0.5 mmol / ml solution for injection / solution for injection , pre-filled syringe
Gadodiamide
What Omniscan is and what it is used for
This medicine is for diagnostic purposes only.
Omniscan is a contrast agent used in magnetic resonance imaging (MRI) examinations of the brain or spinal cord, as well as in whole-body examinations such as the head and neck region, the thoracic cavity including the heart, extremities (arms and legs), organs in the abdominal cavity ( prostate, bladder, and abdomen ). liver), kidney, female breast, musculoskeletal system, and blood vessels.
Omniscan can help to more clearly identify certain conditions, which helps the doctor to find and examine these conditions more easily and can improve the information needed to make a diagnosis.
What you need to know before you are given an Omniscan injection
Do not use Omniscan
– if you are allergic (hypersensitive) to gadodiamide or any of the other ingredients of Omniscan (listed in section 6).
You should not receive Omniscan if you have severe and/or acute kidney problems, or if you are a patient who is about to undergo or has recently had a liver transplant, as the use of Omniscan in patients with these conditions has been linked to a disease called nephrogenic systemic fibrosis (NSF). NSF is a disease that causes thickening of the skin and connective tissue. NSF can lead to severely reduced joint mobility, muscle weakness, or impaired function of internal organs, which can be life-threatening.
Omniscan should also not be given to newborns up to 4 weeks of age.
Warnings and cautions
Talk to your doctor before receiving Omniscan:
- if you have a pacemaker or have any implants in your body that contain iron
- if you have previously had a severe reaction after being given contrast medium
- if you have or have had any allergies (eg shellfish allergy, hay fever, hives ), asthma or other allergic diseases of the respiratory system
- if you have heart disease or disorders of the central nervous system ( epilepsy or brain damage)
- if you have moderate renal impairment
Tell your doctor
- Your kidneys are not working properly
- You have recently had or are expected to undergo a liver transplant
Before you receive Omniscan, you will need a blood test to check how well your kidneys are working.
Children and young people
Omniscan should not be given to newborns up to 4 weeks of age. Because infants up to 1 year of age have the immature renal function, Omniscan should only be given to infants after careful consideration by a physician.
Use of other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you should have a blood test the same day or within 12-24 hours after an Omniscan injection. Omniscan interferes with some of the methods commonly used to measure the level of electrolytes (such as iron and calcium ) in the blood.
Pregnancy and breastfeeding
Consult a doctor before taking any medicine.
Pregnancy
You must tell your doctor if you think you are or may become pregnant as Omniscan should not be used during pregnancy unless necessary.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding should be discontinued for at least 24 hours after receiving Omniscan.
Driving and using machines
Avoid driving as nausea may occur after the examination.
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.
Omniscan contains 0.62 mg / ml sodium . This should be considered if you are going to eat a low-salt diet.
How to use Omniscan
Dosage and administration
Omniscan will be injected, usually as a single injection, into one of your veins before or during your MRI scan. Sometimes a second injection may be of additional diagnostic value.
The amount injected depends on your body weight and which part of your body is to be examined. The usual dose is 0.2 ml / kg body weight or sometimes up to 0.6 ml / kg body weight. Even if you weigh more than 100 kg, you will not normally receive more than 20 ml or for some conditions up to 60 ml.
Dosage in special patient groups
You should not receive Omniscan if you have severe kidney problems and/or acute kidney damage, or if you are a patient who is about to undergo surgery or has recently had a liver transplant. Omniscan should also not be given to newborns up to 4 weeks of age.
If you have moderate kidney problems, you should only receive a dose of Omniscan during an examination and you should not get a second injection until after at least 7 days.
As infants up to 1 year of age have an immature renal function, only one dose of Omniscan should be given during an examination and a second injection should not be given until after at least 7 days.
It is not necessary to adjust the dose if you are 65 years or older, but you will have to take a blood sample to check how well your kidneys are working.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Omniscan can cause side effects, although not everybody gets them.
The following rare symptoms can be serious. Contact a doctor immediately if you experience:
Symptoms of angioedema, such as
- swelling of the face, tongue, throat
- difficulty swallowing
- hives and difficulty breathing
Symptoms of Nefrogen Systemic Fibrosis (NSF), such as
- thickening of the skin
- grave immobility in joints
- muscle weakness
This is a list of side effects that may occur during or after the study:
Common (may affect up to 1 in 10 people):
- Short-term discomfort in the form of heat
- Cold or local pressure sensation associated with injection one
- Short-term pain at the injection site
- Headache
- Nausea
Uncommon (may affect up to 1 in 100 people):
- Allergy-like skin and mucous membrane reactions
- Hypersensitivity
- Dizziness
- Teasing feeling
- Short-term change in your sense of taste
- Vomiting
- Diarrhea
- Redness
- Itching
Rare (may affect up to 1 in 1,000 people):
- Short-term change in your sense of smell
- Cramps
- Drowsiness
- Difficulty breathing
- Joint pain
- Shaking
- Anxiety
- Visual disturbances
- Chest pain
- Acute renal failure
- Cough
- Rash and hives
- Swelling, including swelling of the face
- Fever
- Overindulge
Has been reported (occurs in an unknown number of users):
- Severe hypersensitivity reaction
- Fast pulse
- Sneezing
- Throat irritation
- Severe shortness of breath
- Thickening of the skin
Most of the allergic reactions occur within half an hour after injection one. In rare cases, side effects may occur after hours or days.
How to store Omniscan
Keep out of sight and reach of children.
Do not use Omniscan after the expiry date which is stated on the label.
The peelable trace label on the vial and pre-filled syringe should be affixed to the patient record to allow accurate documentation of the gadolinium-containing contrast agent used. The dose used must also be documented.
If electronic patient records are used, the product name, batch number, and dose must be entered in the patient record.
Keep the vial/glass vial / polypropylene vial and the pre-filled syringe in the outer carton. Sensitive to light. Store the plastic bottles with a swivel top at a maximum of 30 ºC. Do not freeze.
Do not use Omniscan if discoloration, presence of particles, or a broken container.
Chemical and physical in-use stability has been demonstrated for 8 hours at 25 ° C. From a microbiological point of view, the product should be used immediately, unless the method of opening excludes the risk of microbiological contamination. If it is not used immediately, the responsibility for shelf life and storage lies with the user.
Contents of the pack and other information
Content declaration
– The active substance is gadodiamide (287 mg gadodiamide per ml, equivalent to 0.5 mmol / ml)
1 ml contains 287 mg of gadodiamide, equivalent to 0.5 mmol.
5 ml contains 1.44 g of gadodiamide, which corresponds to 2.5 mmol.
10 ml contains 2.87 g of gadodiamide, which corresponds to 5.0 mmol.
15 ml contains 4.31 g of gadodiamide, which corresponds to 7.5 mmol.
20 ml contains 5.74 g of gadodiamide, which corresponds to 10.0 mmol.
50 ml contains 14.35 g of gadodiamide, which corresponds to 25.0 mmol.
100 ml contains 28.7 g of gadodiamide, which corresponds to 50.0 mmol.
The other ingredients are sodium kaldiamide and sodium hydroxide 3.8% solution or hydrochloric acid 3.65% (for pH adjustment) and water for injections.
Omniscan appearance and pack sizes
Omniscan is a solution for injection. The product is a clear, colorless to the pale yellow, water-like solution.
Omniscan is provided in:
5 ml, 10 ml, 15 ml, 20 ml, and 100 ml glass bottles with a chlorobutyl rubber stopper (latex-free).
The packages contain 10 bottles.
10 ml, 15 ml and 20 ml polypropylene bottles with a swivel top, fitted with a Luer lock socket.
The packages contain 10 bottles.
50 ml and 100 ml polypropylene bottles with a chlorobutyl rubber stopper, plastic screw cap, and a safety ring. The packages contain 10 bottles.
10 ml, 15 ml, and 20 ml pre-filled syringes with a flask of bromobutyl or styrene-butadiene rubber (does not contain latex).
The packages contain 10 pre-filled syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
GE Healthcare AS
Nycoveien 1-2
PO Box 4220 Nydalen
NO-0401 Oslo
Norway
Manufacturer:
GE Healthcare AS
Nycoveien 1-2
PO Box 4220 Nydalen
NO-0401 Oslo
Norway
or
GE Healthcare Ireland Limited
IDA Business Park
Carrigtohill
Co. Cork, Ireland
This medicine is authorized in the EEA Member States under the following names:
Germany: Omniscan 0.5 mmol/ml Solution for injection
Ireland: Omniscan 0.5 mmol/ml Solution for injection
Norway: Omniscan 0.5 mmol/ml Solution for injection