2 mg / ml solution for injection / infusion; 5 mg / ml, 7.5 mg / ml and 10 mg / ml solution for injection
What Narop is and what it is used for
Narop contains the active substance ropivacaine hydrochloride, which is a topical anesthetic ( local anesthetic ).
Narop is used in adults to numb certain parts of the body and to relieve pain during various types of surgeries. Narop is also used in children and adolescents for certain types of pain relief and in surgeries.
Narop acts in the surgical area by preventing nerves from sending sensory impulses for pain, heat or cold. Still, you can feel pressure and touch. In this way, the nerves in the operating area are anesthetized and prepared. In many cases, Narop also causes blockage of the motor nerves, ie. temporary muscle weakness and inability to e.g. touch the leg (or lift the arm).
Ropivacaine hydrochloride contained in Narop may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you get Narop
You must not be given Narop
- if you are allergic to ropivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic (hypersensitive) to other similar anesthetics ( amide-type local anesthetics ).
- if you have low blood volume ( hypovolemia ). This is measured by the health care staff.
- as an injection into a blood vessel to numb a certain part of the body.
- as an injection in the cervix to relieve labor pains.
Warnings and cautions
Be especially careful to avoid injecting Narop directly into a blood vessel to avoid direct toxic effects. Injection must not be given in inflamed areas.
Talk to a doctor or nurse before receiving Narop:
- if you have poor general condition due to old age or other factors
- if you have heart problems (partial or total AV block)
- if you have severe liver disease
- if you have severe kidney disease
- if you have acute porphyria (problems with the production of red blood cells ).
Tell your doctor if you have any of these conditions, as dose one of Narop may need to be adjusted.
Children
Physicians and healthcare professionals will take special care when treating:
- of newborns, as they are more sensitive to Narop.
- of children under 12 years of age, as certain types of injection of Narop have not been established in younger children.
Other medicines and Narop
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Care must be taken if you get
- other local anesthetics (eg lidocaine ) or medicines similar to amide-type local anesthetics, e.g. certain medicines for irregular heartbeat (eg amiodarone )
- other anesthetics or opioids (strong painkillers)
- certain antidepressants (eg fluvoxamine)
- certain antibiotics (eg enoxacin).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not known if Narop affects pregnancy or is excreted in human milk.
Driving and using machines
Narop can temporarily affect your reactivity and muscle coordination.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Narop contains sodium
This medicine contains no more than 3.7 mg of sodium per milliliter. This should be considered by patients on a low-salt diet.
How to get Narop
Narop is given by a doctor by injection . Your doctor will decide on a dose based on your needs and physical condition.
Healthcare professionals: detailed information on the use of this product can be found at the end of this leaflet.
If you take more Narop than you should
Serious side effects caused by overdose are rare, but require special care. The treating physician is trained in and prepared for these situations.
The first symptoms after narop overdose are usually intoxication, hearing and vision disorders, numbness around the mouth and tongue, speech difficulties, muscle twitching, tremors, low blood pressure , slow or irregular heartbeat. These symptoms may be preceded by cardiac arrest, respiratory arrest and severe seizures.
If you get any of these symptoms, you must tell your doctor or healthcare professional immediately.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Important side effects are to be aware of:
Sudden life-threatening allergic reactions (eg anaphylaxis , angioneurotic edema and urticaria ) are rare (may affect up to 1 in 1,000 people). Possible symptoms include:
- sudden onset of rash, itchy or raised rash (hives),
- swelling of the face, lips, tongue, throat or other parts of the body,
- difficulty swallowing,
- shortness of breath, wheezing or difficulty breathing.
If you think Narop has given you an allergic reaction , tell your doctor or healthcare professional immediately.
Other side effects have been reported for Narop
Very common (may affect more than 1 user in 10)
- low blood pressure
- nausea.
Common (may affect up to 1 in 10 people)
- tingling, dizziness, headache
- slow or fast heartbeat
- high blood pressure
- vomiting
- urination problem
- fever, chills, back pain.
Uncommon (may affect up to 1 in 100 people)
- concern
- Some symptoms may occur if injection was accidentally given into a blood vessel or if you received too much Narop. Symptoms include seizures, strokes, intoxication, tingling around the mouth, numbness of the tongue, hearing and vision disorders, tinnitus , speech and articulation difficulties, muscle twitching, tremors, decreased sensitivity of the skin.
- fainting
- breathing difficulties
- low body temperature.
Rare (may affect up to 1 in 1,000 people)
- cardiac arrest, cardiac arrhythmias.
Has been reported (occurs in an unknown number of users)
- involuntary muscle movements ( dyskinesia ).
Side effects such as headache, slow heartbeat, vomiting, difficulty urinating, decreased sensitivity or sensation in the skin, fainting, difficulty breathing and low body temperature are more common when injection takes place in the lower back ( intrathecal administration ). In addition to the above side effects , stiffness can also occur in up to 1 in 10 users with this type of use.
Additional side effects in children
Children experience the same side effects as adults, except that low blood pressure is less common in children (may occur in more than 1 in 100 users) and that vomiting occurs more often (may occur in more than 1 in 10 users).
Tell your doctor as soon as possible if you do not feel well during the administration of Narop.
How to store Narop
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Do not freeze.
For information on shelf life after opening or adding other medicines, see section “The following information is intended for healthcare professionals only” at the end of this leaflet.
Doctors or hospitals usually store Narop products. The staff is trained in storing, dosing and disposing of Narop injection and infusion fluid .
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is ropivacaine hydrochloride.
- The other ingredients are sodium chloride, sodium hydroxide and / or hydrochloric acid , water for injections.
What the medicine looks like and contents of the pack
Narop solution for injection / infusion is a sterile , isotonic , isobaric, clear aqueous solution with a pH value adjusted with sodium hydroxide and / or hydrochloric acid to 4.0‑6.0. Narop contains no preservatives and is for single use only.
Narop solution for injection is supplied in polypropylene plastic ampoules ( Polyamp ).
Narop 2 mg / ml is available in pack sizes of 5 x 10 ml and 5 x 20 ml.
Narop 5 mg / ml is available in the pack size: 5 x 10 ml.
Narop 7.5 mg / ml is available in the pack size: 5 x 20 ml.
Narop 10 mg / ml is available in pack sizes of 5 x 10 ml and 5 x 20 ml.
Narop 2 mg / ml infusion solution is supplied in polypropylene plastic bags (Polybag ® ) and is available in pack sizes of 5 x 100 ml and 5 x 200 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24, Ireland
Manufacturer
AstraZeneca AB
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