Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Terlipressin acetate

Tilgængelig fra:

EVER Valinject GmbH

ATC-kode:

H01BA04

INN (International Name):

Terlipressin acetate

Dosering:

0.2 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Terapeutisk område:

terlipressin

Autorisation status:

Marketed

Autorisation dato:

2021-04-30

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TERLIPRESSIN ACETATE EVER PHARMA 0.2 MG/ML SOLUTION FOR INJECTION
_ _
terlipressin 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 EVER Pharma is and what it is used for
2. What you need to know before you are given Terlipressin acetate
EVER Pharma
3. How Terlipressin acetate EVER Pharma will be given
4. Possible side effects
5. How to store Terlipressin acetate EVER Pharma
6. Contents of the pack and other information
1. WHAT TERLIPRESSIN ACETATE EVER PHARMA IS AND WHAT IT IS USED FOR
Terlipressin acetate EVER Pharma contains the active ingredient
terlipressin, which is a synthetic
pituitary hormone (this hormone is usually produced by the pituitary
gland found in the brain).
It will be given to you by injection into a vein.
Terlipressin acetate EVER Pharma is used for the treatment of:
• bleeding from dilated (widening) veins in the food pipe leading to
your stomach (called
bleeding oesophageal varices).
• emergency treatment of type 1 hepatorenal syndrome (rapidly
progressive renal failure) in
patients with liver cirrhosis
(scarring of the liver) and ascites (abdominal dropsy).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TERLIPRESSIN ACETATE
EVER PHARMA
YOU SHOULD NOT RECEIVE TERLIPRESSIN ACETATE EVER PHARMA:
- If you are allergic to terlipressin or any of the other ingredients
of this medicine (listed in section 6)
- If you are pregnant.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Terlipressin acetate
EVER Pharma:
- If you have a severe infection known as septic shock
- If you have bronchial asthma or other conditions that affect your
breathin

Produktets egenskaber

Health Products Regulatory Authority
18 July 2023
CRN00DQ9F
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of injection solution contains 1 mg terlipressin acetate
corresponding to 0.85 mg terlipressin.
10 ml of injection solution contains 2 mg terlipressin acetate
corresponding to 1.7 mg terlipressin.
Each ml contains 0.2 mg terlipressin acetate corresponding to 0.17 mg
terlipressin
Excipient with known effect:
Each ml contains 3.68 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear colourless aqueous solution with a pH of 4.0 – 5.0 and an
osmolarity of 270 - 330 mOsm/L.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of bleeding oesophageal varices.
Emergency treatment of type 1 hepatorenal syndrome, as defined by IAC
(International Ascites Club) criteria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_ _
_Adults_
1) Short term management of bleeding oesophageal varices:
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.
Initial dose: The recommended initial dose is 1 to 2 mg terlipressin
acetate
#
(equivalent to 5 to 10 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 (5 ml)
- weight 50 kg to 70 kg:
1.5 mg terlipressin acetate (7.5 ml)
- weight exceeding 70 kg:
2 mg terlipressin acetate (10 ml).
Maintenance dose: After the initial injection, the dose can be reduced
to 1 mg terlipressin acetate every 4 to 6 hours.
#
1 to 2 mg terlipressin acetate corresponding to 0.85 to 1.7 mg
terlipressin
The approx