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ARZERRA 100 mg. 5 ml. 3 vials

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What Arzerra is and what it is used for
Arzerra contains ofatumumab, which belongs to a group of medicines called monoclonal antibodies.
Arzerra is used to treat chronic lymphocytic leukemia (CLL). CLL is a cancer of the blood that affects a type of white blood cell called lymphocytes. Lymphocytes multiply very quickly and live too long, so too many of them circulate in your blood. The disease may also affect other organs in your body. The antibody in Arzerra recognizes a substance on the surface of lymphocytes and causes them to die.
Arzerra is used to treat CLL in patients who have not responded to other types of chemotherapy or other treatments.

2. What you need to know before using Arzerra
You should not use Arzerra:
If you are allergic (hypersensitive) to ofatumumab or any of the other ingredients of Arzerra (listed in section 6 "Package contents and further information").
Tell your doctor if you think this may apply to you.

Warnings and precautions
Talk to your doctor or nurse before using Arzerra:
If you have had heart problems;
If you have pulmonary disease;
If you have had hepatitis B (liver disease). Arzerra may cause your hepatitis B to be re-activated. Your doctor may treat you with a suitable antiviral medication to prevent the activation of the virus.
Tell your doctor if you think any of the above may apply to you. You may need to go through additional medical examinations while you are on Arzerra.

Vaccination and Arzerra
If you are taking any vaccinations, tell your doctor or tell the specialist who is giving you the vaccine that you are being treated with Arzerra. The response to the vaccine may be reduced and you are not completely protected.

Infusion reactions
Drugs of this type (monoclonal antibodies) can cause infusion reactions when introduced into the body. You will be given medicines such as antihistamines, steroids or painkillers to reduce these reactions. See also Section 4, Possible side effects.
If you think you have had a similar reaction before, tell your doctor before you are given Arzerra.

Progressive Multifocal Leukoencephalopathy (PML)
Medicinal products such as Arzerra have been reported as progressive multifocal leukoencephalopathy (PML), a serious life-threatening brain disorder. Tell your doctor immediately if you have memory loss, thinking problems, walking problems, or loss of vision. If you have had these symptoms before starting treatment with Arzerra, tell your doctor immediately about any changes in the symptoms.

Children and adolescents
It is not known whether Arzerra works in children and adolescents. Therefore, Arzerra is not recommended for use in children and adolescents.

Other medicines and Arzerra
Tell your doctor or pharmacist if you are using, have recently used or are likely to use other medicines. This includes herbal medicines and other medicines that are available without a prescription.

Pregnancy, breastfeeding and fertility
Arzerra is generally not recommended for use during pregnancy. There is no information on the safety of Arzerra in pregnant women.
Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will evaluate the benefits to you of the risks to the baby when taking Arzerra while you are pregnant;
Use a reliable method of contraception to avoid becoming pregnant while on Arzerra and for 12 months after the end of treatment;
If you become pregnant during treatment with Arzerra, tell your doctor.
It is not known whether the ingredients of Arzerra pass into breast milk. Breastfeeding is not recommended during treatment with Arzerra and for 12 months after the time of last administration of Arzerra.

Driving and using machines
Arzerra is unlikely to affect your ability to drive or use machines.

Arzerra contains sodium
Arzerra contains 34.8 mg of sodium in each dose of 300 mg and 232 mg of sodium in each 2000 mg dose. You should keep this in mind if you are on a controlled sodium diet.

3. How to use Azerzer
If you have any questions about the administration of Arzerra, ask your doctor for the infusion.

Usual dose
The usual dose of Arzerra for the first infusion is 300 mg. For the other infusions, this dose will increase, usually up to 2,000 mg.

How it is applied
Arzerra is given as an infusion (drip) intravenously (intravenously) for several hours.
You will usually be given a course of 12 infusions. They will give you one infusion every week for eight weeks, followed by a 4-5 week interval without treatment. You will then be given the other infusions, one per month for 4 months.

Medicines given before each infusion
Before each infusion of Arzerra, you will be given premedication - medicines that help reduce infusion reactions. This may include antihistamines, steroids and painkillers. They will follow you closely, and if you have any reactions, you will be treated.

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

Infusion reactions
Drugs of this type (monoclonal antibodies) can cause infusion reactions, which can sometimes be severe. Their appearance is more likely during the first infusion.

Very common symptoms of an infusion reaction (may affect more than 1 in 10 people):
Skin rash.
Common symptoms of an infusion reaction (may affect up to 1 in 10 people):
Allergic reactions, sometimes severe with swelling of the face or mouth leading to breathing difficulties (anaphylactoid reactions);
Shortness of breath, shortness of breath, tightness in the chest, cough;
Low blood pressure (may cause dizziness when standing up);
Redness, fever;
Excessive sweating;
Shaking or chilling;
Palpitations;
Nausea;
Diarrhea;
Back pain;
high blood pressure;
Itchy, raised rash (urticaria);
Pain or irritation in the throat;
Lack of energy;
Nose obstruction.
Tell your doctor or nurse immediately if you get any of these symptoms.

Very common side effects: These may affect more than 1 in 10 people:
Infections of the lungs or airways (airways) such as pneumonia;
Infections of the ear, nose or throat.
Very common side effects that can be manifested by blood tests:
Low white blood cell counts;
Low red blood cell counts (anemia).
Common side effects: These may affect up to 1 in 10 people:
Fever due to infection and low white blood cell counts;
Blood infections;
Urinary tract infections;
Herpes zoster;
Herpes of the mouth;
Blockage of the intestine, which can be felt as stomach pain.
If you have permanent stomach pain, go to your doctor as soon as possible.

Common side effects that can be manifested by blood tests:
Low blood platelet counts (cells that help the blood to clot).
Uncommon side effects: These may affect up to 1 in 100 people:
Increased levels of potassium, phosphate and uric acid in the blood, which may cause kidney problems (tumor lysis syndrome).
Symptoms of this condition include:
Less urine than usual;
muscle spasms.
If you notice these symptoms, contact your doctor as soon as possible.

Uncommon side effects that can be manifested by blood tests:
Problems with blood clotting;
Inability of the bone marrow to produce enough red or white blood cells.
If you get side effects
Tell your doctor or nurse if any of the side effects gets serious or troublesome, or if you notice any side effects not listed in this leaflet.

5. How to store Azerbaijan
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label. The expiry date refers to the last day of that month.
Store and transport refrigerated (2 ° C - 8 ° C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Keep the diluted solution for infusion at a temperature between 2 ° C and 8 ° C and use it within 24 hours. The remaining unused solution for infusion should be discarded 24 hours after preparation.
Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will destroy your unnecessary medicines. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Arzerra contains
The active substance is ofatumumab. One milliliter of concentrate contains 20 mg of ofatumumab.
The other ingredients are: arginine, sodium acetate (E262), sodium chloride, polysorbate 80 (E433), disodium edetate (E386), hydrochloric acid (E507) (for pH adjustment), water for injections.

What Arzerra looks like and contents of the pack
Arzerra is a colorless concentrate for solution for infusion.
Arzerra 100 mg is available in packs containing 3 vials and two sets of infusion systems. Each glass vial is sealed with a latex rubber stopper and an aluminum seal and contains 5 ml of concentrate (100 mg of ofatumumab).
Arzerra 1000 mg is available in packs containing 1 vial and two sets of infusion systems. Each glass vial is sealed with a latex-free rubber stopper and an aluminum seal and contains 50 ml of concentrate (1,000 mg of ofatumumab).
The following information is intended for medical professionals only:
1) Before dilution with Arzerra
Check Arzerra concentrate for visible particles and discoloration before dilution. Offatumab should be a colorless solution. Do not use Arzerra concentrate if there is a change in color.
Do not shake the botulinum of ofatumumab for this check.
The concentrate may contain a small number of apparent opaquimumab transparent to white, amorphous particles. Filters from the provided infusion systems will remove these particles.

2) How to thin the infusion solution
Arzerra concentrate should be diluted in sodium chloride 9 mg / ml (0.9%) solution for injection prior to administration using aseptic technique.

300 mg dose - Use 3 x 100 mg / 5 ml vial (15 ml total, 5 ml per vial):
Withdraw and discard 15 ml of 1000 ml sodium chloride 9 mg / ml (0.9%) solution for injection;
Withdraw 5 ml of ofatumumab from each of the 3 x 100 mg vials and inject them into the 1000 ml bottle;
Do not shake, mix the diluted solution by gently inverting.
Dose of 2,000 mg - Use 2 x 1,000 mg / 50 ml vial (100 ml total, 50 ml per vial):
Withdraw and discard 100 ml of a 1000 ml sodium chloride 9 mg / ml (0.9%) solution for injection;
Withdraw 50 ml of ofatumumab from each of the 2 x 1000 mg vials and inject them into the 1000 ml bottle;
Do not shake, mix the diluted solution by gently inverting.
3) How to use the diluted solution
Arzerra should not be given as an intravenous injection or bolus. Apply using an intravenous infusion pump with the infusion systems provided with 0.2 micron filters. The internal filter should be used throughout the infusion.
The infusion should be completed within 24 hours after reconstitution. Discard the remaining unused solution after this period of time has elapsed.
Arzerra should not be mixed or given as an infusion with other medicinal products or intravenous solutions. To avoid this, clean the venous cannulas and catheters before and after administration of ofatumumab with a sodium chloride 9 mg / ml (0.9%) solution for injection.

For the first and second infusion, the infusion time should be over 6.5 hours (see section 4.2 of the SPC) via a peripheral vessel or a central catheter according to the following schedule:

Infusions 1 and 2: Schedule
Time (minutes) ml per hour
0 - 30 12
31 - 60 25
61-90 50
91 - 120 100
121 + 200
If the second infusion is complete without severe adverse reactions, the remaining infusions (3-12) should be over 4 hours (see section 4.2 of the SPC) via a peripheral vessel or a central catheter, according to the following schedule

 

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