0.5 mg / ml concentrate for solution for infusion alprostadil
What Prostivas is and what it is used for
Prostivas is a medicine that contains the substance alprostadil. Prostivas are given to newborns who have a heart defect which makes it necessary to keep the blood vessel ductus arteriosus open until surgery can take place. The prostate works by relaxing the muscles in the vessel wall in the ductus arteriosus and in this way the blood vessel is kept open.
What you need to know before giving Prostivas to your child
Prostivas should not be given:
- if your child is allergic to alprostadil or any of the other ingredients of this medicine (listed in section 6).
- if your child has shortness of breath (also called “Respiratory Distress Syndrome” or hyaline membrane disease).
Warnings and cautions
Talk to a doctor before your child receives Prostivas:
- If your baby is prone to bleeding.
- If your baby has a movement of the large blood vessels (a congenital heart defect).
- If your child has decreased blood flow to the lungs (cyanotic heart disease).
Other medicines and Prostivas
Children born with heart defects usually need several different medications.
The prostate may increase the effect of medicines containing oxytocin (used to induce contractions in the uterus).
The following medicines are common in combination with Prostivas for children with heart defects and have been combined without any interaction being reported:
- Digoxin is used to improve the pumping ability of the heart).
- Dopamine and isoproterenol are cardiac stimulants.
- Diuretics, e.g. furosemide used to reduce the strain on the heart.
- Antibiotics, e.g. penicillin and gentamicin used for infection.
Children
Prostivas contain alcohol ( ethanol ) and are likely to affect children (see “Prostivas contains alcohol ( ethanol )”).
Prostate contains alcohol (ethanol)
This medicine contains 790 mg of alcohol ( ethanol ) per 1 ml vial , equivalent to 790 mg / ml (79% w / v). The amount of alcohol per 1 ml vial corresponds to less than 20 ml of beer or 8 ml of wine.
The alcohol in this drug probably affects children with e.g. drowsiness and behavioral changes.
Because this drug is administered slowly over 24 hours, the effect of alcohol may be lower.
Concomitant use of drugs containing e.g. propylene glycol or ethanol, can lead to the accumulation of ethanol and cause side effects, especially in younger children with low or undeveloped metabolic capacity.
If your child has epilepsy or liver problems, consult a doctor or pharmacist before receiving this medicine.
The alcohol in this medicine may affect the effectiveness of other medicines. Tell your doctor or pharmacist if your child is taking other medicines.
How Prostivas is given to your baby
The medicine should only be given by healthcare professionals and in a place where intensive care is immediately available if needed.
Prostivas are given as an infusion.
The doctor adjusts the dose individually according to the effect your child gets from Prostivas.
The usual starting dose is 0.05 micrograms / kg / minute. If the starting dose is insufficient, it can be gently increased up to 0.4 micrograms/kg / minute. When the desired effect is obtained, the infusion rate is reduced to the lowest possible while maintaining the effect. Prostivas are given for the shortest possible time. The doctor carefully weighs the risks of giving Prostivas to a seriously ill child for an extended period against the potential benefits of the treatment for the child.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you notice that your child is experiencing the following symptoms which may be a sign of a very common serious side effect.
- Temporary respiratory arrest ( apnea )
Very common (may affect more than 1 user in 10)
- Transient fever
Common (may affect up to 1 in 10 people)
- Cramps
- Slower heart rate than normal ( bradycardia ), low blood pressure, faster heart rate than normal ( tachycardia )
- Low levels of potassium in the blood (potassium deficiency)
- Diarrhea
- Reddening of the skin
Uncommon (may affect up to 1 in 100 people)
- Obstacles in the outflow from the stomach to the small intestine, thickening of the gastric mucosa
- Bone growth from the skeleton
- Fragile blood vessels
How to store Prostivas
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 carton and label. The expiration date is the last day of the specified month.
Ampoule one is stored in a refrigerator (2 ºC – 8 ºC). The reconstituted solution is stable for 8 hours at a maximum of 25 ° C and 24 hours in a refrigerator (2 ° C – 8 ° C).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is alprostadil 0.5 mg / ml.
- The other ingredient is ethanol (see section 2 “Prostivase contains alcohol ( ethanol )”).
What the medicine looks like and the contents of the pack
Pack of 5 x 1 ml ampoules .