Medicinal Products

ALPROSTADIL INTSEL CHIMOS 0.5 mg / 1 mL

Prostine VR Generic Drug
Therapeutic class: Cardiology and angiology
Active ingredients: Alprostadil
laboratory: Intsel-Chimos

Injectable solution
Box of 1 ampoule of 1 mL
All forms

Indication

Temporary maintenance of arterial duct patency until curative or palliative intervention in children with ductal-dependent congenital heart disease, including:

Right obstacles:

· Stenosis or pulmonary atresia,

· Tricuspid atresia,

· Tetralogy of Fallot,

· Transposition of the big ships.

Left obstacles:

· Coarctation of the aorta,

· Interruption of the aortic arch,

· Transposition of large vessels with intact interventricular septum.

Dosage ALPROSTADIL INTSEL CHIMOS 0.5 mg / 1 mL Solution for injection Box of 1 ampoule of 1 mL

Important: Never administer the product directly by intravenous injection and always dilute beforehand.

The recommended route of administration for Alprostadil INTSEL CHIMOS is an IV infusion in a large vein. Another possibility is that of a catheter whose tip is placed next to the entrance of the arterial canal, via the umbilical artery.

· The starting dose is 0.1 μg alprostadil per kilogram body weight per minute (0.1 μg per kg per min). When an answer is obtained (increase of PaO 2 in the right obstacles, systemic blood pressure and blood pH in the left obstacles), reduce the infusion rate in order to administer the minimal dosage allowing the maintenance of a therapeutic response. Thus the infusion rate can be reduced from 0.1 to 0.05, then 0.025 and 0.01 μg per kg per min. If the response at a dosage of 0.01 μg / kg / min is insufficient, the flow may be increased to 0.4 μg / kg / min, although, in general, higher infusion rates do not produce no more marked effects.

· The infusion will be continued until the surgical procedure can be performed, which is usually only a matter of hours.

· Alprostadil is recommended in children under 10 days of age. Exceptions may be considered if the use of such a treatment seems justified in the eyes of the user physician.

• There is no evidence to date that the development of inoperable lesions, such as left ventricular hypoplasia, may be aggravated by the use of alprostadil.

Dilute 1 ml of INTSEL CHIMOS Alprostadil solution for injection (500 μg alprostadil) in a sterile isotonic solution of sodium chloride or glucose (see Storage conditions).

The dilution and infusion rate to bring 0.1 μg / kg / min are according to the table below:

Volume (ml) to dilute 500 μg

alprostadil

Approximate concentration obtained (μg / ml)

Infusion rate (ml / kg / min)

250

2

0.05

100

5

0.02

50

10

0.01

25

20

0.005

Example : to give 0.1 μg / kg / min to a child weighing 2.5 kg, by the intervention of a 1 ml solution of Alprostadil INTSEL CHIMOS diluted in 100 ml of isotonic serum:

Infusion rate:

0.02 ml / kg / min × 2.5 kg = 0.05 ml / min or 3.0 ml / h of solution containing 5 μg / ml of alprostadil.

Reduce the dosage from 0.1 μg / kg / min to 0.05 μg / kg / min by reducing pump flow when the desired effect on the arterial duct is achieved.

Do not use the preparation obtained after 24 hours.

Dosing table providing 0.1 μg / kg / min of Alprostadil INTSEL CHIMOS

Newborn weight (in kg)

Alprostadil INTSEL CHIMOS per minute (μg / min)

Alprostadil INTSEL CHIMOS per hour (μg / h)

Alprostadil INTSEL CHIMOS sol 5 μg / ml perf.rate (ml / h)

0.5

0.05

3

0.6

1

0.10

6

1.2

1.5

0.15

9

1.8

2

0.20

12

2.4

2.5

0.25

15

3

3

0.30

18

3.6

3.5

0.35

21

4.2

4

0.40

24

4.8

4.5

0.45

27

5.4

5

0.50

30

6

5.5

0.55

33

6.6

Dosing table providing 0.05 μg / kg / min of Alprostadil INTSEL CHIMOS:

Newborn weight (in kg)

Alprostadil INTSEL CHIMOS per minute (μg / min)

Alprostadil INTSEL CHIMOS per hour (μg / h)

Alprostadil INTSEL CHIMOS sol 5 μg / ml perf.rate (ml / h)

0.5

0, 025

1.5

0.3

1

0, 050

3

0.6

1.5

0, 075

4.5

0.9

2

0, 100

6

1.2

2.5

0, 125

7.5

1.5

3

0, 150

9

1.8

3.5

0, 175

10.5

2.1

4

0, 200

12

2.4

4.5

0, 225

13.5

2.7

5

0, 250

15

3

5.5

0, 275

16.5

3.3

The effectiveness of alprostadil will be appreciated as follows:

For the straight obstacles:

· An increase in PaO 2,

· Observation of the opening of the arterial duct during surgery or, possibly, angiocardiography.

For the left obstacles:

A decrease in the pressure gradient between the pulmonary artery and the aorta,

· An increase in femoral pulse,

· A decrease in acidosis,

· An increase in diuresis,

· An improvement in congestive heart failure,

· Confirmation of dilation of the arterial duct by angiocardiography and / or surgery.

Side effects Alprostadil Intsel Chimos

Out of a total of 436 observations, the most common adverse events or concomitant events with alprostadil infusion were:

· Cardiovascular system: flush (10%), bradycardia (6.7%), hypotension (3.9%), tachycardia (2.8%), cardiac arrest (1.1%) and edema (1.1%) ;

Central nervous system: fever (13.8%) and stroke (4.1%);

· Respiratory system: apnea (11.5%) most commonly observed in cyanotic infants, particularly those with a birth weight of less than 2 kg, and usually appearing during the first hour of infusion. Thus, alprostadil should only be used in the presence of respiratory resuscitation;

· Digestive system: diarrhea (1.6%);

· Hematology: disseminated intravascular coagulation (1.1%);

· Metabolism: hypokalemia (1.1%).

If flush, fever (and therefore tachycardia), apnea are likely related to alprostadil (disappearance by changing the position of the catheter), other complications may be considered as consequences of heart disease

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