USA

 Indication for use 

The Mallya®G Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors. 

 Device features 

MallyaG is able to :  • be assembled with Novo Nordisk® pen injector designed for growth disorder treatment,  • record the amount of dose increments injected by the pen,  • record the timestamp (date & time) of each injection,  • transmit information relating to dose, time, and date of each injection to a mobile app on a smartphone,  when the device is connected to it, using Bluetooth® technology. 

MallyaG compatibilities

Molecule Concentration Drug name in France
Somatropin 3,3 mg/mL Norditropin® FlexPro® 5 mg
6,7 mg/mL Norditropin® FlexPro® 10 mg
10 mg/mL Norditropin® FlexPro® 15 mg
Somapacitan 3,3 mg/mL Sogroya® 5 mg
6,7 mg/mL Sogroya® 10 mg
10 mg/mL Sogroya® 15 mg

Distributor

If you have any questions/complaints, please contact:

1-609-987-5800
adressemail@help.us

NOVO NORDISK USA
800 Scudders Mill Road
Plainsboro, NJ 08536

Mobile application




Coming soon.

Instruction
for use
Technical
note

FAQ

GENERAL
QUESTIONS

MallyaG® is a connected medical device compatible with the Novo Nordisk FlexPro® pens.

MallyaG® records information about the dose, time and date of each injection and transmits it via Bluetooth to a compatible mobile application.

MallyaG® records dose data and shares this data with partner applications.

MallyaG® enables complete and accurate data tracking for patients and sharing with their healthcare team, when this functionality is activated in partner applications.

MallyaG® enables you to manage your treatment by automatically collecting data and transferring this data to a mobile application.
MallyaG® is compatible with FlexPro® pens, and only with those. For a complete list of compatible pens, please refer to MallyaG® instructions for use (or find detailed information on www.my-mallya.com).

It is not possible today to use the same MallyaG® device on two or more connected devices. In other words, a MallyaG® can be used with only one smartphone. If you wish to use MallyaG® with another phone, you will need to reset it.

No, no medical authorization is required to use the MallyaG® device. However, it is recommended that you discuss with your doctor prior to using MallyaG®.
Once installed on your FlexPro® pen, MallyaG® does not interfere in any way with your usual way of performing an injection. MallyaG® can even guide you by indicating the end of your injection with a light signal. For more information, please refer to your FlexPro® pen and MallyaG® instructions for use.

TECHNICAL
QUESTIONS

You must first charge MallyaG® using the USB cable provided in the box. Once plugged in, check that the LED turns blue. Allow the battery to charge for at least ten minutes, then disconnect the USB cable and check that the LED is still blue. Then, you can assemble Mallya on your FlexPro® pen as described in Mallya instructions for use. You can now pair your MallyaG®
a to the partner smartphone application.
The battery is low. Plug in and leave to charge for about 2 hours for a full charge.

When you turn on MallyaG® for the first time, plug it to its USB cable and put on charge for at least 10 minutes. You can then pair your Mallya®G for use.

A full battery charge takes about 2 hours.
Yes, the LED lights in orange. You should connect MallyaG® with the supplied USB cable and leave it to charge for about 2 hours for optimal charging.
MallyaG® needs to be recharged every 2 weeks.
Two years.

MallyaG® must be assembled on the injection button of your pen. Carefully follow the instructions for use to attach it.

Hold MallyaG® by the transparent body part and align its notch with the FlexPro® pen dose window.

Insert Mallya®G on the FlexPro® pen and then Push Mallya®G with the palm of your hand until it is fully inserted on the pen.
Remember to activate MallyaG® after mounting or transferring it to a new FlexPro® pen
As per FlexPro® pen instructions for use, injection up to 2 increments will be pre-tagged as priming, waiting 2 minutes for a therapy dose to be delivered. If the therapy dose is delivered within 2 minutes, the “check of flow” tag is assigned, if not the dose is recorded as therapy dose.

If you are not certain that you injected your drug, do not repeat your injection.

Monitor your treatment as instructed by your doctor.

MallyaG® dose recording accuracy is 99% ±1 increment which means that you may experience occasional increment variations between the injected dose and the recorded dose.
No. For practical reasons, it is better to leave MallyaG® mounted on your pen.
Yes, you can. Please follow the instructions for use of your pen for appropriate storage conditions.

Make sure MallyaG® is unplugged and not connected to the USB charging cable.

Wipe the external surfaces with a slightly damp lint-free cloth, being careful not to get the micro-USB port wet. If needed, a small amount of neutral detergent may be used. Dry surfaces with a soft cloth.

MallyaG® is not waterproof, never wet the micro-USB port.

Yes, you can.

No, it can’t.
If the device experiences an external mechanical impact (knocking, bumping, dropping, etc.) or excessive stress, this may cause malfunctioning of the device. In case of malfunctioning, do not use the device and continue your injection pen treatment. Please contact Novo Nordisk call center as identified in the instructions for use for technical support.
MallyaG® must be used and stored between +2°C and +35°C.

SECURITY
AND CONFIDENTIALITY

MallyaG® incorporates appropriate technical security measures to maintain the security and confidentiality of the collected data stored in the internal memory of the MallyaG® device and to prevent it from being distorted, damaged, disclosed and accessed by unauthorized third parties.
For data retrieved by authorized third parties app, please refer to application.
Only you have access to this data and can possibly decide to share it with a third party, be it a relative or a health professional; this functionality will depend on the partner smartphone application.

MallyaG® stores the last 100 injections (including check of flow).

All data collected in MallyaG® internal memory is erased by resetting it.

MOBILE APPLICATION

A list of compatible apps is available on Mallya®G website:
https://www.my-mallya.com/us/growth-disorder. 
Pairing a Mallya®G is done from the app, not from the phone Bluetooth settings. After downloading the app, simply activate Bluetooth on your phone, and pair the Mallya®G with your smartphone following the app instructions to pair.

As soon as Mallya®G is in the vicinity of your phone, the data will be fed back into the app, if it is properly launched and Bluetooth is enabled on your smartphone.

You don’t have to have your phone along when you inject, the synchronization can happen later and automatically.

You do not have to be connected to the application when you make an injection. Mallya®G records the data without being logged in. When you want to upload the data back to the app, you don’t have to do anything, just put the Mallya®G device close to your smartphone: if Bluetooth is enabled on your phone, and your app is launched, synchronization will happen.
You cannot use several applications at the same time. During the pairing phase, a secure connection is created between Mallya®G and the application, preventing it from pairing with another application for data security (personal and health) reasons. If you wish to pair Mallya with another application, you will need to reset it.
You can pair Mallya®G with the App when the phone is not connected to the Internet, simply activate Bluetooth.
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