Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Insulin soluble bovine
Wockhardt UK Ltd
A10AB02
Insulin soluble bovine
100unit/1ml
Solution for injection
Subcutaneous; Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010101; GTIN: 5012727745879
MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used Wockhardt UK Limited LFT HYPUR B 100U-ML VIA COMMON 104495/4 As per uploaded pdf 148 x 350mm elkie.bramall 3 29/10/2015 607803 115 Process Black Keyline (non-printing) artwork.leicester@MULTIPKG.com CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. UK English 8pt * WARNING operator name has been made static change manually or change back to a dynamic panel PACKAGE LEAFLET: INFORMATION FOR THE USER HYPURIN ® BOVINE RANGE OF INSULIN INJECTION Read all of this leaflet carefully before you inject your insulin. - Keep this leaflet. You may need to read it again while you are receiving your treatment. - If you have any further questions, please ask your doctor, pharmacist or diabetes nurse. - This medicine has been prescribed for you. It must not be shared with other patients. It may harm them even if their symptoms are the same as yours. IN THIS LEAFLET: 1. What Hypurin ® is and what it is used for 2. Before you receive Hypurin ® 3. How to use Hypurin ® 4. Possible side effects 5. How to store Hypurin ® 6. Further information 1. WHAT HYPURIN ® IS AND WHAT IT IS USED FOR The name of your medicine is Hypurin Bovine Insulin. Hypurin Bovine is the brand name for a range of highly purified bovine (cow) insulin injections. Hypurin Bovine Neutral is a sterile, clear solution of bovine insulin (100 international units/ml). It is short acting. Hypurin Bovine Isophane is a sterile, white suspension of bovine insulin (100 international units/ml) with protamine sulphate and zinc chloride in water. It is longer acting than Hypurin Bovine Neutral. Přečtěte si celý dokument
OBJECT 1 HYPURIN BOVINE NEUTRAL VIALS Summary of Product Characteristics Updated 04-Mar-2016 | Wockhardt UK Ltd 1. Name of the medicinal product Hypurin® Bovine Neutral 2. Qualitative and quantitative composition Crystalline Insulin Ph Eur (Bovine) 100IU/ml. Neutral Insulin Injection Ph Eur (Bovine) For excipients, see 6.1 3. Pharmaceutical form Solution for injection A clear, colourless solution 4. Clinical particulars 4.1 Therapeutic indications The treatment of insulin dependent diabetes mellitus. May be used for diabetics who require an insulin of prompt onset and short duration. It is a suitable preparation for admixture with longer acting insulins. It is particularly useful where intermittent, short term or emergency therapy is required, during initial stabilisation and in the treatment of labile diabetes. 4.2 Posology and method of administration To be determined by the physician according to the needs of the patient. Usually administered subcutaneously but where necessary it may be given intramuscularly or intravenously. After subcutaneous injection onset of action occurs within 30-60 minutes with an overall duration of 6-8 hours. Maximum effect is exerted over the mid-range. 4.3 Contraindications Hypoglycaemia. Hypersensitivity to insulin or to any of the excipients. 4.4 Special warnings and precautions for use Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9). Blood or urinary glucose concentrations should be monitored and the urine tested for ketones by patients on insulin therapy. Newly diagnosed diabetic patients may experience fluctuating insulin requirements during the first weeks, months or even years of treatment (the so-called 'honeymoon period'). Patients transferred to Hypurin® Bovine insulins from other commercially Přečtěte si celý dokument