10 mg / ml solution for injection / infusion solution
Atracurium besylate
1. WHAT THE ATRACURIUM HAMEL IS AND WHAT IT IS USED FOR
Atracurium Hameln belongs to a group of medicines called muscle relaxants. It is used to relax muscles during surgery.
The Atracurium Hamel is used:
- during surgical and other procedures as well as in intensive care.
- under anesthesia to facilitate tracheal intubation (a tube inserted into the trachea) and controlled ventilation.
2. BEFORE YOU GET THE ATRACURIUM HAMEL
Do not use the Atracurium Hamel if:
- you are allergic to atracurium besylate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, difficulty breathing, or swelling of the face, lips, throat, or tongue. It is possible that you have experienced this before.
Take special care with the Atracurium Hamel
Before you receive the Atracurium Hamel, tell your doctor if you have:
- a disease that affects the muscles and/or their nerve control (neuromuscular disease such as myasthenia gravis or Eaton-Lambert’s syndrome)
- a severe electrolyte disturbance
- cancer with the wide spread from a primary source (carcinomatosis)
- sensitivity to histamine
- asthma-like symptoms (previous allergy, asthma, or bronchospasm )
- burns
- insufficient blood volume ( hypovolemia )
Children:
The use of the Atracurium Hamel is not recommended for newborns (children under one month of age). Dose one must be significantly reduced in the treatment of newborns or premature babies. If you have any further questions, ask your doctor or pharmacist.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with the Atracurium hamel:
- antibiotics (eg aminoglycosides , polymyxins, spectinomycin, tetracyclines , lincomycin, clindamycin and vancomycin)
- antiarrhythmics (used to regulate heart rhythm eg lidocaine , procainamide , quinidine )
- diuretics ( eg diuretics ) (eg furosemide , thiazides , acetazolamide and mannitol)
- medicines used to control blood pressure , angina or other heart problems (eg propranolol, oxprenolol, diltiazem , nicardipine, nifedipine and verapamil)
- antiepileptics (eg carbamazepine, phenytoin )
- medicines used to treat rheumatism (eg chloroquine, d-penicillamine)
- corticosteroids are (treatment for inflammation )
- trimethaphane, hexamethonium (used to lower blood pressure during surgery )
- dantrolene (a muscle relaxant)
- magnesium sulfate
- ketamine (an anesthetic)
- lithium, chlorpromazine (treatment for mental disorders)
- quinine (treatment for malaria or leg cramps)
It may still be a good idea to get the Atracurium hamel and your doctor will decide what is right for you.
Pregnancy and breastfeeding
Atracurium hamel should only be given to pregnant women when it is medically justified.
Mothers should stop breastfeeding for 24 hours after receiving the Atracurium hamel. Always consult a doctor or pharmacist before taking any medicine.
Driving and using machines
After receiving the Atracurium hamel, you must not drive, use machines or work in dangerous situations. You should not go home alone and should not drink alcohol until you are fully recovered.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. HOW TO GET ATRACURIUM-HAMELN
The atracurium Hamel should only be given by an experienced doctor under closely monitored conditions.
Dose
The atracurium Hamel is used during procedures that require the patient to be fully anesthetized (unconscious), or given strong sedatives.
The doctor will calculate the dose one. The atracurium Hamel may only be given as an injection directly into a vein ( intravenous use) The atracurium Hamel may not be injected into a muscle.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Information for healthcare professionals is provided at the end of this information.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Atracurium Hameln can cause side effects, although not everybody gets them.
The following side effects have been reported:
Common (affects 1 to 10 users in 100)
- tachycardia (high heart rate)
- temporary hypotension (low blood pressure )
- breathing with beeping sound
- bronchospasm (asthma-like symptoms)
- reddening of the skin
- urticaria ( hives )
Very rare (affects less than 1 user in 10,000)
- myasthenia gravis and / or myopathy (weak or dysfunctional muscles)
- severe allergic reactions including shock , circulatory failure and heart attack in patients receiving atracurium with one or more anesthetics
- (seizures) seizures when taken concomitantly with other drugs in patients at risk
- laryngospasm ( spasm of the vocal cords)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. HOW TO STORE ATRACURIUM HAMELN
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after “EXP:”. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Keep the vial are in the outer carton. Sensitive to light.
- The product should be used immediately after the first opening.
- The shelf life of reconstituted solution for infusion: Chemical and physical in-use stability have been demonstrated in sodium chloride, BP infusion for up to 24 hours at 30 ° C and in other standard infusion fluids for up to 4 and 8 hours respectively (see dilution instructions at the end of this leaflet). The following information is intended for medical or healthcare professionals only ‘). From a microbiological point of view, the product should be used immediately. If the solution is not used immediately, the user is responsible for storage times after dilution and conditions before use which should not normally exceed 24 hours at 2 to 8 ° C unless dilution has taken place under controlled and verified aseptic conditions.
- Do not use the Atracurium hammer if you notice that the solution is not clear, colorless and free of particles or if the packaging is damaged.
- The remaining solution in opened ampoules must be discarded.
6. FURTHER INFORMATION
Content declaration
Content declaration
The active substance is atracurium besylate.
1 ml of Atracurium Hameln contains 10 mg of atracurium besylate.
One ampoule of 2.5 ml solution for injection contains 25 mg of atracurium besylate.
One ampoule of 5.0 ml solution for injection contains 50 mg of atracurium besylate.
The other ingredients are water for injections and benzenesulfonic acid
What the medicine looks like and the contents of the pack
Atracurium Hamel is a clear and colorless solution for injection/infusion.
3 ml or 5 ml clear glass ampoules.
Carton with 5 ampoules is 2.5 ml or 5 ml.
Carton of 10 ampoules is 2.5 ml or 5 ml.
Carton with 5 x 10 ampoules is 2.5 ml or 5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
hameln pharma plus gmbh
Langes Feld 13
31789 Hameln
Germany
Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
Rotexmedica GmbH
Bunsenstraße 4
22946 Trittau
Germany
This medicinal product is authorized under the European Economic Area under the names:
| THE: | Atracurium hameln 10 mg/ml solution for injection or infusion |
| IT: | Atracurium-hameln 10 mg/ml unreachable solution |
| NL: | Atracurium hameln 10 mg/ml solution for injection and infusion |
| ES: | Besilato de Atracurio-Hameln 10 mg/ml solution for EFG injection |
| SEE: | Atracurium Hameln 10 mg / ml solution for injection / infusion solution |
| UK: | Atracurium besilate 10 mg / ml solution for injection |