RHESONATIV 625 IU/mL Roztwór do wstrzykiwań
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Treść ulotki
Rhesonativ
625 IU/mL, injectable solution
Human anti-D immunoglobulin
Read this leaflet carefully before you start this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Rhesonativ is and what it is used for
- 2. What you need to know before you use Rhesonativ
- 3. How to use Rhesonativ
- 4. Possible side effects
- 5. How to store Rhesonativ
- 6. Contents of the pack and other information
- 1. What Rhesonativ is and what it is used forRhesonativ is an immunoglobulin and contains antibodies against the Rhesus factor. If a woman who lacks the Rhesus factor in her red blood cells (i.e., a Rh-negative woman) is pregnant with a fetus that has the Rhesus factor (i.e., a Rh-positive fetus), the woman's immune defense system may be stimulated to form antibodies against the Rhesus factor. These antibodies can be dangerous for the fetus, especially in subsequent pregnancies. Rhesonativ is used to prevent immunization of the Rh-negative woman during pregnancy and childbirth and to prevent, in this way, harm to the fetus. Rhesonativ is used in the Rh-negative woman in case of: prophylactic anti-D therapy for pregnant women who are Rh-negative birth of an Rh-positive baby abortion/threatened abortion (spontaneous abortion/threatened spontaneous abortion) pregnancy outside the uterus, formation of masses inside the uterus (mole) or passage of fetal blood into the mother's bloodstream normally separated or fetal death in a late stage of pregnancy invasive procedures during pregnancy, such as amniotic fluid sampling with a syringe (amniocentesis) or fetal blood sampling from the umbilical vein, biopsy or obstetric manipulative procedures, for example, procedures to manually rotate the baby into a correct position inside the uterus, or abdominal trauma, surgical treatment of the fetus inside the uterus Rhesonativ can also be used in Rh-negative subjects who have mistakenly received a transfusion of Rh-positive blood.
2. What you need to know before using Rhesonativ
Do not use Rhesonativ
if you are allergic to human immunoglobulin or to any of the other ingredients of this
medicinal product (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Rhesonativ.
If you suffer from any other disorder, inform your doctor.
Rhesonativ is not intended for use in Rh(D) positive subjects, nor in subjects already
immunized to the Rh(D) antigen.
True hypersensitivity reactions (allergic reactions) are rare, but may occur.
If you suspect an allergy or a severe allergic reaction (anaphylactic reaction), inform
your doctor or nurse immediately. Symptoms include, for example, dizziness, palpitations
of the heart, low blood pressure, difficulty breathing and swallowing, tightness
of the chest, itching, widespread hives (urticaria), swelling of the face, tongue or
throat, collapse and skin rash. All these conditions require immediate treatment.
If you experience symptoms such as shortness of breath, pain and swelling in a limb, chest pain, seek
immediate medical attention from your doctor or nurse, as these may be signs of a
blood clot.
Children
No data are available on use in children.
Overweight patients
In the case of overweight/obese patients, the use of an
anti-D product by intravenous route should be considered.
Viral safety
When medicines are prepared from human blood or plasma, certain measures are taken to prevent the risk of transmitting infections to patients. These
include:
- careful selection of blood and plasma donors to ensure the exclusion of subjects at risk of carrying infectious diseases
- examination of each donation and plasma pools to check for signs of viruses/infections
- inclusion of procedures in the processing of blood or plasma that can inactivate or remove viruses. Despite these measures, when administering medicinal products prepared from blood or plasma, it is not possible to completely exclude the possibility of transmitting infectious diseases. This also applies to viruses of currently unknown or emerging nature or other types of infections.
The measures taken are considered effective for enveloped viruses such as the human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus and for the
non-enveloped hepatitis A virus.
The measures taken may have limited value against non-enveloped viruses, such as the
parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections,
probably because the antibodies against these infections contained in the medicinal product are
protective.
With each administration of Rhesonativ, it is recommended to record the patient's name and
the batch number of the product, in order to keep a record of the batches used.
Other medicines and Rhesonativ
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Rhesonativ may decrease the effect of vaccines such as those for measles, rubella, mumps
and varicella. This applies to vaccines administered approximately 2-4 weeks before
the administration of an anti-D antibody injection, as well as to subsequent
vaccinations. Three months must pass after treatment with Rhesonativ before
vaccination with one of these vaccines. Therefore, it is important that the doctor performing
the vaccination is aware of the fact that you are receiving or have received treatment
with Rhesonativ.
When a blood sample is taken, inform your doctor that you are taking
immunoglobulin, as this treatment may affect the results.
Pregnancy and breastfeeding
Rhesonativ is intended for use during pregnancy and can be used during breastfeeding.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Rhesonativ contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 1 mL of solution
(625 IU), i.e. essentially “sodium-free”.
3. How to use Rhesonativ
Your doctor will decide whether and in what dose you should be administered Rhesonativ. Rhesonativ
is administered as an intramuscular injection (into a muscle) by medical personnel.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The frequency of the following side effects is not known (frequency cannot be estimated
based on available data): headache, palpitations, low blood pressure, dyspnea,
vomiting, nausea, skin reactions, joint pain, back pain, dizziness, fever, feeling of
discomfort including chest pain, chills, local reactions at the injection site such as swelling and
pain, degradation of red blood cells and serious allergic reactions including anaphylactic shock.
If you notice symptoms of an anaphylactic reaction such as dizziness, nausea, vomiting, stomach
cramps, cough, difficulty breathing and swallowing, bluish skin, itching, hives, rashes,
accelerated heartbeat, low blood pressure, swelling of the
face, tongue or throat, collapse or chest pain, contact your doctor immediately
because all these conditions require immediate treatment.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you
can help provide more information on the safety of this medicine.
5. 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. Keep the vials in the outer packaging
to protect them from light.
Within the expiry period, the product can be stored at a temperature below 25
°C for up to 1 month, without being refrigerated again during this period, and
must be discarded if not used after this period.
Do not use this medicine after the expiry date which is stated on the label and on
the packaging, after “Exp”. The expiry date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Rhesonativ contains
The active substance is human anti-D immunoglobulin.
1 mL contains 625 IU (125 μg) of human anti-D immunoglobulin.
1 vial of 1 mL contains 625 IU (125 μg) of human anti-D immunoglobulin. 1 vial of
2 mL contains 1250 IU (250 µg) of human anti-D immunoglobulin.
The human protein content is 165 mg/mL, of which immunoglobulin G
represents at least 95%.
The excipients are: glycine, sodium chloride, sodium acetate, polysorbate 80 and water for
injections.
Description of the appearance of Rhesonativ and contents of the pack
Rhesonativ is an injectable solution (625 IU/mL or 1250 IU/2 mL per vial).
Packs of: 1x1 mL, 1x2 mL and 10x2 mL.
The colour of the solution may vary from colourless to pale yellow to light brown.
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
| Member State Name | o Medicinal Product Name |
| Austria | c Rhesonativ 625 I.E./mL Injektionslösung |
| Bulgaria | a Rhesonativ 625 IU/mL, solution for injection |
| Cyprus | Rhesonativ 625 IU/mL, διάλυμα για ένεση |
| Denmark | Rhesonativ, Injectionsvæske, opløsning |
| Estonia | m Rhesonativ, 625 RÜ/mL, süstelahus |
| Finland | Rhesonativ 625 IU/mL injektioneste, liuos |
| France | r Rhesonativ 625 UI/mL, solution injectable |
| Ireland | a Rhesonativ 625 IU/mL, solution for injection |
| Iceland | Rhesonativ 625 a.e./mL, stungulyf, lausn |
| Italy | F Rhesonativ 625 IU/mL Soluzione iniettabile |
| Latvia | Rhesonativ 625 SV/mL šķīdums injekcijām |
| Lithuania | Rhesonativ 625 TV/mL injekcinis tirpalas |
| Luxembourg | l Rhesonativ 625 UI/mL, solution injectable |
| Malta | e Rhesonativ 625 IU/mL, solution for injection |
| Norway | Rhesonativ 625 IE/mL injeksjonsvæske, oppløsning |
| Netherlands | d Rhesonativ 625 IE/mL, oplossing voor injectie |
| Poland | Rhesonativ, 625 j.m./mL, roztwór do wstrzykiwań |
| Portugal | Rhesonativ 625 UI/mL, solução injetável |
| Czech Republic | a Rhesonativ 625 IU/mL, injekční roztok |
| Romania | Rhesonativ 625 UI/mL, solutie injectabila |
| Slovakia | n Rhesonativ 625 IU/mL injekčný roztok |
| Slovenia | a Rhesonativ 625 i.e./mL, raztopina za injiciranje |
| Sweden | Rhesonativ 625 IE/mL injektionsvätska, lösning |
| Hungary | i Rhesonativ 625 NE/mL oldatos injekció |
Marketing Authorisation Holder
OCTAPHARMA ITALY S.p.A.
Via Cisanello, 145
56100 Pisa
Italy
Manufacturer
Octapharma AB
SE-112 75 Stockholm, Sweden
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The following information is intended exclusively for healthcare
professionals:
The product must be brought to room or body temperature before use.
Do not use turbid solutions or solutions containing deposits.
The contents of an opened vial must be used immediately. Any unused medicinal
product and waste derived from such medicinal product must be disposed of in accordance with
current local regulations.
Injections must be administered intramuscularly and care must be taken
to pull back the syringe plunger before injection to ensure that the needle
is not in a blood vessel.
If intramuscular administration is contraindicated (bleeding disorders), the injection may
be administered subcutaneously if no other intravenous product is
available. After injection, careful manual pressure, with a swab, must be
applied to the injection site.
If a large volume is required (>2 mL for children or >5 mL for adults), it is recommended
to divide it into several doses to be injected at different sites.
This medicinal product must not be mixed with other medicinal products.
Due to a possible lack of efficacy in case of intramuscular administration in
overweight/obese patients, the use of an intravenous anti-D product is recommended.
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- Kraj rejestracji
- Postać farmaceutycznaInjectable solution, 625 IU/mL
- Kod ATCJ06BB01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki RESONATIVPostać farmaceutyczna: Injectable solution, 1500 IU/2 MLSubstancja czynna: anti-D (rh) immunoglobulinProducent: INSTITUTO GRIFOLS S.A.Wymaga receptyPostać farmaceutyczna: Powder and solvent for injectable solution, 300 MCGSubstancja czynna: anti-D (rh) immunoglobulinProducent: KEDRION S.P.A.Wymaga receptyPostać farmaceutyczna: Injectable solution, 200 MICROGRAMSSubstancja czynna: anti-D (rh) immunoglobulinProducent: CSL BEHRING GMBHWymaga recepty
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RESONATIV wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w RESONATIV jest anti-D (rh) immunoglobulin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
RESONATIV jest produkowany przez OCTAPHARMA ITALY S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie RESONATIV jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić RESONATIV w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (anti-D (rh) immunoglobulin) to m.in. IGAMAD, IMMUNORO, ROPYLAK. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
