HYPURIN Suspension for injection (2020)

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Περιεχόμενα

1. Name of the medicinal product

Hypurin Porcine Isophane.

2. Qualitative and quantitative composition

Crystalline Insulin Ph Eur (Porcine) 100 IU/ml. Isophane Insulin Injection Ph Eur (Porcine) For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Suspension for injection. A white suspension.

4.1. Therapeutic indications

The treatment of insulin dependent diabetes mellitus. May be used for diabetics requiring a depot insulin of medium duration. Where a more rapid, intense onset is desirable it may be mixed with Hypurin ...

4.2. Posology and method of administration

Method of administration Usually administered subcutaneously but where necessary it may be given intramuscularly in which case onset is more rapid and overall duration shorter. It should not be given intravenously. ...

4.3. Contraindications

Hypoglycaemia. Hypersensitivity to insulin or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

In no circumstances must Hypurin Porcine Isophane be given intravenously. Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission ...

4.5. Interaction with other medicinal products and other forms of interaction

Drugs that may increase the requirement for insulin Antipyschotics: chloropromazine Corticosteroids Diazoxide Diuretics: thiazide diuretics or loop diuretics Sympathomimetic agents Thyroid hormone replacement ...

4.6. Fertility, pregnancy and lactation

Pregnancy A decreased requirement for insulin may be observed in the early stages of pregnancy. However, in the second and third trimesters, insulin requirements may increase. Insulin requirements should ...

4.7. Effects on ability to drive and use machines

The patients ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car ...

4.8. Undesirable effects

Immune system disorders Insulin hypersensitivity can occur with animal insulins, but appears less likely with purified insulins and there is minimal evidence that such effects occur with Hypurin insulins. ...

4.9. Overdose

Symptoms Overdosage causes hypoglycaemia. Symptoms include yawning, hunger, pallor, restlessness, weakness, sweating, trembling, confusion, anxiety, nervousness, excitement, irritability, aggression, altered ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Insulins and analogues for injection, intermediate-acting ATC Code: A10AC03 Insulin output from the pancreas of a healthy person is about 50 units per day, which ...

5.2. Pharmacokinetic properties

Insulin is rapidly absorbed from subcutaneous tissue or muscle following injection. Insulin is metabolised mainly in the liver and a small amount is excreted in the urine. The plasma half life is 4 to ...

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections.

6.1. List of excipients

Protamine sulfate Zinc chloride m-Cresol Phenol Sodium phosphate Glycerol Water for injections

6.2. Incompatibilities

None.

6.3. Shelf life

36 months. Following injection of the first dose the product should be used within 28 days. Discard any unused material after this time.

6.4. Special precautions for storage

Store at 2°C-8°C. Do not freeze. Chemical and physical in-use stability has been demonstrated for 28 days at 25°C. From a microbiological point of view the opening carries a risk of microbial contamination ...

6.5. Nature and contents of container

10ml neutral glass vial sealed with a rubber bung and metal closure.

6.6. Special precautions for disposal and other handling

Prior to use the vial of Hypurin Porcine Isophane should be rolled gently between the palms or inverted several times. The vial must not be used if the contents have been frozen or it contains lumps that ...

7. Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K.

8. Marketing authorization number(s)

PL 29831/0121

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 12/02/1997 Date of latest renewal: 03/07/2002

10. Date of revision of the text

20/08/2020

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