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CEFUROXIME SODIUM FOR INJECTION 1.5G

Active substance(s): CEFUROXIME SODIUM / CEFUROXIME SODIUM

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Cefuroxime sodium
750mg & 1.5g Powder for
Injection
Cefuroxime sodium
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your
doctor or pharmacist.
n If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Cefuroxime Injection is and
what it is used for
2. What you need to know before you are given
Cefuroxime Injection
3. How you are given Cefuroxime Injection
4. Possible side effects
5. How to store Cefuroxime Injection
6. Contents of the pack and other information

1. What Cefuroxime Injection is and
what it is used for
Cefuroxime Injection is an antibiotic used in adults
and children. It works by killing bacteria that cause
infections. It belongs to a group of medicines called
cephalosporins.
Cefuroxime Injection is used to treat
infections of:
n the lungs or chest
n the urinary tract
n the skin and soft tissue
n the abdomen

Cefuroxime Injection is also used:
n to prevent infections during surgery.
Your doctor may test the type of bacteria
causing your infection and monitor whether the
bacteria are sensitive to Cefuroxime Injection
during your treatment.

2. What you need to know before you are
given Cefuroxime Injection
You must not be given Cefuroxime Injection
n if you are allergic to any cephalosporin
antibiotics or any of the other ingredients of
Cefuroxime Injection (listed in section 6).
n if you have ever had a severe allergic
(hypersensitive) reaction to any other type of
betalactam antibiotic (penicillins, monobactams
and carbapenems).
Tell your doctor before you start on Cefuroxime
Injection if you think that this applies to you. You
must not be given Cefuroxime Injection.
Warnings and precautions
Talk to your doctor or pharmacist before you are
given Cefuroxime Injection.
You must look out for certain symptoms such as
allergic reactions, skin rashes, gastrointestinal
disorders such as diarrhoea or fungal infections
while you are being given Cefuroxime Injection.
This will reduce the risk of possible problems.
See (‘Conditions you need to look out for’) in
section 4. If you have had any allergic reaction to
other antibiotics such as penicillin, you may also be
allergic to Cefuroxime Injection.
If you need a blood or urine test
Cefuroxime Injection can affect the results of urine
or blood 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 Cefuroxime Injection.
Other medicines and Cefuroxime Injection
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines you can obtain
without a prescription.
Some medicines may affect how Cefuroxime
Injection works, or make it more likely that you’ll
have side effects. These include:
n aminoglycoside-type antibiotics
n water tablets (diuretics), such as furosemide
n probenecid
n oral anticoagulants
➔ Tell your doctor if this applies to you. You may
need extra check-ups to monitor your renal
function while you are taking Cefuroxime Injection.
Contraceptive pills
Cefuroxime Injection may reduce the effectiveness
of the contraceptive pill. If you are taking the
contraceptive pill while you are being treated
with Cefuroxime Injection you also need to use
a barrier method of contraception (such as a
condom). Ask your doctor for advice.
Pregnancy, 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 or pharmacist for advice before you
are given this medicine.
Your doctor will consider the benefit of treating
you with Cefuroxime Injection against the risk to
your baby.
Driving and using machines
Cefuroxime Injection should not affect your ability
to drive or use machines.

The following information is intended for
healthcare professionals only:
Instructions for reconstitution
Intramuscular injection:
For Cefuroxime 750mg powder for injection:
Add 3ml of water for injections to 750mg.
Shake gently to produce a suspension.
For Cefuroxime 1.5g powder for injection:
Add 6ml of water for injections to 1.5g.
Shake gently to produce a suspension.
Intravenous administration:
For Cefuroxime 750mg powder for injection:
Dissolve cefuroxime in water for injections using
at least 6ml for 750mg.
For Cefuroxime 1.5g powder for injection:
Dissolve cefuroxime in water for injections using
at least 15ml for 1.5g.
For short intravenous infusion, 1.5g may be
dissolved in 50ml of water for injections.
Reconstituted solutions may be diluted with:
5% or 10% dextrose
5% dextrose containing 0.2%, 0.225%, 0.45%
or 0.9% sodium chloride injection
5% dextrose containing 20mEq potassium chloride
0.9% sodium chloride injection
M/6 sodium lactate injection
Ringer’s injection
Lactated Ringer’s injection
Heparin (10 and 50 units/ml) in 0.9% sodium
chloride injection
10 and 40 mEqL potassium chloride in 0.9% sodium
chloride injection
These solutions may be given directly into a vein or
introduced into the tubing of the giving set if the
patient is receiving parenteral fluids.
Any unused medicinal product or waste material
should be disposed of in accordance with local
requirements.

Cefuroxime Injection contains 40.6mg sodium per
750 mg dose, or 81.3mg sodium per 1.5g dose. The
maximum dose of Cefuroxime Injection that you
may be given in one day contains 309mg sodium.
You need to take this into consideration if you are
on a controlled sodium diet.

3. How you are given Cefuroxime Injection
Cefuroxime Injection 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.
The recommended dose
The correct dose of Cefuroxime Injection will be
decided by your doctor and depends on:
the severity and type of infection, whether you are
on any other antibiotics, your weight and age and
how well your kidneys are working.
Use in adults and adolescents:
750mg to 1.5g of Cefuroxime Injection two, three or
four times daily. Maximum dose: 6g per day.
Use in babies (over 3 weeks) and children:
For every 1kg the baby or child weighs, they’ll be
given 30 to 100mg of Cefuroxime Injection per day
divided in three or four doses.
Use in newborn babies (0 -3 weeks):
For every 1kg the baby weighs, they’ll be given 30
to 100mg Cefuroxime Injection per day divided in
two or three doses.
Patients with kidney problems
If you have a kidney problem your doctor may
change your dose.
➔ Talk to your doctor if this applies to you.



Package leaflet: Information for the user

Marketing Authorisation Holder
Flynn Pharma Ltd, Alton House,
4 Herbert Street, Dublin 2, Ireland
Marketing Authorisation Numbers
Cefuroxime sodium for injection 750mg:
PL 13621/0018
Cefuroxime sodium for injection 1.5g:
PL 13621/0019
This leaflet was last revised in
December 2016

If you are given more Cefuroxime Injection than
you should receive
It is unlikely that you will be given too much, but if
you think that you have been given too much
Cefuroxime Injection, tell your doctor, pharmacist or
nurse immediately. Signs might include fits
(convulsions).
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
All medicines can cause allergic reactions, although
serious allergic reactions are very rare.
Contact a doctor or nurse immediately if you get
any of these symptoms:
n High temperature (fever), a sore throat or other
signs of an infection. Common (may affect up to
1 in 10 people)
n Abnormal reduction in white blood cells
(leucopenia) – shown by blood tests.
Uncommon (may affect up to 1 in 100 people)
n Get potentially serious allergic reactions.
Symptoms of these reactions include:
severe allergic reaction. Signs include raised
and itchy rash, swelling, sometimes of the face
or mouth causing difficulty in breathing.
n 
skin rash, which may blister, and looks like
small targets (central dark spot surrounded by
a paler area, with a dark ring around the edge)
n 
a widespread rash with blisters and peeling
skin. (These may be signs of Stevens-Johnson
syndrome or toxic epidermal necrolysis).

 ot known (cannot be estimated from
N
available data)
n 
fungal infections on rare occasions, medicines
like Cefuroxime Injection can cause an
overgrowth of yeast (Candida) in the body which
can lead to fungal infections (such as thrush).
This side effect is more likely if you take
Cefuroxime Injection for a long time. Not known
(cannot be estimated from available data)
n 
severe diarrhoea (Pseudomembranous
colitis). Medicines like Cefuroxime Injection can
cause inflammation of the colon (large intestine),
causing severe diarrhoea, usually with blood and
mucus, stomach pain, fever. Not known (cannot
be estimated from available data)
n Decrease in the number of platelets in the blood
resulting in bruising easily or episodes of
excessive bleeding (Thrombocytopenia and
haemolytic anaemia). Not known (cannot be
estimated from available data)
n Changes in kidney function shown by blood or
urine tests. Not known (cannot be estimated
from available data)
Other side effects have also been reported:
Common (may affect up to 1 in 10 people)
n Temporary pain at the injection site
n Temporary changes in your blood such as
reduced red blood cells and reduced
haemoglobin levels or changes in liver function,
which will be shown by blood tests
Uncommon (may affect up to 1 in 100 people)
n Rash
n Itchy red wheals (urticaria)
n Diarrhoea and nausea (feeling sick)
n Temporary yellowing of the skin and whites of
the eyes which usually return to normal after
treatment (due to an increase in a substance
made in the liver called bilirubin)
n Positive Coombes test (blood test)

Not known (cannot be estimated from
available data)
n High temperature and chills (fever)
Side effects that may show up in blood tests:
n decrease in number of blood platelets (cells that
help blood to clot - thrombocytopenia)
n increase in levels of urea nitrogen and serum
creatinine in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme – Website:
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 Cefuroxime Injection
Cefuroxime Injection is for use in hospital only and
the expiry date and storage instructions stated on
the vial label and carton are for the doctor, nurse or
pharmacist’s information. The doctor, pharmacist or
nurse will make up your 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 label. The expiry date refers
to the last day of that month.
Before it is made up it should be stored below 25°C.
Keep the vial in the outer carton in order to
protect from light.
For single use only. Discard any unused contents.
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 Cefuroxime Injection contains
The active substance is cefuroxime (as sodium salt)
Each 750mg vial contains 750mg cefuroxime
(as sodium salt). Each 1.5g vial contains 1.5g
cefuroxime (as sodium salt).
There are no other ingredients.
What Cefuroxime Injection looks like and
contents of the pack
Cefuroxime Injection is contained in glass vials with
rubber stoppers. Pack sizes of 5, 10, 50 or 100 vials
for Cefuroxime 750mg Powder for Injection and 1,
10 or 50 vials for Cefuroxime 1.5g Powder for
Injection.
Vials contain an off-white to slightly yellow powder
which will be made up with Water for Injections or
other recommended diluting solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Ireland
Manufacturer
FACTA Farmaceutica S.P.A
Nucleo Industrial S. Atto
Frazione S. Nicolo a Tordino
64020 Teramo
Italy
This leaflet was last revised in
December 2016.

Artwork for:
Product name:
PL/PA no:
Type:
Artwork dimensions:
Profile supplied:
Date of first artwork:
Reason for request:
Version no:
Date of revision:
Colours:
Font(s):
Artwork software:
Proof software:
BAC ref:

Flynn Pharma Limited
Cefuroxime Injection
PL 13621/0018 & 0019
Leaflet
140mm x 340mm
Yes
6 December 2016
New leaflet size
5FP
1 February 2017
As swatch(es)
8pt FF Zwo on 9pt
InDesign CC
PDF
U091 (formerly T079)

Black

Cefuroxime sodium
750mg & 1.5g Powder for
Injection
Cefuroxime sodium
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your
doctor or pharmacist.
n If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Cefuroxime Injection is and
what it is used for
2. What you need to know before you are given
Cefuroxime Injection
3. How you are given Cefuroxime Injection
4. Possible side effects
5. How to store Cefuroxime Injection
6. Contents of the pack and other information

1. What Cefuroxime Injection is and
what it is used for
Cefuroxime Injection is an antibiotic used in adults
and children. It works by killing bacteria that cause
infections. It belongs to a group of medicines called
cephalosporins.

Cefuroxime Injection is used to treat
infections of:
n the lungs or chest
n the urinary tract
n the skin and soft tissue
n the abdomen
Cefuroxime Injection is also used:
n to prevent infections during surgery.
Your doctor may test the type of bacteria
causing your infection and monitor whether the
bacteria are sensitive to Cefuroxime Injection
during your treatment.

2. What you need to know before you are
given Cefuroxime Injection
You must not be given Cefuroxime Injection
n if you are allergic to any cephalosporin
antibiotics or any of the other ingredients of
Cefuroxime Injection (listed in section 6).
n if you have ever had a severe allergic
(hypersensitive) reaction to any other type of
betalactam antibiotic (penicillins, monobactams
and carbapenems).
Tell your doctor before you start on Cefuroxime
Injection if you think that this applies to you. You
must not be given Cefuroxime Injection.
Warnings and precautions
Talk to your doctor or pharmacist before you are
given Cefuroxime Injection.
You must look out for certain symptoms such as
allergic reactions, skin rashes, gastrointestinal
disorders such as diarrhoea or fungal infections
while you are being given Cefuroxime Injection.
This will reduce the risk of possible problems.

See (‘Conditions you need to look out for’) in
section 4. If you have had any allergic reaction to
other antibiotics such as penicillin, you may also be
allergic to Cefuroxime Injection.
If you need a blood or urine test
Cefuroxime Injection can affect the results of urine
or blood 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 Cefuroxime Injection.
Other medicines and Cefuroxime Injection
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines you can obtain
without a prescription.
Some medicines may affect how Cefuroxime
Injection works, or make it more likely that you’ll
have side effects. These include:
n aminoglycoside-type antibiotics
n water tablets (diuretics), such as furosemide
n probenecid
n oral anticoagulants
➔ Tell your doctor if this applies to you. You may
need extra check-ups to monitor your renal
function while you are taking Cefuroxime Injection.
Contraceptive pills
Cefuroxime Injection may reduce the effectiveness
of the contraceptive pill. If you are taking the
contraceptive pill while you are being treated
with Cefuroxime Injection you also need to use
a barrier method of contraception (such as a
condom). Ask your doctor for advice.

Pregnancy, 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 or pharmacist for advice before you
are given this medicine.
Your doctor will consider the benefit of treating
you with Cefuroxime Injection against the risk to
your baby.

Use in babies (over 3 weeks) and children:
For every 1kg the baby or child weighs, they’ll be
given 30 to 100mg of Cefuroxime Injection per day
divided in three or four doses.

Driving and using machines
Cefuroxime Injection should not affect your ability
to drive or use machines.
Cefuroxime Injection contains 40.6mg sodium per
750 mg dose, or 81.3mg sodium per 1.5g dose. The
maximum dose of Cefuroxime Injection that you
may be given in one day contains 309mg sodium.
You need to take this into consideration if you are
on a controlled sodium diet.

Patients with kidney problems
If you have a kidney problem your doctor may
change your dose.
➔ Talk to your doctor if this applies to you.

3. How you are given Cefuroxime Injection
Cefuroxime Injection 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.
The recommended dose
The correct dose of Cefuroxime Injection will be
decided by your doctor and depends on:
the severity and type of infection, whether you are
on any other antibiotics, your weight and age and
how well your kidneys are working.
Use in adults and adolescents:
750mg to 1.5g of Cefuroxime Injection two, three or
four times daily. Maximum dose: 6g per day.

Use in newborn babies (0 -3 weeks):
For every 1kg the baby weighs, they’ll be given 30
to 100mg Cefuroxime Injection per day divided in
two or three doses.

If you are given more Cefuroxime Injection than
you should receive
It is unlikely that you will be given too much, but if
you think that you have been given too much
Cefuroxime Injection, tell your doctor, pharmacist or
nurse immediately. Signs might include fits
(convulsions).
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
All medicines can cause allergic reactions, although
serious allergic reactions are very rare.
Contact a doctor or nurse immediately if you get
any of these symptoms:
n High temperature (fever), a sore throat or other
signs of an infection. Common (may affect up to
1 in 10 people)
n Abnormal reduction in white blood cells
(leucopenia) – shown by blood tests.

Uncommon (may affect up to 1 in 100 people)
potentially serious allergic reactions.
Symptoms of these reactions include:
severe allergic reaction. Signs include raised
and itchy rash, swelling, sometimes of the face
or mouth causing difficulty in breathing.
n 
skin rash, which may blister, and looks like
small targets (central dark spot surrounded by
a paler area, with a dark ring around the edge)
n 
a widespread rash with blisters and peeling
skin. (These may be signs of Stevens-Johnson
syndrome or toxic epidermal necrolysis).
Not known (cannot be estimated from
available data)
n 
fungal infections on rare occasions, medicines
like Cefuroxime Injection can cause an
overgrowth of yeast (Candida) in the body which
can lead to fungal infections (such as thrush).
This side effect is more likely if you take
Cefuroxime Injection for a long time. Not known
(cannot be estimated from available data)
n 
severe diarrhoea (Pseudomembranous
colitis). Medicines like Cefuroxime Injection can
cause inflammation of the colon (large intestine),
causing severe diarrhoea, usually with blood and
mucus, stomach pain, fever. Not known (cannot
be estimated from available data)
n Decrease in the number of platelets in the blood
resulting in bruising easily or episodes of
excessive bleeding (Thrombocytopenia and
haemolytic anaemia). Not known (cannot be
estimated from available data)
n Changes in kidney function shown by blood or
urine tests. Not known (cannot be estimated
from available data)
n Get

Other side effects have also been reported:
Common (may affect up to 1 in 10 people)
n Temporary pain at the injection site
n Temporary changes in your blood such as
reduced red blood cells and reduced
haemoglobin levels or changes in liver function,
which will be shown by blood tests
Uncommon (may affect up to 1 in 100 people)
n Rash
n Itchy red wheals (urticaria)
n Diarrhoea and nausea (feeling sick)
n Temporary yellowing of the skin and whites of
the eyes which usually return to normal after
treatment (due to an increase in a substance
made in the liver called bilirubin)
n Positive Coombes test (blood test)
Not known (cannot be estimated from
available data)
n High temperature and chills (fever)
Side effects that may show up in blood tests:
n decrease in number of blood platelets (cells that
help blood to clot - thrombocytopenia)
n increase in levels of urea nitrogen and serum
creatinine in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme – Website:
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 Cefuroxime Injection
Cefuroxime Injection is for use in hospital only and
the expiry date and storage instructions stated on
the vial label and carton are for the doctor, nurse or
pharmacist’s information. The doctor, pharmacist or
nurse will make up your 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 label. The expiry date refers
to the last day of that month.
Before it is made up it should be stored below 25°C.
Keep the vial in the outer carton in order to
protect from light.
For single use only. Discard any unused contents.
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.

The following information is intended for healthcare professionals only:

Vials contain an off-white to slightly yellow powder
which will be made up with Water for Injections or
other recommended diluting solution.
Not all pack sizes may be marketed.

Instructions for reconstitution
Intramuscular injection:
For Cefuroxime 750mg powder for injection:
Add 3ml of water for injections to 750mg.
Shake gently to produce a suspension.
For Cefuroxime 1.5g powder for injection:
Add 6ml of water for injections to 1.5g.
Shake gently to produce a suspension.
Intravenous administration:
For Cefuroxime 750mg powder for injection:
Dissolve cefuroxime in water for injections using
at least 6ml for 750mg.
For Cefuroxime 1.5g powder for injection:
Dissolve cefuroxime in water for injections using at least 15ml for 1.5g.
For short intravenous infusion, 1.5g may be dissolved in 50ml of water for injections.
Reconstituted solutions may be diluted with:
5% or 10% dextrose
5% dextrose containing 0.2%, 0.225%, 0.45% or 0.9% sodium chloride injection
5% dextrose containing 20mEq potassium chloride
0.9% sodium chloride injection
M/6 sodium lactate injection
Ringer’s injection
Lactated Ringer’s injection
Heparin (10 and 50 units/ml) in 0.9% sodium chloride injection
10 and 40 mEqL potassium chloride in 0.9% sodium chloride injection
These solutions may be given directly into a vein or introduced into the tubing of the giving
set if the patient is receiving parenteral fluids.
Any unused medicinal product or waste material should be disposed of in accordance with
local requirements.
Marketing Authorisation Holder
Flynn Pharma Ltd, Alton House,
4 Herbert Street, Dublin 2, Ireland
Marketing Authorisation Numbers
Cefuroxime sodium for injection 750mg:
PL 13621/0018
Cefuroxime sodium for injection 1.5g:
PL 13621/0019

Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Ireland
Manufacturer
FACTA Farmaceutica S.P.A
Nucleo Industrial S. Atto
Frazione S. Nicolo a Tordino
64020 Teramo
Italy
This leaflet was last revised in
December 2016.

6. Contents of the pack and
other information
What Cefuroxime Injection contains
The active substance is cefuroxime (as sodium salt)
Each 750mg vial contains 750mg cefuroxime
(as sodium salt). Each 1.5g vial contains 1.5g
cefuroxime (as sodium salt).
There are no other ingredients.
What Cefuroxime Injection looks like and
contents of the pack
Cefuroxime Injection is contained in glass vials with
rubber stoppers. Pack sizes of 5, 10, 50 or 100 vials
for Cefuroxime 750mg Powder for Injection and 1,
10 or 50 vials for Cefuroxime 1.5g Powder for Injection.

This leaflet was last revised in
December 2016



Package leaflet: Information for the user

Artwork for:
Product name:
PL/PA no:
Type:
Artwork dimensions:
Profile supplied:
Date of first artwork:
Reason for request:
Version no:
Date of revision:
Colours:
Font(s):
Artwork software:
Proof software:
BAC ref:

Flynn Pharma Limited
Cefuroxime Injection (1 vial)
PL 13621/0018 & 0019
Leaflet
140mm x 340mm
Dimensions supplied
13 February 2017
New leaflet size
1FP
As swatch(es)
8pt FF Zwo on 9pt
InDesign CC
PDF
U091

Black

Expand view ⇕

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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