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przed pierwszym użyciem

3

before the first use

Before the first use of MEGAPTH Pen pen injector carefully read ALL instructions included in this user's manual. 

MEGAPTH Pen

 is a reusable, intuitive automatic teriparatide injector. It provides you or your child with a precise, safe 

and  effortless way to administer teriparatide doses recommended by the doctor, in the range from 

2,5

 to 20 

micrograms (

mcg

), with incremental dose of 

2,5

 mcg.

 MEGAPTH Pen is recommended for use exclusively with teriparatide 3.0 ml cartridges according to ISO 11608-3.

Use 

MEGAPTH Pen

 only in doses recommended by your doctor.

MEGAPTH Pen

 is recommended for use with disposable needles: BD Micro-Fine 0.25mm x 5mm, BD Micro-Fine 0.23mm x 

4mm and BD Micro-Fine 0.25mm x 8mm according to ISO11608-2

Use a new needle for each injection to ensure sterility, prevent infections or leakage of teriparatide and reduce the risk of 

needle clogging.

MEGAPTH Pen

 is intended for use by one person only and should not be shared with others.

Do not use 

MEGAPTH Pen

, if it is not working properly, or any of its parts look damaged.

Using 

MEGAPTH Pen

 without teriparatide cartridge may cause defective operation.

MEGAPTH Pen

 is not recommended for self-administration of teriparatide by people who are blind, visually impaired, 

with severely limited motor skills or children without the assistance of a third party, trained in its use.

Содержание MEGAPTH Pen

Страница 1: ...REUSABLE TERIPARATIDE PEN INJECTOR 0 1 9 7 MEGAPTH Pen USER S MANUAL MEGAPTH Pen...

Страница 2: ...of pen injector pen needle and cartridge installation of cartridge and pen needle priming your MEGAPTH Pen injecting a dose removing a needle replacing a cartridge replacing a needle storage and clean...

Страница 3: ...PTH Pen is recommended for use with disposable needles BD Micro Fine 0 25mm x 5mm BD Micro Fine 0 23mm x 4mm and BD Micro Fine 0 25mm x 8mm according to ISO11608 2 Use a new needle for each injection...

Страница 4: ...r selector window release button p dose selector pen needle teriparatide cartridge rubber cartridge tip outer needle shield paper tab metalic cartridge cap cartridge plunger 2 window displaying the en...

Страница 5: ...items 3 installation of cartridge and pen needle Step 1 Pull off the cap Step 2 Unscrew the cartridge holder from the pen body by turning it according to the direction shown on the drawing MEGAPTH Pen...

Страница 6: ...Make sure that it is not cracked or broken the teriparatide solution is clear and transparent and check the medicine expiration date Do not use the teriparatide after the medicine expiration date Wip...

Страница 7: ...needle Step 6 Step 5 Insert teriparatide cartridge into the cartridge holder metallic tip to the front Attach the cartridge holder to the pen body by turning it according to direction shown on the dr...

Страница 8: ...needle with a damaged unit pack paper cover is not in line with epidemiological recommendations Step 8 Take a new sterile needle and remove the paper tab from the outer needle shield Hold the pen inj...

Страница 9: ...ce removed If by accident you puncture your skin clean the wounded spot with a skin disinfectant 3 installation of cartridge and pen needle Step 9 Step 10 Remove the outer needle shield Retain it for...

Страница 10: ...e direction shown on the drawing 2 Turn the dose selector until figure 5 appears in the dose selector window Step 12 Hold the pen with the needle pointing upwards Using your thumb slide the release bu...

Страница 11: ...the direction shown on the drawing until the desired figure corresponding to the number of teriparatide mcg appears in the dose selector window Make sure that dose selector window shows the correct n...

Страница 12: ...ons described in steps 7 to 10 Perform the priming dose injection Next complete the interrupted dose delivery by turning the dose selector according to the direction shown on the drawing until the fig...

Страница 13: ...ach of children Step 16 Step 17 Remove the needle from the skin at the same angle it was inserted into subcutaneous tissue After the injection put the outer needle shield on the needle Holding the car...

Страница 14: ...ridge holder from the pen body by turning it according to the direction shown on the drawing Shake the empty cartridge and remove it in accordance with information provided by the manufacturer of teri...

Страница 15: ...e refrigerated at 2 C to 8 C MEGAPTH Pen without the teriparatide cartridge can be stored at 40 C to 70 C Keep the pen injector far from extreme temperatures humidity dust and direct sun exposure MEGA...

Страница 16: ...nnot attach the cartridge holder onto the pen body Check if the cartridge was properly insert into the cartridge holder metallic cap first Pushed out plunger Problem Possible cause HOW TO ELIMINATE Us...

Страница 17: ...aying the end of injection There was not enough teriparatide in the cartridge to inject the full set dose HOW TO ELIMINATE Note the number of units remaining as it corresponds to the number of mcg of...

Страница 18: ...intended for use with disposable needles BD Micro Fine 0 25mm x 5mm BD Micro Fine 0 23mm x 4mm and BD Micro Fine 0 25mm x 8mm MEGAPTH Pen should be replaced after 2 years in use when decided by your d...

Страница 19: ...cessary when operating the device or control close to where the symbol is placed or that the current situation needs operators awareness or operator action in order to avoid undesirable consequences I...

Страница 20: ...notes...

Страница 21: ...disposal of pen injector Remember to dispose Your pen injector 2 years after first use Below note the date of first and last use of MEGAPTH Pen 1st use on Throw away after _ _ _ _...

Страница 22: ...N INJECTOR Read the instructions carefully before using MEGAPTH Pen Failure to follow of these instruc tions may have serious consequences to your health Using the device in a different way from the p...

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