Variquel 1mg/5ml 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:

200microgram/1ml

Lääkemuoto:

Solution for injection

Antoreitti:

Intravenous

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 06050200; GTIN: 5060084040137

Pakkausseloste

Variquel solution PIL UK 001
PACKAGE LEAFLET: INFORMATION FOR THE USER
VARIQUEL
®
, 0.2MG/ML, 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 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.
Variquel 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 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 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 below:
-
a severe infection known as septic shock
-
bronchial asthma or other conditions that affect your breathing
-
uncontrolled high blood pressure, insufficient blood circulation in
the heart vessels (e.g.

Valmisteyhteenveto

OBJECT 1
VARIQUEL 0.2 MG/ML, SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 26-Aug-2016 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Variquel 0.2 mg/ml, solution for injection
2. Qualitative and quantitative composition
Each 5 ml of injection solution contains 1 mg terlipressin acetate
corresponding to 0.85 mg terlipressin.
Each ml contains 0.2 mg terlipressin acetate corresponding to 0.17 mg
terlipressin
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear colourless aqueous solution with a pH of 5.7 – 6.3 and an
osmolarity of 270 - 330 mOsm/L.
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.
For intravenous use only. The solution should be inspected prior to
administration. Do not use Variquel if
it contains particles or is discoloured.
For administration, the required volume should be extracted from the
vial with a syringe.
_Adults_
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 50kg 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 approximate value for the maximum daily dose of Variquel is 120
μg/kg body weight.
The therapy is to b