SANERGY 5 mg /Ml Roztwór Do Wstrzykiwań
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Treść ulotki
Sanergy 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, ask your doctor or nurse. See section 4.
Contents of this leaflet
- 1. What Sanergy is and what it is used for
- 2. What you need to know before Sanergy is administered to you
- 3. How Sanergy is administered to you
- 4. Possible side effects
- 5. How to store Sanergy
- 6. Contents of the pack and other information
1. What Sanergy is and what it is used for
Sanergy is a local anesthetic (agents with a numbing effect at the local level) exclusively
for single use.
Sanergy is used to numb (anesthetize) some parts of the body during surgical procedures and
also to eliminate pain. The most important methods in terms of use are listed below:
- to numb the part of the body where the surgical procedure will be performed;
- to relieve pain after surgery or after an acute injury.
Sanergy is used to numb (anesthetize) some parts of the body during surgical procedures
in adults and children of all ages.
Sanergy is administered in the lower part of the spine if it is needed to cause
numbness of the legs or the lower parts of the body.
Sanergy works in such a way that the nerve fibers in the numbed part temporarily stop
transmitting the sensation of pain, heat or cold. It is still possible to perceive pressure and
touch. In the part of the body that is numbed, a surgical procedure will be performed. In many cases, the nerve
fibers in the numbed area do not transmit impulses to the muscles and the muscles are weakened or
temporarily non-functional.
2. What you need to know before you are given Sanergy
You must not be given Sanergy:
- if you are allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Tell your doctor if you are allergic to other local anaesthetics as the risk of allergy to Sanergy is increased;
- if you suffer from blood clotting disorders or if you are taking medicines used to prevent blood clots from forming;
- if you suffer from other problems for which your doctor has concluded that you should not be given Sanergy.
If any of the above conditions apply to you, your doctor must not give you this medicine.
If you have any doubts, ask your doctor before you are given this medicine.
Warnings and precautions
Consult your doctor before you are given Sanergy if you suffer from heart, kidney or liver disease
as your doctor may need to adjust the dose of the medicine.
Children and adolescents
This medicine is suitable for children of all ages.
Other medicines and Sanergy
Tell your doctor if you are taking, have recently taken or might take any other medicines,
e.g. other local anaesthetics or medicines used to correct irregular heartbeat which can affect
the correct dose of Sanergy.
The doctor needs to have a complete picture of other medicines to correctly calculate the dose
required.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor for advice before you are given this medicine.
It has not been demonstrated that Sanergy has a harmful effect on pregnancy.
Breastfeeding
Inform your doctor about breastfeeding before you are given this medicine.
It has not been demonstrated that Sanergy has a harmful effect on the baby during breastfeeding.
Driving and operating machinery
After the administration of Sanergy your reaction time may be delayed and muscle coordination
reduced. After the administration of Sanergy, you must not drive or use machinery and
tools until the next day.
Sanergy contains sodium chloride
This medicine contains less than 1 mmol of sodium (12.59 mg) per vial, i.e. essentially
“sodium-free”.
3. How Sanery is administered to you
The doctor will administer the medication to you. The required dose will be calculated by the doctor based on the
clinical need and your physical condition.
Use in children and adolescents
An anesthesiologist with experience in anesthetic techniques in children will administer the anesthetic
solution slowly into the spinal canal (part of the spine where the spinal cord is also located). The size of the
dose also depends on the patient's age and body weight and is always calculated by an anesthesiologist.
If you are given too much Sanery
Serious adverse effects from excessive administration of Sanery are very rare and require special
treatment. The doctor administering this medication is prepared to manage these situations.
Rare side effects of this type of anesthesia are a high or total block. Elderly patients or
pregnant women in advanced stages of pregnancy should be given a lower dose to avoid
this side effect. Excessive block manifests with shortness of breath, decreased
blood pressure and reduced heart activity.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest them.
Serious allergic reactions(may affect up to 1 in 1,000 people)
- If you have a serious allergic reaction, tell your doctor immediately. The symptoms can include sudden: swelling of the face, lips, tongue and throat. This can make it difficult to swallow. severe or sudden swelling of the 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;
- slowed heartbeat;
- feeling unwell.
Common(may affect up to 1 in 10 people):
- headache;
- vomiting;
- difficulty urinating;
- involuntary loss of urine (incontinence).
Uncommon(may affect up to 1 in 100 people):
- tingling sensation on the skin;
- partial paralysis;
- unusual perceptual sensation;
- muscle weakness;
- back pain.
Rare(may affect up to 1 in 1,000 people):
- temporary numbness of arms, legs and respiratory muscles;
- bilateral paralysis;
- paralysis;
- nervous system disorders;
- arachnoiditis (inflammation of the arachnoid);
- cardiac arrest;
Tell your doctor immediately if you feel unwell during treatment with Sanergynon.
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 pharmacist. 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 Sanergy
Do not freeze.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the pack after
"Exp". The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
The doctor or the hospital generally stores Sanergy. The staff is responsible for the correct storage,
handling and use of this medicine.
6. Contents of the pack and other information
What Sanergy contains
The active ingredient is bupivacaine hydrochloride.
Each ml of injectable solution contains 5 mg of bupivacaine hydrochloride.
One vial (4 ml) contains 20 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 Sanergy and contents of the pack
Clear, colorless liquid, practically free from visible particles.
4 ml injectable solution in a 5 ml colorless type I hydrolytic borosilicate glass vial, with a
break or pre-break line at the 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: SANERGY SPINAL
Netherlands: Bupivacaïne HCl Grindeks Spinaal 5 mg/ml solution for injection
Romania: SANERGY SPINAL 5 mg/ml injectable solution
Slovakia: SANERGY SPINAL 5 mg/ml injection solution
Austria: Bupivacain Grindeks Spinal 5 mg/ml Injektionslösung
Bulgaria: Санерджи Спинал 5 mg/ml инжекционен разтвор
Germany: Sanergy 5 mg/ml Injektionslösung
Hungary: Sanergy Spinal 5 mg/ml oldatos injekció
Italy: Sanergy
Slovenia: Sanergy Spinal 5 mg/ml raztopina za injiciranje
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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 SANERGYPostać 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
Odpowiedniki SANERGY w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik SANERGY w Hiszpania
Odpowiednik SANERGY w Polska
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SANERGY wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w SANERGY jest bupivacaine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SANERGY 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 SANERGY 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 SANERGY 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.
