PROSTIN 0.5 MG/ML Injectable solution

Зміст інструкції

1. PROSTIN VR 500 mcg/1 ml injectable solution
   1. What is Prostin VR and what is it used for
   2. What you need to know before using Prostin VR
   3. How to use Prostin VR
   4. Possible side effects
   5. How to store Prostin VR
   6. Content of the pack and other information

PROSTIN VR 500 mcg/1 ml injectable solution

Alprostadil

Read this leaflet carefully before you use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Prostin VR is and what it is used for
• 2. What you need to know before you use Prostin VR
• 3. How to use Prostin VR
• 4. Possible side effects
• 5. How to store Prostin VR
• 6. Contents of the pack and other information

1. What is Prostin VR and what is it used for

Prostin VR contains the active ingredient alprostadil which belongs to a group of medicines called
prostaglandins and works by dilating blood vessels.
This medicine is used in newbornsborn with heart problems to keep
temporarily open the ductus arteriosusuntil surgery can be performed.
The ductus arteriosus (or ductus arteriosus Botalli) is a blood vessel present in all newborns and normally
closes after birth, when the lungs begin to breathe. Sometimes, however, it is necessary to keep it open
with medicines (such as Prostin VR) when the newborn is born with heart problems, while waiting for these
problems to be resolved with surgery.

2. What you need to know before using Prostin VR

Do not use Prostin VR if the baby:

• is allergic to alprostadil or any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsConsult your doctor, pharmacist or nurse beforeusing Prostin VR.

Tell the doctor before using Prostin VR if your baby:

• has a tendency to bleedeasily;
• has difficulty breathingdue to a lung problem called “respiratory distress syndrome/hyaline membrane disease”. This disease appears shortly after birth, especially if your baby was born before the end of the normal pregnancy.

During treatment with Prostin VR your baby may experience one of the following conditions:

• suspension of breathing (apnea);
• bone problemsthat tend to disappear when treatment is stopped;
• weakeningof the wall of some blood vessels(ductus arteriosus and pulmonary artery) which may make surgery more difficult;
• stomach problems, which can create an obstacle in the passage of food from the stomach to the intestine (antral hyperplasia).

Laboratory tests
During treatment with Prostin VR, careful and regular checks will be carried out to establish the most
appropriate dose of this medicine.

Other medicines and Prostin VR
Tell your doctor, pharmacist, or nurse if your baby is taking, has recently taken, or
may take any other medicine.
Tell your doctor if your baby is taking insulin(medicine used in case of diabetes) in
as the combination with Prostin VR may cause an excessive decrease in blood glucose levels.

Prostin VR contains alcohol
This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose.

3. How to use Prostin VR

This medicine must be administered to your child only by experienced doctors, within suitable healthcare facilities equipped with a pediatric intensive care unit.
Prostin VR will be administered to your child via injectioninto a large vein or, alternatively, into the umbilical artery or directly into the Botallo duct.
The recommended initial dose is 0.05-0.1 micrograms per kg of body weight per minute.
During treatment with Prostin VR, the doctor will carefully monitor your child's condition in order to determine the most appropriate dose to administer.

If more Prostin VR is administered than it should be
If you believe that more Prostin VR than necessary has been administered to your child, immediately inform your doctor, pharmacist, or nurse, as the following symptoms may occur
(see also section 4 “Possible undesirable effects”):
temporary interruption of breathing (apnea);
decreased heart rate (bradycardia);
fever (pyrexia);
decreased blood pressure (hypotension);
hot flashes.
The doctor will take the most appropriate measures depending on your child's condition.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Very common(may affect more than 1 in 10 people):

• respiratory arrest (apnea)
• transient fever

Common(may affect up to 1 in 10 people):

• convulsions
• decrease or increase in heart rate (bradycardia/tachycardia)
• decrease in blood pressure (hypotension)
• diarrhea
• hot flushes

Uncommon(may affect up to 1 in 100 people):

• obstruction hindering the passage of food from the stomach to the intestine (gastric obstruction)
• increased thickening of the stomach wall (hypertrophy of the gastric mucosa)
• formation of bumps on the bones, especially of the legs and arms (exostosis)
• fragility of blood vessels

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor, pharmacist, or nurse. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili . By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Prostin VR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the vial after “Exp.”. The
expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What contains Prostin VR
The active ingredient is alprostadil.
Each vial contains 500 micrograms of alprostadil.
The other component is: alcoholdehydrated (see paragraph 2 “Prostin VR contains alcohol”).

Description of the appearance of Prostin VR and content of the pack
The Prostin VR 500 micrograms/ml injectable solution is available in a pack containing 1 vial
of 1 ml glass, with safety break-seal.

Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo,71
04100 Latina

Manufacturer
Pfizer Manufacturing Belgium N.V.
Rijksweg 12,
Puurs, 2870 Belgium

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The following information is intended exclusively for doctors or healthcare professionals
PROSTIN VR 500 mcg/1 ml injectable solution
Alprostadil

DOSAGE AND ADMINISTRATION
Prostin VR sterile solution must be diluted before administration.
It is preferable to administer Prostin VR sterile solution by continuous intravenous infusion,
using a large vein. Alternatively, Prostin VR can be administered via a catheter inserted
into the umbilical artery and positioned at the level of the ductus arteriosus opening. In neonates in whom both routes of administration described above have been used, equivalent increases in arterial pO
have been observed.
The infusion should begin with 0.05-0.1 micrograms of alprostadil per kilogram of body weight per
minute. Good results have also been reported using lower initial doses; however, this data is largely anecdotal.
In most cases, an initial dose of 0.1 micrograms/kg/minute has been used.
After obtaining a therapeutic response (definable as an increase in pO in neonates with restriction
of pulmonary blood flow or an increase in systemic arterial pressure and pH in neonates with
restriction of systemic blood flow), the infusion rate should be reduced to reach the minimum
effective dosage, practically decreasing the dosage from 0.1 to 0.05 to 0.025 to 0.001 micrograms per
kilogram of body weight per minute.
If an adequate response is not obtained with an initial dose of 0.1 micrograms/kg/minute, the
dosage may be increased up to 0.4 micrograms/kg/minute, although, in general, higher infusion rates
do not produce an increase in efficacy.

INSTRUCTIONS FOR DILUTION
To prepare infusion solutions, it is necessary to dilute 1 ml of Prostin VR sterile solution with a
sterile intravenous infusion solution of sodium chloride or dextrose to reach the volumes
required by the available infusion system. Prepare fresh infusion solutions every 24 hours. Discard
any solution that is more than 24 hours old.
The table below allows you to determine the infusion rate of a diluted sample of
Prostin VR, in order to administer a dosage of 0.05 or 0.1 micrograms of alprostadil per kilogram
of body weight per minute.

DILUTION AND INFUSION RATE OF PROSTIN VR
Dilution
volume
of one vial
(500
micrograms)
of alprostadil
Approximate
concentration
of the solution
(micrograms/ml)
Infusion rate
(ml/min per kg) to
administer a
dosage of 0.05
micrograms/kg/min
Infusion rate
(ml/min per kg) to
administer a
dosage of 0.1
micrograms/kg/min
250 ml
100 ml
2
5
0.025 0.05
0.01 0.02
50 ml
25 ml
0.01
0.005
Example: to administer 0.1 micrograms/kg of body weight per minute to a neonate weighing
10
20
0.005
0.0025
of 2.8 kg, having to dilute one vial of Prostin VR in 100 ml of physiological or
glucose solution, the infusion rate = 0.02 ml/min per kg x 2.8 kg = 0.056 ml/min or 3.36
ml/h.