TEVAGRASTIM . 30 MIU 0.5 ml. 5 syringes

TEVAGRASTIM . 30 MIU  0.5 ml. 5 syringes
€ 299.00
Add to Cart
Tevagrastim contains the active substance filgrastim. Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli. It belongs to a group of proteins called cytotoxin, and is very similar to the natural protein granulocyte-colony stimulating factor produced in your body. 

TEVAGRASTIM . 30 MIU / 0.5 ml. 5 syringes

 
 
What Tevagrastim and what it is used
What Tevagrastim
Tevagrastim contains the active substance filgrastim. Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli. It belongs to a group of proteins called cytotoxin , and is very similar to the natural protein granulocyte- colony stimulating factor produced in your body . Filgrastim stimulates the bone marrow (the tissue in which new blood cells) to produce more cells, particularly certain types of white blood cells. White blood cells are important because they help your body fight infection.

What is it used Tevagrastim
Your doctor has given Tevagrastim, to help your body make more white blood cells. Your doctor will tell you why you are being treated with Tevagrastim.
Tevagrastim is useful in several different conditions :
chemotherapy ;
bone marrow transplantation ;
severe chronic neutropenia (low white blood cells) ;
neutropenia in patients with HIV infection ;
mobilization of peripheral blood progenitor cells ( for stem cell donation ) .

2 . What you should know before using Tevagrastim
Do not use Tevagrastim:
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 Tevagrastim:
if you have a cough, fever and difficulty breathing. They can be the result of lung disease (see section 4 "Possible side effects") ;
if you have sickle cell anemia ( an inherited disease which is characterized by the presence of red blood cells with sickle form) ;
if you get pain in the left upper abdomen or pain in the upper part of the shoulder. It can be the result of a spleen disorder (see section 4 "Possible side effects") ;
if you have a certain blood diseases (e.g., syndrome Kostman , myelodysplastic syndrome , various types of leukemia ) ;
if you have osteoporosis. Your doctor may regularly check your bone density ;
if you suffer from any other disease, especially if you think you have an infection.
Tell your doctor or nurse that you are being treated with Tevagrastim, if you are receiving imaging bone.
While being treated with Tevagrastim, need to have regular blood tests , the number of neutrophils and other white blood cells in your blood. This will tell your doctor how well your treatment is working and whether it should be continued .

Other medicines and Tevagrastim
Tell your doctor or pharmacist if you are using or have recently used it is possible to use other drugs.
Do not use Tevagrastim within 24 hours before or 24 hours after chemotherapy .

Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine. Tevagrastim not been studied in pregnant women. Therefore, your doctor may decide that you should not use this medicine.
It is unknown whether filgrastim passes into breast milk. Therefore, your doctor may decide that you should not use this medicine if you are breastfeeding.

Driving and using machines
Do not drive or operate any tools or machines if you feel tired .

Tevagrastim contains sorbitol and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
This product contains sodium, less than 1 mmol ( 23 mg) of a pre-filled syringe , ie essentially sodium .

3 . How to use Tevagrastim
Always use this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.

The recommended dose is:
The required amount you Tevagrastim depend on the condition being treated with Tevagrastim, and your body weight . Your doctor will tell you when to stop using Tevagrastim. Quite normal to have several courses of treatment with Tevagrastim.

Tevagrastim and chemotherapy
The usual daily dose is 0.5 million international units (MIU) per kilogram body weight. For example, if you weigh 60 kg, your daily dose will be 30 million international units (MIU). Usually you will receive your first dose of Tevagrastim at least 24 hours after your chemotherapy . The duration of treatment will usually last about 14 days. In certain diseases , however, require longer treatment for about a month.

Tevagrastim and bone marrow transplantation
The usual starting dose is 1 million international units (MIU) per kilogram of body weight each day . For example, if you weigh 60 kg, your daily dose will be 60 million international units (MIU). Generally the first dose Tevagrastim will be given approximately 24 hours after chemotherapy , but not later than 24 hours after bone marrow transfusion . Your doctor will test your blood to see how well the treatment is working and to determine the optimal dose for you. Treatment will be discontinued when white blood cells in your blood reach a certain number.

Tevagrastim and SCN
The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram of body weight each day . Your doctor will test your blood to see how well the treatment is working and to determine the optimal dose for you. Neutropenia requiring prolonged treatment with Tevagrastim.

Tevagrastim and neutropenia in patients with HIV infection
The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram of body weight each day . Your doctor will test your blood regularly to see how well your treatment. When the number of white blood cells in the blood returned to normal , the frequency of application may be reduced to less than once per day . Your doctor will continue to test your blood regularly and will recommend the best dose for you. Maintaining a normal number of white blood cells in your blood may require prolonged treatment with Tevagrastim.

Tevagrastim and mobilization of peripheral blood stem cells
If you are donating stem cells for yourself , the usual dose is 0.5 million to 1 million international units (MIU) per kilogram of body weight daily. Tevagrastim treatment will last up to 2 weeks and in exceptional cases even longer . Your doctor will monitor your blood to determine the best time to collect the stem cells.
If you are donating stem cells to another person, the usual dose is 1 million international units (MIU) per kilogram of body weight daily. Tevagrastim treatment will last for 4 to 5 days.

Method of administration
This medication is given by injection - by intravenous (iv) infusion (drip ) or subcutaneous (sc) injection ( into the tissue just under the skin) . If using this medicine by subcutaneous injection , your doctor can offer training for self- injection . Your doctor or nurse will show you how to do this. Do not attempt to inject yourself unless you are trained . part of
necessary information can be found at the end of this leaflet, but proper treatment of your disease requires close and constant cooperation with your doctor.

If you use more than the amount of Tevagrastim
If you use more than the amount of Tevagrastim, you should contact your doctor or pharmacist as soon as possible.

If you forget to use Tevagrastim
Do not use a double dose to make up for a missed injection .

If you stop using Tevagrastim
Ask your doctor before you stop using Tevagrastim.

If you have any further questions on 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 everybody gets them .

Important side effects
There are reports of allergic reactions such as skin rash , raised itchy areas of the skin and serious allergic reactions with weakness, drop in blood pressure, shortness of breath and swelling of the face . If you think you have this type of reaction , stop injecting Tevagrastim and seek immediate medical assistance;
There are reports of splenic enlargement and rupture of the spleen . 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 since they may be related to a problem with the spleen ;
Cough , fever and difficulty or painful breathing can be signs of serious side effects from the lungs, such as pneumonia and acute respiratory distress syndrome, which can be fatal. If you have a fever or any of these symptoms , it is important to contact your doctor immediately ;
If you have sickle cell disease , be sure to tell your doctor before starting treatment with Tevagrastim. Observed crises of sickle cell disease patients who have been given filgrastim ;
As a very common side effect ( likely to affect more than 1 in 10 people) , filgrastim may cause pain in the bones or muscles. Ask your doctor which medicine you can take to help .
You may experience the following additional adverse reactions :
In cancer patients
Very common ( may affect more than 1 in 10 people):
elevated levels of certain enzymes in the liver and the blood, high levels of uric acid in the blood ;
unwell; vomiting ;
chest pain .
Common ( may affect up to 1 in 10 people):
headache ;
cough, sore throat ;
constipation ; loss of appetite ; diarrhea ; mucositis - a painful inflammation and ulceration of the lining of the digestive tract ;
hair loss ; rash ;
fatigue ; general weakness .
Uncommon ( may affect up to 1 in 100 people):
unspecified pain .
Rare ( may affect up to 1 in 1,000 people):
vascular disorders that can cause pain, redness and swelling of the extremities.
Very rare (may affect up to 1 in 10,000 people):
darkviolet painful swellings on the limbs and sometimes on the face and neck, accompanied by fever ( Sweet's syndrome ) ; inflammation of blood vessels , often with skin rash ;
worsening of rheumatic diseases;
pain or difficulty in urination.
Not known ( data can not be estimated ):
rejection of transplanted bone marrow ;
a transient decrease in blood pressure ;
pain and swelling of the joints similar to gout .
In healthy donors of stem cells
Very common ( may affect more than 1 in 10 people):
increasing the number of white blood cells; reduce the number of blood platelets, which increases risk of bleeding or bruising ;
headache.
Common ( may affect up to 1 in 10 people):
elevated levels of certain enzymes in the blood .
Uncommon ( may affect up to 1 in 100 people):
elevated levels of certain enzymes in the liver ; high levels of uric acid in the blood ;
deterioration of rheumatic diseases.
Not known ( data can not be estimated ):
cough, fever , shortness of breath or coughing up blood .
In patients with severe chronic neutropenia
Very common ( may affect more than 1 in 10 people):
reduce the number of red blood cells, which express the skin pale and cause weakness or breathlessness ;
low levels of blood glucose ; elevated levels of certain enzymes in the blood ; high levels of uric acid in the blood ;
nosebleeds .
Common ( may affect up to 1 in 10 people):
reduce the number of blood platelets, which increases risk of bleeding or bruising ;
headache ;
diarrhea ;
Enlarged liver ;
hair loss ; inflammation of blood vessels , often with skin rash ; Pain at the injection site ; rash ;
loss of calcium from bones ; joint pain .
Uncommon ( may affect up to 1 in 100 people):
blood in the urine , protein in the urine.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet .

Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet . You can also report side effects directly through the national system of communication. As reported side effects , you can do your bit to get more information on the safety of this medicine.

5 . How to store Tevagrastim
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after " EXP" on the pre-filled syringe after "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C).
Do not use this medicine if you notice it is cloudy or there are particles .
Do not dispose of medications in the sewer. 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 Tevagrastim
The active substance is filgrastim . Each ml of solution for injection or infusion contains 60 million international units [MIU] ( 600 microgram) of filgrastim .
Tevagrastim 30 MIU / 0,5 ml: Each pre-filled syringe contains 30 million international units [MIU] ( 300 microgram ) of filgrastim in 0,5 ml solution.
Tevagrastim 48 MIU / 0,8 ml: Each pre-filled syringe contains 48 million international units [MIU] ( 480 microgram ) of filgrastim in 0,8 ml solution.

Other ingredients are: sodium hydroxide , glacial acetic acid , sorbitol ( E420), polysorbate 80, water for injections.

Tevagrastim looks like and contents of the pack
Tevagrastim is for injection or infusion in pre-filled syringe. Tevagrastim is clear and colorless liquid . Each pre -filled syringe contains or 0,5 ml, 0,8 ml , or saline.
Tevagrastim is available in packs of 1, 5 or 10 pre-filled syringes or bulk packs of 10 ( 2 packs of 5 ) pre-filled syringes with injection needles with or without a needle safety guard .
Not all pack sizes may be marketed.
 
 
€ 299.00
Add to Cart
Close