RHESONATIV amp. 625 IU ml. 2 ml.
RHESONATIV amp. 625 IU / ml. 2 ml.
What Rhesonativ and what it is used
Rezonativ is immunoglobulin and include antibodies to Rh factor . If the woman in whose red cells lack Rh (= Rh negative) , is pregnant with an unborn child who is Rh (= Rh positive) , its immunity can be stimulated to form antibodies against the Rh factor . These antibodies can harm her unborn child , particularly in subsequent pregnancies .
Rhesonativ is used to prevent Rh negative woman immunization during pregnancy and childbirth , thereby preventing damage to the unborn child.
Rezonativ applied in Rh negative women , in cases of :
Prophylactic anti -D for treating pregnant women who are Rh negative;
Delivery of an Rh positive child ;
Abortion / threatened abortion ( miscarriage / threatened miscarriage ) ;
Ectopic pregnancy , a particular type of growth inside the uterus ( mole) or bleeding from the unborn child in the individual normal circulation of the mother or the death of an unborn child in the later stages of pregnancy ;
Invasive procedures during pregnancy , for example removal of amniotic fluid with a syringe ( ie, amniocentesis ) , or sampling the blood of the unborn baby from umbilical vein , biopsy or obstetric manipulations , e.g., procedures for manually rotating the infant to its proper position in the uterus or abdominal trauma , surgery of the unborn child in the womb.
Rezonativ can be used in Rh negative individuals who inadvertently transfused with Rh positive blood.
2 . What you should know before using Rhesonativ
Do not use Rezonativ
if you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine ( listed in Section 6).
Warnings and Precautions
Talk to your doctor before using Rezonativ .
Tell your doctor if you suffer from any other diseases.
Rezonativ is not intended for use in either the Rh (D) positive subjects or in subjects who are already immune to the Rh (D) antigen.
True hypersensitivity reactions (allergic ) reactions are rare but may occur .
In case of suspected allergy or severe allergic reaction ( anaphylactic reaction), you should immediately tell your doctor or nurse . Symptoms are dizziness, palpitations (heart palpitations) , low blood pressure, difficulty breathing and swallowing, chest tightness, itching, generalized urticaria (hives) , swelling of the face, tongue , or throat collapse and rash , for example. Any of these conditions require immediate treatment.
No data available for use in children.
When medicines prepared from human blood or plasma are adopted and implemented certain measures to prevent the transmission of infection to patients. These include careful selection of donors of blood and plasma to ensure the exclusion of those who are at risk of carriers of infections, and testing of each donation and pools of plasma for detecting signs of virus / infections. Manufacturers of these products also include steps in the processing of blood or plasma, in which viruses can be inactivated or removed. Despite these measures, when medicinal products prepared from human blood or plasma, can not completely exclude the possibility of transmission of infection . This also applies to unknown or emerging viruses and other infections.
The measures taken are considered effective for viruses containing coatings , e.g. human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus , and against the virus of hepatitis A , containing no shell.
It is possible that the measures implemented have limited effect against viruses, containing shells , such as parvovirus B19.
Immunoglobulins are related to infection with hepatitis A and B19 parvovirus , presumably because the antibodies against these infections, which contain the product, are protective.
It is strongly recommended that every time you put a dose of Rezonativ to record the name and batch number of the product to maintain a list of batches used the product.
Other medicines and Rezonativ
Tell your doctor if you are taking or have recently taken any other medicines;
Rezonativ can reduce the effect of vaccines , such as measles, rubella, mumps and varicella . After treatment with Rezonativ must pass three months before being vaccinated with either of these vaccines. It is therefore important that the doctor who performed the vaccination to know that you are being or have received treatment with Rezonativ ;
When you give blood samples for testing , tell your doctor that immunoglobulins , as this medication may affect the results.
Pregnancy and lactation
Rezonativ is intended for use during pregnancy and may be used during lactation .
Driving and using machines
No effects on ability to drive and use machines.
Important information about some of the ingredients of Rezonativ
This product contains less than 1 mmol of sodium (23 mg) per dose, i.e. he practically sodium-free .
3 . How to use Rhesonativ
Your doctor will decide whether you should be treated with Rezonativ and in what dose. Rezonativ is given as an intramuscular injection ( into the muscle ) by a health worker.
4 . Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
May cause the following side effects : headache , palpitations, low blood pressure , dizziness, vomiting , nausea, skin reactions , joint pain , fever, discomfort , including chest discomfort , trembling, reactions at the site of injection, such as swelling and pain , destruction of red blood cells and severe allergic reactions, including allergic shock .
If you notice any symptoms of an anaphylactic reaction , such as wheezing, nausea , vomiting , painful stomach cramps , coughing, difficulty breathing and swallowing , bruising , itching , urticaria ( hives ), rash , palpitations, low blood pressure, swelling of the face , tongue, or throat collapse or chest pain , please contact your doctor immediately , as each of these conditions require immediate treatment .
If you get any side effects, tell your doctor. This includes all listed in this leaflet .
5 . How to store Rhesonativ
Keep out of reach of children.
Keep 2 ° C - 8 ° C. Keep the ampoules in the outer carton to protect from light .
Rezonativ not use after the expiry date stated on the label and carton after used to mark the expiry date . The expiry date refers to the last day of that month.
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 Rhesonativ
The active substance is human anti -D immunoglobulin. 1 ml contains 625 IU ( 125 ?g) of human anti -D immunoglobulin.
The ampoule of 1 ml containing 625 IU ( 125 ?g) of human anti -D immunoglobulin.
Ampoule of 2 ml contains 1250 IU ( 250 ?g) of human anti-D immunoglobulin.
The content of the human protein is 165 mg / ml, immunoglobulin G of which is at least 95%.
Other ingredients are: glycine, sodium chloride , sodium acetate, and water for injection.
Rezonativ looks like and contents of pack
Rezonativ a solution for injection. The color of the solution ranges from colorless , pale yellow to light brown. Rezonativ is available in ampoule with 1 ml and 2 ml (glass type I).
CONTENTS : 1 x 1 ml, 1 ml and 2 x 10 x 2 ml.
Not all pack sizes may be marketed.
Date of last revision of package : 02 /2012 .
The following information is intended for healthcare professionals only :
Before use, the product should be brought to room or body temperature. Do not use solutions that are cloudy or contains particles .
The content of open vials should be used immediately. Any unused product or waste material should be disposed of in accordance with local requirements.
Injections should be placed before intramuscular injection must carefully pull the plunger rod in order to ensure that the needle has entered a blood vessel. If intramuscular injections are contraindicated (coagulation disorders) , the injection should be administered subcutaneously , if not available intravenous product. After injection at the site of an injection should be placed and pressed gently compress.
If required a large volume (> 2 ml for children , > 5 ml of an adult) , it is advisable to apply a divided dose injected in different locations.
This medicinal product must not be mixed with other medicinal products.