ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION
Cómo usar ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION
Traducción generada por IA
Este contenido ha sido traducido automáticamente y se ofrece solo con fines informativos. No sustituye la consulta con un profesional sanitario.
Ver originalContenido del prospecto
Introduction
Package Leaflet: Information for the User
Rocuronio Kalceks 10mg/ml solution for injection and infusion EFG
Rocuronium bromide
Read all of 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 further questions, ask your anesthesiologist or another doctor.
- If you experience any side effects, talk to your anesthesiologist or another doctor, even if they are not mentioned in this leaflet. See section 4.
Contents of the package leaflet
- What is Rocuronio Kalceks and what is it used for
- What you need to know before you are given Rocuronio Kalceks
- How Rocuronio Kalceks is given to you
- Possible side effects
- Storage of Rocuronio Kalceks
- Package contents and further information
1. What is Rocuronio Kalceks and what is it used for
Rocuronio Kalceks belongs to a group of medicines called muscle relaxants.
Muscle relaxants are used during an operation as part of general anesthesia. When you undergo an operation, your muscles must be completely relaxed. This makes the operation easier for the surgeon.
Rocuronio Kalceks can be used if you are receiving anesthesia to facilitate the insertion of a tube into your trachea for mechanical ventilation (mechanical assistance with breathing).
Rocuronio Kalceks can also be used in the intensive care unit to keep your muscles relaxed.
2. What you need to know before you are given Rocuronio Kalceks
Rocuronio Kalceks must not be given to you:
- if you are allergic to rocuronium or any of the other ingredients of this medicine (listed in section 6).
Tell your anesthesiologist if this applies to you.
Warnings and precautions
Tell your anesthesiologist before you are given this medicine:
- if you are allergic to any muscle relaxant
- if you have had kidney, heart, vascular, liver, gallbladder, or bile duct disease
- if you have had diseases that affect the nerves and muscles
- if you have fluid retention (edema)
- if you have a history of malignant hyperthermia (sudden fever with palpitations, rapid breathing, and muscle stiffness, pain, and/or weakness).
Tell your anesthesiologist if any of the above situations apply to you.
Certain conditions may influence the effects of Rocuronio Kalceks, for example:
- low calcium levels in the blood
- low potassium levels in the blood
- high magnesium levels in the blood
- low protein levels in the blood
- too much carbon dioxide in the blood
- excessive water loss from the body, for example, due to illness, diarrhea, or sweating
- excessive breathing that causes insufficient carbon dioxide in the blood (alkalosis)
- poor general health
- burns
- being severely overweight (obesity)
- very low body temperature (hypothermia).
If you have any of these conditions, your anesthesiologist will take them into account when deciding the correct dose of Rocuronio Kalceks for you.
Children and elderly
Rocuronio Kalceks can be used in children (newborns and adolescents) and elderly patients, but your anesthesiologist must evaluate your medical history first.
Other medicines and Rocuronio Kalceks
Tell your anesthesiologist or doctor if you are taking, have recently taken, or might take any other medicines. This includes medicines or herbal remedies bought without a prescription. Rocuronio Kalceks may affect other medicines or be affected by them.
Medicines that increase the effect of Rocuronio Kalceks:
- certain antibiotics
- certain medicines used for heart disease or high blood pressure (diuretics, calcium channel blockers, beta blockers, and quinidine)
- certain anti-inflammatory medicines (corticosteroids)
- certain medicines used to treat manic depressive syndrome (bipolar disorder)
- magnesium salts
- certain medicines used to treat malaria.
Medicines that decrease the effect of Rocuronio Kalceks:
- certain medicines used to treat epilepsy
- calcium chloride and potassium chloride
- certain protease inhibitors called gabexate and ulinastatin.
Additionally, you may be given other medicines before or during surgery that may alter the effects of Rocuronio Kalceks. These include certain anesthetics, other muscle relaxants, medicines such as phenytoin, and medicines that reverse the effect of Rocuronio Kalceks. Rocuronio Kalceks may make certain anesthetics work more quickly. Your anesthesiologist will take this into account when deciding the correct dose of Rocuronio Kalceks for you.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or anesthesiologist before you are given this medicine.
Pregnancy
No adverse effects have been observed in animal studies. However, there are no clinical data on the use of rocuronium bromide in pregnant women. Therefore, rocuronium bromide should be used with caution in pregnant women.
Cesarean section
A doctor will decide whether rocuronium bromide can be used during a cesarean section. The use of rocuronium bromide during a cesarean section has been shown to be safe with a dose of 0.6 mg/kg body weight and has no adverse effects on the baby.
Breastfeeding
Breastfeeding should be discontinued 6 hours after administration of this medicine.
Driving and using machines
Do not drive or use machines until you are told it is safe to do so. Because Rocuronio Kalceks is given as part of general anesthesia, you may feel tired, weak, or dizzy for some time after. Your anesthesiologist can advise you on the likely duration of these effects.
Rocuronio Kalceks contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml, which is essentially "sodium-free".
3. How Rocuronio Kalceks is given to you
Dose
Your anesthesiologist will calculate the dose of Rocuronio Kalceks you need based on:
- the type of anesthetic,
- the expected duration of the operation,
- other medicines you are taking,
- your state of health.
The usual dose is 0.6 mg per kg body weight and its effect lasts for 30 to 40 minutes.
How Rocuronio Kalceks is given to you
Your anesthesiologist will give you Rocuronio Kalceks by injection into a vein, either as single injections or as a continuous infusion (with a drip).
If you are given too much Rocuronio Kalceks
Because your anesthesiologist will be monitoring your condition carefully, it is unlikely that you will be given too much Rocuronio Kalceks. However, if this happens, your anesthesiologist will keep you breathing artificially (with a respirator) until you can breathe on your own again. You will remain asleep while this happens.
If you have any further questions on the use of this medicine, ask your doctor or anesthesiologist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur while you are under anesthesia, your anesthesiologist will see them and treat them.
Uncommon side effects(may affect up to 1 in 100 people)
- the medicine is too effective, not effective enough
- the medicine acts for longer than expected
- decrease in blood pressure
- increase in heart rate
- pain at the injection site.
Rare side effects(may affect up to 1 in 10,000 people)
- allergic reactions (hypersensitivity) (such as difficulty breathing, circulatory collapse, and shock)
- chest tightness
- muscle weakness
- swelling, rash, or redness of the skin.
Frequency not known(cannot be estimated from the available data):
- allergic spasm and severe coronary artery spasms (Kounis syndrome) causing chest pain (angina) or heart attack (myocardial infarction)
- dilated pupils (mydriasis) or fixed pupils that do not change size with light or other stimuli.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your anesthesiologist or another doctor.
Reporting of side effects
If you experience any side effects, talk to your anesthesiologist or another doctor. Even if it is possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Rocuronio Kalceks
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C‑8°C). Do not freeze.
Store below 25°C:
Rocuronium bromide can also be stored below 25°Cfor a maximum period of 12 weeks, after which it must be discarded. The product must not be returned to the refrigerator once it has been stored at room temperature. The storage period must not exceed the shelf-life.
After dilution:
After dilution with intravenous fluids, the chemical and physical stability in use has been demonstrated for 72 hours at 30°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at a temperature of 2 to 8°C, unless the dilution has been made in controlled and validated aseptic conditions.
Do not use this medicine if you notice visible signs of deterioration (e.g. particles).
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and further information
Composition of Rocuronio Kalceks
- The active substance is rocuronium bromide.
1 ml of solution contains 10 mg of rocuronium bromide.
Each 5 ml vial of solution contains 50 mg of rocuronium bromide.
- The other ingredients are sodium chloride; sodium acetate trihydrate; glacial acetic acid (for pH adjustment); water for injections.
Appearance and package contents
Clear, colorless or yellowish solution for injection and infusion.
Package size:
Rocuronio Kalceks is available in packs of 10 vials with 5 ml of solution.
Marketing authorization holder and manufacturer
AS KALCEKS
Krustpils iela 71E, Riga, LV-1057, Latvia
Phone: +371 67083320
Email: [email protected]
For further information about this medicine, please contact the local representative of the marketing authorization holder
EVER Pharma Therapeutics Spain SL
C/ Toledo 170
28005 Madrid
Spain
This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Czech Republic, Estonia, Norway Rocuronium bromide Kalceks
Austria Rocuronium Kalceks 10 mg/ml Injektions-/Infusionslösung
Croatia Rokuronijev bromid Kalceks 10 mg/ml otopina za injekciju/infuziju
France ROCURONIUM KALCEKS 10 mg/mL, solution injectable/pour perfusion
Hungary Rocuronium Kalceks 10 mg/ml oldatos injekció vagy infúzió
Ireland Rocuronium bromide 10 mg/ml solution for injection/infusion
Latvia Rocuronium bromide Kalceks 10 mg/ml šķidums injekcijām/infūzijām
Lithuania Rocuronium bromide Kalceks 10 mg/ml injekcinis ar infuzinis tirpalas
Netherlands Rocuronium Kalceks 10 mg/ml oplossing voor injectie/infusie
Poland Rocuronium Kalceks
Slovakia Rocuronium bromide Kalceks 10 mg/ml injekčný/infúzny roztok
Slovenia Rokuronijev bromid Kalceks 10 mg/ml raztopina za injiciranje/infundiranje
Spain Rocuronio Kalceks 10 mg/ml solución inyectable y para perfusión EFG
United Kingdom (Northern Ireland) Rocuronium bromide 10 mg/ml solution for injection/infusion
Date of last revision of this leaflet June 2023
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)
-
- País de registro
- Forma farmacéuticaINJECTABLE, 10 mg/ml
- Código ATCM03AC09
- Principio activo
- Requiere recetaSí
- Fabricante
- ComposiciónCLORURO DE SODIO (3,30 mg mg), ACETATO DE SODIO TRIHIDRATO (2 mg mg)
- Esta información es de carácter general y no sustituye la consulta con un profesional sanitario.
- Alternativas a ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTIONForma farmacéutica: INJECTABLE, 10 mg rocuronium bromide/ mlPrincipio activo: rocuronium bromideFabricante: Schering Plough S.A.Requiere recetaForma farmacéutica: INJECTABLE, 10 mg/mlPrincipio activo: rocuronium bromideFabricante: Laboratoire AguettantRequiere recetaForma farmacéutica: INJECTABLE, 10 mg/mlPrincipio activo: rocuronium bromideFabricante: B. Braun Melsungen AgRequiere receta
Médicos online para ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION
Comenta la dosis, los posibles efectos secundarios, interacciones, contraindicaciones o la revisión de receta de ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION, sujeto a valoración médica y a la normativa local.
Obtén una receta de ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION online
Rellena un formulario de 2 minutos
Cuéntanos tus síntomas, historial y el medicamento que necesitas.
Elige un médico o nosotros te asignamos uno
Escoge un especialista o te conectamos con el próximo médico disponible.
El médico revisa tu caso
Normalmente en 30 minutos. Puede hacerte preguntas adicionales por chat.
Recógela en cualquier farmacia
Receta electrónica enviada a tu correo, válida en toda España.
Preguntas frecuentes
¿Se requiere receta para ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION requires receta en Spain. Puedes confirmarlo con un médico online según tu caso.
¿Cuál es el principio activo de ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
El principio activo de ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION es rocuronium bromide. Esta información ayuda a identificar medicamentos con la misma composición pero con diferentes nombres comerciales.
¿Quién fabrica ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION es fabricado por Kalceks As. La marca y el envase pueden variar según el distribuidor.
¿Qué médicos pueden recetar ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION online?
Los Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists pueden valorar la prescripción de ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION cuando esté clínicamente indicado. Puedes reservar una videoconsulta para comentar tu caso y las opciones de tratamiento.
¿Cómo comprar ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION en España?
España cuenta con una infraestructura sanitaria bien desarrollada en ciudades principales como Madrid, Barcelona, Valencia y Sevilla. Las farmacias están ampliamente disponibles y operan bajo estrictas regulaciones, garantizando el acceso a medicamentos con receta.
Puedes comprar ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION en Madrid, Barcelona, Sevilla o Valencia en cualquier farmacia local con una receta válida.
Para obtener una receta, puedes utilizar Oladoctor:
¿Cuáles son las alternativas a ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
Otros medicamentos con el mismo principio activo (rocuronium bromide) incluyen ESMERON 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION, ROCURONIUM AGUETTANT 10 mg/mL Injectable Solution in Pre-filled Syringe, ROCURONIUM B. BRAUN 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION. Pueden tener diferentes nombres comerciales o formulaciones, pero contienen el mismo componente terapéutico. Consulta siempre con un médico antes de cambiar o iniciar un nuevo medicamento.
