Indications For Use; Product Description - ConvaTec Neria guard Gebrauchsanweisung

E N G L I S H ( e n)

Indications for use:

The product is indicated for subcutaneous infusion of
medication administered by an external pump.
INTENDED USE
The product is intended for the subcutaneous infusion
of immunoglobulins for the treatment of primary
immune deficiency, apomorphine and foslevodopa/
foscarbidopa for parkinson's disease, morphine
(hydromorphone, morphine sulfate and morphine
chloride) for pain management therapy, saline for
dehydration and deferoxamine
thalassemia. The product has been tested to be
compatible with the above-mentioned drugs approved
for subcutaneous infusion. Clinical
supports infusion set use from age 2 years and up.

PRODUCT DESCRIPTION

The product (drawing 1a, 1b, 1c, page 12) consists of
a cannula housing (H) with a 90-degree soft cannula
(I) and a tubing (J) with a standard pump connector
(luer-lock) (L) combined with an integrated insertion
device (A). The product is delivered ready for use as
a sterile unit.
CONTRAINDICATIONS
The product is neither intended nor indicated for in-
travenous (I.V.) infusion of medication, including
blood and blood products.
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CLINICAL BENEFITS
Continuous subcutaneous infusion to mimic
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stimulation of receptors (Parkinson), serum IG
range (Immunodeficiency),
treatment
dehydration, and pain relief (Pain Management).
Less invasive administration route associated
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with fewer adverse events and more locations to
infuse compared to the intravascular route.
Less injections (insertions) compared to injection
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therapy.
WARNINGS
mesylate for
Carefully examine the instructions for use
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before inserting the product. Failure to follow
evaluation
instructions may result in pain or injury.
Do not use the product if the box and/or
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blister pack are already opened or damaged.
Make sure that the safeguard (B) on top of the
insertion device (A) has not been removed. If
this occurs please use a new product.
Do not reposition the product as this may
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compromise the adhesion of the adhesive
tape (E).
If blood is seen in the cannula housing (H)
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and/or tubing (J), change to a new product
and a new site.
If the adhesive tape (E) becomes loose,
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change to a new product and a new site.
The product integrity may be compromised if
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exposed to solvents containing substances,
iron chelation
(Thalassemia), prevent or treat
e.g. disinfectants, perfumes and deodorants
and/or cosmetics and skincare products.
Do not reuse the infusion set.
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fusion set may cause infection, site irritation, or
damage to the cannula/needle. A damaged can-
nula/needle may lead to inaccurate medication
delivery.
Never attempt to repair a clogged tubing (J)
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while the product is connected to the body.
An uncontrolled quantity of medication may
accidentally be infused. If clogged, change
to at new product and a new site.
Choice of product and insertion site is close-
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ly linked and should always be done by a
healthcare professional.
Never point the insertion device towards any
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body part where insertion is not desired.
PRECAUTIONS
When using the product for the first time, do so in
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the presence of a healthcare professional.
The product is a single use item which must be
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disposed of after use. Do not clean or re-sterilize.
Wash hands with soap and water when tempora-
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rily disconnecting the product. Seal the cannula
housing (H) and site connector (K) with the covers
(B and M) provided. Consult with a healthcare
professional on how to compensate for missed
medication when disconnected, and for how long
the product can be disconnected from the pump.
Do not leave air in the tubing (J) when priming.
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Reuse of the in-