CORDARONE. 150 mg. 3 ml.6.ampules
CORDARONE. 150 mg. 3 ml.6.ampules
Information on medicinal products
NAME OF THE MEDICINAL PRODUCT CORDARONE
KORDARON 150mg/3ml solution for injection ampoules
1 ampoule contains : Amiodarone hydrochloride 150 mgPomoshtni Excipients: Polysorbate 80 , benzyl alcohol, water for injection to 3 ml
Solution for injection for intravenous infusion
( C: Cardiovascular system)
2 . WHAT cases the CORDARONE 150MG/3ML INJECTION ?
- This medicine is indicated for treatment of certain cases of arrhythmia .
3 . BEFORE YOU ARE GIVEN CORDARONE 150mg/3ml INJECTION ?
A / B WHAT CASES DOES NOT APPLY KORDARON 150mg/3ml INJECTION ?
This medicinal product must not be applied in the following cases :
- Known allergy to iodine or amiodarone, or to any of the excipients
- Hyperthyroidism ( overactive thyroid gland )
- Some arrhythmias and / or cardiac conduction disorders
- Suddenly unwell with a fall in blood pressure
- Frontline hypotension
- Very slow heart rhythm
- From the second trimester of pregnancy
- For children under 3 years due to the presence of benzyl alcohol
- In combination with medicinal products that can cause serious heart rhythm disorders :
- Class 1 - antiritmichni drugs ( quinidine, hydroquinidine , disopyramide )
- Class III - antiritmichni drugs ( sotalol , dofetilide , ibutilide )
- Sultopride ( neuroleptics )
- And others such as bepridil , cisapride, diphemanil , erythromycin IV, mizolastine , moxifloxacin , vincamine IV). (see Drug Interactions ) .
B / SPECIAL WARNINGS
Kordaron should never be injected through a peripheral vein , but only through a central venous catheter. Even very slow injection can cause a deepening of hypotension, heart failure or respiratory nedostatachnost.Vazmozhno may need you to have laboratory tests during treatment for liver function tests .
In / PRECAUTIONS
This medicine is used with caution in patients with electrolyte imbalance , especially low potassium. It applies only in a hospital setting under medical kontrol.Vazhno to inform the anesthesiologist before surgery , are being treated with amiodarone .
D / medicines and other forms of interaction
This medicine should not be used in combination with certain antiarrhythmic drugs ( quinidine, hydroquinidine , disopyramide , sotalol , dofetilide , ibutilide ) with sultopride ( neuroleptics ) with bepridil , cisapride, diphemanil , erythromycin IV, mizolastine , moxifloxacin , spiramycin IV, vincamine IV, which can induce "torsades de pointes" ( serious heart rhythm disorders ) should be avoided combinations of this product with diltiazem injection , some antibiotics ( halofantrine, pentamidine, lumefantrine ), some imunosulresori (cyclosporine ) with some neuroleptics ( chlorpromazine, tsiamemazin , levomepromazine , thioridazine, trifluoperazine , amisulpride , sulpiride , tiapride , veralipride , droperidol , pimozide, haloperidol ) .
To avoid any adverse effect at simultaneous use of multiple medicinal product, you should regularly inform your doctor of any conducted by the SAC treatment.
D / Pregnancy and lactation
Because the iodine content , the use of the drug is contraindicated in the second trimester of bremennostta.Karmeneto is contraindicated during treatment with this medicine .
As a general rule , Always tell your doctor or pharmacist before use of a medicinal product during pregnancy or breastfeeding.
E) DRIVE AND USE MACHINES
G / ATHLETES
3 / Excipients with known effects
4 . HOW TO USE CORDARONE 150me/3ml INJECTION ?
Applying Kordaron solution for injection should be performed only in a hospital setting and under medical supervision.
A / HOW CORDARONE 150mg/3ml solution for injection should it apply?
The usual dose for initiation of therapy is 5mg/kg body weight. The dosage may be repeated 2 to 3 times for 24 chasa.Pri supportive therapy , the dose is 10 to 20 mg / kg per day , for several dni.Lechenie c Kordaron tablets can also be directed by your first day nalechenieto by injection , the dosage is 3 tablets dentazi dose may be increased to 4 or 5 tablets per day as needed.
B / HOW TO USE CORDARON 150mg/3ml INJECTION
Through a central venous katetar.Tozi medicinal product is administered only as an intravenous infusion in 5% isotonic glyukoza.Upotrebata of PVC material and plastic medical devices containing DEHP di (2- ethylhexyl ) phthalate can lead to otdelyanato of DEHP in contact with the injection solution of amiodarone . To avoid this risk, it is recommended that the last dilution of the amiodarone to be conducted before infusion with the help of devices containing DEHP, such as PVC ( no DEHP), polyolefins ( polyethylene, polypropylene ) , glass and the like .
In / frequency of administration
During the initial treatment amiodarone may be given 2 or 3 times dnevno.G / When and how often can be applied KORDARON 150mg/3ml INJECTION RAZTVORPo during early therapy medicinal product may be administered 2 or 3 times daily.
5 . SIDE EFFECTS
Each medication and the CORDARONE can cause some patients more or fewer side effects:
mild and transient drop in blood pressure
slow heart rate ( bradycardia ), which in rare cases can be characterized by severe arrhythmias ( sinus arrest ) , local : it is possible that local inflammation of the vein when administered by direct peripheral line
reaction at the injection site : pain , redness, swelling , induration at the injection site inflammation ( phlebitis indication ) and cellulitis
severe hepatic impairment ( occurring within 24 hours and in some instances fatal) or chronic liver disorders , moderate and transient increases in some liver enzymes (transaminases ) hot flushes, sweating , hair loss,
In rare cases, these side effects were observed after intravenous administration directly : anaphylactic ( allergic ) shock, benign intracranial hypertension (increased intracranial pressure), breathing difficulties ( respiratory discomfort and / or respiratory arrest ( apnea ) of varying duration in patients with severe respiratory failure, especially in asthmatics , acute respiratory distress syndrome, which can lead to very serious or even lung infection with fatal outcome after previous surgery ) .
Tell your doctor about the occurrence of any adverse reactions not mentioned in this leaflet.
6 . STORAGE
Do not use after the expiry Store at temperatures below 25 ° C. Keep out of reach of children.