Hypurin Porcine Isophane 100units/ml suspension for injection 3ml cartridges

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
07-06-2018
Tabia za bidhaa Tabia za bidhaa (SPC)
07-06-2018

Viambatanisho vya kazi:

Insulin isophane porcine

Inapatikana kutoka:

Wockhardt UK Ltd

ATC kanuni:

A10AC03

INN (Jina la Kimataifa):

Insulin isophane porcine

Kipimo:

100unit/1ml

Dawa fomu:

Suspension for injection

Njia ya uendeshaji:

Intramuscular; Subcutaneous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Caution - AMP level prescribing advised

Bidhaa muhtasari:

BNF: 06010102; GTIN: 5012727904047

Taarifa za kipeperushi

                                MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
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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
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.
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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
                                
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Tabia za bidhaa

                                OBJECT 1
HYPURIN PORCINE ISOPHANE CARTRIDGES - PL
29831/0122
Summary of Product Characteristics Updated 25-Jan-2018 | 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® Porcine Neutral.
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 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.
Hypurin® Porcine Isophane in cartridges is only suitable for
subcutaneous injections from a reusable pen.
If administration by syringe is necessary, a vial should be used.
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 f
                                
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