Hypurin Porcine Isophane 100units/ml suspension for injection 10ml vials

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Insulin isophane porcine

Disponibbli minn:

Wockhardt UK Ltd

Kodiċi ATC:

A10AC03

INN (Isem Internazzjonali):

Insulin isophane porcine

Dożaġġ:

100unit/1ml

Għamla farmaċewtika:

Suspension for injection

Rotta amministrattiva:

Intramuscular; Subcutaneous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 06010102; GTIN: 5012727901923

Fuljett ta 'informazzjoni

MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
Item Code
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Min. Point Size
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Proof By
Proof No.
Date
Artwork No.
Pharma
Code
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Wockhardt UK Limited
LFT HYPUR P 100U-ML VIA COMMON
104498/5
As per uploaded pdf
148 x 350mm
matt.pirie-scott
2
29/10/2015
607804
120
Process Black
Keylines
[e-mail]
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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.
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UK
English
8pt (main body) / 8pt (variables)
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYPURIN
® PORCINE 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 Porcine Insulin.
Hypurin Porcine is the brand name for a range of highly
purified porcine (pig) insulin injections.
Hypurin Porcine Neutral is a sterile, clear solution of porcine
insulin (100 international units/ml). It is short acting.
Hypurin Porcine Isophane is a sterile, white suspension of
porcine insulin (100 international units/ml) with protamine
sulphate and zinc chloride in water. It is longer acting than
Hypurin Porcine Neutral.
Hypurin Porcine 30/70 Mix is a sterile, white suspension
of porcin

Karatteristiċi tal-prodott

OBJECT 1
HYPURIN PORCINE ISOPHANE VIALS - PL 29831/0121
Summary of Product Characteristics Updated 19-Jan-2016 | Wockhardt UK
Ltd
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 excipients, see 6.1
3. Pharmaceutical form
Suspension for injection.
A white suspension
4. Clinical particulars
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 Neutral.
4.2 Posology and 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. Onset of action
occurs within 2 hours after subcutaneous injection with an overall
duration of 18-24 hours. Maximum
effect is exerted between 6-12 hours.
4.3 Contraindications
Hypoglycaemia.
Hypersensitivity to insulin or to any of the excipients.
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 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® Porcine insulins from other
commercially available preparations may
require dosage adjustments.
The w