ceftriaxone 2 g Powder for Solution for Injection or
Infusion
(Ceftriaxone sodium)
Please refer to the Summary of Product Characteristics
for full prescribing information.
Presentation
Ceftriaxone 1 g Powder for Solution for Injection or
Infusion is supplied in a 10ml Type II clear & colourless
glass vial with a bromobutyl stopper and aluminium and
polypropylene cap.
Ceftriaxone 2 g Powder for Solution for Injection or
Infusion is supplied in a 50ml Type II clear & colourless
glass vial with a bromobutyl stopper and aluminium and
polypropylene cap.
The vials contain a sterile white to yellowish crystalline
powder. There are no excipients.
Each gram contains 3.6 mmol sodium.
The 1 g vials are packed in boxes of 1 or 5 vials.
Not all pack sizes may be marketed.
The 2 g vials are packed in boxes of 1 vial.
Posology and method of administration
Ceftriaxone may be administered by slow intravenous
injection, by slow intravenous infusion or by deep
intramuscular injection after reconstitution of the solution
according to the directions given below.
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 calcium-containing
solutions in the same intravenous administration line.
Therefore, ceftriaxone and calcium-containing solutions
must not be mixed or administered simultaneously.
The intramuscular method of administration should only
be used in exceptional clinical situations and should
undergo a risk-benefit assessment.
Adults and children 12 years and over with a body
weight ≥ 50 kg
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.
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 bodyweight intravenously,
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 with a body
weight < 50 kg
Standard therapeutic dosage: 20-50 mg/kg bodyweight
once daily
In severe infections up to 80 mg/kg bodyweight 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
for the dosage to be reduced provided liver function
is intact. Only in cases of pre-terminal renal failure
(creatinine clearance < 10 ml/min) should the daily dose
of ceftriaxone 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.

40 mm

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 or
your nurse.
• If you get any side effects talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.

PROSP. TEST CEFTRIAXONA 1G y 2G
Tamaño / Size

40 mm

Ceftriaxone 1 g Powder for Solution for Injection or Infusion
Ceftriaxone 2 g Powder for Solution for Injection or Infusion

REIG JOFRE

Tamaño final plegado / Final size folded

Prueba N.º
Version No.
Fecha
Date

170 mm
Prueba N.º
Version No.
Fecha
Date

8
16.01.2015

The dose and how your doctor gives it to you depend on
the type of infection and how bad the infection is. It also
depends on your age, weight and how well your kidneys
are working. Your doctor will explain this to you.
The length of treatment will depend on the type of
infection and the course of the disease. In general
treatment should be continued for at least 2-3 days after
you have started to recover.
The recommended doses are:

REIG JOFRE
Código
Factory Code

XXXXXX/XXXX

Sustituye a
--Replace to
Producto / Product Name

Adults, the elderly and children aged 12 years and
over who weigh 50 kg or more
• The usual dose is 1 g once a day. In serious infections,
this can be increased to 2-4 g a day, normally as a
single dose every 24 hours. Your doctor will decide the
duration of therapy which depends on the course of the
infection.
• The usual dose for gonorrhoea is a single dose of
250 mg as an injection into a muscle.
• To prevent infections during surgery, the doctor may
give you between 1 g and 2 g as one or two injections
or as an infusion before your operation.

PROSP. TEST CEFTRIAXONA 1G y 2G
Tamaño / Size

Diseño realizado a escala: 100%
Image prints @ 100%

170 x 520 mm
Plegado / Folded

170 x 40 mm
N.º de Colores / No Colours

1/1
Colores / Colours

Children up to 12 years
• The doctor will work out the dose based on the child’s
body weight. It will usually be given to the child once a
day.
• Up to 80 mg per kg may be given in severe infections.
• Children weighing 50 kg or more can receive the usual
adult dosage.
• Doses of 50 mg per kg or over needs slow intravenous
infusion over at least 30 minutes.

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Newborn babies
• The doctor will work out the dose based on the baby’s
body weight. It will usually be given to the baby once a
day, by intravenous infusion over 1 hour.
• More than 50 mg per day must not be given, even in
severe infections.

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Technical Leaflet Page 2:
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Correcciones
Not Approved

People with liver or kidney problems
• For people with kidney problems the dose does
not need to be reduced if liver function is normal. If
the condition of the kidney is very poor (creatinine
clearance of < 10 ml/min) the daily dose of ceftriaxone
should not exceed 2 g in adult patients.
• People with liver problems do not need the dose
reducing unless they have kidney problems as well.
• In severe kidney impairment accompanied by liver
problems the blood ceftriaxone concentrations should
be monitored regularly and the dosage adjusted.
• If you are on dialysis, the doctor will do tests to make
sure you are on the right dose.
If the patient is a child under 2 years old or a pregnant or
breast-feeding woman, ceftriaxone should only be given
by slow injection into a vein.

Aprobado
Approved

Por favor, marque lo que corresponda
Please check the appropiate box

Fecha y Firma / Date and Signed

If you are given too much ceftriaxone
This medicine is usually given to you by a doctor or nurse.
If you think you may have received too much medicine
please tell your doctor or nurse at once.

Anverso / Front
Reverso / Back

If you think you have missed an injection please tell
your doctor or nurse.
If you stop using Ceftriaxone
It is important to finish the course of treatment your doctor
has prescribed, even if you start to feel better. If you do
not finish the course of treatment, your infection may get
worse again.
If you do not feel well at the end of the prescribed
treatment course or feel worse during treatment, you
should talk to your doctor.
If you have any further questions on the use of this
medicine ask your doctor, pharmacist or nurse.

520 mm

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects
although not everybody gets them.
If any of the following serious side effects happen, stop
taking this medicine and tell your doctor immediately
or go to your nearest hospital accident and emergency
department:
• a severe allergic reaction; signs may include sudden
wheeziness, difficulty swallowing and tightness of the
chest, sudden swelling of the eyelids, face, lips, throat
or mouth, sudden swelling of the hands, feet or ankles
• a severe skin rash that develops quickly with blisters or
peeling of the skin and may involve the eyes, mouth,
throat and genitals
• diarrhoea that is severe, or has blood in it, with
stomach pain or fever. This can be a sign of a serious
bowel inflammation (called “pseudomembranous
colitis”) that can happen after using antibiotics.
Other possible side effects:
If any of the following happen, inform your doctor:
Very common: may affect more than 1 in 10 people
• in children: gallbladder problems which may cause
pain, feeling sick and being sick

• loose stools or diarrhoea
• liver problems, shown by changes in blood tests that
check how your liver is working
• allergic reactions; these include skin rash, itching,
hives, nettle rash, swellings of the skin and joints
• pain and hardness when injected into a muscle
• pain or a burning feeling when injected into a vein.
Uncommon: may affect up to 1 in 100 people
• kidney problems including passing less urine than is
normal
• other types of infection, such as those caused by fungi
and yeasts, e.g. thrush
• headache, dizziness, vertigo (a feeling that you or your
surroundings are moving)
• a sore mouth, inflammation of the tongue
• loss of appetite, pain in the abdomen
Rare: may affect up to 1 in 1,000 people
• in adults: problems with your gallbladder which may
cause pain, feeling sick and being sick
• blood problems; signs include feeling tired, being short
of breath, bleeding, bruising easily
• inflammation of the pancreas; signs include severe
pain in the stomach (caused by inflammation of the
pancreas)
• kidney stones
• blood or sugar in your urine
• high temperature (fever) or shivering.
Very rare: may affect up to 1 in 10,000 people
• inflammation of the large bowel; signs include
diarrhoea, pain in the abdomen and fever
• problems with the way your blood clots; signs include
bruising easily and pain and swelling of your joints
• changes in the number of white blood cells in your
blood; signs include fever, severe chills, sore throat or
mouth ulcers
• positive results in a type of blood test called a Coombs’
test.
Additional side effects in children
• deposits of ceftriaxone-calcium salt have been reported
in the lungs and kidneys of newborn babies.
Reporting of side effects
If you get any side effects talk to your doctor, nurse or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.
5. HOW TO STORE CEFTRIAXONE INJECTION
• Keep this medicine out of the sight and reach of
children.
• Do not store above 25˚C. Keep the vial in the outer
carton in order to protect from light.
• Once reconstituted, this medicine should be used
within 24 hours if stored at a temperature of 2-8˚C or
within 6 hours if stored at 25˚C.
• Do not use this medicine after the expiry date which is
stated on the label and carton after EXP. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION.
What Ceftriaxone 1 g Powder for Solution for Injection
or Infusion contains:
The active substance is ceftriaxone. Each vial contains 1 g
of ceftriaxone as the sodium salt.
There are no other ingredients.
What Ceftriaxone 2 g Powder for Solution for Injection
or Infusion contains:
The active substance is ceftriaxone. Each vial contains 2 g
of ceftriaxone as the sodium salt.
There are no other ingredients.
What Ceftriaxone Injection looks like and contents of
the pack
Ceftriaxone Injection is an almost white to yellowish
crystalline powder, supplied in a glass vial. Before it is
given to the patient the powder is dissolved in sterile
liquid. The ready-to-use solutions are pale yellow to
amber.
Ceftriaxone 1 g vials are available in packs of 1 vial and 5
vials. Not all pack sizes may be marketed.
Ceftriaxone 2 g vials are available in packs of 1 vial.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and manufacturer:
Laboratorio Reig Jofré, SA,
Gran Capitán, 10-08970 Sant Joan Despi,
Barcelona (Spain)
This leaflet was last revised in May 2014

Common: may affect up to 1 in 10 people
• nausea (feeling sick), vomiting (being sick)

In severe renal impairment accompanied by hepatic
insufficiency, the plasma concentration of ceftriaxone
should be determined at regular intervals and the dosage
adjusted appropriately.
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 and handling
Preparation of solutions for injection and infusion
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.
This medicinal product must not be mixed with other
medicinal products except those mentioned below.
After addition of the recommended reconstitution
solution specified below, shake well (up to 60 seconds)
until the contents of the vial have dissolved completely.
Reconstituted solutions should be inspected visually. Only
clear solutions free of visible particles should be used.
The reconstituted product is for single use only and any
unused solution must be discarded.
When reconstituted for intramuscular or intravenous
injection, the white to yellowish crystalline powder gives a
pale yellow to amber solution.
Ceftriaxone should not be mixed in the same syringe with
any drug other than 1% w/v Lidocaine Injection BP (for
intramuscular injection only).
Intramuscular injection:
1 g ceftriaxone should be dissolved in 3.5 ml of 1 %
w/v Lidocaine Injection BP. The solution should be
administered by deep intramuscular injection. Dosages
greater than 1 g should be divided and injected at more
than one site. Not more than 1 g should be injected
on either side of the body. The maximum dose by
intramuscular injection should not exceed 2 g.
Solutions in lidocaine should not be administered
intravenously.
Intravenous injection:
1 g ceftriaxone should be dissolved 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 ceftriaxone should be dissolved in 40 ml of one of
the following calcium-free solutions: Sodium Chloride
Intravenous Infusion BP 0.9%, Sodium Chloride and
Glucose Intravenous Infusion BP (sodium chloride 0.45%
and glucose 2.5%), Glucose Intravenous Infusion BP 5%
or 10%, Dextran 6% in Glucose Intravenous Infusion BP
5%. The infusion should be administered over at least 30
minutes.

Displacement value
Vial Diluent
size

Volume Approximate Approximate
of diluent resulting
displacement
added
volume of
volume
ceftriaxone
solution
1 g 1% lidocaine 3.5 ml
4.0 ml
0.5 ml
hydrochloride
injection
1 g Water for
10 ml
10.5 ml
0.5 ml
Injections
2 g 0.9% sodium 40.0 ml 41.0 ml
1.0 ml
chloride
solution
Any unused product or waste material should be disposed
of in accordance with local requirements.
Incompatibilities
Do not use diluents containing calcium, such as Ringer’s
solution or Hartmann’s solution, 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 calcium-containing solutions
in the same intravenous administration line. Ceftriaxone
must not be mixed or administered simultaneously with
calcium-containing intravenous solutions, including
continuous calcium-containing infusions such as
parenteral nutrition via a Y-site. However, in patients
other than neonates, ceftriaxone and calcium-containing
solutions may be administered sequentially of one
another if the infusion lines are thoroughly flushed
between infusions with a compatible fluid. In vitro studies
using adult and neonatal plasma from umbilical cord
blood demonstrated that neonates have an increased risk
of precipitation of ceftriaxone-calcium.
Based on literature reports ceftriaxone is incompatible
with amsacrine, vancomycin, fluconazole and
aminoglycosides.
Shelf life
Unopened:
Powder: 3 years.
Opened and after reconstitution:
For reconstituted solutions, chemical and physical in-use
stability has been demonstrated for 6 hours at 25°C and
for 24 hours at 2-8°C. Protect from light.
From a microbiological point of view, once opened,
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 24 hours at 2-8°C or 6 hours at 25°C,
unless reconstitution has taken place in controlled and
validated aseptic conditions.
Special precautions for storage
Unopened: Do not store above 25°C. Keep the container
in the outer carton in order to protect from light.
This leaflet was last revised in December 2014.
xxxxxx-xxxx

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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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