País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diamorphine hydrochloride
Accord-UK Ltd
N07BC06
Diamorphine hydrochloride
100mg
Powder for solution for injection
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5012617017864
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. DIAMORPHINE HCI 100MG & 500MG SOLUTION FOR INJECTION PIL - UK Black BBBA1713 C.Grant 24/01/18 05/02/18 C.Grant 182 x 265 9pt Baccinex 24/01/18 30/01/18 03 READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU ARE GIVEN THIS INJECTION. • Keep this leaflet. You may need to read it again. • If you have any other questions, please ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. Before being used, the powder in the ampoules will be mixed with a liquid to make a solution which will be given to you by injection. This is called Diamorphine Hydrochloride BP Injection in this leaflet. 1. WHAT DIAMORPHINE HYDROCHLORIDE BP INJECTION IS AND WHAT IT IS USED FOR 2. BEFORE YOU ARE GIVEN THE INJECTION 3. HOW THE INJECTION IS GIVEN 4. POSSIBLE SIDE EFFECTS 5. STORING THE INJECTION 6. FURTHER INFORMATION 1. WHAT DIAMORPHINE HYDROCHLORIDE BP INJECTION IS AND WHAT IT IS USED FOR Diamorphine hydrochloride belongs to a class of medicines known as opioid analgesics. They help to relieve pain. Diamorphine Hydrochloride BP Injection can be used to • relieve severe pain associated with surgery, a heart attack or a terminal illness, or • relieve breathlessness caused by fluid in the lungs. 2. BEFORE DIAMORPHINE HYDROCHLORIDE BP INJECTION IS GIVEN TO YOU DIAMORPHINE HYDROCHLORIDE BP INJECTION IS NOT SUITABLE FOR EVERYONE. TELL THE DOCTOR OR NURSE THAT YOU MUST NOT HAVE THE INJECTION IF: • you are aware that you are allergic to diamorphine or any other opioid analgesic such as c Llegiu el document complet
OBJECT 1 DIAMORPHINE HYDROCHLORIDE BP 100 MG LYOPHILISATE FOR SOLUTION FOR INJECTION Summary of Product Characteristics Updated 07-Aug-2017 | Accord-UK Ltd 1. Name of the medicinal product Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection. 2. Qualitative and quantitative composition Each ampoule contains 100 mg of Diamorphine Hydrochloride BP. 3. Pharmaceutical form Lyophilisate for solution for injection. A white to off-white, sterile, freeze dried powder of Diamorphine Hydrochloride BP for reconstitution for injection. 4. Clinical particulars 4.1 Therapeutic indications Diamorphine may be used in the treatment of severe pain associated with surgical procedures, myocardial infarction or pain in the terminally ill and for the relief of dyspnoea in acute pulmonary oedema. 4.2 Posology and method of administration Diamorphine may be given by the intramuscular, intravenous or subcutaneous routes. Glucose intravenous infusion is the preferred diluent, particularly when the drug is administered by a continuous infusion pump over 24 to 48 hours, although it is also compatible with sodium chloride intravenous infusion. The dose should be suited to the individual patient. Adults: _Acute pain_, 5 mg repeated every four hours if necessary (up to 10 mg for heavier, well muscled patients) by subcutaneous or intramuscular injection. By slow intravenous injection, one quarter to one half the corresponding intramuscular dose. _Chronic pain_, 5-10 mg regularly every four hours by subcutaneous or intramuscular injection. The dose may be increased according to individual needs. _Myocardial infarction_, 5 mg by slow intravenous injection (1 mg/minute) followed by a further 2.5 mg to 5 mg if necessary. _Acute pulmonary oedema_, 2.5 mg to 5 mg by slow intravenous injection (1mg/minute). If breakthrough pain occurs give a subcutaneous (preferable) or intramuscular injection of diamorphine equivalent to one-sixth of the total 24-hour subcutaneous infusion dose. It is kinder to give an intermittent bolus inject Llegiu el document complet