PLYZARI 6 mg /Ml Преднаполненный Инъекционный Раствор В Ручке

Содержание инструкции

1. Plyzari 6 mg/ml injectable solution in pre-filled pen
   1. What is Plyzari and what is it used for
   2. What you need to know before you use Plyzari
   3. How to use Plyzari
   4. Possible side effects
   5. How to store Plyzari
   6. Content of the pack and other information

Plyzari 6 mg/ml injectable solution in pre-filled pen

Liraglutide
Generic medicine

Read this leaflet carefully before you start to use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Plyzari is and what it is used for
• 2. What you need to know before you use Plyzari
• 3. How to use Plyzari
• 4. Possible side effects
• 5. How to store Plyzari
• 6. Contents of the pack and other information

1. What is Plyzari and what is it used for

What is Plyzari
Plyzari is a medicine used for weight loss that contains the active ingredient liraglutide. It is similar to a
hormone found naturally in the body, called glucagon-like peptide-1 (GLP-1), which is released
from the intestine after a meal. Plyzari acts on receptors in the brain that control appetite,
causing a feeling of increased fullness and reduced hunger. This can help you eat less
food and reduce body weight.

What is Plyzari used for
Plyzari is used for weight loss in addition to diet and exercise in adults 18 years of age and older
with

• a body mass index (BMI) of 30 kg/m² or more (obesity)
• a body mass index (BMI) of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal fat levels in the blood, or breathing problems called ‘obstructive sleep apnea’). BMI is a measure of weight in relation to height.

Continue using Plyzari only if you have lost at least 5% of your body weight after 12
weeks with a daily dose of 3.0 mg per day (see section 3). Consult your doctor
before continuing.
Plyzari is used for weight loss in addition to a healthy diet and exercise in
adolescents 12 years of age and older with:

• obesity (diagnosed by the doctor)
• body weight greater than 60 kg

Continue using Plyzari only if you have lost at least 4% of your BMI after 12 weeks
with a dose of 3.0 mg per day or with the maximum tolerated dose (see section 3). Consult your
doctor before continuing.

Diet and exercise
Your doctor will start you on a diet and exercise program. Continue this program
while using Plyzari.

2. What you need to know before you use Plyzari

Do not use Plyzari

• if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Plyzari.
The use of Plyzari is not recommended if you suffer from severe heart failure.
There is limited experience in the use of this medicine with patients aged 75 years or older. The use of
Plyzari is not recommended if you are 75 years or older.
There is limited experience in the use of this medicine in patients with kidney problems. If you have
kidney disease or are on dialysis, consult your doctor.
There is limited experience in the use of this medicine in patients with liver problems. If you have
liver problems, consult your doctor.
The use of this medicine is not recommended if you have severe problems with your stomach or intestines, which
manifest with delayed stomach emptying (called gastroparesis), or if you have inflammatory bowel disease.
If you know that you are going to have surgery with anesthesia (falling asleep), tell your doctor that
you are taking Plyzari.
People with diabetes
If you have diabetes, do not use Plyzari as a substitute for insulin.
Pancreatitis
Talk to your doctor if you have or have had a disease of the pancreas.
Inflammation and gallstones
If you lose a substantial amount of weight, you are at risk of gallstones with resulting
inflammation of this organ. Stop treatment with Plyzari and contact your doctor immediately if you experience severe pain in the right side of your abdomen, below the ribs, which usually
may worsen. The pain may be felt up to reaching your back or right shoulder.
See section 4.
Thyroid disease
If you have thyroid diseases, including nodules and enlargement of the thyroid gland, consult your
doctor.
Heart rate
Talk to your doctor if you have palpitations (feeling your heartbeat) or if you feel a
rapid heartbeat at rest during treatment with Plyzari.
Fluid loss and dehydration
When you start treatment with Plyzari, you may lose body fluids or become dehydrated. This may be
due to feeling unwell (nausea), feeling sick (vomiting) and diarrhea. It is important to avoid
dehydration by drinking plenty of fluids. If you have any questions or concerns, talk to your doctor, your
pharmacist or nurse. See section 4.

Children and adolescents
The safety and efficacy of Plyzari have not been studied in children and adolescents under the age of
12 years.

Other medicines and Plyzari
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicine.
In particular, talk to your doctor, pharmacist or nurse if:

• you are taking medicines for diabetes called ‘sulfonylureas’ (such as glimepiride or glibenclamide) or if you are taking insulin - your blood sugar level may decrease (hypoglycemia) when using these medicines with Plyzari. Your doctor may adjust the dose of your diabetes medicines to avoid a decrease in your blood sugar level. See section 4 for the warning signs of low blood sugar. If you adjust the dose of insulin, your doctor will recommend that you check your blood sugar more frequently.
• you are taking warfarin or other oral medicines to reduce blood clotting (anticoagulants). More frequent blood tests may be needed to determine your blood's ability to clot.

Pregnancy and breastfeeding
Do not use Plyzari if you are pregnant, suspect you may be pregnant or are planning a pregnancy because
it is not known whether Plyzari may have effects on the fetus.
Do not breastfeed while using Plyzari. This is because it is not known whether Plyzari passes into breast milk.

Driving and using machines
It is unlikely that Plyzari will affect your ability to drive and use machines. Some patients
may experience dizziness while taking Plyzari, especially during the first 3 months of
treatment (see the section "Possible side effects"). If you feel dizzy, be especially
careful when driving or using machines. For more information, talk to your doctor.

Plyzari contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say it is essentially
‘sodium-free’.

3. How to use Plyzari

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor, pharmacist or nurse.
Your doctor will start you on a diet and exercise program. Continue this program
while using Plyzari.

Amount to inject

Adults
Treatment will begin at a low dose that will be gradually increased over the first five
weeks of treatment.

• When you start using Plyzari for the first time, the initial dose is 0.6 mg once a day, for at least one week.
• Your doctor will tell you to gradually increase the dose of 0.6 mg, usually every week, until you reach the recommended dose of 3.0 mg once a day. Your doctor will tell you how much Plyzari to use each week. Usually you will be told to follow the table below.

Once you reach the recommended dose of 3.0 mg in week 5 of treatment, continue to use
this dose until the end of the treatment period. Do not increase the dose further.
Your doctor will evaluate your treatment at regular intervals.

Adolescents (≥ 12 years)
For adolescents aged 12 to less than 18 years, the dose should be increased similarly to that
reported in the table above for adults. The dose should be increased until reaching 3.0
mg (maintenance dose) or the maximum tolerated dose. Doses higher than 3.0 mg daily are not recommended.

How and when to use Plyzari

• Before using the pen for the first time, your doctor or nurse will show you how to do it.
• You can use Plyzari at any time of day, with or without food and drinks.
• Use Plyzari approximately at the same time each day; choose a time of day that is convenient for you.

Where to inject
Plyzari is administered by injection under the skin (subcutaneous injection).

• The best areas to inject are the abdomen, the front of the thighs, or the upper arms.
• Do not inject the medicine into a vein or a muscle.

Injection needles are not included with the pen. For example, BD Ultra-Fine single-use needles or NovoFine thin single-use needles up to 32 G and up to 8 mm long can be used.
Detailed instructions for use are provided on the back of this leaflet.

People with diabetes
Tell your doctor if you have diabetes. Your doctor may adjust the dose of diabetes medications
to avoid a decrease in blood sugar levels.

• Do not mix Plyzari with other injectable medicines (e.g. insulins).
• Do not use Plyzari together with other medicines that contain GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more Plyzari than you should
If you use more Plyzari than you should, inform your doctor immediately or go to the hospital. Bring
the medicine packaging with you. You may need medical treatment. The following effects may occur:

• Feeling unwell (nausea)
• Illness (vomiting)
• low blood sugar (hypoglycemia). See “Common side effects” for the warning signs of low blood sugar.

If you forget to use Plyzari

• If you forget a dose and notice it within 12 hours of when you usually use the dose, inject it as soon as you remember.
• However, if more than 12 hours have passed since you should have used Plyzari, skip the missed dose and inject the next one the next day at the usual time.
• Do not use a double dose or increase the dose the next day to make up for the missed dose.

If you stop using Plyzari
Do not stop treatment with Plyzari without talking to your doctor.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects
Rarely, some serious allergic reactions (anaphylaxis) have been reported in patients using
Plyzari. Seek immediate medical attention if you experience symptoms such as breathing problems,
swelling of the face and throat, and a fast heartbeat.
Cases of inflammation of the pancreas (pancreatitis) in patients using Plyzari have been reported uncommonly.
Pancreatitis is a serious condition that can be potentially life-threatening.
If you notice any of the following serious side effects, stop Plyzari and contact your doctor immediately:

• Severe and persistent abdominal (stomach area) pain that can reach the back, as well as nausea and vomiting, may be a sign of inflammation of the pancreas (pancreatitis).

Other side effects
Very common:affects more than 1 in 10 people

• Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation, headache - generally disappear after a few days or weeks

Common:affects up to 1 in 10 people

• Problems with the stomach and intestines, such as indigestion (dyspepsia), inflammation of the stomach lining (gastritis), stomach pain, upper abdominal pain, heartburn, abdominal bloating, gas (flatulence), belching and dry mouth
• Feeling weak or tired
• Changes in sense of taste
• Dizziness
• Difficulty sleeping (insomnia). Usually occurs during the first 3 months of treatment
• Gallstones
• Skin rash
• Reactions at the injection site (such as bruising, pain, irritation, itching and rash)
• Low blood sugar (hypoglycemia). Signs of low blood sugar can occur suddenly and may include: cold sweat, cold and pale skin, headache, fast heartbeat, nausea, feeling very hungry, changes in vision, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating and trembling. Your doctor will tell you how to treat low blood sugar levels and what to do if you notice these signs
• Increased pancreatic enzymes, such as lipase and amylase.

Uncommon:affects up to 1 in 100 people

• Loss of fluids (dehydration). This is more likely to occur at the beginning of treatment and may be caused by feeling sick (vomiting), feeling unwell (nausea) and diarrhoea
• Delayed stomach emptying
• Inflammation of the gallbladder
• Allergic reactions including skin rash
• Feeling generally unwell
• Fast heartbeat.

Rare:affects up to 1 in 1,000 people

• Reduced kidney function
• Acute kidney failure. Signs may include reduced urine volume, metallic taste in the mouth, and easy bruising.

Not known(frequency cannot be estimated from available data)

• Bowel obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Plyzari

Keep this medicine out of sight and reach of children.
Do not use Plyzari after the expiry date which is stated on the pen label and the carton after
‘Exp.’. The expiry date refers to the last day of that month.
Before first use:
Store in a refrigerator (2°C - 8°C). Do not freeze.
After you have started using the pen:
You can store the pen for 1 month below 30°C or in a refrigerator (2 °C - 8 °C). Do not freeze.
Keep away from the freezer compartment.
When you are not using the pen, store it with the cap on to protect the medicine from light.
Do not use the medicine if the solution is not clear and colourless or almost colourless.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Plyzari contains

• The active ingredient is liraglutide. 1 ml of injectable solution contains 6 mg of liraglutide. One pre-filled pen contains 18 mg of liraglutide.
• The other excipients are sodium citrate dihydrate, propylene glycol, phenol and water for injections. In addition, hydrochloric acid and sodium hydroxide may be added to adjust the pH.

Description of the appearance of Plyzari and contents of the pack
Plyzari is supplied as a clear and colourless to almost colourless injectable solution, in a pen
pre-filled. Each pen contains 3 ml of solution and is able to deliver doses of 0.6 mg, 1.2 mg,
1.8 mg, 2.4 mg and 3.0 mg.
Plyzari is available in packs containing 1, 3 or 5 pens. Not all pack sizes
may be marketed.
Needles are not included.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin
Industrial Park,
Paola PLA 3000,
Malta.

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria: Luntin 6 mg/ml Injektionslösung in einem Fertigpen
Sweden, Norway, Germany: Nevolat
Spain: Plyzari 6mg/ml solución inyectable en pluma precargada
Poland, Czech Republic, Italy, Portugal: Plyzari
Netherlands: Nevolat 6 mg/ml oplossing voor injectie in een voorgevulde pen
Hungary: Nevolat 6 mg/ml oldatos injekció előretöltött injekciós tollban
France: LIENDAX 6 mg/mL, solution injectable en stylo prérempli

Instructions for use of Plyzari 6 mg/ml solution
for injection in a pre-filled pen
Read these instructions carefullybefore using
the Plyzari pre-filled pen.

Do not use the pen without having received
adequate trainingfrom your doctor or
nurse. Start by checking the pen for

making sure it contains Plyzari 6 mg/ml, then
look at the illustrations below to learn the
different parts of the pen and the needle.

If you are blind or have severe visual impairment and
cannot read the dose counter on the
pen, do not use this pen without help.Ask
for help from a person who has good eyesight and is
trained in the use of the Plyzari pre-filled pen.
The pen is a pre-filled pen with a selectable dose.
It contains 18 mg of liraglutide and delivers
doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. For
use of this device, single-use needles BD Ultra-fine or NovoFine are recommended.
Needles are not included in the pack.

Important information
Pay particular attention to these notes because they are
important for safe use of the pen.

1 Preparing the pen with a new needle

• Check the name and the coloured labelof the pen to make sure it contains Plyzari. This is particularly important if you are using more than one type of injectable medicine. Using the wrong medicine can be harmful to your health.
• Remove the cap from the pen.

Check that the solution in the pen is clearand
colourless. Look through the pen window. If the
solution appears cloudy, do not use the pen.

Take a new needleand remove the protective seal.

Press the needle firmly straight onto the pen. Rotate it until
it locks into place.

Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.	a c o
Remove the inner needle cap and throw it away. If you try to put it back on, you could accidentally puncture yourself with the needle. A drop of solution may appear on the tip of the needle. This is normal, but you should still check the flow if you are using a new pen for the first time. Do not attach a new needle to the pen until you are ready to give the injection. Always use a new needle for each injection. This prevents needle blockages, contamination, infection and incorrect dosing. Never use a bent or damaged needle.	e l F a r m
2 Checking the flow Check the flow before your first injection with each new pen. If your pen has already been used, go directly to step 3 n ‘Selecting the dose’. Rotate the dose selector to the symbol until the dose counter shows the flow control symbol. i Hold the pen with the needle pointing upwards. a Press and hold the injection button until the dose counter returns to 0. t 0 must align with the dose indicator. I A drop of solution should appear on the tip of the needle. a A small drop may remain on the tip of the needle, but it will not be injected. i If no drop appears, repeat step 2 “Checking the flow with each new pen” up to 6 times. If no drop still appears, change the needle and repeat step 2 “Checking the flow with each new pen” again. z If no drop appears, discard the pen and use a new one. n Always make sure a drop appears on the tip of the needle before using a new pen for the first time. The presence of the drop ensures the solution flows. e If the drop does not appear, the medicine will not be injected, even if the dose counter may move. This situation may indicate a blocked or damaged needle.	a d

If you do not check the flow before the first injection
with each new pen, you may not inject the prescribed
dose and not get the desired effect of Plyzari.

3 Selecting the dose

• Rotate the dose selector until the

counter shows the dose (0.6 mg,
1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).
If you select the wrong dose, you can correct it by rotating
the dose selector forwards or backwards. The pen can
select a maximum of 3.0 mg.
The dose selector changes the dose. Only the
dose counter and the dose indicator
show how many mg have been selected for each
dose.
You can select up to 3.0 mg per dose. When the
pen contains less than 3.0 mg, the dose counter will
stop before displaying 3.0.
The dose selector makes a different click if
rotated forwards, backwards or if it exceeds the number
of mg remaining. Do not count the clicks of the pen.

Always use
the dose counter and the dose
indicator to see how many mg have
been selected before injecting the medicine.
Do not count the clicks of the pen.
Do not use the pen scale, which only
approximately shows how much solution is
left in the pen.

Only doses of 0.6 mg, 1.2 mg, 1.8
mg, 2.4 mg or 3.0 mg must be
selected with the dose selector.The selected dose must
align precisely with the dose indicator to ensure that a
correct dose is delivered.

How much solution is left?

• The pen scaleshows approximatelyhow much solution is left in the pen.
• To see precisely how much solution isleft,use the dose counter: rotate the dose selector until the dose counterstops. If it shows 3.0, there are at least 3.0 mgleft in the pen. If the dose counter stops before 3.0 mg, it means there is not enough solution left for a full 3.0 mg dose.

If you need more medicine than is left in the
pen
Only after receiving specific training or
instructions from your doctor or nurse, you can divide
the dose between the pen currently in use and a new pen.
Use a calculator to plan the doses
according to the instructions of your doctor or nurse.

Be very careful to calculate the correct dose. If you are unsure how to divide the dose between two pens, select and inject the dose you need using a new pen.	a r m a c o
4 Injecting the dose Insert the needle into the skin as shown to you by your doctor or nurse. Make sure you can see the dose counter. Do not cover it with your fingers to avoid interrupting the injection.	a d e l F
n Press and hold the injection button. Watch as the dose counter returns to 0. 0 must align with the dose indicator. You may feel or hear a click. I
Keep the needle in the skin until the dose counter has returned to 0 and count slowly to 6. a If the needle is removed before this, you may notice a z flow of solution leaking from the tip of the needle. In this case, the entire dose will not be injected. e
A Remove the needle from the skin. If blood appears at the injection site, apply light pressure. Do not rub the area. After the injection, you may see a drop of solution on the tip of the needle. This is normal and does not affect the dose just administered.

Always look at the dose counter to know

how many mg you are injecting.Keep the
injection button pressed until the dose
counter shows 0.

How to identify a blocked or damaged needle?

• If a 0 does not appear on the dose counter after continuously pressing the injection button, it is possible that a blocked or damaged needle has been used.
• In this case - nomedicine will have been administered - even if the dose counter has moved from the originally set dose.

How to manage a blocked needle?
Replace the needle as described in step 5 “After
the injection” and repeat all steps starting from
step 1 “Preparing the pen with a new
needle”. Make sure to select the entire dose needed.

Do not touch the dose counter during
the injectionto avoid interrupting the injection.

5 After the injection

• Insert the tip of the needle into the outer capresting it on a flat surface, without touching the needle or the outer needle cap.
• When the needle is covered,press the outer needle cap fully

down.

• Unscrew the needleand dispose of it carefully.
• Put the pen cap back on the penafter each use to protect the solution from light.

Always dispose of the needle after each injectionto
ensure comfortable injections and prevent blocked needles. If
the needle is blocked, it will notinject any medicine.
When the pen is empty, discard it withoutthe needle attached
as instructed by your doctor, nurse, pharmacist or
local authorities.

Never try to replace the inner cap
of the needle.You may prick yourself with the needle.

Always remove the needle from the pen after each
injection.