CAVERJECT Powder for solution for injection (2017)
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Περιεχόμενα
Name of the medicinal product
Caverject 20 micrograms powder for solution for injection.
Qualitative and quantitative composition
Alprostadil 20 micrograms. When reconstituted, each 1ml delivers a dose of 20 micrograms of alprostadil. Excipients with known effect: Each 1ml of reconstituted solution contains 8.04 mg of benzyl alcohol. ...
Pharmaceutical form
Powder for solution for injection. A white to off-white powder.
Therapeutic indications
Caverject is indicated for the treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed aetiology. Caverject may be a useful adjunct to other diagnostic tests ...
Posology and method of administration
Caverject is administered by direct intracavernous injection. A half inch, 27 to 30 gauge needle is generally recommended. The dose of Caverject should be individualised for each patient by careful titration ...
Contraindications
Alprostadil should not be used in patients who have a known hypersensitivity to alprostadil or to any of the excipients listed in section 6.1; in patients who have conditions that might predispose them ...
Special warnings and precautions for use
Prolonged erection and/or priapism may occur following intracavernosal administration of alprostadil. To minimize the risk, select the lowest effective dose. Patients should be instructed to report immediately ...
Interaction with other medicinal products and other forms of interaction
The effects of combinations of alprostadil with other treatments for erectile dysfunction (e.g. sildenafil) or other drugs inducing erection (e.g. papaverine) have not been formally studied. Such agents ...
Pregnancy and lactation
Not applicable. High doses of alprostadil (0.5 to 2.0 mg/kg subcutaneously) had an adverse effect on the reproductive potential of male rats, although this was not seen with lower doses (0.05 to 0.2 mg/kg). ...
Effects on ability to drive and use machines
Alprostadil would not be expected to have an influence on the ability to drive or operate machines.
Undesirable effects
The most frequent adverse reaction after intracavernosal injection of alprostadil is penile pain. Thirty percent of the patients reported penile pain at least once; however, this event was associated with ...
Overdose
The pharmacotoxic signs of alprostadil are similar in all animal species and include depression, soft stools or diarrhoea and rapid breathing. In animals, the lowest acute LD<sub>50</sub> was 12 mg/kg ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in erectile dysfunction ATC code: G04BE01 Alprostadil is present in various mammalian tissues and fluids. It has a diverse pharmacologic profile, among which some ...
Pharmacokinetic properties
Following intracavernous injection of 20 micrograms of alprostadil, mean peripheral levels of alprostadil at 30 and 60 minutes after injection are not significantly greater than baseline levels of endogenous ...
Preclinical safety data
No relevant information additional to that already contained in this SPC.
List of excipients
Lactose monohydrate Sodium citrate α-cyclodextrine Hydrochloric acid for pH adjustment Sodium hydroxide for pH adjustment
Incompatibilities
Caverject is not intended to be mixed or coadministered with any other products.
Shelf life
Shelf life: 2 years. Reconstituted solutions should be used immediately and not stored.
Special precautions for storage
Do not store above 25°C. Reconstituted solutions are intended for single use only, they should be used immediately and not stored.
Nature and contents of container
Single pack containing a 5 ml clear, colourless, glass vial of Caverject 20 micrograms powder with a bromobutyl rubber stopper and an aluminium overseal with polypropylene flip-off cap. Packs also each ...
Special precautions for disposal and other handling
The presence of benzyl alcohol in the reconstitution vehicle decreases the degree of binding to package surfaces. Therefore, a more consistent product delivery is produced when Bacteriostatic Water for ...
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0942
Date of first authorization / renewal of the authorization
4 August 2010
Date of revision of the text
03/2017
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