Gerodolan 10 mg/ml Injektions-/infusionsvätska, lösning

Nazione: Svezia

Lingua: svedese

Fonte: Läkemedelsverket (Medical Products Agency)

Principio attivo:

hydromorfonhydroklorid

Commercializzato da:

G.L. Pharma GmbH

Codice ATC:

N02AA03

INN (Nome Internazionale):

hydromorphone hydrochloride

Dosaggio:

10 mg/ml

Forma farmaceutica:

Injektions-/infusionsvätska, lösning

Composizione:

hydromorfonhydroklorid 10 mg Aktiv substans

Tipo di ricetta:

Receptbelagt

Dettagli prodotto:

Förpacknings: Ampull, 5 x 1 ml; Ampull, 5 x 10 ml

Stato dell'autorizzazione:

Godkänd

Data dell'autorizzazione:

2019-04-11

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gerodolan
2 mg/ml solution for injection/infusion
Gerodolan
10 mg/ml solution for injection/infusion
Gerodolan
20 mg/ml solution for injection/infusion
Gerodolan
50 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ 2 mg/ml solution for
injection/infusion_
Each 1 ml ampoule contains 2 mg hydromorphone hydrochloride
(corresponding to
1.77 mg hydromorphone).
Excipient with known effect: 1 ml contains 0.153 mmol of sodium (3.52
mg/ml of
sodium)
_ 10 mg/ml solution for injection/
infusion_
Each 1 ml ampoule contains 10 mg hydromorphone hydrochloride
(corresponding to
8.87 mg hydromorphone).
Each 10 ml ampoule contains 100 mg hydromorphone hydrochloride
(corresponding
to 88.7 mg hydromorphone).
Excipient with known effect: 1 ml contains 0.128 mmol of sodium (2.93
mg/ml of
sodium)
_ 20 mg/ml solution for injection/
infusion_
Each 1 ml ampoule contains 20 mg hydromorphone hydrochloride
(corresponding to
17.73 mg hydromorphone).
Excipient with known effect: 1 ml contains 0.107 mmol of sodium (2.46
mg/ml of
sodium)
_ 50 mg/ml solution for injection/
infusion_
Each 1 ml ampoule contains 50 mg hydromorphone hydrochloride
(corresponding to
44.33 mg hydromorphone).
Excipient with known effect: 1 ml contains 0.041 mmol of sodium (0.94
mg/ml of
sodium)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless to pale yellow solution with a pH of 3.5 – 4.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of severe pain in adults and adolescents over 12
years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosing of has to be adjusted to the
patients’ severity of
pain and to their individual response.
The dose should be titrated until optimum analgesic effect is
achieved.
While a su