INSULIN HUMAN, BIPHASIC 30-70 UI/ml, 3ml, pref. pen N

STD DINJINSHB3APN

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The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
18.5.1 - Insulins
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
A018006 - Hypodermic needles pen injectors
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
A10AD01
Anatomical Therapeutic Chemical Classification according to WHOCC
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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INSULIN BIPHASIC human, pre-filled pen

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Full Name

Mixtard 30 InnoL® or Mixtard 30 FlexPen®

Therapeutic Action

Pancreatic hormone, antidiabetic

Pre-mixed (or biphasic) insulin containing Isophane (NPH) human insulin (intermediate-acting) combined with regular human insulin (rapid-acting) at 30:70 ratio.

The insulin action profile is a combination of the rapid and intermediate acting insulins.

Action profile:

  • onset of action: 30 - 90 min
  • peak action: 2 - 8 hrs
  • duration of action: 10 - 16 hrs

These action profiles are based on subcutaneous injections and are only approximations. They depend on the dose injected, the type and brand of insulin and are highly variable from one patient to another.

See Preliminary remarks on Insulins.

Indications

Diabetes

Insulin pre-filled pens are the preferred option for the patient self-administration (and OPD use).

Instructions for use

A portable, hand-held device, typically in the form of a large pen, prefilled with a pharmaceutical agent and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical via a replaceable needle. The device typically includes a dial for dosing and is discarded when the pharmaceutical is exhausted and is therefore used over a short period (single-use).

Must be given as deep SC injection only.

Before using insulin for the first time, store it at room temperature for 1 or 2 hours (cold insulin is more painful).

Preparation for administration:

  • Wash hands.
  • Check the pen label (type and strength of insulin, expiry date) and the solution (cloudy, white and aqueous).
  • Stir the insulin by gently rolling the pen between the palms of the hands. Do not shake the pen.
  • Remove the cap from the pen.
  • Wipe the pen tip (rubber seal) with a disinfectant.
  • Attach a pen needle to the pen after removing the protective seal of the needle. Push the needle straight onto the pen. Screw the needle on the pen.
  • Remove the outer cap of the needle and save it (you will need it to remove the needle after the injection).
  • Remove the inner cap of the needle.
  • Remove air from the pen. Pointing the needle up in the air, select one or two units on the pen. Gently tap the pen to move air bubbles to the top of the pen.
  • Press the injection button. A drop of insulin should appear on the tip of the needle. If no drop appears, change the needle and repeat this step.
  • Select the correct dose on the pen. Turn the dose selector to the required number of units.

How to administer SC insulin:

  • Insulin can be injected into the abdomen (two fingers away from the belly button), upper arm, buttocks, hips, buttocks, or the front or side of the thigh.
  • Injecting insulin in the same area repeatedly can cause lumps, swelling and thickened skin, and it may keep insulin from absorbing properly. See the picture below on “rotating” injection sites.
  • Do not inject insulin into areas that have wounds or bruising.
  • Clean the chosen injection site with soap and water. Allow to dry.
  • Pinch the skin.
  • Keep the pen straight at a 90-degree angle to the skin and insert the needle with one quick motion.
  • Push the injection button with the thumb to inject the dose of insulin. Wait for 10 seconds before releasing the button and removing the needle from the skin.
  • Apply gentle pressure on the injection site with the finger for 5-10 seconds to keep insulin from leaking out.
  • Remove the needle from the pen by replacing the outer needle cap on and unscrewing. Leaving the needle on the pen can result in leakage or air bubbles.
  • Safety discard the needle into a sharps container.
  • Replace the cap on the pen after each injection to protect it from light.

Education of patients

Set up several counselling sessions to determine whether the patient is ready to start self-injecting and understands the risks and management of hypoglycaemia, the use of the pre-filled pen (including the units of insulin), the injection technique, the insulin storage, the waste management. Involve the family/carers if possible and provide an information leaflet adapted to the local context. Contact your OC referent for more details.

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Precautions for Use

Depending on the model, the number of units contained in a pen may vary. It is not possible to dial more units than the number remaining in the pen (the pen is fitted with a safety stop).

In case the number of units remaining in the pen does not cover the complete dose to inject, inject part of the dose with the insulin remaining and use a new pen for the rest of the dose (select.the missing dose).

When empty, the pen should be discarded.

It is not recommended to switch the patient from insulin type or brand (manufacturer).

The manufacturer is identified by a letter at the end of the code and the label: N = Novo Nordisk, S = Sanofi, L = Lilly.

Storage

  • Unopened pens: Keep refrigerated between 2ºC and 8ºC - Protect from sunlight
  • Pens in use Mixtard 30 InnoL® or Mixtard 30 FlexPen®may be kept for a maximum of 6 weeks not above 30ºC.
  • Do not freeze. Discard any pen that has been frozen.
  • Do not store the pen with a needle attached.

(Cf Introduction: Thermosensitive products)