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VARIQUEL 1 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): TERLIPRESSIN DIACETATE

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Package leaflet:
Information for the user

Variquel
1 mg powder and solvent for solution for injection

IS Pharmaceuticals Limited
Office Village, Chester Business Park
Chester, CH4 9QZ, United Kingdom
Phone + 44 (0) 1244 625150
Fax + 44 (0) 1244 625151

Terlipressin acetate

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask you doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

In this leaflet:
1. What Variquel is and what it is used for
2. Before you use Variquel
3. How to use Variquel
4. Possible side effects
5. How to store Variquel
6. Further information
1. What Variquel is and what it is used for
Variquel is a synthetic pituitary hormone.
Variquel is used for treatment of bleeding from dilated
veins in the food pipe leading to your stomach (bleeding
oesophageal varices).
2. Before you use Variquel
Do not use Variquel
• if you are hypersensitive (allergic) to terlipressin or any
of the other ingredients of Variquel.
Take special care with Variquel
This medicine is administered 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 then 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 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 heart beats
(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) or 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 pregnant.
Using other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.
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)
• a type of medicine 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).
Using Variquel with food and drink
There are no limitations.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine. Variquel should only be used during pregnancy
if it is vital to treat your condition. It is not known if
Variquel is present in breast milk, therefore it is not known
if there may be an effect on your baby. You should discuss
the potential risk to your baby with your doctor.
Driving and using machines
No studies on the effects on the ability to drive and use
machines have been performed.
Important information about some ingredients of Variquel
After reconstitution with the accompanying solvent, this
medicinal product contains less than 1 mmol (23 mg) of
sodium per 5 ml, i.e. essentially “sodium-free“.
3. How to use Variquel
This medicine is not to be used by yourself but will always
be administered to you by your doctor. Please ask your
doctor for further information regarding its use.
Adults
Initially 1-2 mg terlipressin acetate equivalent to 1-2 vials
of Variquel are administered. Your dose will depend on
your body weight.
After the initial injection, your dose may be reduced to
1 mg every 4 to 6 hours.
The maximum dose you can receive each day is
approximately 120 micrograms/kg body weight.
Elderly
If you are over 70 years of age speak with your doctor
before you receive Variquel.
Children and adolescents
Variquel is not recommended for use in children and
adolescents due to insufficient experience.
Method and route of administration
The powder should be dissolved in the accompanying
solvent and is slowly injected intravenously.
Duration of treatment
The use is limited to 2 – 3 days, depending on the course
of your condition.

The following information is intended for medical or healthcare professionals only
Posology
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.

The therapy is to be limited to 2–3 days in adaptation to
the course of the disease.
Variquel is injected intravenously and should be given
over a period of one minute.
Variquel should only be used with caution in patients
over 70 years, and patients with chronic renal failure.

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

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

The approximate value for the maximum daily dose of
Variquel is 120 micrograms/kg body weight.

A dose adjustment is not required in patients with liver
failure.
p.t.o

If you use more Variquel than you should
You must not use more Variquel 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.
You may also experience a low heart rate. This can be
treated with a medicine called atropine.
If you forget to use Variquel
You will be given Variquel in hospital under the
supervision of your doctor
If you stop using Variquel
If you have any further questions on the use of this
product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, Variquel can cause side effects,
although not everybody gets them.
The assessment of side effects is based on the following
frequencies:
very common: more than 1 of 10 treated
common:

1 to 10 of 100 treated

uncommon:

1 to 10 of 1,000 treated

rare:

1 to 10 of 10,000 treated

very rare:

less than 1 of 10,000 treated

not known:

cannot be estimated from the available
data

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 Variquel. 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 any more Variquel to you.
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
heart beats, locally dead skin (necrosis), convulsions
(seizure), kidney failure.
Other possible side effects:
Metabolism and nutrition disorders
Uncommon: too little sodium in the blood
(hyponatraemia)
too much sugar in the blood
Very rare:
(hyperglycaemia)
Nervous system disorders
headache
Common:
Uncommon: triggering of a fit
stroke
Very rare:
Cardiac disorders
irregular heart beats, too slow heart rate,
Common:
signs of insufficient blood circulation in
the heart vessels in the ECG
Uncommon: chest pain due to insufficient blood
circulation in the heart vessels (angina
pectoris), rapid increase in blood pressure,
irregular heart rate, too fast heart rate
(palpitations), chest pain, heart attack,
excess fluid on the lungs
severe angina
Very rare:
Not known: heart failure
Vascular disorders
high blood pressure, low blood pressure,
Common:
insufficient blood circulation in arms, legs
and skin, paleness of face
Uncommon: insufficient blood flow to the intestines,
bluish colouration of the skin or lips, hot
flushes
Respiratory, thoracic and mediastinal disorders
Uncommon: pain in the chest, shortness of breath due
to spasm in the bronchial muscles, severe
difficulty with or stopping breathing
shortness of breath
Rare:
Gastrointestinal disorders
temporary abdominal cramps, temporary
Common:
diarrhoea
Uncommon: temporary nausea, temporary vomiting
Skin and subcutaneous tissue disorders
pale skin
Common:
Uncommon: inflammation of the lymph vessels
Not known: dead skin (necrosis) not related to the
injection site

Preparation of the injection:
Reconstitute the powder only with the solvent provided.
The entire contents of the solvent ampoule should be
slowly added to the powder vial and the vial rolled gently
until the powder is completely dissolved. The powder
should dissolve within 10 seconds. A clear colourless
solution results.
A further dilution to 10 ml with sterile sodium chloride
9 mg/ml (0.9%) solution for injection is possible.
The solution should be inspected visually for particles
and discolouration prior to administration.

Reproductive system and breast disorders
abdominal cramps (in women)
Common:
Pregnancy and postnatal conditions
Not known: uterine cramps, decreased blood flow to
the uterus
General disorders and administration site conditions:
Uncommon: locally dead skin (necrosis)
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. How to store Variquel
Keep out of the reach and sight of children.
Do not store above 25°C.
Keep the vial in the outer carton in order to protect from
light.
The reconstituted Variquel-solution has to be used
immediately.
Do not use Variquel after the expiry date which is stated
on the carton and the vial after ‘EXP‘. The expiry date
refers to the last date of that month.
Do not use Variquel if you notice
• that the powder does not dissolve in the accompanying
solvent
• that the solution discolours after dissolving the powder.
6. Further information

What Variquel contains
The active substance is terlipressin acetate.
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.
The other ingredients are:
The powder contains mannitol, acetic acid (for pH
adjustments).
The solvent contains sodium chloride, water for injections.
What Variquel looks like and contents of the pack
This medicine is presented as a powder and solvent for
solution for injection (a powder which is made into a
solution and then given as an injection). It is supplied
in clear glass vials containing a white to off-white solid
powder together with a clear glass ampoule containing
solvent. The powder must be dissolved in the solvent
prior to use.
Each vial contains 11 mg of powder
Each ampoule contains 5 ml of solvent
This medicine is available in pack sizes of:
1 vial with powder and 1 ampoule of solvent
5 vials with powder and 5 ampoules of solvent
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
IS Pharmaceuticals Limited,
Office Village, Chester Business Park,
Chester, CH4 9QZ,
United Kingdom
Manufacturer:
BAG Health Care GmbH,
Amtsgerichtsstrasse 1-5, D-35423 Lich,
Germany

This medicinal product is authorised in the Member States
of the EEA under the following names:
Belgium:
Denmark:
Finland:
France:

Germany:
Greece:
Ireland:
Italy:
Luxembourg:
Netherlands:
Norway:
Portugal:
Spain:
Sweden:
United Kingdom:

Variquel 1 mg
Variquel 1 mg
Stemflova 1 mg
Haemopressin 1 mg, poudre et
solvant pour solution injectable
Haemopressin 1 mg
Haemopressin 1 mg
Haemopressin 1 mg
Variquel 1 mg
Variquel 1 mg
Haemopressin 1 mg
Stemflova 1 mg
Variquel 1 mg
Variquel 1 mg
Variquel 1 mg
Variquel 1 mg

This leaflet was last approved in 05/2012

Do not use Variquel if you notice
• that the powder does not dissolve in the accompanying
solvent
• that the solution discolours after dissolving the powder.
Do not store the medicinal product above 25°C.
Keep the vial in the outer carton to protect from light.
After reconstitution the solution should be used
immediately.
For single use only. Discard any unused solution.

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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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