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Variquel 0.2mg/Ml Solution For Injection

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Document: leaflet MAH BRAND_PL 13538-0021 change

175mm

I 8 mm


Package leaflet: Information for the user


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Variquel

0.2mg/ml, solution for injection


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Terlipressin acetate


IS Pharmaceuticals Limited,

Office Village, Chester Business Park Chester, CH4 9QZ, United Kingdom Thone+^r(0n244 6251517 Fax + 44 (0) 1244 625151


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

j- Keep this leaflet. You may need to read it again.

^ If you have any further questions, ask your doctor, or pharmacist.

r 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.

j- 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.


FINAL SIZE FOLDED


What is in this leaflet


1. What Variquel is and what it is used for i2. What you need to know before you use Variquel 5. How to use Variquel j4. 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:

1- are hypersensitive (allergic) to terlipressin or any of the other ingredients of Variquel (see section 6).

Warnings and precautions

tlhis 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 ihe conditions below:

-    a severe infection known as septic shock

j- bronchial asthma or other conditions that affect your breathing

r 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 the arteries (arteriosclerosis)

-    irregular heart beats (cardiac arrythmias) or a history of QT interval prolongation (disturbance of heart rhythm)

-    poor blood circulation to your brain (e.g. you have had a stroke) or to your limbs (peripheral vascular disease)

r impaired kidney function (renal insufficiency)

-    disturbances in the level of salt (electrolytes) in your blood

1- reduced amount of fluid in your circulation or have already lost a large amount of blood

-    are over the age of 70 years are pregnant

Other medicines and Variquel

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescriptions.

Please inform your doctor immediately if you take any of the following medicines: r drugs that have an effect on your heart rate (e.g. beta-blockers, sufentanil or propofol) drugs that can trigger irregular beating of the heart J (axrhythmia) such as the following:

• anti-arryhthmic drugs known as Class IA (quinidine, procainamide, disopyramide) and Class III (amiodarone, sotalol, ibutilide, dofetilide)


•    erythromycin (an antibiotic)

•    antihistamines (mainly used to treat allergies but also found in certain cough and cold remedies)

•    tricyclic antidepressants used to treat depression

•    medicines that may alter the level of salt or electrolytes in your blood, particularly diuretics (water tablets used to treat high blood pressure and heart failure)

Pregnancy and breast-feeding

Variquel should only be used during pregnancy if it is vital to treat your condition. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if Variquel is present in breast milk, therefore the possible effects on your baby are unknown. You should discuss the potential risk to your baby with your doctor.

Ask your doctor or pharmacist for advice before taking anymedidne.______________

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, if you feel unwell after receiving the injection, do not drive or operate machinery.

Important information about some ingredients of Variquel

This medicinal product contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially "sodium-free".


J. How to use Variquel


This medicine will always be given to you by a doctor into your vein. The doctor will decide the most appropriate dose for you and your heart and blood circulation will be continuously monitored during the injection. Please ask your doctor for further information regarding its use.

Use in adults

Initially 1-2 mg terlipressin acetate (5-10 ml of Variquel) is given by injection into your vein. Your dose will depend on your body weight.

After the initial injection, your dose may be reduced to 1 mg terlipressin acetate (5 ml) every 4 to 6 hours.

Use in the elderly

If you are over 70 years of age speak with your doctor before you receive Variquel.

Use in patients with kidney problems

Variquel should be used with caution in patients with long standing kidney failure.

Use in patients with liver problems

Nodose adjustment is required in patients with liver— failure.

Use in children and adolescents

Variquel is not recommended for use in children and adolescents due to insufficient experience.

Duration of treatment

The use of this medicine is limited to 2 - 3 days, depending on the course of your condition.


The following information is intended for healthcare professionals only


Posology

Initial dose: 1 to 2 mg terlipressin acetate* (equivalent to

5 to 10 ml solution) is administered by intravenous___

injection over a period of one minute.

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

The therapy is to be limited to 2 to 3 days depending on the response to treatment and the course of the disease.


If you use more Variquel than you should

/Vs this medicine is given by a healthcare professional, then it is unlikely you will be given more than the recommended dose. If you are given too much then you may have a rapid increase in your blood pressure (this yvill be noticed during the continuous monitoring), especially if you already suffer with high blood pressure. If this happens then you will be given another medicine tailed an alpha blocker (e.g. clonidine) to control your blood pressure.--------------


Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Variquel


If you experience lightheadedness, dizziness, or feeling faint, tell your doctor because these could be signs of a low heart rate. This can be treated with another medicine called atropine.

If you forget to use Variquel

You will be given Variquel in hospital under the supervision of a doctor.

If you stop using Variquel

Your doctor will advise when it is time to stop receiving

khis medicine._______________

If you have any further questions on the use of this medicine, ask your doctor or nurse or pharmacist.


4. Possible side effects


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the vial after 'EXP' .The expiry date refers to the last day of that month.

Store in a refrigerator (2“C-8°C).

Keep the vial in the outer carton in order to protect from light. The solution should be inspected visually for particles and discolouration prior to administration.

Do not use this medicine if you notice discoloration.__

Do not throw away any medicines via wastewater or household waste. The doctor will dispose of this medicine. These measures will help protect the environment.


Like all medicines, this medicine can cause side effects, Although not everybody gets them.

Important side effects which need immediate Attention:

In very rare cases, there may be severe side effects when

you are given Variquel.____________

If you are affected by any of the following side effects, please tell your doctor immediately if you are able to. your doctor should not give you any more Variquel. 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 dead skin around the injection site (necrosis) convulsions (seizure) kidney failure.

Other possible side effects:

Common (affects less than 1 in 10 people):

very slow heart rate

signs of insufficient blood circulation in the heart vessels in the ECG high or low blood pressure insufficient blood circulation in arms, legs and skin paleness of face pale skin headache

temporary abdominal cramps--------

temporary diarrhoea abdominal cramps (in women)

Uncommon (affects less than 1 in 100 people):

chest pain

rapid increase in blood pressure heart attack

too fast heart rate (palpitations) swelling of the tissues in the body or fluid on the lungs bluish colouration of the skin or lips hot flushes


excess fluid on the lungs heart failure (Torsade de Pointes) temporary nausea temporary vomiting

reduced blood supply to the intestinal system uterine cramps

decreased blood flow to the uterus inflammation of the lymph vessels - seen as fine red streaks under your skin extending from the affected area to the armpit or groin and by fever, chills,

headache^ndmusdepam---------

dead skin (necrosis) in areas other than at the injection site

too little sodium in the blood (hyponatraemia) if not monitored

Rare (affects less than 1 in 1000 people):

shortness of breath

Very rare (affects less than 1 in 10,000 people):

stroke

results of blood tests

o too much sugar in the blood (hyperglycaemia)

The frequency of the following side effects is not known:

decreased blood flow to the uterus uterine cramps (cramps in the womb)


yariquel 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.

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

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


6. Contents of the pack and other information


What Variquel contains

-    the active substance is terlipressin acetate. Each vial contains 1 mg terlipressin acetate in 5 ml solution, corresponding to 0.85 mg terlipressin. Each ml contains 0.2 mg terlipressin acetate, corresponding to 0.17 mg terlipessin per ml.

-    the other ingredients are: glacial acetic acid, sodium acetate trihydrate and water for injections (see also end of section 2 for further information on sodium).

What Variquel looks like and contents of the pack

This medicine is supplied in a clear glass vial containing 5 ml of a clear, colourless solution.

This medicine is available in pack sizes of: 5 x 5ml Marketing Authorisation Holder IS Pharmaceuticals Limited

Office Village, Chester Business Park-------

Chester, CH4 9QZ, United Kingdom

Manufacturer

Rovi Contract Manufacturing, S.L., d Julian Camarillo n° 35,28037 Madrid, Spain.

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium:    Variquel 0.2mg/ml, oplossing voor

injectie

Denmark:    Variquel injektionsvaeske,

oplosning 0,2 mg/ml

Finland:    Variquel 0.2mg/ml, injektioneste, liuos

France:    Variquel, 0.2 mg/mL, solution injectable

Germany:    Variquel Losung, 0,2mg/ml, injektionslosung

Ireland:    Variquel Solution, 0.2mg/ml,

solution for injection

Italy:    Stemflova 0.2mg/ml, soluzione iniettabile

Luxembourg: Variquel Solution 0,2mg/ml, solution injectable

Netherlands: Variquel Oplossing 0.17mg/ml, oplossing voor injectie Portugal:    Variquel 1mg/5ml (0.2mg/ml),

-----solu^ao injetavel--------

Spain:    Variquel 1 mg, solucion inyectable

Sweden:    Variquel, 0,2mg/ml, injektionsvatska,

losning

UK:    Variquel, 0.2mg/ml, solution for injection

This leaflet was last revised in 10/2014.


Preparation of the injection

For administration, the required volume should be extracted from the vial with a syringe.

Store in a refrigerator (2°C-8°C)________

Keep the vial in the outer carton to protect from light. For single use only. Discard any unused solution.

From a microbiological point of view, after first opening, the product should be used immediately.


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