Gerodolan 10 mg/ml Injektions-/infusionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

hydromorfonhydroklorid

Tillgänglig från:

G.L. Pharma GmbH

ATC-kod:

N02AA03

INN (International namn):

hydromorphone hydrochloride

Dos:

10 mg/ml

Läkemedelsform:

Injektions-/infusionsvätska, lösning

Sammansättning:

hydromorfonhydroklorid 10 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

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

Bemyndigande status:

Godkänd

Tillstånd datum:

2019-04-11

Produktens egenskaper

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