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Warnings and precautions

Talk to your doctor or radiologist if the following applies to you:

•    you have previously reacted to a contrast agent during an examination

•    you have asthma

•    you have a history of allergies (such as seafood allergy, urticaria, hay fever)

•    you are taking a beta-blocker (a medicine used against high blood pressure, heart problems and other conditions; such as metoprolol)

•    your kidneys do not work properly

•    you have recently had, or soon expect to have, a liver transplant

•    you have a disease affecting your heart or blood vessels

•    you have had convulsions or you are being treated for epilepsy.

In all these cases, your doctor or radiologist will assess the benefit-to-risk ratio and decide whether you should be given Dotagita. If you are given Dotagita, your doctor or radiologist will take the precautions necessary and the administration of Dotagita will be carefully monitored.

Your doctor or radiologist may decide to take a blood test to check how well your kidneys are working before making the decision to use Dotagita, especially if you are 65 years of age or older.

Neonates and infants

As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Dotagita will only be used in these patients after careful consideration by the doctor.

Remove all metallic objects that you wear before the examination.

Inform your doctor if you have:

•    a pacemaker

•    a vascular clip

•    an infusion pump

•    a nerve stimulator

•    a cochlear implant (implant in the inner ear)

•    any suspected metallic foreign bodies, particularly in the eye.

This is extremely important as these can result in serious problems, as magnetic resonance imaging devices use very strong magnetic fields.

Other medicines and Dotagita

Tell your doctor, radiologist or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, please inform your doctor or radiologist if you are taking or have recently taken medicines for heart and blood pressure disorders such as beta-blocking agents (such as metoprolol), vasoactive substances (such as doxazosin), angiotensinconverting enzyme inhibitors (such as ramipril), angiontensin II receptor antagonists (such as valsartan).

Dotagita with food and drink

There are no known interactions between Dotagita and food and drinks. However, please check with your doctor, radiologist or pharmacist if it is required not to eat or drink before the examination.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, radiologist or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think you are or might become pregnant as Dotagita should not be used during pregnancy unless strictly necessary.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive Dotagita.

Driving and using machines

No data are available on the effects of Dotagita on the ability to drive. If you feel unwell after the examination, you should not drive or use machines.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

After the administration, you will be kept under observation for at least half an hour. Most side effects occur immediately or sometimes delayed. Some effects can occur up to seven days after Dotagita injection.

There is a small risk that you may have an allergic reaction to Dotagita.

Such reactions can be severe and result in shock (case of allergic reaction that could put your life in danger).

The following symptoms may be the first signs of a shock. Inform immediately your doctor, radiologist or health professional if you feel any of them:

•    swelling of the face, mouth or throat which may cause you difficulties in swallowing or breathing

•    swelling of hands or feet

•    lightheadedness (hypotension)

•    breathing difficulties

•    whistling respiration

•    coughing

•    itching

•    runny nose

•    sneezing

•    eye irritation

•    hives

•    skin rash

Altogether, the side effects which have been described for Dotagita are the following:

Very common side effects (may affect more than 1 in 10 people):

•    headaches

•    tingling sensation

Common side effects (may affect up to 1 in 10 people):

•    sensation of warmth or cold and/or pain at the injection site

•    nausea (feeling sick)

•    vomiting (being sick)

•    redness of the skin, itching and rash

Uncommon side effects (may affect up to 1 in 100 people):

•    allergic reactions

Rare side effects (may affect up to 1 in 1,000 people):

•    unusual taste in the mouth

•    hives, increased perspiration

Very rare side effects (may affect up to 1 in 10,000 people):

•    agitation, anxiety

•    coma, seizures, syncope (brief loss of consciousness), faintness (dizziness and feeling of imminent loss of consciousness), dizziness, disorder of smell (perception of often unpleasant odours), tremor

•    conjunctivitis, red eye, blurred vision, increased tear secretion, eye swelling

•    cardiac arrest, accelerated or slow heart beat, irregular heart beat, palpitations, low or high blood pressure, vascular dilatation, pallor

•    respiratory arrest, pulmonary oedema, breathing difficulties, feeling of tight throat, wheezing, stuffy nose, sneezing, cough, dry throat

•    diarrhoea, stomach pain, increased saliva secretion

•    eczema

•    muscle contractures, muscle weakness, back pain

•    malaise, chest pain, chest discomfort, fever, chills, swelling of the face, fatigue, injection site discomfort, injection site reaction, injection site swelling, diffusion of the product outside of blood vessels that can lead to inflammation (redness and local pain) or tissue dying off at the injection site, inflammation of a vein

•    decrease in oxygen level in blood

Not known (frequency cannot be estimated from the available data):

•    nephrogenic systemic fibrosis

There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs), most of which were in patients who received Dotagita together with other gadolinium-containing contrast agents. If, during the weeks following the MRI examination, you notice changes in the colour and/or thickness of your skin in any part of your body, inform the radiologist who performed the examination.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

How to store Dotagita

This medicinal product does not require any special storage conditions.

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 vial and on the carton, after the abbreviation "Exp". The expiry date refers to the last day of that month.

Do not use this medicinal product, if you have found any visible signs of damage (for example, particles in the solution of cracks in the glass vial).

Chemical and physical in-use stability has been demonstrated for 48 hours at 21°C to 23°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless opening has taken place in controlled and validated aseptic conditions.

Contents not used in a patient during one investigation must be discarded. Each vial is for single patient use only.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Dotagita contains

•    The active substance is gadoteric acid. One ml solution for injection contains 279.32 mg gadoteric acid (as meglumine salt), equivalent to 0.5 mmol.

•    The other ingredients are meglumine and water for injection.

What Dotagita looks like and contents of the pack

Dotagita is a clear, colourless to pale yellow solution practically free from visible particles, for intravenous injection. Each pack contains one or 10 single-dose vials with 10 ml (filled with 5 ml or 10 ml), and 20 ml (filled with 15 ml or 20 ml) or 60 ml of solution for injection.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Agfa HealthCare Imaging Agents GmbH Am Coloneum 4 50829 Cologne Germany

This leaflet was last revised in 07/2015

The following information is intended for healthcare professionals only:

Posology

•    Brain and spinal MRI:

In neurological examinations, the recommended dose is 0.1 mmol/kg body weight, corresponding to 0.2 ml/kg body weight. In some cases, after administration of 0.1 mmol/kg body weight to patients with brain tumours, an additional dose of 0.2 mmol/kg body corresponding to 0.4 ml/kg body weight, may improve tumour characterisation and facilitate therapeutic decision-making.

•    MRI of other organs and Angiography:

The recommended dose for intravenous injection is 0.1 mmol/kg (i.e. 0.2 ml/kg) to provide diagnostically adequate contrast.

•    Angiography: In exceptional circumstances (e.g. failure to gain satisfactory images of an extensive vascular territory) administration of a second consecutive injection of 0.1 mmol/kg body weight, equivalent to 0.2 ml/kg body weight may be justified. However, if the use of 2 consecutive doses of Dotagita is anticipated prior to commencing angiography, use of 0.05 mmol/kg body weight, equivalent to 0.1ml/kg body weight for each dose may be of benefit, depending on the imaging equipment available.

•    Children: The 0.1 mmol/kg body weight dose applies to all indications except angiography due to insufficient data on efficacy and safety in this indication.

•    Due to immature renal function in neonates up to 4 weeks of age and in infants up to 1 year of age, Dotagita should only be used to this group of patients after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Dotagita injections should not be repeated unless the interval between injections is at least 7 days.

•    In neonates and infants the required dose should be administered by hand.

•    Patients with renal impairment: The adult dose applies to patients with mild to moderate renal impairment (GFR S 30 ml/min/1.73m²).

See also below "Impaired renal function".

•    Patients with hepatic impairment: The adult dose applies to these patients. Caution is recommended, especially in the case of perioperative liver transplantation period.

Method of administration

•    Dotagita is indicated for intravenous administration only.

Dotagita must not be administered by subarachnoid (or epidural) injection.

•    Infusion rate: 3-5 ml/min (for angiographic procedures, higher infusion rates up to 120 ml/min, i.e. 2 ml/sec, may be used for angiographic procedures).

•    Optimal imaging: within 45 minutes after injection.

•    Optimal image sequence: T1-weighted.

•    Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time.

•    Prepare a syringe with a needle. Remove the plastic disk. After cleaning the stopper with a pad soaked in alcohol, puncture the stopper with the needle. Withdraw the quantity of product required for the examination and inject it intravenously.

•    Each vial is for single patient use only. Contents not used in a patient during one investigation must be discarded.

•    The solution for injection should be inspected visually prior to use. Only clear solutions free of visible particles should be used.

Impaired renal function

Prior to administration of Dotagita, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment

(GFR< 30 ml/min/1.73 m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with Dotagita, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. If it is necessary to use Dotagita, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Dotagita injections should not be repeated unless the interval between injections is at least 7 days.

Haemodialysis shortly after Dotagita administration may be useful at removing Dotagita from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

Elderly

As the renal clearance of gadoteric acid may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

Instructions on handling

The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.

If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.

AGFA

Healthcare

Imaging Agents

140717_V9_Agfa_UK_Dotagita_PIL_210x460mm

Montag, 3. August 2015 15:46:28