Land: Sverige
Språk: svensk
Kilde: Läkemedelsverket (Medical Products Agency)
hydromorfonhydroklorid
G.L. Pharma GmbH
N02AA03
hydromorphone hydrochloride
20 mg/ml
Injektions-/infusionsvätska, lösning
hydromorfonhydroklorid 20 mg Aktiv substans
Receptbelagt
Förpacknings: Ampull, 5 x 1 ml
Godkänd
2019-04-11
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) _ Les hele dokumentet10 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