Variquel 1mg powder and solvent for solution for injection vials

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Terlipressin acetate

Saatavilla:

Alliance Pharmaceuticals Ltd

ATC-koodi:

H01BA04

INN (Kansainvälinen yleisnimi):

Terlipressin acetate

Annos:

1mg

Lääkemuoto:

Powder and solvent for solution for injection

Antoreitti:

Intravenous

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 06050200; GTIN: 5060084040083

Pakkausseloste

Variquel 1mg powder PIL UK 002
PACKAGE LEAFLET: INFORMATION FOR THE USER
VARIQUEL® 1 MG POWDER AND SOLVENT FOR 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 or pharmacist.
-
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, or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What Variquel is and what it is used for
2.
What you need to know before you use Variquel
3.
How to use Variquel
4.
Possible side effects
5.
How to store Variquel
6.
Contents of the pack and other information
1.
WHAT VARIQUEL IS AND WHAT IT IS USED FOR
Variquel is a synthetic pituitary hormone.
Variquel is used for the treatment of:

bleeding from dilated (widening) veins in the food pipe leading to
your stomach (bleeding
oesophageal varices).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VARIQUEL
YOU SHOULD NOT BE GIVEN VARIQUEL IF YOU:
-
are hypersensitive (allergic) to terlipressin or any of the other
ingredients of Variquel (see section 6).
WARNINGS AND PRECAUTIONS
This medicine is administered to you if you have:

severe or life-threatening bleeding in your food pipe (oesophagus).
It is given under continuous 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 yo

Valmisteyhteenveto

OBJECT 1
VARIQUEL 1MG POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 17-Oct-2017 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Variquel 1 mg powder and solvent for solution for injection
2. Qualitative and quantitative composition
Each vial of powder contains:
1 mg terlipressin acetate equivalent to 0.85 mg terlipressin.
1 ml of reconstituted solution contains 0.2 mg terlipressin acetate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection
White to off white solid powder and a clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
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.
Posology
Adults
Initially 1-2 mg terlipressin acetate (equivalent to 1-2 vials of
Variquel) are administered.
Depending on the patient's body weight the dose can be adjusted as
follows:
- Weight less than 50 kg: 1 mg.
- Weight 50 kg to 70 kg: 1.5 mg.
- Weight exceeding 70 kg: 2 mg.
After the initial injection, the dose can be reduced to 1 mg every 4
to 6 hours.
The approximate value for the maximum daily dose of Variquel is 120
μg/kg body weight.
Elderly
Variquel should only be used with caution in patients over 70 years
(see section 4.4).
Children and adolescents
Variquel is not recommended in children and adolescents due to
insufficient experience on safety and
efficacy (see section 4.4)
Renal insufficiency
Variquel should only be used with caution in patients with chronic
renal failure (see section 4.4).
Hepatic insufficiency
A dose adjustment is not required in patients with liver failure.
Method of administration
The therapy is to be limited to 2 – 3 days in adaptation