Original ALPROSTADIL 20mcg powder solution for infusion/injection Rompharm
Price: 100 Euro / vial 20mcg
e-mail: sales@gerovital-gh3.com
Alprostadil, the active substance in Alprostadil Rompharm, is a so-called prostaglandin, which stimulates blood circulation, thus leading to an improvement in blood circulation.
It is used for the treatment of chronic peripheral occlusive arterial disease stages III and IV, if restoration of the blood supply to the tissue is not possible or has not been successful.
Intravenous administration (administration into a vein) in stage IV peripheral occlusive arterial disease is not recommended.
Contraindications:
Do not use Alprostadil:
- if you are allergic to alprostadil or any of the other ingredients of this medicine.
Precautions:
Talk to your doctor or pharmacist before using Alprostadil.
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Alprostadil Rompharm should not be given to women who are planning to become pregnant, pregnant or breast-feeding.
Women of childbearing potential who are to be treated with alprostadil must use an effective method of contraception during treatment.
Driving and using machines:
This medicine may affect your ability to react and your ability to drive and use machines.
This medicine may lower your blood pressure and, even when used as directed, may alter your ability to react to such an extent that your ability to drive, use machines or work without a secure hold is impaired.
Method of administration:
Intravenous administration in stage IV peripheral arterial occlusive disease is not recommended.
Alprostadil should only be used by physicians experienced in the treatment of peripheral arterial disease, who are familiar with monitoring cardiovascular function and in centers with appropriate equipment.
Intravenous therapy in stage III:
Based on the results obtained so far, intravenous therapy can be carried out according to the following therapeutic scheme:
The content of 2 vials of Alprostadil Rompharm (40 micrograms alprostadil) is diluted in 50-250 ml of saline and infused i.v. over 2 hours (= 333 ng/min: infusion rate 0.4-2 ml/min; 50 ml amounts should be administered via an infusion pump).
This dose is infused intravenously twice daily.
Alternatively, i.v. can be performed once a day, using the contents of 3 vials of Alprostadil Rompharm (60 micrograms alprostadil) diluted in 50 - 250 ml of saline, over a period of 3 hours (= 333 ng/min: infusion rate 0.3-1.4 ml/min; 50 ml amounts must be administered via an infusion pump).
Intra-arterial therapy in stages III and IV:
Based on the knowledge gained so far, intra-arterial therapy with alprostadil (into an artery) can be performed according to the following therapeutic scheme:
The contents of one vial of Alprostadil Rompharm (equivalent to 20 micrograms alprostadil) are diluted in 50 ml of saline. This initial dose is administered intraarterially as ½ (half) a vial of Alprostadil Rompharm (10 micrograms alprostadil) once daily over 60-120 minutes by infusor (= 83 to 167 ng/min for 0.8 ml/min infusions or 42 to 83 ng/min for 0.4 ml/min infusions). As needed and if well tolerated, the dose can be increased to 1 vial (20 micrograms alprostadil) with the same infusion duration (= 333 ng/min for 0.8 ml/min infusions or 167 ng/min for 0.4 ml/min infusions). This dose is administered intraarterially once daily.
If intra-arterial infusion via an indwelling catheter is used, a dose of 0.1-0.6 ng/kg body weight/min [equivalent to ¼ (a quarter) vial – 1 ½ (one and a half vial) of Alprostadil Rompharm] is recommended for 12 hours, depending on the tolerability and severity of the disease, using an infusion pump during this time.
Elderly:
In patients over 65 years of age, treatment will be carried out according to the general therapeutic regimen.
Renal insufficiency:
In patients with renal insufficiency (creatinine values >1.5 mg/100 ml, GFR <90 ml/min) treatment should be initiated with one vial of Alprostadil Rompharm (equivalent to 20 micrograms of alprostadil) in 50-250 ml of physiological saline solution, for 2 hours, twice a day. Depending on the overall clinical picture, the dose may be increased within 2-3 days to the “usual dose” mentioned above.
In patients with renal insufficiency and in patients with heart failure, the infusion volume should be limited to 50-100 ml/day and should be administered intravenously, using an infusion pump.
Hepatic impairment:
Treatment is contraindicated in patients with signs of acute hepatic insufficiency or known severe hepatic insufficiency (See section “Do not use Alprostadil Rompharm”).
Use in children and adolescents:
Alprostadil Rompharm is contraindicated in children and adolescents under 18 years of age (see section “Do not use Alprostadil Rompharm”).
Method of administration:
For intravenous or intraarterial administration (administration into a vein or artery) after reconstitution and dilution with a suitable solvent.
Alprostadil Rompharm should not be administered by bolus injection.
If you have any further questions on this medicine, ask your doctor or pharmacist.
Composition:
- The active substance is alprostadil. One vial of white or almost white powder contains 20 micrograms of alprostadil.
- The other ingredients are: alfadex, lactose monohydrate, sodium citrate, hydrochloric acid (for pH adjustment).
Presentation: 1 vial