1 million international units (IU) Powder for infusion , solution
colistimethate sodium
WHAT TADIM IS AND WHAT IT IS USED FOR
Tadim contains colistimethate sodium. It is an antibiotic given by injection to treat certain types of serious infections caused by certain bacteria.
Tadim is used when other antibiotics are not suitable.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TADIM
In some cases, your doctor may decide not to prescribe Tadim.
Do not use Tadim and consult your doctor if:
- if you are allergic to colistimethate sodium, colistin, or other polymyxins.
If this applies to you, talk to your doctor before receiving Tadim.
Take special care with Tadim and consult a doctor, pharmacist or doctor if:
- you have or have had kidney problems;
- you suffer from myasthenia gravis (a rare disease where your muscles are extremely weak and tire very quickly);
- you suffer from porphyria (a rare metabolic disease that some people are born with).
In premature and newborn babies, special care should be taken when using Tadim because the kidneys are not fully developed.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. These medicines can affect the effect of Tadim.
- Medicines that can affect your kidney function. If you take Tadim at the same time as these medicines, the risk of kidney damage may increase.
- Medicines that can affect the nervous system. If you take Tadim at the same time as these medicines, the risk of side effects in the nervous system may increase.
- Medicines called muscle relaxants, are often used during anesthesia. Tadim can increase the effect of these medicines. If you are going to be anesthetized, you must tell the anesthesiologist that you have Tadim.
If you suffer from myasthenia gravis and also use other antibiotics called macrolides (such as azithromycin, clarithromycin, or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin, and ciprofloxacin ), while taking Tadim increases the risk of muscle weakness and breathing difficulties.
If you receive Tadim as an infusion at the same time as colistimethate sodium as an inhalation, it may increase the risk of side effects.
Pregnancy and breastfeeding
You can use Tadim if you are pregnant or trying to become pregnant if your doctor considers that the benefits outweigh the possible risks. It is not known whether using Tadim can harm your unborn baby.
You should not breastfeed while using this medicine, as Tadim can pass into breast milk.
Driving ability and use of machinery
Tadim can make you dizzy, confused, or cause vision problems e.g. blurred vision If this happens, do not drive, use tools or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
HOW TO GET TADIM
Your treatment with Tadim is given by your doctor as an infusion into a vein over 30-60 minutes.
The normal daily dose for adults is 9 million international units, divided into two or three doses. If you are quite sick, you will receive a higher dose of 9 million international units once at the start of treatment.
In some cases, your doctor may decide to give a higher daily dose of up to 12 million international units.
The normal dose for a child weighing up to 40 kg is 75,000 to 150,000 international units per kilogram of body weight, divided into three doses.
Higher doses have sometimes been given in cystic fibrosis.
Children and adults with kidney problems, including people treated with dialysis, are normally given a lower dose. Your doctor will check your kidney function regularly while you are receiving Tadim.
If you receive too much Tadim.
Because a doctor or nurse will give you Tadim, it is unlikely that you will receive an incorrect dose. Tell your doctor or healthcare professional if you have any questions about the amount of medicine you are given.
Symptoms that you may get if you have received too much Tadim:
- dizziness and vertigo
- slurred speech
- visual disturbances
- confusion
- mental disorder
- flushing ( redness of the face)
- kidney problems
- muscle weakness
- feeling like you can’t breathe
If you have not received Tadim as you should
Contact a doctor or healthcare professional if you think you have missed a dose of Tadim and it has been less than 3 hours since you should have received a dose.
If it is more than 3 hours after the missed dose, the doctor or nurse will wait until the next dose.
If you stop receiving Tadim
Your doctor will decide how long you should receive Tadim. The treatment must be completed according to the doctor’s instructions, otherwise, the symptoms may worsen.
If you have any further questions about this medicine, ask your doctor.
POSSIBLE SIDE EFFECTS
Like all medicines, Tadim can cause side effects, although not everybody gets them.
Tadim can sometimes cause allergic reactions such as skin rash or red and raised skin rash, swollen eyelids, face, lips, mouth, or tongue, itching, and difficulty breathing or swallowing. If this occurs, treatment with Tadim must be stopped immediately.
Tadim can also affect your kidneys, especially if the dose is high or if you are using other medicines that affect the kidneys.
Very common side effects (affects more than 1 person in 10)
- blood tests can show changes in kidney function
- headache
- tingling or numbness around the mouth, lips and face
- itching
- muscle weakness
Rare side effects (affects less than 1 person in 1,000)
- kidney failure
Other side effects can be
- dizziness
- difficulty controlling movements
- tenderness at the injection site
HOW TO STORE TADIM
Keep Tadim out of the sight and reach of children.
Use Tadim before the expiry date which is stated on the vial or carton. The expiration date is the last day of the specified month.
Unopened Tadim bottles do not require special storage instructions.
Tadim contains no preservatives. After preparation, Tadim should be used immediately.
Doctors or healthcare professionals will dispose of unused medicine safely. These measures will help to protect the environment.
OTHER INFORMATION
Contents declaration
- The active substance is colistimethate sodium
- Each vial contains 1 million international units (IU) of colistimethate sodium, which weighs approximately 80 mg. There are no other ingredients.
Appearance and package sizes of the medicine
Tadim is supplied as a powder in a glass vial. The powder must be prepared into an infusion solution.
Tadim is delivered packaged in boxes of 10 vials.
Marketing Authorisation Holder
Zambon S.p.A
Via Lillo del Duca 10
20091 Bresso (MI) – Italy
Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK- 2300, Copenhagen S
Denmark
Agent
Zambon Sweden, Branch of Zambon Nederland BVMedicon Village
223 81 Lund,
Phone: +47 815 300 30
Email: contact@zambongroup.com
This medicine is approved in the European Economic Area under the names:
Austria, Netherlands, Sweden: Tadim
Germany, Denmark, Norway, UK: Promixin