SALVUDEX 5 mg /Ml Roztwór Do Wstrzykiwań
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Treść ulotki
Salvudex 5 mg/ml injectable solution
bupivacaine hydrochloride
Generic medicine
Read this leaflet carefully before you are given 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 or nurse.
- If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Salvudex is and what it is used for
- 2. What you need to know before you are given Salvudex
- 3. How Salvudex will be given to you
- 4. Possible side effects
- 5. How to store Salvudex
- 6. Contents of the pack and other information
1. What is Salvudex and what is it used for
Salvudex contains bupivacaine hydrochloride. It is a local anesthetic used to numb
(anesthetize) the lower parts of the body during surgical procedures in adults and children of all
ages. It is used, for example, to numb the legs to be operated on, in urological or abdominal
surgery.
The medicine temporarily blocks nerve signals in the area where it is injected and reduces or
temporarily eliminates sensation in some parts of the body.
2. What you need to know before you are given Salvudex
Salvudex will not be given to you if:
- you are allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- you are allergic to other local anaesthetics of the same class (e.g. mepivacaine, lidocaine). Spinal anaesthesia should not be given if:
- you have active acute diseases of the brain or spinal cord, such as meningitis, poliomyelitis or spondylitis
- you have a severe headache caused by internal bleeding in the head (intracranial haemorrhage)
- you have blood poisoning (septicemia)
- you have purulent infections at or near the injection site
- you have suffered a recent trauma (e.g. a fracture of the spine)
- you have tuberculosis or a tumour of the spinal cord
- you have spinal stenosis (narrowing of the spinal cord)
- you have a severe condition in which the heart is unable to supply sufficient blood to the body (cardiogenic shock)
- you have very low blood pressure leading to collapse (hypovolemic shock)
- you have a heart problem (heart failure)
- your blood does not clot properly or you are taking medicines to prevent blood clots from forming
- you have problems with the spinal cord due to anaemia.
Warnings and precautions
Talk to your doctor or nurse before you are given Salvudex if:
you suffer from a cardiac arrhythmia called AV block II or III
you suffer from a liver disease
you suffer from kidney diseases
you are elderly or debilitated;
if you are pregnant, especially if in an advanced stage
Neurological diseases are not thought to be aggravated by anaesthesia, but caution is necessary.
Other medicines and Salvudex
Tell your doctor or nurse if you are taking, have recently taken or might
take any other medicines.
Salvudex can interact with other medicines, such as:
- other local anaesthetics
- medicines structurally similar to Salvudex, for example medicines for cardiac arrhythmias (antiarrhythmics).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or nurse for advice before you are given
this medicine.
Salvudex can be used during pregnancy and breastfeeding. The doctor will adjust the dose
if the pregnancy is in an advanced stage.
Driving and operating machinery
On the day of the operation, you must not drive or operate machinery as Salvudex can affect
your ability to react and your muscle coordination.
Salvudex contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially
"sodium-free".
3. How Salvudex will be administered to you
Salvudex will be administered to you by a doctor, who will decide the correct dose. The medicine
is injected into the lower part of the spine.
The dosage depends on the type of surgery, the patient's age and weight and will be established by the
doctor.
Use in children and adolescents
Salvudex is injected slowly into the spinal canal (lower part of the spine)
by an anesthesiologist experienced in pediatric anesthesia techniques.
If you are given too much Salvudex
It is unlikely that you will receive an excessive dose of this medicine, as it is administered in
hospital and by healthcare professionals. If you are concerned that you have been given too high a dose or
if you have doubts about the dose you have been given, talk to your doctor or nurse.
The first signs of an overdose of Salvudex are usually as follows:
- Low blood pressure
- Slow pulse
- Irregular heartbeat
- Feeling dizzy or lightheaded
- Numbness of the lips and mouth
- Numbness of the tongue
- Hearing problems
- Vision problems (vision).
To reduce the risk of serious side effects, the doctor will stop administering
Salvudex as soon as these signs appear.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If any of the following symptoms occur, stop treatment and contact a doctor immediately:
- Signs of central nervous system intoxication, such as numbness, tingling, loss of movement (paresis), muscle weakness or dysesthesia (abnormal sensation) ( uncommon side effects, may affect up to 1 in 100 people)
- The heart suddenly stops beating and you lose consciousness (cardiac arrest) (rare side effect, may affect up to 1 in 1,000 people)
- Slow and shallow breathing (respiratory depression) ( rare side effect, may affect up to 1 in 1,000 people)
- Severe allergic reaction with symptoms such as difficulty breathing, swelling of the lips, throat and tongue and low blood pressure (anaphylactic shock) ( rare side effect, may affect up to 1 in 1,000 people)
Other side effects
Very common: (may affect more than 1 in 10 people)
- Nausea
- Low blood pressure
- Slow heartbeat (bradycardia) Common: (may affect up to 1 in 10 people)
- Headache
- Vomiting
- Difficulty urinating (urinary retention)
- Involuntary urination (urinary incontinence) Uncommon (may affect up to 1 in 100 people)
- Back pain
- Tingling, burning or numbness of the skin (paresthesia) Rare: (may affect up to 1 in 1000 people)
- Involuntary blockage of the nerves of the spinal cord (spinal block), which can cause temporary loss of sensation in the abdomen and/or lower body, respiratory depression and even loss of consciousness.
- Bilateral paralysis, often in the lower part of the body or in both legs (paraplegia)
- Pain and sensory disturbances due to inflammation of the nerves (neuropathy)
- Loss of voluntary movements (paralysis)
- Inflammation of a membrane surrounding the spinal cord (arachnoiditis) which can cause pain in the lower back, or pain, numbness or weakness in the legs.
- Allergic reactions
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 national reporting system at
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 Salvudex
Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Salvudex contains
- The active ingredient is bupivacaine hydrochloride. Each ml of solution contains 5 mg of bupivacaine hydrochloride (as anhydrous).
- The other ingredients are glucose monohydrate, sodium hydroxide (for pH adjustment) and water for injections
Description of the appearance and package contents
Colourless hydrolytic class borosilicate glass vials with a one-point break. The vials are
packaged in a liner and inserted into a cardboard box.
Pack: 5 vials.
Marketing authorisation holder
AS GRINDEKS.
Krustpils iela 53,
Rīga LV-1057,
Latvia
Manufacturer
HBM Pharma s.r.o.
Sklabinska 30
036 80, Martin
Slovakia
This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
Sweden Bupivacaine Spinal Tung Grindeks
Austria Bemevax 5 mg/ml Injection solution
Bulgaria Bemevax 5 mg/ml инжекционен разтвор
Czech Republic Salvudex
Germany Bupivacain Grindeks Glucose 5 mg/ml Injection solution
Estonia Bemevax
Hungary Salvudex 5 mg/ml oldatos injekció
Italy Salvudex
Latvia Bupivacaine Grindeks 5 mg/ml šķīdums injekcijām ar glikozi
Lithuania Bemevax 5 mg/ml injekcinis tirpalas
Netherlands Bupivacaine Grindeks Glucose 5 mg/ml solution for injection
Poland Sanergy Heavy
Romania Bemevax 5 mg/ml soluție injectabilă
Slovakia Bupivacaine Grindeks Heavy 5 mg/ml injekčný roztok
Slovenia Mofecet 5 mg/ml raztopina za injiciranje
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The following information is intended exclusively for doctors or healthcare professionals:
The solution must be used immediately after opening.
As with all parenteral medicines, the solution must be inspected before use. Only clear and particle-free solutions can be
used.
The addition of additives to spinal solutions is not recommended.
Do not dispose of medicines via drains or household waste.
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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 SALVUDEXPostać 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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SALVUDEX wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w SALVUDEX jest bupivacaine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SALVUDEX 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 SALVUDEX 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 SALVUDEX 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.
