Victoza 6 mg/ml solucion inyectable en pluma precargada
Introduction
Label: information for the user
Victoza 6mg/ml injectable solution in pre-filled pen
liraglutida
Read this label carefully before starting to use this medicine,because it contains important information for you.
- Keep this label, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.
1. What is Victoza and how is it used
Victoza contains the active ingredient liraglutide. It helps your body reduce your blood sugar level only when this level is too high. Additionally, it slows down the passage of food through your stomach and may help prevent heart disease.
Victoza is used alone if your blood sugar level is not adequately controlled solely with diet and exercise, and you cannot use metformin (another diabetes medication).
Victoza is used in combination with other diabetes medications when these are insufficient to control your blood sugar level. These may be:
- oral anti-diabetic medications [such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter 2 (SGLT2) inhibitors] and/or insulin.
2. What you need to know before starting to use Victoza
No use Victoza
- If you are allergic to liraglutide or any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse:
- Before starting to use Victoza.
- If you have or have had a pancreatic disease.
If you are aware that you will undergo a surgical procedure under anesthesia (sleep state), inform your doctor that you are taking Victoza.
This medication should not be used if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels and increased respiratory effort). It is not an insulin and should not be used as an insulin substitute.
Victoza should not be used if you are on dialysis.
Victoza should not be used if you have severe liver disease.
The use of Victoza is not recommended if you have severe heart failure.
Victoza should not be used if you have a severe stomach or intestinal problem that causes delayed stomach emptying (called gastroparesis), or inflammatory bowel disease.
If you experience symptoms of acute pancreatitis, such as intense and persistent stomach pain, you should consult your doctor immediately (see section 4).
If you have thyroid disease, including thyroid nodules and thyroid gland enlargement, consult your doctor.
In some cases, when starting treatment with Victoza, dehydration (loss of fluids) may occur, for example, in the case of vomiting, nausea, and diarrhea. It is essential to avoid dehydration by drinking plenty of fluids. Consult your doctor if you have any doubts.
Children and adolescents
Victoza can be used in adolescents and children aged 10 years and older. There are no available data in children under 10 years of age.
Other medications and Victoza
Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.
Specifically, inform your doctor, pharmacist, or nurse if you are using medications containing any of the following active ingredients:
- Sulfonilurea (such as glimepiride or glibenclamide) or insulin. You may experience hypoglycemia (low blood sugar) when using Victoza with a sulfonilurea or insulin, as sulfonilureas and insulin increase the risk of hypoglycemia. When starting to use these medications together for the first time, your doctor may instruct you to reduce the dose of sulfonilurea or insulin. For more information on hypoglycemia warning symptoms, see section 4. If you are also taking a sulfonilurea (such as glimepiride or glibenclamide) or insulin, your doctor may request blood sugar level tests. This will help your doctor decide if you need to change the dose of sulfonilurea or insulin.
- If you are receiving insulin, your doctor will instruct you to reduce the dose of insulin and recommend that you monitor your blood sugar levels more frequently to avoid hyperglycemia (high blood sugar levels) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough insulin).
- Warfarin or other anticoagulant medications. You may need more frequent blood tests to determine your blood clotting ability.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Victoza should not be used during pregnancy because it is unknown whether it could harm the fetus.
It is unknown whether Victoza passes into breast milk, therefore, do not use this medication during lactation.
Driving and operating machinery
Low blood sugar levels (hypoglycemia) may impair your concentration. Avoid driving or operating machinery if you experience symptoms of hypoglycemia. See section 4 for more information on hypoglycemia warning symptoms. Consult your doctor for more information.
Important information about some components of Victoza
This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.
Consultar lainformoacuteacute;n sobre eluso de este medicameto ensuéto.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Severe side effects
Frequent: can affect up to 1 in 10 people
- Hypoglycemia (low blood sugar). Warning signs of low blood sugar may appear suddenly and include: cold sweat, pale and cold skin, headache, palpitations, nausea, excessive appetite, visual disturbances, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating, and tremors. Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs. This is more likely to happen if you also use a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before starting Victoza.
Rare: can affect up to 1 in 1,000 people
- Severe allergic reaction (anaphylactic reaction) with additional symptoms such as respiratory problems, throat and face swelling, palpitations, etc. If you notice any of these symptoms, seek medical help immediately and consult your doctor as soon as possible.
- Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
Very rare: can affect up to 1 in 10,000 people
- Cases of pancreatitis (inflammation of the pancreas). Pancreatitis can be a serious and potentially life-threatening disease. Stop using Victoza and contact your doctor immediately if you notice any of the following severe side effects:
- Intense and persistent abdominal pain (stomach area) that can reach the back, as well as nausea and vomiting, which could be a sign of pancreatitis (pancreatitis).
Other side effects
Frequently: can affect more than 1 in 10 people
- Nausea. This effect usually disappears over time.
- Diarrhea. This effect usually disappears over time.
Frequent
- Vomiting.
When starting treatment with Victoza, in some cases, you may experience fluid loss/dehydration. For example, in cases of vomiting, nausea, and diarrhea. It is essential to avoid dehydration by drinking plenty of fluids.
- Headache
- Indigestion
- Stomach inflammation (gastritis). Symptoms include stomach pain, nausea, and vomiting.
- Gastroesophageal reflux disease (GERD). Symptoms include heartburn.
- Abdominal bloating or abdominal pain
- Abdominal discomfort
- Constipation
- Flatulence (gas)
- Loss of appetite
- Bronchitis
- Common cold
- Dizziness
- Palpitations
- Fatigue
- Toothache
- Reactions at the injection site (hematomas, pain, irritation, itching, and rash).
- Increased pancreatic enzymes (such as lipase and amylase).
Poorly frequent: can affect up to 1 in 100 people
- Allergic reactions such as pruritus (itching) and urticaria (a type of skin rash)
- Dehydration, sometimes with decreased renal function
- Discomfort (not feeling well)
- Galstones
- Inflamed gallbladder
- Change in taste
- Delayed gastric emptying.
Frequency unknown: cannot be estimated from available data
•Under the skin, lumps may occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this occurrence is unknown).
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.
5. Victoza Storage
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the label and on the pen after CAD. The expiration date is the last day of the month indicated.
Before use:
Store in refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer.
During use:
You can store the pen for a month if it is stored below 30°C or in refrigerator (between 2°C and 8°C), away from the freezer. Do not freeze.
When not in use, store the pen with the cap on to protect it from light.
Do not use this medication if you observe that the solution is not transparent and is colored or almost colorless.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Victoza
- The active ingredient is liraglutide.1ml of injectable solution contains 6mg of liraglutide. A pre-filled pen contains 18mg of liraglutide.
- The other components are disodium dihydrogen phosphate, propylene glycol, phenol, and water for injection preparations.
Appearance of the product and contents of the pack
Victoza is supplied as a transparent and colourless or almost colourless injectable solution in a pre-filled pen. Each pen contains 3ml of solution, which can administer 30doses of 0.6mg, 15doses of 1.2mg or 10doses of 1.8mg.
Victoza is available in packs of 1, 2, 3, 5 or 10pre-filled pens. Only some pack sizes may be marketed.
The needles are not included.
Marketing authorisation holder and manufacturer responsible
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Last update of this leaflet:
Other sources of information
The detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu
INSTRUCTIONS FOR USE OF THE VICTOZA PEN Read these instructions carefully before using your pen. Your pen contains 18mg of liraglutide..You can select doses of 0.6mg, 1.2mg and 1.8mg.. The pen is designed to be used with disposable NovoFine or NovoTwist injection needles of up to 8mm in length and a gauge of up to 32G (0.25/0.23mm). | |
Preparing the pen Check the name and colour of the labelof your pen to ensure it contains liraglutide. Using the wrong medicine could cause serious harm. Remove the pen cap. | |
Remove the paper clip from a new disposable needle. Screw the needle straight and firmly onto the pen. | |
Remove the outer needle cap and store it for later use. | |
Remove the inner needle cap and discard it. | |
Always use a new needle for each injection. This reduces the risk of contamination, infection, loss of liraglutide, needle blockage and inaccurate dosing. Be careful not to bend or damage the needle. Never attempt to reattach the inner needle cap. You may prick yourself with the needle. | |
Maintaining your pen
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Important information
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Check the flow with each new pen Check the flow before the first injection with each new pen. If your pen is already in use, go to “Selecting the dose”, step H. Turn the dose selector until the indicator shows the flow check symbol. | |
Hold the pen with the needle pointing upwards. Gently tap the cartridge several times with your finger. This concentrates the air bubbles at the top of the cartridge. | |
Hold the needle pointing upwards and press the plunger until the indicator shows 0mg. A drop of liraglutide should appear at the needle tip. If no drop appears, repeat steps E to G up to four times. If no drop still appears, change the needle and repeat steps E to G once more. Do not use the pen if no drop has appeared. This indicates that the pen is faulty and you should use a new one. | |
If you have dropped the pen on a hard surface or suspect it is not working correctly, always place a new disposable needle and check the flow before using it. | |
Selecting the dose Always check that the indicator shows 0mg. Turn the dose selector until the indicator shows the required dose (0.6mg, 1.2mg or 1.8mg). If you select the wrong dose by mistake, to change it, simply turn the dose selector backwards or forwards until the indicator shows the correct dose. Be careful not to press the injection plunger while turning the dose selector backwards, as liraglutide may be released. If the dose selector stops before the indicator shows the required dose, it means there is not enough liraglutide left for a full dose. In this case, you can: Divide your dose into two injections: Turn the dose selector in either direction until the indicator shows 0.6mg or 1.2mg. Inject the dose. Then prepare a new pen and inject the remaining mg to complete your dose. You should only divide your dose between the current pen and a new pen if you have received adequate training or advice from your healthcare professional. Use a calculator to plan your doses. If you divide your dose incorrectly, you may inject too much or too little liraglutide. Inject the full dose with a new pen: If the dose selector stops before the indicator shows 0.6mg, prepare a new pen and inject the full dose. | |
Do not attempt to select doses other than 0.6mg, 1.2mg or 1.8mg. The numbers on the display must be aligned exactly with the indicator to ensure you receive the correct dose. You will hear a click each time you turn the dose selector.Do not use these clicks to select your dose. Do not use the cartridge scale to measure the amount of liraglutide to be injected, as it is not precise enough. | |
Injecting the dose Insert the needle under the skin according to the injection technique advised by your doctor or nurse.Then follow these instructions: Press the plunger until the indicator shows 0mg. Be careful not to touch the display with your other fingers or press the dose selector while injecting. The reason is that the injection may be blocked.Keep the plunger pressed and leave the needle under the skin for at least 6seconds. This ensures the full dose is administered. | |
Remove the needle. You may then see a drop of liraglutide at the needle tip. This is normal and does not affect your dose. | |
Insert the needle tip into the outer needle cap without touching the needle or the outer needle cap. | |
When the needle is protected, press the outer needle cap gently until it clicks into place. Then unscrew the needle.Dispose of the needle carefully and replace the pen cap. When the pen is empty, dispose of it carefully without any needle attached. Please dispose of the pen and needle according to local regulations. | |
Always remove the needle after each injection, and store your pen without the needle attached. This reduces the risk of contamination, infection, loss of liraglutide, needle blockage and inaccurate dosing. Care should be taken by healthcare professionals handling used needles to avoid accidental pricks and infections. |
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