Terlipressin 1mg/8.5ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Terlipressin acetate

Available from:

Sun Pharmaceutical Industries Europe B.V.

INN (International Name):

Terlipressin acetate

Dosage:

120microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 8718531941458

Patient Information leaflet

R001
1
B. PACKAGE LEAFLET
R001
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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
Terlipressin acetate 0.12 mg/ml solution for injection is a synthetic
pituitary hormone.
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).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TERLIPRESSIN ACETATE 0.12
MG/ML SOLUTION FOR
INJECTION
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).
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

Summary of Product characteristics

OBJECT 1
TERLIPRESSIN ACETATE 0.12 MG/ML SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 23-Jan-2018 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
1. Name of the medicinal product
Terlipressin acetate SUN 0.12 mg/ml solution for injection
2. Qualitative and quantitative composition
One ampoule contains 1 mg terlipressin acetate in 8.5 ml solution for
injection, corresponding to 0.85 mg
terlipressin.
Each ml contains 0.12 mg terlipressin acetate, corresponding to 0.1 mg
terlipressin.
Excipient(s) with known effect:
Sodium.
Each ampoule contains 1.142 mmol (26.272 mg) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear colourless solution, with pH between 3.7 and 4.2, and osmolality
between 290 and 360 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Terlipressin is indicated in the treatment of bleeding oesophageal
varices.
4.2 Posology and method of administration
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.
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.
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).
After the initial injection, the dose can be reduced to 1 mg
terlipressin acetate every 4 to 6 hours.
The approximate value for the maximum daily dose of Terlipressin
acetate SUN 0.12 mg/ml solution for
injection is 120 μg terlipressin acetate per kg body weight.
The therapy is to be limited to 2 – 3 days in adaptation to the
course of the diseas