Nebcina 10 mg / ml solution for injection. Nebcina 40 mg / ml solution for injection . Nebcina 80 mg / ml solution for injection .
tobramycin
What Nebcina is and what it is used for
Nebcina contains the active substance tobramycin (an antibiotic ) which is used to treat bacterial infections. Tobramycin works by killing bacteria that cause you infections.
Nebcina is used to treat:
- Infection is in the lungs
- Serious urinary tract infection
- Infection in the intestines and abdomen
- Infection is in your heart
What you need to know before you receive Nebcina
You should not receive Nebcina:
- if you are allergic to tobramycin, other aminoglycosides or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Nebcina about:
- you have any kidney disease
- you have hearing problems (including disturbing sound in the ears and dizziness)
- you have a muscle disease called myastena gravis
- you have Parkinson’s disease
- you have dehydration, e.g. due to vomiting or diarrhea
- you or someone in your family has a mitochondrial mutation disease (a condition caused by variants of the mitochondrial genome, the parts of the cells that help produce energy) or hearing loss due to antibiotics (some mitochondrial mutations may increase the risk of hearing loss when used of this medicine).
Nebcina can have a detrimental effect on your kidneys and your auditory nerve. You will therefore be closely observed during treatment to detect possible signs of such an injury.
Other medicines and Nebcina
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The risk of damage to the kidneys and auditory nerve may increase if Nebcina is given with:
- other medicines to treat your infection
- certain diuretics _
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Nebcina is usually given to you when you are in hospital, so you will probably not drive or use machines during treatment. However, Nebcina can cause side effects such as confusion, disorientation, dizziness, dizziness, and drowsiness, which could affect the ability to drive.
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.
Nebcina contains sodium metabisulfite and sodium
Sodium metabisulfite can in rare cases cause severe hypersensitivity reactions and convulsions in the trachea.
This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.
How to use Nebcina
This medicine will be given to you by a doctor or nurse as an injection into a muscle or as a drip ( infusion ) into a blood vessel.
Your doctor will determine the appropriate dose for you. Dose one depends on the type of infection you have, wherein the body the infection is located, and how serious it is.
If you take more Nebcina then you should
Because you are getting Nebcina from a doctor or other healthcare professional, it is unlikely that you will be given the wrong dose. If you still think you have been given an overdose or if you experience side effects, tell your doctor immediately.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor or nurse immediately if you get any of the following symptoms:
- Signs of damage to the inner ear or the auditory nerve (common in patients with renal impairment and less common in patients with normal renal function), such as:
- fraud, dizziness
- hissing and howling sound in the ear, hearing loss
- numbness, ant crawling, muscle twitching or cramps.
- Signs of impaired renal function (common in patients with renal impairment and less common in patients with normal renal function), such as:
- decreased urine outputRenal impairment initially causes few symptoms and your doctor monitors that treatment is taking into account the risk of kidney damage. With greater and more prolonged deterioration of renal function, symptoms such as pronounced fatigue, loss of appetite, nausea and / or itching may occur. Note that some of these signs may also be due to your infection or may be due to another underlying disease.
- Severe and severe allergic reaction in skin and mucous membranes which may cause:
- skin rash usually in the form of blisters and sores in the oral cavity and eyes as well as other mucous membranes, e.g. genitals (Stevens-Johnson syndrome; occurs in an unknown number of users)
- peeling of the skin or widespread skin damage (skin detachment of the epidermis and superficial mucous membranes) (exfoliative dermatitis , toxic epidermal necrolysis; occurs in an unknown number of users)
Tell your doctor immediately if you have severe diarrhea. A doctor needs to assess if you have contracted Clostridium difficile – an infection, a bacterial infection in the gut that may require treatment.
Other side effects:
Common ( may affect up to 1 in 10 people):
- increase in the number of a certain type of white blood cell ( eosinophils )
- vasculitis
- increased blood levels of certain liver enzymes ( AST , ALT )
- pain and local reactions at the injection site.
Uncommon ( may affect up to 1 in 100 people) :
- headache
- nausea, vomiting
- increased blood levels of bilirubin and certain liver enzymes ( alkaline phosphatase, lactate dehydrogenase )
- allergic skin rash, hives , itching
Rare ( may affect up to 1 in 1,000 people) :
- low number of red blood cells , low number of white blood cells ( leukopenia ), granulocytes and platelets
- confusion, disorientation
- diarrhea
- fever, drowsiness
- low blood levels of calcium , magnesium , sodium and potassium
Has been reported (occurs in the unknown number of users):
- fungal infection of the oral cavity and abdomen.
How to store Nebcina
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.
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 tobramycin. 1 ml solution for injection contains 10, 40 and 80 mg of tobramycin respectively.
- The other ingredients are sodium edetate, sodium metabisulfite and water for injections.
What the medicine looks like and contents of the pack
Nebcina is a clear, colorless solution for injection in a glass ampoule.
Pack sizes:
Nebcina 10 mg / ml: 10 ampoules are 2 ml.
Nebcina 40 mg / ml: 10 ampoules are 2 ml, 10 x 10 ampoules are 2 ml.
Nebcina 80 mg / ml: 10 ampoules are 2 ml.
Marketing Authorisation Holder
Meda AB
Box 906
170 09 Solna