VICTOZA injection 6 mg. Ml. 3
VICTOZA injection 6 mg. / Ml. 3
What is Victoza and what it is used
Victoza contains the active substance liraglutide . It helps your body reduce blood sugar levels only when blood sugar is too high . It also slows down the passage of food through the stomach .
Victoza is used for the treatment of adults with diabetes mellitus type 2 , where:
self-acceptance at the maximum tolerated dose of metformin or sulphonylurea ( glibenclamide or glimepiride ) is not enough to control your blood sugar;
combination of metformin and a sulphonylurea ( glimepiride or glibenclamide ) or metformin and a glitazone (eg pioglitazone ) is not enough to control your blood sugar.
2 . What you should know before using Victoza
Do not use Victoza
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 , nurse or pharmacist before using Victoza.
If you are also taking a sulphonylurea ( glibenclamide or glimepiride ), your doctor may tell you to monitor your blood sugar. This will help to determine whether the dose of sulphonylurea should be changed .
Victoza should not be used if you have type 1 diabetes or diabetic ketoacidosis. Victoza is not insulin.
Victoza should not be used in children and adolescents under 18 years of age.
Not recommended the use of Victoza in patients with inflammatory bowel disease and / or diabetic gastroparesis .
If you have symptoms of acute pancreatitis as persistent, severe abdominal pain , you should consult your doctor .
When initiating treatment with Victoza, in some cases may be fluid loss / dehydration , eg . with vomiting , nausea and diarrhea. It is important to avoid dehydration by taking enough fluids . Contact your doctor if you have any questions or concerns.
Children and adolescents
Victoza is not recommended in children and adolescents under 18 years of age as safety and efficacy in this age group have not yet been established.
Other medicines and Victoza
Please tell your doctor, nurse or pharmacist if you are taking , have recently taken or might take other medicines.
In particular , tell your doctor, nurse or pharmacist if you are using medicines for diabetes containing any of the following active substances:
Insulin. Victoza is not recommended if you are already using insulin.
Sulphonylurea ( such as glimepiride or glibenclamide ) . When using Victoza with sulphonylureas can get hypoglycemia (low blood sugar ) as sulphonylureas increase the risk of hypoglycaemia. When you start using these medicines together , your doctor may tell you to reduce the dose of the sulphonylurea . Please see section 4 of the warning signs of low blood sugar.
Pregnancy and lactation
Tell your doctor if you are pregnant , think you may be pregnant or planning to become pregnant. Victoza should not be used in pregnancy . It is not known if Victoza could harm an unborn child.
It is not known if Victoza passes into breast milk . Do not use Victoza, if you are breastfeeding .
Driving and using machines
Low blood sugar (hypoglycemia ) can reduce your ability to concentrate. Avoid driving or using machinery if you feel a hypo. Please see section 4 on the warning signs of low blood sugar. Please consult your doctor for more information on this topic .
3 . How to use Victoza
Always use this medicine exactly as your doctor tells you . If you are unsure about anything, ask your doctor , nurse or pharmacist.
The initial dose is 0,6 mg once daily for at least one week;
Your doctor will tell you when to increase to 1,2 mg once daily ;
Your doctor may tell you to increase your dose to 1,8 mg once daily if your blood glucose is not adequately controlled with a dose of 1,2 mg.
Do not change your dose unless your doctor tells you to do so.
Victoza is given by injection under the skin ( subcutaneously). Do not inject into a vein or muscle. The best places to inject are the front of the thighs , the front of your waist (abdomen) , or upper arm .
You can make the injection at any time of day without regard to meals . Once the most convenient time for you , it is preferable to inject Victoza approximately the same time of day.
Before using the pen for the first time, your doctor or nurse will show you how to use it.
If you use more than the amount of Victoza
If you use more than the amount of Victoza, tell your doctor immediately . You may need medical attention . You may experience nausea or vomiting.
If you forget to use Victoza
If you miss a dose , use Victoza as soon as you remember.
However, if more than 12 hours after the last administration of Victoza, skip the missed dose. The next day the next dose as usual.
The next day a double dose and increase the dose to make up for a missed dose.
If you stop using Victoza
Do not stop taking Victoza, without talking to your doctor. If you stop , your blood sugar may be increased .
If you have any further questions on the use of this product, ask your doctor , nurse or pharmacist.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Serious side effects
Common: may affect up to 1 in 10 people :
Hypoglycemia (low blood sugar). The warning signs of low blood sugar may occur suddenly and can include : cold sweat, cool pale skin, headache, fast heartbeat , nausea , excessive hunger , vision changes , drowsiness , weakness , nervousness , anxiety , confusion , difficulty concentrating , shaking ( tremor) . Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs . If you are taking a sulphonylurea medicine when you start using Victoza, your doctor may tell you to reduce the dose of medicine.
Uncommon: may affect up to 1 in 100 people :
Thyroid events - as nodes , elevated calcitonin levels and goiter .
Rare: may affect up to 1 in 1000 people :
Angioedema ( swelling of face , lips, tongue , etc.);
Severe allergic reaction ( anaphylactic reaction) with additional symptoms such as breathing problems, swelling of the throat and face , palpitations, etc. If you experience these symptoms , you should seek immediate medical attention and tell your doctor as soon as possible .
Other side effects:
Very common: may affect more than 1 in 10 people :
Nausea ( feeling sick) . This usually goes away with time ;
Diarrhea. This usually goes away with time.
Common: may affect up to 1 in 10 people :
When initiating treatment with Victoza, in some cases may be fluid loss / dehydration , eg . with vomiting , nausea and diarrhea. It is important to avoid dehydration by taking enough fluids .
Inflamed stomach ( gastritis) . Signs include stomach pain, nausea and vomiting ;
Gastroesophageal reflux disease (GERD ) . Signs include acids;
Painful or swollen abdomen ;
Abdominal discomfort ;
Viral infection in the stomach ;
Gas ( flatulence ) ;
Decreased appetite ;
Reactions at the injection site (such as bruising, pain , irritation, itching and rash);
Dehydration, sometimes with decreased renal function.
Uncommon: may affect up to 1 in 100 people :
Allergic reactions such as pruritus and urticaria ( skin rash type ) .
If you get any side effects , contact your doctor , nurse or pharmacist. This includes all listed in this leaflet .
5 . How to store Victoza
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the pen label and carton after 'EXP' . The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze . Keep away from the freezer .
During use :
For 1 month can store the stylus at a temperature below 30 ° C or in a refrigerator ( 2 ° C - 8 ° C ) away from the freezer . Do not freeze .
When not using the pen, keep the cap in order to protect from light.
Do not use this medicine if the solution is clear and colorless .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Victoza
The active substance is liraglutide . One ml solution for injection contains 6 mg of liraglutide . One pre-filled pen contains 18 mg liraglutide .
The other ingredients are disodium phosphate dihydrate, propylene glycol , phenol, and water for injection.
Victoza looks like and contents of the pack
Victoza is supplied as a clear, colorless solution for injection in pre-filled pen. Each pen contains 3 ml solution , delivering 30 doses of 0,6 mg, 15 doses of 1,2 mg or 10 doses of 1,8 mg.
Victoza is available in packs containing 1, 2, 3 , 5 or 10 pens.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A / S, Denmark .
Instructions for use of Victoza pen
Please read these instructions carefully before using the pen Victoza.
Victoza pen comes with 18 mg liraglutide . You can select doses of 0,6 mg, 1,2 mg and 1,8 mg.
Victoza pen is designed for use with injection needles for single use NovoFine or NovoTwist a length of 8 mm and up to 32G.
Preparing your Victoza pen
A. Remove the cap of the pen ;
B. Remove the paper tab from a new disposable needle . Screw the needle straight and tightly onto your pen ;
B. Take off the outer needle cap and keep it for later ;
D. Pull off the inner needle cap and discard it ;
Always use a new needle for each injection to prevent contamination ;
Be careful not to bend or damage the needle ;
Never replace the inner needle cap on after you have removed it from . This reduces the risk of hurting yourself with the needle.
Check the expiration
Before you inject with a new pen , always check the expiration , as indicated below;
D. Turn the dose selector until the character to check the drain lines up with the arrow ;
E. Hold the pen with the needle pointing upwards . Tap the cartridge gently with your finger a few times . Thus, the air bubbles will collect at the top of the cartridge ;
G. Keep the needle pointing up and press the button until 0 mg lines up with the pointer. Repeat steps D to F, while the tip of the needle drop of liraglutide appears . If after several attempts no drop appears , change the needle and repeat steps E to G to six times . If you still do not see a drop of liraglutide pen is broken and you must use a new one.
If you drop a pen on a hard surface or suspect that something is wrong with her , always use a new disposable needle and check the flow prior to injection.
Select the dose
Always check that the pointer 0 mg;
H. Turn the dose selector until your needed dose lines up with the pointer (0,6 mg, 1,2 mg or 1,8 mg).
If you selected the wrong amount by mistake , just change it by turning the dose selector backwards or forwards until the correct dose lines up with the pointer.
When turning the dose selector back, be careful not to press the button as liraglutide may come out .
If the dose selector stops before your needed dose lines up with the pointer, there is not enough liraglutide left for a full dose. Then you can :
Divide your dose into two injections :
Turn the dose selector in either direction until 0,6 mg or 1,2 mg up with the pointer . Inject the dose . Prepare a new pen and inject the remaining amount mg, to complete your dose .
Inject the full dose with a new pen :
If the dose selector stops before 0,6 mg lines up with the pointer, prepare a new pen and inject the full dose with it.
The dose selector clicks when you turn . You should not use these clicks to select the amount of liraglutide to inject.
Do not use the cartridge scale to measure how much liraglutide to inject - it is not accurate enough .
Do not try to set a dose different from 0,6 mg, 1,2 mg or 1,8 mg. The figures on the scale of the dose should stand opposite the arrow to ensure the application of correct dose.
Insert the needle into your skin using the injection technique shown by your doctor or nurse . Then follow the instructions below:
I. Press the button to inject until 0 mg lines up with the pointer. Be careful not to touch the rock dose with your other fingers or press the dose selector sideways when you inject. It is necessary to block the injection . Hold the button and leave the needle under the skin for at least six seconds. This is done in order to ensure the full dose ;
K. Remove the needle.
Thereafter, the needle tip can have a drop liraglutide .
This is normal and does not affect the dose that you have just applied ;
L. Place the tip of the outer needle cap without touching the cap ;
M. When the needle is covered, carefully push the outer needle cap completely . Then unscrew the needle. Carefully discard the needle and put the cap on the pen. When the pen is empty, dispose of it carefully without the needle attached . Please throw away the pen and needle in accordance with local requirements.
Always remove the needle after each injection and store the Victoza pen without an attached needle ;
This will prevent contamination , infection or leakage of liraglutide . Thus is ensured and accurate dosing ;
Caregivers should be most careful when handling used needles to avoid hurting them.
Caring for your Victoza pen
Victoza pen is accurate and safe to use . But you have to take care of it:
Do not attempt to repair or disassemble ;
Keep the pen from dust, dirt and liquids of any kind ;
Clean pen with a cloth dampened with a mild detergent . Do not try to wash , soak or lubricate the pen - this can damage it.
Do not share your Victoza pen to anyone ;
Keep your Victoza pen out of reach for others , especially children .