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OMNISCAN 0.5 mmol/ml
Vial containing solution for IV Injection
It is used as an intravenous injection.
Active Ingredient: Gadodiamide (287 mg gadodiamide/ml is equivalent to 0.5 mmol/ml)
10 ml contains: 2.87 g (5.0 mmol) Gadodiamide
15 ml contains: 4.31 g (7.5 mmol) Gadodiamide
20 ml contains: 5.74 g (10.0 mmol) Gadodiamide
Excipients: sodium caldiamide 12.0 mg in 1 ml, sufficient amount of sodium
hydroxide solution or hydrochloric acid and sufficient water for injections
1. What OMNISCAN is and what it is used for
This medicine is for diagnosis only.
OMNISCAN can be applied to the brain or spine, as well as the whole body (including the head and neck region, heart
thoracic cavity, arms and legs, prostate in the abdominal cavity, bladder, pancreas and liver
organs, kidneys, breast in women, musculoskeletal system and blood vessels) Magnetic
It is a product used for examination with Resonance Imaging (MRI) technique.
OMNISCAN can help some medical conditions be seen more clearly. This,
It helps the doctor understand and examine these conditions more easily. So the diagnosis
More information can be provided to put.
Read this DIRECTIONS FOR USE carefully before you start using this medicine.
Please read it because it contains important information for you.
Keep this user manual. You can need to read again.
If you have other questions, please talk your doctor or pharmacist.
This medicine has been prescribed for you personally, do not give it to others.
During the use of this medicine, when you go to the doctor or hospital, you are using this medicine.
tell your doctor.
Follow exactly what is written in this instruction. Apart from the dose recommended to you about the drug
Do not use high or low doses.
2. Before you use OMNISCAN
NO INTRATHECAL USE.
Intrathecal use has caused convulsions, coma, sensory and motor nerve damage.
DO NOT USE OMNISCAN in the following situations
If you are allergic to gadodiamide or any other ingredient in the OMNISCAN formula
if you have severe kidney impairment or are about to have a liver transplant, or
if you have recently had a liver transplant.
The use of OMNISCAN in patients with the above conditions has been associated with a disease called Nephrogenic Systemic Fibrosis (NSF). NSF is a disease characterized by thickening of the skin and connective tissue. NSF impaired joint movements, muscle weakness
or the functions of internal organs, which can be life-threatening.
It should not be used in newborn babies up to 4 weeks of age.
USE OMNISCAN CAREFULLY in the following situations
If you have a pacemaker or an iron-containing implant in your body
If you have ever had a severe reaction after receiving a contrast agent If you have or have ever had an allergy (e.g. seafood allergy, hay fever, urticaria), asthma or other allergic respiratory problems. like brain problems)
If you have moderate kidney problems.
If any of the above-mentioned conditions apply to you, tell your doctor.
Tell your doctor if the following apply to you:
- If your kidneys are not working well
- If you have a liver transplant in the near past or in the near future.
Before OMNISCAN is given to you, it is necessary to find out if your kidneys are working well.
Your blood tests should be done.
OMNISCAN should not be used in newborns up to 4 weeks of age. up to 1 year old
Since infants do not develop kidney function, OMNISCAN can only be used if the doctor considers it appropriate after careful evaluation.
If these warnings apply to you, even at any time in the past, please consult your doctor.
Using OMNISCAN with food and drink
Follow your doctor's recommendations in this regard.
OMNISCAN should not be used during pregnancy unless absolutely necessary. If you notice that you are pregnant during your treatment or think you may be pregnant, consult your doctor immediately. Consult your doctor or pharmacist before using Lactation Medicine. Tell your doctor if you are a breastfeeding mother or if you are about to start breastfeeding.
Interrupt breast-feeding prior to administration of the drug and restart breast-feeding for at least 24 hours after administration of OMNISCAN.
Do not give. Driving and using machines:
Do not drive as nausea may occur after the imaging procedure.
Important information about some of the ingredients of OMNISCAN
The glass container of this medicine contains latex rubber. This substance can cause severe allergic reactions.
This medicine contains 0.62 mg/ml sodium. This is a consideration for those on a controlled sodium diet.
should be taken into account.