NIVESTIM. 48 MU 0.5 ml. 5 ampules
NIVESTIM. 48 MU / 0.5 ml. 5 ampules
What Nivestim and what it is used
Nivestim contains the active substance filgrastim. It belongs to a group of proteins called cytokines , and is very similar to a natural protein (granulocyte -colony stimulating factor [G-CSF]), which is produced by the body. Filgrastim stimulates the bone marrow (the tissue in which new blood cells are produced ) to produce more cells, particularly certain types of white blood cells. White blood cells are important because they help your body fight infections .
What is it used Nivestim
Your doctor has prescribed Nivestim, to help your body to produce more blood cells. Your doctor will tell you why you are being treated with Nivestim.
Nivestim is useful in a number of different conditions which are :
bone marrow transplantation ;
severe chronic neutropenia ( neutropenia is a condition of abnormally low numbers of certain white blood cells called neutrophils ) ;
neutropenia in patients with HIV infection ;
mobilization of peripheral blood stem cells.
2 . What you should know before using Nivestim
Do not use Nivestim:
if you are allergic to filgrastim 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 Nivestim:
if you suffer from another disease (especially if you think you might have an infection ) ;
if you have a cough , fever and difficulty breathing . This may be due to a disorder of the lung (see section 4 'POSSIBLE SIDE EFFECTS') ;
If you have sickle cell anemia (an inherited blood disorder that affects red blood cells) ;
If you feel pain in the left upper abdomen or pain in the upper part of the shoulder. It can be caused by disease of the spleen (see section 4 'POSSIBLE SIDE EFFECTS') .
While being treated with Nivestim may need to do regular blood tests to determine the number of neutrophils and other white blood cells in your blood. This will give your doctor information about the course of treatment and will also show whether treatment should be continued .
Other medicines and Nivestim
You should not take Nivestim 24 hours before and 24 hours after receiving chemotherapy.
Tell your doctor or pharmacist if you are taking , have recently taken or taking other medicines.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine .
Filgrastim has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant , the doctor may decide that you should not use this medicine. Filgrastim could affect your ability to become pregnant or maintain pregnancy .
It is unknown whether filgrastim passes into breast milk . For this reason , your doctor may decide that you should not use this medicine if you are breastfeeding.
Driving and using machines
Filgrastim has negligible influence on the ability to drive and use machines. If the patient is experiencing fatigue, caution should be exercised when driving or operating machinery.
Nivestim contains sorbitol
This medicine contains sorbitol (E420). If your doctor has told you that you have an intolerance to some sugars ( fructose) , contact your doctor before taking this medicine. This product contains less than 1 mmol sodium ( 23 mg) per dose , i.e. essentially sodium .
3 . How to use Nivestim
Always use this medicine exactly as your doctor tells you . If you are not sure ask your doctor.
This medication is given by injection - either by intravenous infusion (drip ) or by subcutaneous injection into the tissue just under the skin .
If you are taking this medicine by subcutaneous injection , your doctor may suggest that you learn how to inject yourself . Your doctor or nurse will give you instructions on how to do this (see end of this leaflet for information on self- administration). Do not attempt self- placement without training. Part of the necessary information is given at the end of this leaflet , but proper treatment of your disease requires close and constant cooperation with your doctor. The amount Nivestim, you need will depend on the condition you are taking Nivestim, and your weight .
Nivestim and neutropenia associated with chemotherapy
The usual dose for adults and children is 0.5 million units ( 5 micrograms ) per kilogram of body weight each day . For example, if you weigh 60 kg, your daily dose will be 30 million units ( 300 micrograms). Treatment usually lasts about 14 days. In certain diseases, however , may need a longer treatment , to approximately one month.
Nivestim and bone marrow transplant
The usual initial dose is 1 million units ( 10 micrograms) per kilogram body weight per day in the form of infusion. For example, if you weigh 60 kg, your daily dose will be 60 million units ( 600 micrograms). Usually you will receive the first dose Nivestim at least 24 hours after chemotherapy , but within 24 hours after bone marrow transplantation . Your doctor may test your blood to see how well it goes and how long the treatment should continue.
Nivestim and SCN
The usual initial dose is between 0.5 million ( 5 micrograms) and 1.2m (12 micrograms ) units per kilogram of body weight per day as a single or divided dose . Your doctor may test your blood to see how well the treatment takes place and find the best dose for you. Neutropenia requiring long-term treatment with Nivestim.
Nivestim and neutropenia in patients with HIV infection
The usual starting dose is between 0.1 ( 1 microgram) and 0.4 million units ( 4 micrograms) per kilogram of body weight daily. Your doctor may test your blood at regular intervals to see how well the treatment takes place and decide on the required dose . After the number of white blood cells in the blood return to normal values , it is possible to reduce the frequency of application of the at least once daily . In order to maintain normal levels of white blood cells in the blood may have long-term treatments with Nivestim.
Nivestim and transplantation of peripheral blood stem cells
If you are donating stem cells for yourself , the usual dose is 0.5 million ( 5 micrograms) to 1 million units ( 10 micrograms ) per kilogram of body weight daily. Nivestim treatment will last up to 2 weeks. Your doctor will monitor your blood to determine the best time to collect the stem cells.
If you are a donor of stem cells for another person, the usual dose is 1 million units per kilogram of body weight daily. Nivestim treatment will last for 4 to 5 days.
If you use more than the amount of Nivestim
If you use more than the amount of Nivestim, contact your doctor or pharmacist as soon as possible .
If you forget to use Nivestim
If you forget to inject a dose , contact your doctor or pharmacist to find out when you should inject the next dose. Do not take a double dose to make up for a missed injection.
If you stop using Nivestim
Your doctor will tell you when to stop taking Nivestim. It is quite normal to have several courses of treatment with Nivestim.
If you have any further questions on the use of this medicine, please ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Allergic reactions to filgrastim , including skin rash , itchy raised areas of the skin and anaphylaxis ( weakness, drop in blood pressure, difficulty breathing and swelling of the face ) . If you think you have such a reaction , stop injecting Nivestim and seek medical help immediately.
There have been enlarged spleen and very rare cases of splenic rupture . Some cases of splenic rupture were fatal.
It is important to contact your doctor immediately if you experience pain in the left upper abdomen or left shoulder pain , as this may be related to a problem with the spleen.
It is also very important that you tell your doctor if you think you have an infection.
The infection manifests itself in many ways. You need to keep temperature above 37,8 ° C, chills , or other signs of infection , such as rash , sore throat , diarrhea, earache , difficulty or painful breathing or problems such as cough or wheezing. These symptoms can be a sign of serious adverse effects on the lungs , such as pneumonia and adult respiratory distress syndrome in adults , which can be fatal. If you have a fever or any of these symptoms , contact your doctor immediately and go straight to the hospital.
If you have sickle cell disease , be sure to inform your doctor before you start taking Nivestim. Some patients with sickle cell disease , which is a filgrastim received crisis .
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10);
Common ( affects 1 to 10 users in 100) ;
Uncommon ( affects 1 to 10 users in 1000 ) ;
Rare ( affects 1 to 10 users in 10,000 ) ;
Very rare ( affects less than 1 user in 10,000 ) .
Very common side effects:
Nausea or vomiting ;
Pain in the bones and muscles ;
Bleeding from the nose ;
Decreased levels of blood sugar ;
Elevated levels of some liver enzymes or modification of chemical substances in the blood. For them, your doctor will do blood tests ;
Increased levels of uric acid , which may be such as gout .
Common side effects:
General weakness ;
Constipation or diarrhea ;
Loss of appetite ;
Inflammation and ulcers in the mouth and intestinal mucosa ;
Chest pain ;
Sore throat ;
hair loss ;
Skin rash ;
Enlarged liver ;
Thinning of the bones ;
Pain at the injection site ;
Inflammation of blood vessels ;
Reducing the number of platelets ( cells involved in blood clotting) , which increases the risk of bleeding or bruising .
Uncommon side effects:
Blood or protein in the urine.
Rare side effects:
Problems with blood vessels .
Swelling and pain in the joints, gout ( pseudogout ) .
There are reports that if you had a bone marrow transplant may be more likely to get graft versus host disease (GvHD) after the use of G-CSF. Some cases of GvHD were fatal .
Side effects that you can get if you are a donor of stem cells for another person:
Very common side effects:
Pain in the bones or muscles ;
Changes in white blood cells or platelets ( your doctor will make sure that blood tests) .
Common side effects:
Elevated levels of some liver enzymes (Your doctor will monitor for this).
Uncommon side effects:
Severe allergic reaction ;
Problems with the spleen;
Elevated levels of uric acid, which may be as in gout
Exacerbation of rheumatoid arthritis.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store Nivestim
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton of pre-filled syringe after EXP. The expiry date refers to the last day of that month.
Store and transport refrigerated ( 2 ° C- 8 ° C). Do not freeze . Keep the pre- filled syringe in the outer carton to protect from light. The syringe can be removed from the refrigerator and left at room temperature for a single period of up to 7 days ( but not more than 25 ° C).
Do not use Nivestim, if you notice it is cloudy or there are particles in it.
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 . Contents of the pack and other information
What does Nivestim
The active substance is filgrastim . Each ml contains 60 million units [MU] ( 600 micrograms) or 96 million units [MU] ( 960 microgram) of filgrastim.
Nivestim injection / infusion 12 MU / 0,2 ml: Each pre-filled syringe contains 12 million units (MU), 120 micrograms of filgrastim in 0,2 ml ( corresponding to 0,6 mg / ml).
Nivestim injection / infusion 30 MU / 0,5 ml: Each pre-filled syringe contains 30 million units (MU), 300 micrograms of filgrastim in 0,5 ml ( corresponding to 0,6 mg / ml).
Nivestim injection / infusion 48 MU / 0,5 ml: Each pre-filled syringe contains 48 million units (MU), 480 micrograms of filgrastim in 0,5 ml ( corresponding to 0,96 mg / ml).
Other ingredients are: acetic acid ( glacial ), sodium hydroxide , sorbitol E420, polysorbate 80 and water for injections.
Nivestim looks like and contents of the pack
Nivestim is a clear, colorless solution for injection / infusion in a glass prefilled syringe injection needle (stainless steel) with a needle safety guard . In each package is 1, 5 or 10 syringes.
PLIVA Krakow, S.A., Poland ;
Hospira Enterprises B.V., Netherlands.
Information for self-administration by the patient
This section contains information on how to give yourself an injection Nivestim. It is important to attempt to inject yourself unless you are trained by your doctor or nurse. It is also important to dispose of the syringe in a puncture-proof container . If you are not sure yourself the injections or have any questions , please ask your doctor or nurse for help.
How to use my Nivestim?
Nivestim usually administered once per day by injection, usually in the tissue just beneath the skin. This is known as a subcutaneous injection .
Learn how to give yourself an injection means that you will not have to wait at home nurse , nor should visit the hospital or clinic each day to receive injections .
You will need to inject approximately the same time each day. The best places to inject are :
front of your thighs ;
abdomen, except for the area around the navel .
Good site of injection can be changed every day to avoid the risk of pain at the injection site .
Necessary tools for implementing
To give yourself a subcutaneous injection you will need the following :
New pre-filled syringe Nivestim;
Sharps container ( container , puncture-resistant ) for safe disposal of used syringes ;
Antiseptic wipes (if recommended by your doctor or nurse ) .
How to give yourself a subcutaneous injection Nivestim?
1. Attempt to inject approximately the same time each day.
2 . Nivestim Remove from the refrigerator and allow it to reach room temperature (about 25 ° C). It will take 15-30 minutes. Check the date on the package to make sure that the medicine is out of date . Place sharps near you.
3 . Find a comfortable , well-lit place to inject and check your prescribed dose.
4 . Wash your hands thoroughly with soap and water.
5 . Remove the syringe from the blister and check that the solution is clear, colorless and practically free from visible particles. Do not use Nivestim, if the liquid is floating particles or liquid has leaked from the syringe.
6 . Hold the syringe upright with the needle pointing upwards. Remove the protective cap from the needle. The syringe is ready for use. You may notice a small air bubble in the syringe. No need to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
7 . Decide where to inject Nivestim - find a place in the front of the abdomen or anterior thigh . Each time, a different injection site. Do not choose an area that is sensitive , reddened, with bruises or scars. If your doctor or nurse recommend , clean the area with antiseptic wipe.
8 . Pinched large area of skin, being careful not to touch the cleaned area .
9. With other hand, insert the needle at an angle of 45 °.
10 . Gently pull back the plunger to check the syringe for blood appears. If you see blood in the syringe , remove the needle and put it elsewhere. Slowly push the plunger until the syringe is empty .
11 . Then injecting the solution , remove the needle from the skin.
12. Ensure that the needle guard covers the needle as instructed for active or passive shield below.
13. Insert the syringe into the sharps container . Do not attempt to replace the protective cap .
Most people can learn to give yourself a subcutaneous injection , but if you experience difficulties , please do not be afraid to ask for help and advice from your doctor or nurse.
Use of activated needle guard UltraSafe for injection / infusion Nivestim 12 MU / 0,2 ml
Pre-filled syringe is attached needle guard UltraSafe, protection from injury from the needle. When working with a pre-filled syringe keep your hands behind the needle.
1. Perform the injection using the technique described above .
2 . Injection When finished , slide the needle guard forward until the needle is completely covered ( device snaps in place).
Use of passive needle safety guard UltraSafe for injection / infusion Nivestim 30 MU / 0,5 ml and injection / infusion Nivestim 48 MU / 0,5 ml
Prefilled syringe has attached needle guard UltraSafe to prevent needle stick injuries . When working with a pre-filled syringe keep your hands behind the needle.
1. Inject using the technique described below .
2 . Depress the plunger while holding the edge with your fingers to full dose . Passive needle safety guard will not be activated unless the entire dose was administered .
3 . Withdraw the needle from the skin , release the plunger and allow syringe to move up until the needle is secured and locked into place.
Keep used syringes out of the reach of children.
NEVER put used syringes into the trash waste.
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL PROFESSIONALS :
Nivestim contains no preservatives. In view of the possible risk of microbial contamination, Nivestim syringes are for single use only .
Accidental exposure to freezing temperatures within 24 hours does not affect the stability of Nivestim. Frozen pre-filled syringes can be thawed and then stored in the refrigerator for future use. If the exposure is more than 24 hours or frozen more than once , Nivestim should NOT be used.
Nivestim should not be diluted with sodium chloride solution . This product must be mixed with other drugs , in addition to those described below . Diluted filgrastim may be adsorbed to glass and plastic materials , unless diluted, as mentioned below .
If necessary , Nivestim may be diluted with a 50 mg / ml ( 5%) solution for infusion . It is not recommended to dilute to a final concentration of less than 0,2 MU ( 2 micrograms) per ml. The solution should be visually inspected before use. Should be used only clear solutions without particles . For patients treated with filgrastim concentrations below 1,5 MU ( 15 micrograms) of ml, to a final concentration of 2 mg / ml is necessary to add human serum albumin (HSA).
Example : In a final injection volume of 20 ml, in total doses of less than 30 MU ( 300 micrograms) , filgrastim should be administered with the addition of 0,2 ml of 200 mg / ml ( 20%) human albumin solution . Upon dilution in 50 mg / ml ( 5%) solution for infusion , Nivestim is compatible with glass and various plastics , including PVC, polyolefin ( copolymer of polypropylene and polyethylene ) and polypropylene.
After dilution: It was demonstrated chemical and physical stability of the reconstituted solution for infusion in use for 24 hours at 2 ° C- 8 ° C. From a microbiological point of view, the product should be used immediately. If not used immediately , in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° C- 8 ° C, unless dilution has taken place in controlled and validated aseptic conditions.