DILCEREN 10 mg. 50 ml.

What is DILCEREN and what is it used?
DILCEREN contains an active substance nimodipine.
Nimodipine is a dihydropyridine derivative class of calcium antagonists. Acts primarily on cerebrovascular structures, while its peripheral effects are minimal. Besides its effects on the smooth muscle of the cerebral vessels, nimodipine influences directly on the neurons and glial cells. The effect on the smooth muscle of the cerebral vessels explains antivazokonstriktornoto (ie counteract the effects of vasospasm) and vasodilative (vasodilator) action of nimodipine and direct effect on neuronal calcium channels underlies the neuroprotective action of nimodipine.
DILCEREN used for prevention and treatment of ischemic neurological deficit due to arterial vasospasm (spasm of the blood vessel) after subarachnoid hemorrhage in cerebrovascular aneurysm.
DILCEREN for the treatment of adult patients.

2. What you should know before using DILCEREN?
Do not use DILCEREN
If you are allergic (hypersensitive) to nimodipine or any of the other ingredients of this medicine listed in Section 6.
DILCEREN should not be used in acute myocardial infarction or unstable angina pectoris and during the next month.
Due to lack of clinical experience, the product should not be prescribed to children and adolescents under 18 years.

Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using DILCEREN: if you have hypotension (systolic blood pressure below 100 mm Hg) generalized cerebral edema, increased intracranial pressure strong.
Because of an increased risk of bleeding, DILCEREN should not be used in patients undergoing cardiovascular surgery.
It is necessary to carefully monitor liver and renal function in case of deterioration of their performance.
Careful monitoring of blood pressure in patients with cirrhosis receiving DILCEREN.
Transient increases in liver enzymes may occur during intravenous administration. Values usually return to normal after discontinuation of treatment.
The infusion contains 17% macrogol 400, it must be taken into account during the treatment.
Nimodipine (the active ingredient in this medicine) is absorbed by polyvinyl chloride (PVC), can therefore only be used in infusion pumps with plastic tubes and needles with a plastic handle (or all metal).
The infusion solution is sensitive to light, therefore, exposure to direct sunlight should be avoided. If the infusion solution should be used to direct daylight, infusion pump and pipes must be covered with black, brown, yellow or red, or be protected by a suitable light-impermeable coating. In the case of diffuse daylight or artificial lighting DILCEREN can be applied without special protection for 10 hours.
This medicine may adversely affect alertness. Realistically, however, this has no practical significance in the above indications.

Other medicines and DILCEREN:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use of DILCEREN with antihypertensive drugs is not recommended due to possible enhancement of the hypotensive (blood pressure lowering) effects. Furthermore, combined use with other calcium channel blockers and alpha-methyldopa should be avoided.
Simultaneously intravenous beta-blocker can enhance the negative inotropic effect, which may even lead to circulatory failure. Concomitant use of potentially nephrotoxic drugs (aminoglycosides, cephalosporins, furosemide) may lead to worsening of renal function. Therefore, in a significant deterioration of renal function should stop taking Diltseren infusion. Upon co-administration with cimetidine may increase the blood levels of nimodipine and therefore potentiate its effects. Co-administration of nimodipine and fluoxetine results in a 50% increase in the plasma level of nimodipine, noticeable reduction in the level of fluoxetine, without changes in the plasma level of the active metabolite, norfluoxetine.
Concomitant use of nimodipine and nortriptyline significantly increased plasma concentrations of nimodipine, while that of nortriptyline remains unchanged. /. There is no evidence of a potential interaction between nimodipine and haloperidal patients on continuous treatment.
In a study in monkeys, concomitant intravenous administration of nimodipine and zidovudine lead to increased plasma levels of zidovudine (anti - HIV treatment).

DILCEREN with food, drinks and alcohol:
Taking grapefruit juice is not recommended in combination with nimodipine, as it can lead to increased plasma concentrations of nimodipine, due to inhibition of the oxidative metabolism of dihydropyridines.
DILCEREN contain alcohol and therefore interactions with medicinal products that are incompatible with alcohol. The use of alcohol during treatment nimodipine should be avoided.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Clinical experience with the use of DILCEREN during pregnancy and lactation is insufficient. DILCEREN not recommended for use during pregnancy, in special cases it is necessary to assess the risk / benefit. Breast-feeding should be discontinued if the application of DILCEREN necessary.

Driving and using machines
Patients undergoing treatment with DILCEREN can not drive or operate machinery. DILCEREN contains ethanol and sodium (as excipients):
This medication contains 200 mg of ethanol in 1 ml of infusion solution, i. E. Up to 50 g per daily dose of 250 ml, which is equivalent to 1200 ml beer (5%) or 500 ml of wine (12%) per dose. This can be harmful to patients suffering from alcoholism or impaired alcohol metabolism and should be taken into account in pregnant or lactating women, children, high-risk (group) patients (such as those with liver disease or epilepsy). The amount of alcohol in this medicinal product may alter the effects of other medicines.
This medicine contains 0.5 mg / ml of sodium, which should be considered in patients on a diet with a controlled intake of sodium.

3. How to use DILCEREN?
Always use DILCEREN exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The recommended dosage is as follows:
Continuous intravenous infusion:
The treatment starts with a dose of 1 mg nimodipine (i.e., about 15 micrograms / kg body weight, equivalent to 5 ml DILCEREN) per hour during the first two hours. Provided that tolerated, and in particular in the absence of a significant drop in blood pressure, the dose may be increased to 2 mg nimodipine (i.e., about 30 micrograms / kg of body weight equivalent to 10 ml DILCEREN) of hour after the first two hours.
Patients whose body weight is significantly lower than 70 kg and in those with labile blood pressure, it is recommended to start treatment at a dose of 0.5 mg nimodipine (2.5 ml DILCEREN) per hour.

intracisternal administration
During the surgical procedure, prepare 20 ml of dilute Diltseren by adding 19 ml Ringer's solution to a solution of 1ml Diltseren. The reconstituted solution should be used immediately after dilution.
Provided that the patient develops severe side effects, the dosage should either reduce or discontinue DILCEREN.
In patients with severe renal or hepatic function (particularly liver cirrhosis) may potentiate the side effects, therefore, in such cases the dosage should be reduced or even discontinued.

Method of administration
DILCEREN infusion solution was administered via a central venous catheter as a continuous intravenous infusion (it is best to use an infusion pump). It can be used with the following compatible solutions using a stopcock, with a 5% solution of dextrose, saline, Ringer's solution, sodium lactate, Ringer's solution, sodium lactate and magnesium, Dextran 40 solution, HAES 6% poly- (0 -2-hydroxyethyl) starch in a ratio of 1: 4 (Diltseren: simultaneous use solution). Furthermore, mannitol, 5% Humam albumin and blood are suitable for simultaneous infusion. Diltseren infusion should not be added to infusion bags or bottles, and must not be mixed with other medicines. Application of Diltseren should continue during general anesthesia, surgery or angiography. The use of shut-off valve allows the connection of the plastic tube of Diltseren infusion with simultaneous use infusion and central venous catheter.

Duration of treatment
Prophylactic use:
Intravenous therapy should begin no later than 4 days after subarachnoid kravozliv and should continue throughout the period of increased risk of vasospasm, ie 10-14 days after subarachnoid haemorrhage.
In surgical remediation of the source of bleeding during prophylactic use of Diltseren, intravenous administration should continue for at least 5 days after surgery.
After completion of the infusion therapy, it is recommended a oral administration of nimodipine 60 mg every 4 hours for 7 days.

Therapeutic use:
Treatment of ischemic neurological deficits due to vasospasm arising under, subarachnoid bleeding aneurysm should start as early as possible and continue 5 -14 days.
It is then advisable to switch to oral administration of nimodipine 60 mg every 4 hours for 7 days.
In surgical remediation of the source of bleeding during prophylactic use of Diltseren, intravenous administration should continue for at least 5 days after surgery.

Intraiisternsshno application
During the surgical control of the source of subarachnoid bleeding was prepared 20 ml of dilute Diltseren by addition of 19 ml Ringer's solution to a solution of 1ml Diltseren. The reconstituted solution should be warmed to body temperature and can be used immediately after preparation.

Use in children and adolescents:
Due to lack of clinical experience the medicinal product should not be prescribed to children and adolescents under 18 years.
Overdose may be manifested by flushing, headache, hypotension (low blood pressure), tachycardia (rapid heartbeat) or bradycardia (slow heart rate

treatment
The first measure is the immediate discontinuation of Diltseren. In the presence of marked hypotension required intravenous administration of dopamine or norepinephrine. There is no specific antidote. Therefore, the treatment of intoxication Diltseren is only symptomatic.
If you forget to use DILCEREN
Diltseren only be administered by a doctor.

If you stop using DILCEREN
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Treatment prescribed by your doctor and he decides when to break.

4. Possible side effects
Like all medicines, DILCEREN can cause side effects, although not everybody gets them.
Uncommon: reduced number of platelets, which increases risk of bleeding or hematoma, headache, rapid heartbeat, sweating, flushing and hot flashes, decrease in blood pressure (especially in patients with very high blood pressure) ^ nausea, allergic reactions, rashes .
Rare: slow heartbeat, intestinal obstruction, transient elevated liver enzymes, reactions around the infusion phlebitis and / or occlusion of the vein due to blood clotting at the site of infusion.
With nezvestna frequency: dizziness, extra discomfort in the abdomen, impaired renal function (increased uric acid in the blood, elevated creatinine in the blood).
Use of the undiluted solution of the drug in the peripheral vein may lead to phlebitis.

5. HOW TO STORE DILCEREN?
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the packaging.