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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Caverject Powder for Injection 5, 10, 20, 40 Micrograms (2010)

Εκδότης

Εκδότης Pfizer Limited
Διεύθυνση Ramsgate Road, Sandwich, Kent, CT13 9NJ
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Caverject 5, 10, 20 or 40 micrograms powder for solution for injection.

Qualitative and quantitative composition

Alprostadil 5, 10, 20 or 40 micrograms. When reconstituted, each 1ml delivers a dose of 5, 10, 20 or ...

Pharmaceutical form

Powder for Solution for Injection. Powder: A white to off-white powder.

Therapeutic indications

Caverject is indicated for the treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, ...

Posology and method of administration

Caverject is administered by direct intracavernous injection. A half inch, 27 to 30 gauge needle is generally ...

Contraindications

Caverject should not be used in patients who have a known hypersensitivity to any of the constituents ...

Special warnings and precautions for use

Prolonged erection and/or priapism may occur. Patients should be instructed to report to a physician ...

Interaction with other medicinal products and other forms of interaction

No known interactions. Caverject is not intended for co-administration with any other agent for the treatment ...

Pregnancy and lactation

Not applicable. (High doses of alprostadil (0.5 to 2.0 mg/kg subcutaneously) had an adverse effect on ...

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

The most frequent adverse reaction after intracavernosal injection of Caverject is penile pain. In studies, ...

Overdose

The pharmacotoxic signs of alprostadil are similar in all animal species and include depression, soft ...

Pharmacodynamic properties

Alprostadil is present in various mammalian tissues and fluids. It has a diverse pharmacologic profile, ...

Pharmacokinetic properties

Following intracavernous injection of 20 micrograms of alprostadil, mean peripheral levels of alprostadil ...

Preclinical safety data

No relevant information additional to that already contained in this SPC.

List of excipients

Lactose Sodium citrate Hydrochloric acid Sodium hydroxide

Incompatibilities

Caverject is not intended to be mixed or coadministered with any other products.

Shelf life

24 months. Reconstituted solutions should be used immediately and not stored. 40 micrograms only: 24 ...

Special precautions for storage

Do not store above 25oC. Reconstituted solutions are intended for single use only, they should be used ...

Nature and contents of container

Single pack containing a vial of Caverject 5, 10, 20 or 40 micrograms powder Packs also each contain ...

Special precautions for disposal and other handling

The presence of benzyl alcohol in the reconstitution vehicle decreases the degree of binding to package ...

Marketing authorization holder

Pfizer Limited Ramsgate Road Sandwich Kent, CT13 9NJ United Kingdom

Marketing authorization number(s)

5 mcg PL 00057/0944 10mcg PL 00057/0941 20mcg PL 00057/0942 40mcg PL 00057/0943

Date of first authorization / renewal of the authorization

5 mcg 4 August 2010 10mcg 4 August 2010 20mcg 4 August 2010 40mcg 4 August 2010

Date of revision of the text

27th April 2010 February 2004
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.