Solution for injection 625 IU / ml. Human immunoglobulin anti-D
What Rhesonative is and what it is used for
Rhesonative is immunoglobulin and contains antibodies to the Rhesus factor. If a woman who lacks the Rhesus factor on her red blood cells (= Rh-negative) is pregnant with a fetus that has the Rhesus factor (= Rh-positive), her immune system can be stimulated to form antibodies against the Rhesus factor (Rh immunization). These antibodies can damage her fetus, especially in subsequent pregnancies.
Rhesonatives are used to prevent the Rh-negative woman from being immunized during pregnancy and childbirth, thus preventing the fetus from being harmed.
Rhesonatives are used in Rh-negative women in the following cases:
- Preventive treatment in Rh-negative pregnant women
- At birth when the baby is Rh-positive
- In case of abortion / threatening abortion (miscarriage/risk of miscarriage)
- Pregnancy outside the uterus, in certain types of growth inside the uterus (so-called nodules), if fetal blood enters the mother’s normally separate bloodstream in case of bleeding or fetal death late in pregnancy
- Interventions during pregnancy such as sampling of amniotic fluid with a syringe (so-called. amniocentesis), blood sampling from the umbilical cord, tissue samples, or various measures related to obstetric care, for example, measures to manually return the baby to the correct position in the womb, or abdominal injuries or surgical treatment of the fetus in the womb.
Rhesonatives can also be used in Rh-negative people who have accidentally received an Rh-positive blood transfusion.
What you need to know before using Rhesonativ
Do not use Rhesonative
– if you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Rhesonativ.
Tell your doctor if you have any other illnesses.
Rhesonative is not intended for use in Rh (D) -positive individuals or individuals who have already been immunized against Rh (D) antigen.
True hypersensitivity reactions (allergic reactions) are rare but can occur.
In case of suspected allergy or severe allergic reaction ( anaphylactic reaction ), inform your doctor or nurse immediately. Symptoms include dizziness, palpitations, drop in blood pressure, difficulty breathing and swallowing, pressure over the chest, itching, hives, swelling of the face, tongue, or throat, collapse, and rash. All of these conditions need immediate treatment.
If you experience symptoms such as shortness of breath, pain, swelling in an arm or leg, or chest pain, you should contact a doctor or nurse immediately as this may be a sign of a blood clot. Children
There are no data on use in children.
Patients with overweight/obesity
For overweight / obese patients, the use of an intravenous anti-D drug should be considered.
Virus safety
When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes:
- 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 virus/infection
- including steps in the processing of blood and plasma that can inactivate and secrete viruses.
Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken are considered to be effective against enveloped viruses, such as HIV, hepatitis B, and hepatitis C virus, and the non-enveloped virus and hepatitis A. The measures may be of limited value against non-enveloped viruses such as parvovirus B19.
Immunoglobulins have not been linked to hepatitis A or parvovirus B19 infections, probably due to the protective effect of the antibodies in the product.
When Rhesonativ is used, it is recommended that the product name and batch number be registered to enable the tracking of the product used.
Other Medicines and Rhesonatives
– Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
– Rhesonatives can reduce the effect of vaccines against, for example, measles, rubella, mumps, and chickenpox. This applies to vaccines that are administered approximately 2-4 weeks before injection of the anti-D antibody as well as to vaccinations that are given afterward.
After treatment with Rhesonativ, it should be three months before you are vaccinated with any of these vaccines. It is therefore important that the doctor performing the vaccination knows that you are receiving, or have received, treatment with Rhesonativ.
– Tell your doctor that you are being treated with immunoglobulin when taking blood samples, as the treatment may affect the test results.
Pregnancy and breastfeeding
Rhesonative is intended for use during pregnancy and may be used during breastfeeding.
Driving and using machines
No effects on the ability to drive or use machines have been observed.
Rhesonatives contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per 1 ml solution (625 IU), ie it is essentially ‘sodium-free’.
How to use Rhesonativ
Your doctor will decide if you need Rhesonativ and in what dose. Rhesonative is given as an intramuscular injection (into a muscle) by healthcare professionals.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported (occurring in an unknown number of users): headache, palpitations, low blood pressure, wheezing, vomiting, nausea, skin reactions, joint pain, low back pain, dizziness, fever, discomfort incl. the feeling of discomfort in the chest, chills, local reactions at the injection site such as swelling or pain, degradation of red blood cells, and severe allergic reactions incl. anaphylactic shock.
If you experience symptoms of an anaphylactic reaction such as dizziness, nausea, vomiting, stomach cramps, cough, difficulty breathing or swallowing, bluish discoloration, itching, hives, rash, palpitations, low blood pressure, swelling of the face, tongue, or throat, collapse or chest pain, contact your doctor immediately as these reactions require immediate treatment.
How to store Rhesonativ
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Store ampoule one in the outer carton. Sensitive to light.
During the shelf life, the product may be stored below 25 ° C for up to 1 month without being cooled again during this period and must be discarded thereafter.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
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 pack and other information
Marketing Authorization Holder and Manufacturer
Content declaration
- The active substance is human immunoglobulin anti-D. 1 ml contains 625 IU (125 micrograms) human immunoglobulin anti-D
- One 1 ml ampoule contains 625 IU (125 micrograms) human immunoglobulin anti-D
One 2 ml ampoule contains 1250 IU (250 micrograms) human immunoglobulin anti-D - The content of human proteins is 165 mg per milliliter of which immunoglobulin G is at least 95%
- The other ingredients are glycine, sodium chloride, sodium acetate, polysorbate 80, and water for injections.
What the medicine looks like and the contents of the pack
Rhesonative is a solution for injection (625 IU / ml or 1250 IU / 2 ml per ampoule ).
Pack sizes: 1×1 ml, 1×2 ml and 10×2 ml.
The color of the solution can vary from colorless to pale yellow up to light brown.
Not all pack sizes may be marketed.
Customer phone: 020-311020
e-mail: fraga@octapharma.se
| Name of Member State | The name of the drug |
|---|---|
| Bulgaria | Rhesonative 625 IU / ml, solution for injection |
| Cyprus | Rhesonative |
| Denmark | Rhesonative, Octapharma AB, Solution for injection, 625 IU / ml, anti-D (RH) immunoglobulin , human |
| Estonia | Rhesonativ süstelahus 625TÜ 1ml |
| Finland | Rhesonative 625 IU / ml injection test, limos |
| France | Rhesonativ 625 UI / ml, injectable solution |
| Ireland | Rhesonative 625 IU / ml, solution for injection |
| Iceland | Rhesonative solution for injection 625 IU / ml |
| Italy | Rhesonativ 625 IU / ml Soluble solution |
| Latvia | Rhesonativ 625 SV / ml šķīdums injekcijām |
| Lithuania | Rhesonative 625 TV/ml tyrpalas injection |
| Luxembourg | Rhesonative Sol. Inj. 625 UI / 1 ml |
| Malta | Rhesonative 625 IU / ml, solution for injection |
| Netherlands | Rhesonativ 625 IU / ml, solution for injection |
| Norway | Rhesonative solution for injection 625 IU / ml “Octapharma” |
| Poland | Rhesonative |
| Portugal | Rhesonative |
| Romania | Rhesonativ 625 UI / ml, injectable solution |
| Slovakia | Rhesonative |
| Slovenia | Rhesonativ 625 ie / ml, raztopina for injection |
| Sweden | Rhesonative, 625 IU / ml solution for injection |
| Czech Republic | Rhesonative 625 IU / ml |
| Hungary | Rhesonativ Rhesonativ 625 NE / ml oldatos injection |
| Austria | Rhesonative 625 IU / ml solution for injection |