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TERLIPRESSIN ACETATE 1 MG SOLUTION FOR INJECTION

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

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Package leaflet: information for the user

Terlipressin Acetate 1mg
solution for injection
(Terlipressin acetate)
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.
■ This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Terlipressin Acetate 1mg solution for
injection is and what it is used for
2. What you need to know before you use
Terlipressin Acetate 1mg solution for injection
3. How to use Terlipressin Acetate 1mg solution
for injection
4. Possible side effects
5. How to store Terlipressin Acetate 1mg
solution for injection
6. Contents of the pack and other information

1 What Terlipressin Acetate 1 mg solution for
injection is and what it is used for
Terlipressin Acetate 1mg solution for injection is a
synthetic pituitary hormone
Terlipressin Acetate 1mg solution for injection is used for
the treatment of:
■ bleeding from dilated (widening) veins in the food
pipe leading to your stomach (called bleeding
oesophageal varices).

2 What you need to know before you start
using Terlipressin Acetate 1mg solution
for injection
Do not use Terlipressin Acetate 1mg solution
for injection
■ if you are hypersensitive (allergic) to terlipressin or
any of the other ingredients of Terlipressin Acetate
1mg solution for injection (see section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you start
using Terlipressin Acetate 1mg solution for injection
This medicine will be given to you if you have:
■ Severe or life threatening bleeding in your food pipe
(oesophagus).
It is given under continous monitoring of your heart and
blood circulation.
If you are able, please tell the doctor if you have any of
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 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 the
arteries (arteriosclerosis)
■ if you suffer from irregular heart beats
(cardiac arrythmias)
■ 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 pregnant
■ if you are over the age of 70 years
Other medicines and Terlipressin Acetate 1mg
solution for injection
Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicines.
Please inform your doctor immediately if you take any of
the following medicines:
n drugs that have an effect on your heart rate
(e.g. beta-blockers, sufentanil or propofol)
n drugs that can trigger irregular beating of the heart
(arrhythmia) such as the following:
■ anti-arryhthmic drugs known as Class IA (quinidine,
procainamide, disopyramide) and Class III
(amiodarone, solatol, ibutilide, dofetilide)
■ an antibiotic called erythromycin
■ antihistamines (mainly used to treat allergies but
also found in certain cough and cold remedies)
■ a type of medicine 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)

Terlipressin Acetate 1mg solution for injection
with food and drink
There are no limitations.
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
or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking
any medicine.
Terlipressin Acetate 1mg solution for injection should
only be used during pregnancy if it is vital to treat
your condition.
It is not known if Terlipressin Acetate 1mg solution for
injection is present in breast milk, therefore it is not
known if there may be an effect on your baby. 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.
Important information about some ingredients of
Terlipressin Acetate 1mg solution for injection
Terlipressin Acetate 1mg solution for injection
contains sodium
This medicinal product contains 30.6mg (1.33mmol)
sodium per ampoule. To be taken into consideration by
patients on a controlled sodium diet.

3 How to use Terlipressin Acetate 1mg
solution for injection
This medicine is not to be used by yourself but will
always be administered to you by your doctor. Please ask
your doctor for further information regarding its use.
Adults
The dose will be determined by the doctor depending on
patient’s weight.
Initially 1-2mg terlipressin acetate equivalent to 1-2
ampoules of Terlipressin Acetate 1mg solution for
injection are administered. Your dose will depend on your
body weight.
After the initial injection, your dose may be reduced to
1mg every 4 to 6 hours.
Treatment should be maintained for 24 consecutive
hours until bleeding is under control or for a maximum
period of 48 hours. After the initial injection, the
following doses can be reduced to 1 milligram
(1 ampoule) of Terlipressin Acetate 1 mg solution for
injection if necessary as, for example, by the occurrence
of adverse reactions.
The maximum dose you can receive each day is
approximately 120 microgrammes/kg body weight.
Elderly
If you are over 70 years of age speak with your doctor
before you receive Terlipressin Acetate 1mg solution
for injection
Use in children and adolescents
Terlipressin Acetate 1mg solution for injection is not
recommended for use in children and adolescents due to
insufficient experience.
Method and route of administration
After opening the ampoule, remove the solution with a
syringe and inject it slowly intravenously.
Duration of treatment
The use of this medicine is limited to 2 – 3 days,
depending on the course of your condition.
If you use more Terlipressin Acetate 1mg solution for
injection than you should
You must not use more Terlipressin Acetate 1mg 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.
You may also experience a low heart rate. This can be
treated with a medicine called atropine.
If you forget to use Terlipressin Acetate 1mg
solution for injection
You will be given Terlipressin Acetate 1mg solution for
injection in hospital under the supervision of a doctor.
If you stop using Terlipressin Acetate 1mg solution
for injection
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist or nurse.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Important side effects which need immediate
attention:
In very rare cases, there may be severe side effects
when you are given Terlipressin Acetate 1mg solution
for injection.
If you are affected by any of the following side effects,
please tell your doctor immediately if you are able to.
Your doctor should not give you any more Terlipressin
Acetate 1mg solution for injection to you.
■ 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 heart beats
■ locally dead skin (necrosis)
■ convulsions (seizure)
■ kidney failure.

The following information is intended for medicinal or healthcare professionals only
Posology
Initially 1-2mg terlipressin acetate (equivalent to 1-2
ampoules of Terlipressin Acetate 1mg solution for
injection) are administered.
Depending on the patient’s body weight the dose can be
adjusted as follows:
■ weight less than 50kg: 1mg (1 ampoule of 8.5ml)
■ weight 50kg to 70kg: 1.5mg (1.5 ampoules of 8.5ml)
■ weight exceeding 70kg: 2mg (2 ampoules of 8.5ml).
After the initial injection, the dose can be reduced to
1mg every 4 to 6 hours.
The approximate value for the maximum daily dose of
Terlipressin Acetate 1 mg solution for injection is 120
micrograms/kg body weight.
The therapy is to be limited to 2 – 3 days in adaptation
to the course of the disease.
Terlipressin Acetate 1mg solution for injection is
injected intravenously and should be given over a period
of one minute.
Terlipressin Acetate 1mg solution for injection should
only be used with caution in patients over 70 years, and
patients with chronic renal failure.

Terlipressin Acetate 1mg solution for injection is not
recommended in children and adolescents due to
insufficient experience on safety and efficacy.
A dose adjustment is not required in patients with
liver failure.
Preparation of the injection:
Terlipressin Acetate 1mg solution for injection is
dissolved with the accompanying solvent and is applied
intravenously.
The solution should be inspected visually for particles
and discolouration prior to administration.
Do not use Terlipressin Acetate 1mg solution for injection
if you notice
■ That the solution discolours.
Store in a refrigerator at 2-8˚C.
Keep the vial in the outer carton to protect from light.
After reconstitution the solution should be used
immediately.
For single use only. Discard any unused solution.

Frequency of possible side effects:
Common (affects less than 1 in 10 people):
Heart and circulation
■ very slow heart rate
■ signs of insufficient blood circulation in the heart
vessels in the ECG
■ high or low blood pressure
■ insufficient blood circulation in arms, legs and skin
■ paleness of face
■ pale skin
General
■ headache
Stomach and gut
■ temporary abdominal cramps
■ temporary diarrhoea
■ abdominal cramps (in women)
Uncommon (affects less than 1 in 100 people):
Mind and nervous system
■ triggering of a fit
Heart and circulation
■ chest pain
■ rapid increase in blood pressure
■ heart attack
■ irregular heart rate
■ too fast heart rate (palpitations)
■ bluish colouration of the skin or lips
■ hot flushes
■ heart failure (Torsade de Pointes)
Lungs and breathing
■ excess fluid on the lungs
■ shortness of breath due to spasm in the
bronchial muscles
■ severe difficulty with or stopping breathing
Stomach and gut
■ temporary nausea
■ temporary vomiting
General
■ inflammation of the lymph vessels
■ reduced blood supply to the intestinal system
■ uterine cramps
■ decreased blood flow to the uterus
■ dead skin (necrosis) not related to the injection site
Results of blood tests
■ too little sodium in the blood (hyponatraemia)
if not monitored
Rare (affects less than 1 in 1000 people):
Lungs and breathing
■ shortness of breath
Very rare (affects less than 1 in 10,000 people):
Heart and circulation
■ stroke
■ severe angina
Results of blood tests
■ too much sugar in the blood (hyperglycaemia)
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the United Kingdom 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 Terlipressin Acetate 1mg
solution for injection
Keep this medicine out of the sight and reach of children.
Store in a refrigerator at 2-8˚C. Keep in the original
package in order to protect from light.
The reconstituted Terlipressin Acetate 1mg solution for
injection -solution has to be used immediately.
Do not use this medicine after the expiry date which is
stated on the pack after EXP. The expiry date refers to
the last day of that month.
Do not use Terlipressin Acetate 1mg solution for injection
if you notice
■ that the solution discolours.
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 1mg solution for
injection contains
■ The active substance is terlipressin acetate.
Each ampoule contains: 1mg of terlipressin acetate in
8.5ml solution for injection, corresponding to 0.85mg
terlipressin.
1ml of solution for injection contains 0.12mg/ml of
terlipressin acetate, equivalent to 0.1mg terlipressin.
■ The other ingredients are:
sodium chloride, glacial acetic acid, sodium acetate and
water for injection.

What Terlipressin Acetate 1mg solution for injection
looks like and contents of the pack
This medicine is presented as a solution for injection. It is
supplied in clear Type I glass ampoules containing
solution for injection.
Each ampoule contains 8.5ml of solvent.
Terlipressin Acetate 1mg solution for injection is a clear,
colourless solution for injection.
This medicine is available in pack sizes of:
One carton with 5 ampoules with 8.5ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Inresa Arzneimittel GmbH
Obere Hardtstraße 18
79114 Freiburg
Germany
Manufacturer
GENFARMA LABORATORIO, S.L.
Avda de la Constitución 199, P.I. Monte Boyal
45950 Casarrubios del Monte (Toledo)
Spain
and
Inresa Arzneimittel GmbH
Obere Hardtstraße 18
79114 Freiburg
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
DE: TERLIPRESSIN 1mg SOLUTION FOR INJECTION
UK: TERLIPRESSIN ACETATE 1mg SOLUTION FOR INJECTION
This leaflet was last revised in October 2016

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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