BUPIVACAINA 5 mg /Ml Roztwór Do Wstrzykiwań
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Treść ulotki
Bupivacaina Grindeks 5 mg/ml injectable solution
bupivacaine hydrochloride
Generic medicine
Read this leaflet carefully before using this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet
- 1. What Bupivacaina Grindeks is and what it is used for
- 2. What you need to know before Bupivacaina Grindeks is administered to you
- 3. How Bupivacaina Grindeks is administered to you
- 4. Possible side effects
- 5. How to store Bupivacaina Grindeks
- 6. Contents of the pack and other information
1. What is Bupivacaina Grindeks and what is it used for
Bupivacaina Grindeks contains the active substance bupivacaine hydrochloride. It belongs to a group of
medicines called local anesthetics.
Bupivacaina Grindeks is used to numb (anesthetize) parts of the body. It is used to
stop the perception of pain or to relieve pain. It can be used:
- to numb parts of the body during surgical procedures (operations) in adults and adolescents over 12 years of age;
- to relieve pain in adults and children over 1 year of age.
2. What you need to know before you are given Bupivacaine Grindeks
You must not be given Bupivacaine Grindeks:
- if you are allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to other local anaesthetics similar to it (e.g. lidocaine or ropivacaine) as the risk of allergy to Bupivacaine Grindeks is increased;
- if you have a skin infection at the site where the anaesthetic is to be given;
- if you have cardiogenic shock (a condition in which the heart does not provide enough blood to the body);
- if you have hypovolaemic shock (very low blood pressure leading to collapse);
- if you have blood coagulation problems;
- if you have inflammation of the spinal cord or brain (meningitis, poliomyelitis or spondylitis);
- if you have a persistent headache caused by bleeding in the brain;
- if you have problems with the spinal cord caused by anaemia;
- if you have septicaemia (septic inflammation of the blood);
- if you have had a recent trauma, tuberculosis or spinal tumour;
- if you are undergoing obstetric paracervical block (a type of anaesthesia given during labour).
If any of the above conditions apply to you, your doctor must not give you this medicine.
If you are unsure, ask your doctor before you are given this medicine.
Warnings and precautions
Talk to your doctor before using Bupivacaine Grindeks
- if you suffer from heart, kidney or liver disease as your doctor may need to adjust the dose of the medicine;
- if you are elderly or debilitated;
- if you suffer from partial or complete blockage of the heart’s conduction system;
- if you are in late pregnancy;
- if you are being treated with Class III antiarrhythmic drugs (e.g. amiodarone);
- if you have fluid retention in the abdominal area;
- if you have a stomach tumour;
- if you have a reduced blood volume (hypovolaemia);
- if you have fluid in the lungs.
Children
Children over 12 years of age require special attention because some regional anaesthesia procedures (loss of pain sensation) using Bupivacaine Grindeks during surgical procedures have not been determined in this population.
The safety and efficacy of Bupivacaine Grindeks for children under 1 year of age have not been established.
Other medicines and Bupivacaine Grindeks
Tell your doctor if you are taking, have recently taken or might take any other medicines. This is important because Bupivacaine Grindeks can affect other medicines and other medicines can affect Bupivacaine Grindeks.
In particular, tell your doctor about the following medicines:
- medicines used to treat irregular heartbeats (arrhythmia), e.g. medicines with lidocaine, mexiletine or amiodarone;
- medicines used to stop blood clotting (anticoagulants).
The doctor needs to have a complete picture of other medicines to calculate the required dose correctly.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before you are given this medicine.
Driving and operating machinery
After administration of Bupivacaine Grindeks you may feel sleepy and your reaction speed may be altered. The doctor will decide whether you can actively participate in traffic or use machinery and tools.
Bupivacaine Grindeks contains sodium
This medicine contains 31.48 mg of sodium (the main component of table salt) in each vial (10 ml). This is equivalent to 1.57% of the recommended maximum daily intake of sodium for an adult.
3. How Bupivacaina Grindeks will be administered to you
The doctor will administer Bupivacaina Grindeks to you. The required dose will be calculated by the doctor based on the
necessary degree of pain relief and the part of the body where the medicine will be administered.
It will also depend on your body weight, age and general state of health. Usually a single
dose is sufficient, but in the case of a prolonged surgical operation, another dose may be administered
or the medicine may be administered as a slow infusion.
The site of administration depends on what the purpose of administering the medicine is. The
doctor administers the medicine at one of the following sites:
- near the part of the body that needs to be numbed;
- in an area away from the part of the body that needs to be numbed. This applies in cases where you are given an epidural injection (injection into the spine, around the spinal cord).
When Bupivacaina Grindeks is injected in one of these ways, the nerve fibres interrupt the
conduction of impulses/pain to the brain. At the end of the operation, this effect will gradually
disappear.
Use in children and adolescents
Depending on the desired pain relief (loss of pain perception), Bupivacaina Grindeks is
slowly administered into the epidural space (the area surrounding the spinal canal), or in other parts
of the body by an anaesthetist who has experience in anaesthetic techniques in children. The dose depends
on the patient's age and body weight and is determined by an anaesthetist.
If you are given more Bupivacaina Grindeks than you should
Serious side effects of an overdose of Bupivacaina Grindeks are unlikely. Such side
effects require special treatment and the doctor treating you with this medicine is
familiar with solving such situations. The first symptoms of an overdose with Bupivacaina Grindeks
are generally:
- feeling dizzy, confused;
- numbness of the lips and around the mouth;
- numbness of the tongue;
- hearing problems;
- vision problems.
To reduce the risk of serious side effects, the doctor will stop administering Bupivacaina
Grindeks as soon as these signs appear. This means that if you have any of these
signs, you should inform the doctor immediately.
More serious effects of an overdose of Bupivacaina Grindeks include muscle twitching, muscle
spasms and loss of sensation.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.
Serious allergic reactions(rare, may affect up to 1 in 1000)
If you have a serious allergic reaction, tell your doctor immediately. Signs may include the
sudden onset of:
- swelling of the face, lips, tongue or throat. As a result, it is difficult to swallow;
- severe or sudden swelling of hands, feet and ankles;
- difficulty breathing;
- severe skin itching with blisters.
Other possible side effects:
Very common(may affect more than 1 in 10 people):
- low blood pressure. This may make you feel dizzy and confused;
- feeling unwell (nausea).
Common(may affect up to 1 in 10 people):
- tingling sensation in the skin;
- feeling dizzy;
- slowed heartbeat;
- high blood pressure;
- vomiting;
- problems with fluid elimination (fluid retention in the body).
Uncommon(may affect up to 1 in 100 people):
- seizures (convulsions);
- numbness of the tongue or around the mouth;
- difficulty speaking;
- feeling confused;
- ringing in the ears or sensitivity to sounds;
- blurred vision;
- loss of consciousness;
- tremor;
- muscle contractions.
Rare(may affect up to 1 in 1000 people):
- nerve damage that can cause changes in perception or muscle weakness (neuropathy). This may also include peripheral nerve damage;
- inflammation of the membrane surrounding the spinal cord (arachnoiditis). Symptoms of inflammation include a sharp or burning pain in the lower back or legs and tingling, numbness, or weakness in the legs;
- weakness in the legs or complete immobility of the legs;
- double vision;
- irregular heartbeat (arrhythmia). This can be life-threatening;
- slowing or stopping of breathing or stopping of the heartbeat. This can be life-threatening.
Other possible side effects that have been observed with other local anesthetics and that
may also occur with Bupivacaina Grindeks:
- problems with liver enzymes. These complications can occur if you receive the medicine for a long period;
- nerve damage. Rarely this can cause permanent problems;
- blindness that is not permanent, or problems with the eye muscles that may take a considerable time to resolve. These problems can occur when anesthetic is administered near the eye.
Side effects in children are similar to those in adults.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the 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 Bupivacaina Grindeks
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 label and the packaging after
"Exp". The expiry date refers to the last day of that month.
Do not freeze.
The doctor or hospital generally stores Bupivacaina Grindeks. The staff is responsible for the
correct storage, handling and use of Bupivacaina Grindeks.
6. Contents of the pack and other information
What Bupivacaina Grindeks contains
- The active substance is bupivacaine hydrochloride. Each ml of solution for injection contains 5 mg of bupivacaine hydrochloride. One vial (10 ml) contains 50 mg of bupivacaine hydrochloride.
- The other ingredients are: sodium chloride, sodium hydroxide or hydrochloric acid, concentrate (for pH adjustment), water for injections.
Description of the appearance of Bupivacaina Grindeks and contents of the pack
Clear, colorless liquid, practically free from visible particles.
10 ml of injectable solution in a glass vial made of type I borosilicate glass, hydrolytic class colorless with a
break line or single breaking point.
5 vials are packaged in a polyvinyl chloride film container.
1 container is packaged in a cardboard box.
Marketing authorisation holder
AS Grindeks
Krustpils iela 53,
Rīga, LV-1057,
Latvia
Manufacturer
AS Grindeks
Krustpils iela 53,
Rīga, LV-1057,
Latvia
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Republic: Bupivacaine Grindeks
Romania: Bupivacaină Grindeks 5 mg/ml injectable solution
Slovakia: Bupivacaine Grindeks 5 mg/ml injection solution
Austria: Bupivacain Grindeks 5 mg/ml Injektionslösung
Bulgaria: Бупивакаин Гриндекс 5 mg/ml инжекционен разтвор
Germany: Bupivacain Grindeks 5 mg/ml Injektionslösung
Hungary: Bupivacaine Grindeks 5 mg/ml solution for injection
Italy: Bupivacaina Grindeks
Slovenia: Bupivakain Grindeks 5 mg/ml solution for injection
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- Kraj rejestracji
- Postać farmaceutycznaInjectable solution, 5 MG/ML
- Kod ATCN01BB01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki BUPIVAKAINA GRINDEKSPostać farmaceutyczna: Injectable solution, 2.5 MG/MLSubstancja czynna: bupivacaineProducent: MONICO S.P.A.Wymaga receptyPostać farmaceutyczna: Injectable solution, 2,5MG/MLSubstancja czynna: bupivacaineWymaga receptyPostać farmaceutyczna: Injectable solution, 2.5 MG/MLSubstancja czynna: bupivacaineWymaga recepty
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Substancją czynną w BUPIVAKAINA GRINDEKS jest bupivacaine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
BUPIVAKAINA GRINDEKS jest produkowany przez AS GRINDEKS. 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 BUPIVAKAINA GRINDEKS 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 BUPIVAKAINA GRINDEKS 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 (bupivacaine) to m.in. BUPIKAIN, BUPISEN, BUPIVAKAINA ANJELINI. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
