DEXMEDETOMIDINA 100 МКГ/МЛ Концентрат для инфузионного раствора
Ocena recepty online
Lekarz przeanalizuje Twój przypadek i zdecyduje, czy wystawienie recepty jest medycznie uzasadnione.
Porozmawiaj z lekarzem o tym leku
Omów swoje objawy i opcje leczenia podczas szybkiej konsultacji online.
Jak stosować DEXMEDETOMIDINA ALTAN
Treść ulotki
Dexmedetomidina Altan 100 micrograms/ml concentrate for solution for infusion
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, pharmacist or nurse.
- If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.
Contents of this leaflet:
- 1. What Dexmedetomidina Altan is and what it is used for
- 2. What you need to know before using Dexmedetomidina Altan
- 3. How to use Dexmedetomidina Altan
- 4. Possible side effects
- 5. How to store Dexmedetomidina Altan
- 6. Contents of the pack and other information
1. What is Dexmedetomidine Altan and what is it used for
Dexmedetomidine Altan contains an active ingredient called dexmedetomidine which belongs to a
group of medicines called sedatives. It is used to induce sedation (a state of calmness, drowsiness
or sleep) for adult patients admitted to hospital intensive care units or conscious sedation during
various diagnostic or surgical procedures.
2. What you need to know before you use Dexmedetomidine Altan
You must not be given Dexmedetomidine Altan:
- if you are allergic to Dexmedetomidine Altan or to any of the other ingredients of this medicine (listed in section 6).
- if you have certain heart rhythm disorders (second or third degree heart block).
- if you have very low blood pressure that does not respond to treatment.
- if you have recently had a stroke or another serious condition involving blood flow to the brain.
Warnings and precautions
Before being treated with this medicine, tell your doctor or nurse if any of the
following conditions apply to you, as Dexmedetomidine Altan must be used with caution:
- if you have a slower than normal heartbeat (due to either illness or high levels of physical activity)
- if you have low blood pressure
- if you have a low blood volume, for example after bleeding
- if you suffer from heart disorders
- if you are elderly
- if you suffer from a neurological disorder (for example injuries to the head, spinal cord, or stroke)
- if you suffer from severe liver problems
- if you have ever developed a high fever after taking certain medicines, particularly anesthetics.
Other medicines and Dexmedetomidine Altan
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines.
The following medicines can increase the effect of Dexmedetomidine Altan:
- medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
- powerful pain medicines (e.g. opioids such as morphine, codeine)
- anaesthetic medicines (e.g. sevoflurane, isoflurane)
If you are taking medicines that lower blood pressure and heart rate, the
simultaneous administration of Dexmedetomidine Altan may increase this effect.
Dexmedetomidine Altan must not be used with other medicines that cause temporary paralysis.
Pregnancy, breastfeeding and fertility
Dexmedetomidine Altan should not be used during pregnancy or breastfeeding unless
strictly necessary.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Dexmedetomidine Altan has a significant impact on your ability to drive and use machines.
After you have been given Dexmedetomidine Altan do not drive, use machines or work in dangerous
situations until the effects have completely worn off. Ask your doctor when you can
start doing those activities again and when you can return to this type of work.
Dexmedetomidine Altan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.
3. How to use Dexmedetomidina Altan
Hospital intensive care
Dexmedetomidina Altan is administered to you by a doctor or nurse in hospital intensive care settings.
intensive care.
Procedural/conscious sedation
Dexmedetomidina Altan is administered to you by a doctor or nurse before and/or during
diagnostic or surgical procedures that require sedation, i.e. procedural/conscious sedation.
The doctor will decide the appropriate dose for you. The amount of Dexmedetomidina Altan depends on age, weight,
general health status, the level of sedation required and how you respond to the medicine. The doctor may
adjust the dose if necessary, and will monitor your heart rate and blood pressure during treatment.
Dexmedetomidina Altan is diluted and administered to you as an infusion (drip) into a vein.
After sedation/awakening
- The doctor will keep you under medical supervision for a few hours after sedation to ensure you feel well.
- You should not go home without being accompanied.
- Medicines that help you sleep, that cause sedation or strong painkillers may not be appropriate for a certain period of time after you have been given Dexmedetomidina Altan. Talk to your doctor about the use of these medicines and the use of alcohol.
If you are given more Dexmedetomidina Altan than you should
If you are given too much Dexmedetomidina Altan, your blood pressure may increase or
decrease, your heart rate may slow down, you may breathe more slowly and you may feel more sleepy.
The doctor will know how to treat you based on your condition.
If you have any further questions about the use of this medicine, please ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (affects more than 1 in 10 people)
- Slowed heartbeat
- Low or high blood pressure
Common (affects 1 to 10 people in 100)
- Chest pain or heart attack
- Fast heartbeat
- Blood sugar (glucose) low or high
- Changes in breathing pattern or stopped breathing.
- Nausea, vomiting or dry mouth
- Agitation
- Withdrawal symptoms
- High temperature
Uncommon (affects 1 to 10 people in 1,000)
- A condition in which there is too much acid in the body
- Low level of albumin in the blood
- Shortness of breath
- Hallucinations
- Reduced heart function
- The medicine is not effective enough
- Stomach swelling
- Thirst
Not known (frequency cannot be estimated from available data)
- Need to urinate more than normal
Reporting of side effects
If you get any side effects, talk to your doctor 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 Dexmedetomidine Altan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label and on the package after
Exp.
This medicine does not require any particular storage temperature. Store the vials
in the outer carton to protect the medicine from light.
6. Contents of the pack and other information
What Dexmedetomidine Altan contains
The active ingredient is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride
equivalent to 100 micrograms of dexmedetomidine.
The excipients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for
pH adjustment) and water for injections.
Each 2 ml vial contains 200 micrograms of Dexmedetomidine Altan (as hydrochloride).
The concentration of the final solution after dilution must be 4 micrograms/ml or 8
micrograms/ml.
Description of the appearance of Dexmedetomidine Altan and contents of the pack
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colorless solution.
Containers
Glass vials of 2 ml
5 vials of 2 ml
25 vials of 2 ml
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer:
Altan Pharma Ltd
2 Harbour Square
Dun Laogharie, County Dublin
Ireland
Manufacturer:
Altan Pharmaceuticals, S.A.
Polígono Industrial de Bernedo s/n –
01118 Bernedo (Alava)
Spain
Altan Pharmaceuticals, S.A.
Polígono Industrial Monte Boyal
Avenida De La Constitution 198-199
Casarrubios Del Monte
45950 Toledo
Spain
Further details on this medicine are available on the website of the Italian Medicines Agency
http://www.aifa.gov.it/
---------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:
Dexmedetomidine Altan 100 micrograms/ml concentrate for solution for infusion
Route of administration
Dexmedetomidine Altan must be administered by healthcare professionals specialized in the management of
patients who require intensive care or for the anesthetic management of patients in the operating room or to
undergo diagnostic procedures. It must be administered only by diluted intravenous infusion,
using a controlled infusion device.
Preparation of the solution
Dexmedetomidine Altan can be diluted in glucose 50 mg/ml (5%), Ringer's solution, mannitol or injectable solutions of sodium chloride 9 mg/ml (0.9%) to obtain the required concentration of 4 micrograms/ml or 8
micrograms/ml before administration. See the table below for the volumes required to
prepare the infusion.
If the required concentration is 4 micrograms/ml:
If the required concentration is 8 micrograms/ml:
The solution must be gently shaken to mix it well.
Dexmedetomidine Altan must be visually inspected for the presence of particles and
color changes before administration.
Dexmedetomidine is compatible when administered with the following intravenous solutions and
medicines:
| n Volume of Dexmedetomidine Altan 100 a micrograms/ml concentrate for solution for infusion | Volume of diluent | Total infusion volume |
| 2 ml | 48 ml | 50 ml |
| i 4 ml | 96 ml | 100 ml |
| l 10 ml | 240 ml | 250 ml |
| a 20 ml | 480 ml | 500 ml |
| a Volume of Dexmedetomidine Altan 100 micrograms/ml concentrate for solution for infusion | Volume of diluent | Total infusion volume |
| i 4 ml | 46 ml | 50 ml |
| z 8 ml | 92 ml | 100 ml |
| 20 ml | 230 ml | 250 ml |
| n 40 ml | 460 ml | 500 ml |
Ringer's lactate, glucose 5% solution, sodium chloride 9 mg/ml (0.9%) injectable solution,
mannitol 200 mg/ml (20%), dexamethasone 4 mg, magnesium sulfate 10 mg/kg and 40 mg/kg, sufentanil
10 mcg/ml.
Shelf life
After dilution:
The chemical and physical stability of the diluted solution (stability of the infusion solution) has been
demonstrated for 24 hours at 25 °C and under refrigeration conditions (2 °C – 8 °C).
From a microbiological point of view, the product must be used immediately. If not used
immediately, storage times and conditions before use are the responsibility of
the user and normally should not exceed 24 hours at 2-8°C, unless the dilution
was carried out under controlled and validated aseptic conditions.
Nie jesteś pewien, czy ten lek jest odpowiedni dla ciebie?
Omów swoje objawy i leczenie z lekarzem online.
Zacząłeś przyjmować lek i masz pytania?
Omów swoje objawy i leczenie z lekarzem online.
- Kraj rejestracji
- Postać farmaceutycznaConcentrate for infusion solution, 100 MICROGRAMMI/ML
- Kod ATCN05CM18
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki DEXMEDETOMIDINA ALTANPostać farmaceutyczna: Concentrate for infusion solution, 100 MCG/MLSubstancja czynna: dexmedetomidineProducent: ORION CORPORATIONWymaga receptyPostać farmaceutyczna: Concentrate for infusion solution, 100 MICROGRAMMI/MLSubstancja czynna: dexmedetomidineProducent: EVER VALINJECT GMBHWymaga receptyPostać farmaceutyczna: Concentrate for infusion solution, 100 MICROGRAMMI/MLSubstancja czynna: dexmedetomidineProducent: HIKMA FARMACEUTICA (PORTUGAL) S.A.Wymaga recepty
Odpowiedniki DEXMEDETOMIDINA ALTAN w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik DEXMEDETOMIDINA ALTAN w Hiszpania
Odpowiednik DEXMEDETOMIDINA ALTAN w Polska
Odpowiednik DEXMEDETOMIDINA ALTAN w Ukraina
Lekarze online w sprawie DEXMEDETOMIDINA ALTAN
Omów stosowanie DEXMEDETOMIDINA ALTAN, bezpieczeństwo i ocenę zasadności recepty zgodnie z obowiązującymi przepisami.
Uzyskaj receptę na DEXMEDETOMIDINA ALTAN online
Wypełnij 2-minutowy formularz
Opisz swoje objawy, historię choroby i lek, o który prosisz.
Wybierz lekarza lub pozwól nam przydzielić
Wybierz specjalistę lub dopasujemy Cię do najbliższego dostępnego lekarza.
Lekarz analizuje Twój przypadek
Zazwyczaj w ciągu 30 minut. Może zadawać dodatkowe pytania przez czat.
Odbierz w dowolnej aptece
Recepta elektroniczna wysłana na Twój e-mail — ważna w całej Polsce.
Często zadawane pytania
DEXMEDETOMIDINA ALTAN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w DEXMEDETOMIDINA ALTAN jest dexmedetomidine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DEXMEDETOMIDINA ALTAN jest produkowany przez ALTAN PHARMA LIMITED. 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 DEXMEDETOMIDINA ALTAN 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 DEXMEDETOMIDINA ALTAN 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 (dexmedetomidine) to m.in. DEXDOR, DEXMEDETOMIDINA EVER PARMA, DEXMEDETOMIDINA IKMA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
