Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydromorphone hydrochloride
Napp Pharmaceuticals Ltd
N02AA03
Hydromorphone hydrochloride
50mg/1ml
Solution for injection
Subcutaneous; Intravenous
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 05012854079366
1 /8 PACKAGE LEAFLET: INFORMATION FOR THE USER _PALLADONE_ ® 2 MG/ML, 10 MG/ML, 20 MG/ML AND 50 MG/ML SOLUTION FOR INJECTION OR INFUSION Hydromorphone hydrochloride _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What _PALLADONE_ injection is and what it is used for 2. What you need to know before you use _PALLADONE_ injection 3. How to use _PALLADONE_ injection 4. Possible side effects 5. How to store _PALLADONE_ injection 6. Contents of the pack and other information 1. WHAT _PALLADONE_ INJECTION IS AND WHAT IT IS USED FOR You have been prescribed _PALLADONE_ injection to relieve severe pain. It contains the active substance hydromorphone hydrochloride, which is a potent analgesic (strong “painkiller”) of the opioid group. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE _PALLADONE_ INJECTION DO NOT USE _PALLADONE_ INJECTION IF YOU: are allergic to hydromorphone or to any of the other ingredients of this medicine (listed in section 6); have breathing problems (respiratory depression); suffer from a severe lung disease associated with obstruction of the airways (severe chronic obstructive pulmonary disease or severe COPD); have a heart problem after long-term lung disease (cor pulmonale); have severe pain in your abdomen; have a condition where the small bowel does not work properly (paralytic ileus); are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and line Izlasiet visu dokumentu
OBJECT 1 PALLADONE 2 MG/ML SOLUTION FOR INJECTION OR INFUSION Summary of Product Characteristics Updated 22-Mar-2017 | Napp Pharmaceuticals Limited 1. Name of the medicinal product _PALLADONE_ 2 mg/ml solution for injection or infusion _PALLADONE_ 10 mg/ml solution for injection or infusion _PALLADONE_ 20 mg/ml solution for injection or infusion _PALLADONE_ 50 mg/ml solution for injection or infusion 2. Qualitative and quantitative composition _PALLADONE_ 2 mg/ml_: _ 1 ampoule contains 2 mg hydromorphone hydrochloride (corresponding to 1.77 mg hydromorphone) in 1 ml solution. _PALLADONE_ 10 mg/ml_:_ 1 ampoule contains 10 mg hydromorphone hydrochloride (corresponding to 8.87 mg hydromorphone) in 1 ml solution. _PALLADONE_ 20 mg/ml_:_ 1 ampoule contains 20 mg hydromorphone hydrochloride (corresponding to 17.73 mg hydromorphone) in 1 ml solution. _PALLADONE_ 50 mg/ml_:_ 1 ampoule contains 50 mg hydromorphone hydrochloride (corresponding to 44.33 mg hydromorphone) in 1 ml solution. Excipient(s) with known effect: _PALLADONE_ 2 mg/ml_: _ 1 ml contains 0.153 mmol of sodium (3.52 mg/ml of sodium) _PALLADONE_ 10 mg/ml_:_ 1 ml contains 0.128 mmol of sodium (2.94 mg/ml of sodium) _PALLADONE_ 20 mg/ml_:_ 1 ml contains 0.105 mmol of sodium (2.41 mg/ml of sodium) _PALLADONE_ 50 mg/ml: 1 ml contains 0.040 mmol of sodium (0.92 mg/ml of sodium) This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially 'sodium- free'. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection or infusion. Clear, colourless to pale yellow solution. 4. Clinical particulars 4.1 Therapeutic indications For the relief of severe pain in cancer. _PALLADONE_ injection is indicated in adults and adolescents aged >12 years. 4.2 Posology and method of administration Method of administration Intravenous injection or infusion Subcutaneous injection or infusion The medicinal product is to be visually inspected prior to use. Only clear solutions free from particles should be used. After opening, Izlasiet visu dokumentu