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TERLIPRESSIN ACETATE SUN 0.12 MG/ML SOLUTION FOR INJECTION

Active substance(s): TERLIPRESSIN ACETATE / TERLIPRESSIN ACETATE / TERLIPRESSIN ACETATE

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Package leaflet: Information for the user

Terlipressin acetate 0.12 mg/ml solution for
injection
Terlipressin (as acetate)
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 or 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.

What is in this leaflet
1. What Terlipressin acetate 0.12 mg/ml solution for injection is and what it is used for
2. What you need to know before you are given Terlipressin acetate 0.12 mg/ml solution
for injection
3. How to use Terlipressin acetate 0.12 mg/ml solution for injection
4. Possible side effects
5. How to store Terlipressin acetate 0.12 mg/ml solution for injection
6. Contents of the pack and other information

1. What Terlipressin acetate 0.12 mg/ml solution for injection is and what it is used
for

Other medicines and Terlipressin acetate 0.12 mg/ml solution for injection
Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicines.
Please inform your doctor immediately if you use the following medicines:
- drugs that have an effect on your heart rate (e.g. beta-blockers or propofol)
- drugs that can trigger irregular beating of the heart (arrhythmia) such as the
following:
- anti-arrhythmic drugs known as Class IA (quinidine, procainamide,
disopyramide) and Class III (amiodarone, sotalol, ibutilide, dofetilide)
- an antibiotic called erythromycin
- antihistamines (mainly used to treat allergies but also found in certain cough
and cold remedies)
- medicines used to treat depression called tricyclic antidepressants
- medicines that may alter the level of salt or electrolytes in your blood,
particularly diuretics (used to treat high blood pressure and heart failure).
Pregnancy and breast-feeding
Terlipressin acetate 0.12 mg/ml solution for injection should only be used during
pregnancy if it is vital to treat your condition. 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
you are given this medicine.
It is not known if Terlipressin acetate 0.12 mg/ml solution for injection is present in
breast milk. Therefore the possible effects on your baby are unknown. You should
discuss the potential risk to your baby with your doctor.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
However, if you feel unwell after receiving the injection, do not drive or operate
machinery.
Terlipressin acetate 0.12 mg/ml solution for injection contains sodium
This medicinal product contains 15.7 mmol (or 361 mg) sodium per dose. To be taken
into consideration by patients on a controlled sodium diet.

Terlipressin acetate 0.12 mg/ml solution for injection is a synthetic pituitary hormone.

3. How Terlipressin acetate 0.12 mg/ml solution for injection is used

Terlipressin acetate 0.12 mg/ml solution for injection is used for treatment of bleeding
from dilated veins in the food pipe leading to your stomach (bleeding oesophageal
varices).

This medicine will always be administered to you by your doctor. Please ask your doctor
for further information regarding its use.

2. What you need to know before you are given Terlipressin acetate 0.12 mg/ml
solution for injection

Adults
Initially 1-2 mg terlipressin acetate (equivalent to 8.5-17 ml of injection solution) is given
by injection into your vein. Your dose will depend on your body weight.

You should not be given Terlipressin acetate 0.12 mg/ml solution for injection
- if you are allergic to terlipressin or any of the other ingredients of this medicine (listed
in section 6).

After the initial injection, your dose may be reduced to 1 mg terlipressin acetate
(equivalent to 8.5 ml of solution), every 4 to 6 hours.

Elderly
If you are over 70 years of age speak with your doctor before you receive Terlipressin
acetate 0.12 mg/ml solution for injection.
How Terlipressin acetate 0.12 mg/ml solution for injection is given
Terlipressin acetate 0.12 mg/ml solution for injection should be slowly injected
intravenously.
How often you will be given Terlipressin acetate 0.12 mg/ml solution for injection
The use is limited to 2 – 3 days, depending on the course of your condition.
If you are given more Terlipressin acetate 0.12 mg/ml solution for injection than you
should be
You must not have more Terlipressin acetate 0.12 mg/ml solution for injection than the
recommended dose. If you are given too much then you may have a rapid increase in
your blood pressure, especially if you already suffer with high blood pressure. If this
happens then you need another medicine called an alpha blocker (e.g. clonidine) to
control your blood pressure.

# 1 to 2 mg terlipressin acetate corresponding to
0.85 to 1.7 mg terlipressin.

The therapy is to be limited to 2 – 3 days in
adaptation to the course of the disease.

The approximate value for the maximum daily
dose of Terlipressin acetate 0.12 mg/ml
solution for injection is 120 μg terlipressin
acetate per kg body weight.

After the initial injection, the dose can be
reduced to 1 mg terlipressin acetate every 4 to
6 hours.

If you experience lightheadedness, dizziness, or feeling faint, tell your doctor as these
could be signs of a low heart rate. This can be treated with a medicine called atropine.

Depending on the patient's body weight the
dose can be adjusted as follows:
- weight less than 50 kg: 1 mg terlipressin
acetate (8.5 ml)
- weight 50 kg to 70 kg: 1.5 mg terlipressin
acetate (12.75 ml)
- weight exceeding 70 kg: 2 mg terlipressin
acetate (17 ml).

Administration of Terlipressin acetate
0.12 mg/ml solution for injection
The administration of terlipressin serves the
emergency care for acute bleeding
oesophageal varices until endoscopic therapy
is available. Afterwards the administration of
terlipressin for the treatment of oesophageal
varices is usually an adjuvant therapy to the
endoscopic haemostasis.

Please see the Summary of Product
Characteristics for more information.

INFORMATION FOR THE HEALTHCARE
PROFESSIONALS

The following information is intended for
healthcare professionals only:

Terlipressin (as acetate)

Terlipressin acetate
0.12 mg/ml solution for
injection

Children and adolescents
Terlipressin acetate 0.12 mg/ml solution for injection is not recommended for use in
children and adolescents due to insufficient experience.

The maximum dose you can receive each day is approximately 120 micrograms/kg
body weight.

Adults
The recommended initial dose is 1 to 2 mg
terlipressin acetate# (equivalent to 8.5 to
17 ml of solution), administered by
intravenous injection over a period of time.

Warnings and precautions
This medicine will be given to you if you have severe or life-threatening bleeding in your
food pipe (oesophagus). It is used under continuous monitoring of your heart and blood
circulation.
If you are able to, tell your doctor if you suffer from the conditions shown below:
- if you are suffering from a severe infection known as septic shock
- if you suffer from bronchial asthma or other conditions that affect your breathing
- if you suffer from acute coronary syndrome (ACS describes symptoms related to
poor blood flow to the heart muscle leading to a heart attack. This results in chest
pain, or angina pectoris.)
- if you suffer from uncontrolled high blood pressure, insufficient blood circulation in
the heart vessels (e.g. angina), have previously had a heart attack (myocardial
infarction), or you have hardening of your arteries (arteriosclerosis)
- if you suffer from irregular heartbeats (cardiac arrhythmias)
- if you have poor blood circulation to your brain (e.g. you have had a stroke) or to your
limbs (peripheral vascular disease)
- if you suffer from impaired kidney function (renal insufficiency)
- if you suffer from disturbances in the level of salt (electrolytes) in your blood
- if you are suffering from reduced amount of fluid in your circulation or have already
lost a large amount of blood
- if you are over the age of 70 years
- if you are pregnant.

How much Terlipressin acetate 0.12 mg/ml solution for injection is given

Blank Area
do not print here

If you forget to use Terlipressin acetate 0.12 mg/ml solution for injection
You will be given Terlipressin acetate 0.12 mg/ml solution for injection in hospital under
the supervision of your doctor.
If you stop using Terlipressin acetate 0.12 mg/ml solution for injection
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

5. How to store Terlipressin acetate 0.12 mg/ml solution for injection
Keep this medicine out of the sight and reach of children.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Important side effects or signs you should pay attention to, and measures to be
taken if you are affected
In very rare cases severe side effects are possible when you are given terlipressin. If you
are affected by one of the following side effects, please tell your doctor immediately if
you are able to. Your doctor should not give you any more terlipressin.
Severe shortness of breath due to an asthma attack, severe difficulty with or stopping
breathing, severe pain in the chest (angina), severe and persistent irregular heartbeats,
locally dead skin (necrosis), convulsions (seizure), kidney failure.
Other possible side effects
Common (may affect up to 1 in 10 people)
- headache
- too slow heart rate
- signs of insufficient blood circulation in the heart vessels shown in the ECG
- high blood pressure
- low blood pressure
- insufficient blood circulation in arms, legs and skin, pale skin
- abdominal cramps
- diarrhoea

Do not use this medicine after the expiry date which is stated on the carton and the
ampoule after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator at 2-8˚C.
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 Terlipressin acetate 0.12 mg/ml solution for injection contains
- The active substance is terlipressin (as acetate). Each ampoule contains 1 mg of
terlipressin acetate in 8.5 ml solution for injection, corresponding to 0.85 mg
terlipressin. This is equivalent to 0.12 mg terlipressin acetate per ml, corresponding to
0.1 mg terlipressin per ml
- The other ingredients are sodium acetate trihydrate, sodium chloride, glacial acetic
acid (for pH adjustment) and water for injections.
What Terlipressin acetate 0.12 mg/ml solution for injection looks like and contents of
the pack
Terlipressin acetate 0.12 mg/ml solution for injection is a clear, colourless solution for
injection without visible particles.

Rare (may affect up to 1 in 1,000 people)
- shortness of breath
Very rare (may affect up to 1 in 10,000 people)
- too much sugar in the blood (hyperglycaemia)
- stroke
Not known (frequency cannot be estimated from the available data)
- heart failure
- dead skin (necrosis) not related to the injection site
- uterine cramps
- decreased blood flow to the uterus.
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 via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcardBy reporting side effects you
can help provide more information on the safety of this medicine.

Terlipressin acetate 0.12 mg/ml solution for injection is packed into one carton with
5 ampoules.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania
This medicinal product is authorised in the Member States of the EEA under the
following names:
Denmark:
Terlipressinacetat SUN 1 mg
Germany:
Terlipressin SUN 0,1 mg/ml Injektionslösung
Finland:
Terlipressiini SUN 0,1 mg/ml injektioneste, liuos
France:
Terlipressin SUN 0,12 mg/ml, solution injectable
Italy:
Terlipressina SUN 0,1 mg/ml soluzione iniettabile
The Netherlands:
Terlipressine SUN 0,1 mg/ml, oplossing voor injectie
Norway:
Terlipressin SUN 1 mg injeksjonsvæske, oppløsning
Spain:
Terlipresina SUN 1 mg solución inyectable EFG
Sweden:
Terlipressin SUN 1 mg injektionsvätska, lösning
United Kingdom:
Terlipressin acetate SUN 0.12 mg/ml solution for injection.
This leaflet was last revised in October 2016.

Elderly
Terlipressin should only be used with caution
in patients over 70 years.

Children and adolescents
Terlipressin is not recommended in children
and adolescents due to insufficient experience
on safety and efficacy.

Renal insufficiency
Terlipressin should only be used with caution
in patients with chronic renal failure.

Hepatic insufficiency
A dose adjustment is not required in patients
with liver failure.

Incompatibilities
In the absence of compatibility studies, this
medicinal product must not be mixed with
other medicinal products.

044BP2045C

044BP2045C

Uncommon (may affect up to 1 in 100 people)
- too little sodium in the blood (hyponatraemia)
- rapid increase in blood pressure
- too fast heart rate (palpitations)
- chest pain
- heart attack
- excess fluid on the lungs
- insufficient blood flow to the intestines
- bluish colouration of the skin or lips
- hot flushes
- temporary nausea (feeling sick)
- temporary vomiting
- inflammation of the lymph vessels (fine red streaks under your skin extending from
the affected area to the armpit or groin and by fever, chills, headache, and muscle
pain)

E
E
o

LO

Package leaflet: Information for the user

Terlipressin acetate 0.12 mg/ml solution for injection
Terlipressin (as acetate)
Read all of this leaflet carefully before you are given this medicine because ii conlains Important
Information for you.
Keep this leaflet. You may need to read it again.
li you have any further questions, ask your doctor or nurse.
li you get any side effects, talk to your doctor or nurse. This includes any possit>le side effects not
listed in this leaflet. See seclion 4.
What is in lhis leaflel
1. WhatTerlipressin acetate 0.12 mg/ml solution for injeclion is and what it is used for
2. Whatyou need to know before you are given Terlipressin acetate 0.12 mg/ml solution for injection
3. How to use Terlipressin acetate 0.12 mg/ml solution for injection
4. Possible side effects
5. Howto store Terlipressin acetate 0.12 mg/ml solution for injection
6. Contents of the pack and other information
1. WhalTerlipressin acetate 0.12 mg/ml solution for injection is and what it is used for
Terlipressin acetate 0.12 mg/ml solution for injection îs a synthetic pituitary hormone.
Terllpressin acetate 0.12 mg/ml solution for injection îs used for treatment of bleeding from dilated veins în the food
pipe leading to your stomach (bleeding oesophageal varices).
2. Whal you need to know before you are givenTerlipressin acetate 0.12 mg/ml solulion for injection
You should noi be givenTerlipressin acetate 0.12 mg/ml solulion for injeclion
ii you are anergie to terlipressin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
This medicine will be given to you if you have severe or life-threatening bleeding în your food pipe (oesophagus). lt îs
used under continuous monitoring of yourheart and blood circulation.
li you are able to, teii your doctor ii you suffer from the conditions shown below:
ii you are suffering !rom a severe infection known as septic shock
if you suffer from bronchial asthma or other conditions !hat affect your breathing
ii you suffer from acute coronary syndrome (ACS describes symptoms related to poor blood flow to the heart
musele leading to a heart attack. This results in chest pain, or angina pectoris.)
if you suffer from uncontrolled high blood pressure, insufficient t>lood circulation in the heart vessels (e.g.
angina), have previously had a heart attack (myocardial infarction), or you have hardening of your arteries
(arteriosclerosis)
� you suffer from irregular heartbeats (cardiac arrhythmias)
if you have poor blood circulation to your brain (e.g. you hava had a stroke) or ta your limbs (peripheral vascular
disease)
if you suffer from impaired kidney function (renal insufficiency)
if you suffer from disturbances in the leveI of salt (electrolytes) in your blood
ii you are suffering from reduced amount of fluid in your circulation or have already lost a large amount of blood
ii you are overthe age of 70 years
if you are pregnant.

Severe shortness of breath due to an asthma attack, severe difficulty with or stopping breathing, severe pain in the
chest (angina), severe and persistent irregular heartbeats, locally clead skin (necrosis), convulsions (seizure),
kidney failure.
Other possible side effects
Common (mayaffect up to 1 în 1O people)
headache
too slow heart rate
signs of insufficient blood circulation in the heart vessels shown în the ECG
high blood pressure
low blood pressure
insufficient blood circulation în arms, legs and skin, pale skin
abdominal cramps
diarrhoea
Uncommon (mayaffect up to 1 in 100 people)
too little sodium in the blood (hyponatraemia)
rapid increase in blood pressure
too fast heart rate (palpitations)
chest pain
heart attack
excess fluid on the lungs
insufficient blood flow to the intestines
bluish colouration of the skin or lips
hot flushes
temporary nausea (feeling sick)
temporary vomiting
inflammation of the lymph vessels (fine reci streaks under your skin extending from the affected area to the
armpit or groin and by fever, chills, headache, and musele pain)
Rare (mayaffect up to 1 în 1,000 people)
shortness of breath
Veryrare (mayaffect up to 1 in 10,000 people)
too much sugar în the blood (hyperglycaemia)
stroke
Not known (freguency cannot be estimated from the available data)
heart failure
dead skin (necrosis) noi related to the injection site
uterine cramps
clecreased blood flow to the uterus.
Reporting of side effects
lf 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 via the Yellow Card Scheme at: www.mhra.gav.uk/yellowcard.
By reporting side effects you can help provide more Information on the safety of this medicine.
5. Howto storeTerlipressin acetate 0.12 mg/ml solulion for injeclion
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which îs stated on the carton and the ampoule after EXP. The expiry
date refers to the las! day of that month.
°

Store in a refrigerator at 2-8 C.

Children and adolescenls
Terlipressin acetate 0.12 mg/ml solution for injection is not recommended for use in children and adolescents due to
insufficient experience.

Do nat throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medic Ines you no Ionger use. These measures wlll help protect the envlronment.

Other medicines andTerlipressin acetate 0.12 mg/ml solution lor injection
Teii your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Please inform your doctor lmmediately ii you use the following medicines:
drugs that have an effect on your heart rate (e.g. beta-blockers or propofol)
drugs that can trigger irregular beating of the heart (arrhythmia) such as the following:
anti-arrhythmic drugs known as Class IA (quinidine, procainamide, disopyramide) and Class III
(amiodarone, sotalol, ibutilicle, dofetilide)
an antibiotic called erythromycin
antihistamines (mainly used to treat allergies but also found in certain cough and cold remedies)
medicines used to treat depression called tricyclic antidepressants
medicines !hat may alter the levei of salt or electrolytes in your blood, par ticularly diuretics (used to Ireal
high blood pressure and heart failure).

6. Contents orthe pack and other Information

Pregnancy and breast-leeding
Terlipressin acetate 0.12 mg/ml solution for injection should only be used during pregnancy if it îs vital to treat your
condition. lf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before you are given this meclicine.
lt îs not known if Terlipressin acetate 0.12 mg/ml solution for injection is present în breast milk. Therefore the
possible effects on your baby are unknown. You shoulcl discuss the potential risk to your baby with your doctor.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. However, if you feel unwell
after receiving the injection, do not drive or operate machinery.
Terlipressin acetate 0.12 mg/ml solulion for injeclion contains sodium
This meclicinal product contains 15.7 mmol (or 361 mg) sodium per dose. To be taken into consideration by patients
on a controlled sodium diet.
3. HowTerlipressin acetate 0.12 mg/ml solulion for injeclion is used
This medicine will always be administered to you by your doctor. Please ask your doctor for further information
regarding its use.
How muchTerlipressin acetate 0.12 mg/ml solution for injection is given
Adults
lnitially 1-2 mg terlipressin acetate (equivalent to 8.5-17 ml of injection solution) is given by injection into your vein.
Your dose will depend on your body weight.
After the initial injection, your dose may be reduced to 1 mg terlipressin acetate (equivalent to 8.5 ml of solution),
every 4 to 6 hours.

WhatTerlipressin acetate 0.12 mg/ml solulion for injeclion conlains
The active substance is terlipressin (as acetate). Each ampoule contains 1 mg of terlipressin acetate in 8.5 ml
solution for injection, corresponding to 0.85 mg terlipressin. This is equivalent to 0.12 mg terlipressin acetate
per ml, corresponding to 0.1 mg terlipressin per ml.
The other ingredients are sodium acetate trihydrate, sodium chloride, glacial acetic acid (for p� adjustment)
and water for injections.
WhatTerlipressin acetate 0.12 mg/ml solulion for injeclion looks like and conlents of the pack
Terlipressin acetate 0.12 mg/ml solution for injection îs a clear, colourless solution for injection without visible
particles.
Terlipressin acetate 0.12 mg/ml solution for injection is packed into one carton with 5 ampoules.
Marketing Authorisatlon Holder
Sun Pharmaceutical lndustries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Remania
This medicinal product is authorised in the Member States of the EEA under the following names:
Terlipressinacetat SUN 1 mg
Denmark:
Germany:
Ter1ipressin SUN O, 1 mg/ml lnjektionslosung
Finland:
Ter1ipressiini SUN O, 1 mg/ml injektioneste, liuos
France:
Ter1ipressin SUN O, 12 mg/ml, solution injectable
ltaly:
Terlipressina SUN O, 1 mg/ml soluzione iniettabile
The Netherlands:
Ter1ipressine SUN O, 1 mg/ml, oplossing voor injectie
Norway:
Ter1ipressin SUN 1 mg injeksjonsvreske, oppl0sning
Spain:
Ter1ipresina SUN 1 mg soluci6n inyectable EFG
Sweden:
Ter1ipressin SUN 1 mg injektionsvătska, losning
United Kingdom:
Ter1ipressin acetate 0.12 mg/ml solution for injection.
This leaflel was last revised in Oclober 2016.

The maximum dose you can receive each day îs approximately 120 micrograms/kg body weight.
Elderly
lf you are over 70 years of age speak with your doctor before you receive Terlipressin acetate 0.12 mg/ml solution for
injection.
HowTerlipressin acetate 0.12 mg/ml solution for injection is given
Terllpressin acetate 0.12 mg/ml solution for injection should be slowly lnjected intravenously.
How o11en you will be givenTerlipressin acetate 0.12 mg/ml solulion for injeclion
The use is limited to 2-3 days, depending on the course of your condition.
li you are given moreTerlipressin acetate 0.12 mg/ml solulion for injection than you should be
You must nat have more Terlipressin acetate 0.12 mg/ml solution for injection than the recommended dose. lf you
are given too much then you may have a rapid increase in your blood pressure, especially if you already suffer with
high blood pressure. lf this happens then you need another medicine called an alpha blocker (e.g. clonidine) to
control your blood pressure.

lf you experience lightheadedness, dizziness, or feeling faini, teii your doctor as these could be signs of a low heart
rate. This can be treated with a medicine called atropine.
li you forget to useTerlipressin acetate 0.12 mg/ml solution for injection
You will be given Terlipressin acetate 0.12 mg/ml solution for injection în hospital under the supervision of your
doctor.
li you stop usingTerlipressin acetate 0.12 mg/ml solution for injeclion
lf you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, atthough not everybody gets them.
Important side effects or signs you should pay allention to, and measures to be taken ii you are affected
ln very rare cases severe side effects are possible when you are given ter1ipressin. lf you are affected by one of the
following side effects, please teii your doctor immediately ii you are able to. Your doctor shoulcl noi give you any
more terlipressin.

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Expand Transcript

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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