TERLIPRESSIN ACETATE SUN 0.12 MG/ML SOLUTION FOR INJECTION

Active substance: TERLIPRESSIN ACETATE

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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).

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.

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, talk to the doctor 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.

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

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.

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

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

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

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.

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.

PIL

UK-United Kingdom

SPIL - Halol

Code

044BP2045A

Void artwork Code No:

CD-PDD-SM-M-0265-PIL-28-02-13-PIL

Actual Size

330 x 205 mm

Reason:

REMARKS:

Barcode Area

51 x 17 mm

No. of Colors : 1

Specification / Type of paper

Color codes:
BLACK

Super Fine 40 GSM Tissue Paper ITC

Folding
205 mm----2----51.25
330 mm----3----41.25

Artwork Prepared by :
Sun Pharmaceutical Industries Limited
Packaging Development Department [PDD]
SPIL - Vadodara

Prepared by
Sign

Checked by
Date

Sign

Date Sign

FONTS SPECIFICATION
Patient info. Leaflet

Swiss 721 CN BT - 11 pt & 13 pt

Body Text

14/03/2013 6:51:23 PM

Swiss 721 CN BT - 10 pt

Title and Tiltle Heading

Terlipressin acetate SUN-0-1 mg-ml-EUUK-205x330mm-PIL-07-01-13

Swiss 721 CN BT - 8 pt

Approved by

Approved by RA
Date Sign

# 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.

Size: 330x205 mm
SUN EUROPE
EUUK

Location

ENGLISH

Country

Terlipressin acetate SUN 0.1 mg/ml solution for injection

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.

Language

AWS TYPE

Name of Product:

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

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.

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

Folding
205 mm----2----51.25
330 mm----3----41.25

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).

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.

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.

Date

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.
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 (affects less than 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
Uncommon (affects less than 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)
Rare (affects less than 1 in 1000 people)
- shortness of breath
Very rare (affects less than 1 in 10000 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.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton 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 in 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.
Terlipressin acetate 0.12 mg/ml solution for injection is packed into one carton with
5 ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the Member States of the EEA under the
following names:
Denmark:
Terlipressinacetat SUN 1 mg injektionsvæske, opløsning
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 acetaat SUN 1 mg oplossing voor injectie
Norway:
Terlipressin SUN 1 mg injeksjonsvæske, oppløsning
Spain:
Terlipresina SUN 0,12 mg/ml 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 March 2013.

044BP2045A

If any of the side effects become serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor, nurse or pharmacist.

5. How to store Terlipressin acetate 0.12 mg/ml solution for injection

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

14/03/2013 6:51:23 PM

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

Terlipressin acetate SUN-0-1 mg-ml-EUUK-205x330mm-PIL-07-01-13

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

Folding
205 mm----2----51.25
330 mm----3----41.25

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.

044BP2045A

Size: 330x205 mm
SUN EUROPE
EUUK

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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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