50 IU / ml solution for infusion
human hepatitis B immunoglobulin for intravenous administration
What Neohepatect is and what it is used for
Neohepatect contains the active substance human hepatitis B immunoglobulin, which may protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus. Neohepatect is a solution for infusion (in a vein) and is supplied in vials containing 2 ml (100 International Units [IU]), 10 ml (500 IU), 40 ml (2,000 IU), and 100 ml (5,000 IU).
Neohepatect is used to provide immediate and long-lasting immunity (protection):
- to prevent hepatitis B infection in patients who have not been vaccinated or who do not have adequate vaccination protection against hepatitis B, and who are at risk of developing a hepatitis B infection .
- to prevent infection in a transplanted liver in patients who show positive tests for hepatitis B.
- in newborns whose mothers are infected with the hepatitis B virus .
- to protect patients who have not received adequate protection from hepatitis B vaccination
Human hepatitis B immunoglobulin contained in Neohepatect may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Neohepatect
Do not use Neohepatect
- if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
- if you have immunoglobulin A ( IgA ) deficiency, especially if you have antibodies to IgA , as it may lead to anaphylaxis (severe allergic reaction ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Neohepatect if you
- have not received this medicine before or it has been a long time (eg several weeks) since you last received it (you must be closely monitored during the infusion one and for one hour after the end of the infusion )
- recently received Neohepatect (you must be monitored during infusion one and at least 20 minutes after infusion one)
- have an untreated infection or an underlying chronic inflammationhave had a reaction to other antibodies (in rare cases you may be at risk of allergic reactions)
- have or have had a kidney disease
- have been given medicines that can damage your kidneys (if your kidney function deteriorates, treatment with Neohepatect may need to be stopped).
Your doctor should take extra care if you are overweight, elderly, diabetic, or have high blood pressure, if you have low blood volume ( hypovolemia ), or if your blood is thicker than normal (high blood viscosity) if you have been bedridden or immobile (immobile). for a long time or if you have problems with the blood vessels (vascular diseases) or if you have another risk factor for thrombotic events (blood clots).
Note – reactions
You will be closely monitored during the time you receive an infusion of Neohepatect to ensure that you do not get any reaction (eg anaphylaxis ). Your doctor will check that Neohepatect is given as an infusion at a rate that suits you.
If you notice any of the following signs of a reaction, ie. headache, flushing, chills, muscle aches, tingling, rapid heartbeat, low back pain, nausea, low blood pressure during infusion one with Neohepatect, you should tell your doctor immediately. The infusion rate can be reduced or the infusion can be stopped completely.
Information on the transmission of infectious substances
Neohepatect is made from human plasma (the liquid part of the blood).
When medicines are made from human blood or plasma, certain measures are taken to prevent the transmission of infection to patients. These include:
- careful selection of blood and plasma donors to ensure that people at risk of being infected are excluded
- testing of individual donations and plasma pools for signs of viruses / infections
- introduction of steps in the preparation of one of the blood or plasma that can inactivate or secrete viruses .
Despite these measures, the risk of transmitting infection can not be completely ruled out when administering medicinal products derived from human blood or plasma. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus.
The measures taken may have limited value against uncovered viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19‑ infections, possibly because antibodies to these infections, which are present in the product, have a protective effect.
When you are given Neohepatect, it is recommended that the product name and batch number be registered to enable the tracking of the product used.
Other medicines and Neohepatect
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Neohepatect may reduce the effectiveness of certain vaccines, eg:
- measles
- rubella
- mumps
- chicken-pox
You may have to wait up to three months before you can get certain vaccines and up to a year before you can get the measles vaccine.
Do not use loop diuretics with Neohepatect.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide if Neohepatect can be used during pregnancy and breastfeeding.
Driving and using machines
Neohepatect has little effect on the ability to drive and use machines. If you have experienced side effects during treatment, wait until they have subsided before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Neohepatect
Neohepatect is for intravenous administration ( infusion into a vein). You get it from a doctor or a nurse. The recommended dose depends on your condition and your body weight. The doctor knows how much to take.
At the beginning of infusion, Neohepatect is administered slowly. The doctor can then gradually increase the infusion rate.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during clinical trials with Neohepatect:
No known frequency (can not be calculated from the available data)
- severe allergic reaction (anaphylactic shock )
- hypersensitivity reaction er
- headache
- dizziness
- fast heartbeat ( tachycardia )
- low blood pressure ( hypotension )
- nausea
- Skin reactions such as rash, itching
- fever
- feeling sick
Preparations containing human normal immunoglobulin generally cause the following side effects ( in decreasing frequency):
- chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure , moderate low back pain
- decreased number of red blood cells due to their degradation in the blood vessels ([reversible] haemolytic reactions) and (rare) haemolytic anemia requiring blood transfusion
- (rare) a sudden drop in blood pressure and, in rare cases, anaphylactic shock
- (rare) transient skin reactions (including cutaneous lupus erythematosus – no known frequency)
- (very rare) thromboembolic reactions such as myocardial infarction ( myocardial infarction ), stroke , blood clots in the blood vessels of the lungs ( pulmonary embolism ),blood clots in a vein (deep vein thrombosis )
- case of transient acute inflammation of the protective membrane surrounding the brain and spinal cord ( meningitis )
- blood test results indicating renal impairment and / or sudden renal failure
- cases of transfusion-related acute lung injury (TRALI). This leads to an accumulation of fluid in the air spaces of the lungs that is not due to heart problems (non-cardiogenic pulmonary edema ). You have severe shortness of breath (difficulty breathing), rapid breathing (tachypnea), abnormally low oxygen levels in the blood ( hypoxia ) and elevated body temperature (fever).
If a side effect occurs, the infusion rate is reduced or the infusion is stopped.
How to store Neohepatect
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label.
Keep the vial in the outer carton. Sensitive to light. Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
The solution should be clear or slightly opalescent and colorless to light yellow. Do not use solutions that are cloudy or contain a precipitate.
The solution should be administered immediately after opening the container. The medicine must have reached room or body temperature before use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance in Neohepatect is human hepatitis B immunoglobulin for intravenous administration .
Neohepatect contains 50 mg / ml human plasma protein , of which at least 96% is immunoglobulin G (IgG). The content of hepatitis B antibody is 50 IU / ml. The maximum immunoglobulin A ( IgA ) content is 2000 micrograms / ml. The distribution of subgroups of IgG is approx.
59% IgG1, 35% IgG2, 3% IgG3, 3% IgG4. - The other ingredients are glycine and water for injections.
What the medicine looks like and contents of the pack
Neohepatect is a solution for infusion. The solution is clear to slightly opal shimmering (milk-colored like an opal) and colorless to light yellow.
Pack size: 1 vial with 2 ml, 10 ml, 40 ml, or 100 ml solution.
Marketing Authorization Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Three
Germany
Tel .: + 49 6103 801-0
Fax: + 49 6103 801-150
Email: mail@biotest.com
Local representative:
Unimedic Pharma AB
Box 6216
SE-102 34 Stockholm
Tel: +46 8 130 99 50