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Nepipe Junior

Package leaflet: Information for the user


Nepipe Junior 150 micrograms, solution for injection in pre-filled pen


Adrenaline


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What is in this leaflet

1. What Nepipe Junior is and what it is used for

2. What you need to know before you use Nepipe Junior

3. How to use Nepipe Junior

4. Possible side effects

How to store Nepipe Junior

6. Contents of the pack and other information


What Nepipe Junior is and what it is used for


Nepipe Junior is a sterile solution in pre-filled pen for emergency injection into the muscle (intramuscular).


Nepipe Junior is to be used for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens in e.g.foods, drugs, insect stings or bites as well as triggered by exercise or by unknown causes.


Nepipe Junior Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.


Symptoms that signal the onset of an anaphylactic reaction include: itching of the skin; raised rash (like a nettle rash); flushing; swelling of the lips, throat, tongue, hands and feet; wheezing; hoarseness; nausea; vomiting; abdominal cramps and in some cases, loss of consciousness.


The medicine in the Auto-Injector (the pen) is adrenaline which is an adrenergic drug.


It works directly on the cardiovascular (heart and circulation) system and respiratory (lung) system, countering the potentially fatal effects of anaphylaxis by rapidly constricting the blood vessels, relaxing muscles in the lungs to improve breathing, reducing swelling and stimulating heartbeat.


What you need to know before you use Nepipe Junior


Do Not Use Nepipe Junior

There is no known reason why anyone should not use Nepipe Junior during an allergic emergency.


Warnings and precautions

If you have asthma you may be at increased risk of severe allergic reaction.


Anyone who has an episode of anaphylaxis should see their doctor about testing for substances they may be allergic to, so these can be strictly avoided in future. It is important to be aware that an allergy to one substance can lead to allergies to a number of related substances.


If you have food allergies it is important to check the ingredients in everything you ingest (including medicines) as even small amounts can cause severe reactions.


Tell your doctor if you have


Despite these concerns, adrenaline is essential for the treatment of anaphylaxis. Patients with these conditions, or anyone who may be in the position to give Nepipe Junior to a patient experiencing an allergic reaction, should be properly instructed as to the situations in which it should be given.


The instructions for use must be carefully followed in order to avoid accidental injection.


Nepipe Junior should only be injected into the outer thigh. It should not be injected into the buttock due to the risk of accidental injection into a vein.


Warnings: Accidental injection into the hands or fingers may result in loss of blood supply to the affected area. If there is an accidental injection into these areas, you should go immediately to the nearest hospital casualty department for treatment.


Children and adolescents

Children below 15 kg in weight:

The suitability of Nepipe Junior has to be judged individually by the doctor.

The use in children weighing less than 7.5 kg is not recommended unless in a life-threatening situation and under medical advice.


Children and adolescents over 30 kg in weight:

For these patients Nepipe 300 micrograms, Auto-Injector containing 300 micrograms adrenaline per dose is available.


Other medicines and Nepipe Junior

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


This is especially important if you take any of the following:


Diabetic patients should carefully monitor their glucose levels after use of Nepipe Junior as adrenaline can affect the amount of insulin made by the body, thus increasing the blood glucose level.


Nepipe Junior with food, drink and alcohol

Food or drink has no influence on the use of Nepipe Junior.

Tell your doctor if you are taking alcohol since the effect of adrenaline can be increased.


Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In an acute life threatening situation, do not hesitate to use Nepipe Junior, since your and your child’s lives may be in danger. There is limited experience of the use of adrenaline during pregnancy.


Breast-feeding

Nepipe Junior would not be expected to have any effect on the nursing infant.


Driving and using machines

Not relevant.


Nepipe Junior contains sodium metabisulfite (E223) and sodium chloride.

Sodium metabisulfite may rarely cause severe allergic reactions or breathing difficulty (bronchospasm).


This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.


How to use Nepipe Junior


When your doctor prescribes Nepipe Junior, you must make sure you understand the reason it has been prescribed for you. You should be confident that you know exactly how to use the device. Always use this medicine exactly as your doctor or pharmacist has told you. If you are at all unsure about how to use it, ask to have the instructions repeated by your doctor, nurse or pharmacist.


It is recommended that your family members, carers or teachers are also instructed in the correct use of Nepipe Junior.

For training and demonstration purposes, a Nepipe Junior training device (without drug, without needle) is available. The training device and the active Nepipe Junior Auto-Injector should not be routinely carried together in order to avoid confusion in an emergency situation.


Nepipe Junior is intended to be used by children with a body weight between 15 - 30 kg.


For adults, adolescents, and children with a body weight of more than 30 kg NepipeAuto-Injector containing 300 micrograms adrenaline per dose is available.

For children weighing less than 15 kg see section “Children and adolescents” above.


Dosage

The dose will be decided by your doctor, who will adjust it individually for you. The usual paediatric

(15 - 30 kg) dose for allergic emergencies is 150 micrograms adrenaline for intramuscular use.


If you detect signs of an acute allergic reaction, use Nepipe Junior immediately.


Each Nepipe Junior Auto-Injector delivers one single dose of 0.3 ml liquid which is equal to 150 micrograms adrenaline. After use a small volume will remain in the Auto-Injector but this cannot be reused.


Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a serious allergic reaction. For this reason, your doctor is likely to prescribe more than one Nepipe Junior for you. If your symptoms have not improved or have deteriorated within 5-15 minutes after the first injection, either you or the person with you should give a second injection. For this reason you should carry more than one Nepipe Junior with you at all times.


-How Nepipe Junior is given

The Nepipe Junior is designed to be used easily by people without medical training. Nepipe Junior should simply be jabbed firmly against the outer portion of the thigh from a distance of approximately 10 cm. There is no need for precise placement in the outer portion of the thigh. When you jab the Nepipe Junior firmly into your thigh, a spring activated plunger will be released, which pushes the hidden needle into the thigh muscle and administers a dose of adrenaline. If you are wearing clothes the Nepipe Junior can be injected through the clothes.


The instructions for use of the Nepipe Junior must be carefully followed.


Nepipe Junior should ONLY be injected into the outer thigh. It should not be injected into the buttock.


Directions for use

Fully familiarise yourself with the Nepipe Junior, when and how it should be used.



Blue Safety Cap Orange tip

Viewing window


Follow these directions only when ready to use.


Hold the Auto-Injector by the middle, never by the ends. For proper administration, look at the diagrams and follow these steps:


- Never put thumb, fingers or hand over the orange tip. Never press or push the orange tip with thumb, fingers or hand.

- The needle comes out of orange tip.

- Do NOT remove blue safety cap until ready to use.


1 . Grasp Nepipe Junior in dominant hand (the hand you use to write), with thumb nearest blue cap and form fist around unit (orange tip down).


2. With other hand pull off blue safety cap


3 . Hold the Nepipe Junior in a distance of approximately 10 cm away from the outer thigh. The orange tip should point towards the outer thigh.


4 . Jab the Nepipe Junior firmly into outer thigh at a right angle (90 degree angle) (listen for click).


5. Hold firmly against thigh for 10 seconds. The injection is now complete and the viewing window on the Auto-Injector is obscured.


6 . Nepipe Junior should be removed (the orange needle cover will extend to cover needle) and safely discarded.



Massage the injection area for 10 seconds. Dial 112, ask for ambulance, state anaphylaxis.


A small bubble may be present in the Nepipe Junior Auto-Injector. It has no influence on the product’s effectiveness.

Even though most of the liquid (about 90%) remains in the Nepipe Junior after use, it cannot be reused. However, you have received the correct dose of the medication if the orange needle tip is extended and the viewing window is obscured. Discard Nepipe Junior safely after use in the tube provided and bring it with you when you visit your doctor, hospital or pharmacy.


As the Nepipe Junior is designed as emergency treatment. You should always get medical help immediately after using Nepipe Junior. Dial 112, ask for ambulanceand state “anaphylaxis”even if symptoms appear to be improving. You will need to go to hospital for observation and further treatment as required. This is because the reaction may happen again at some time later.

While waiting for the ambulance you should lie down with your feet raised unless this makes you breathless in which case you should sit up. Ask someone to stay with you until the ambulance arrives in case you feel unwell again.

Unconscious patients should be placed on their side in the recovery position.


If you use more Nepipe Junior than you should

In case of overdose or accidental injection of the adrenaline, you should always seek immediate medical help.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Usual side effects include (frequency not known: frequency cannot be estimated from the available data):


Irregular heartbeat, high blood pressure, sweating, nausea, vomiting, headache, dizziness, weakness, tremor and nervousness or anxiety.


Allergic reactions can appear in patients sensitized to sodium metabisulfite. In rare cases (may affect up to 1 in 1,000 people) cardiomyopathy has been seen in patients treated with adrenaline.


Accidental injection of the pens in hands or feet have been reported and may result in loss of blood supply to the affected area In case of accidental injection always seek immediate medical help.


Reporting of side effects

If you get any side effects, talk to your doctor.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via <[the national reporting system listed in Appendix V*] / [to be completed nationally]>. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Nepipe Junior


Keep this medicine out of the sight and reach of children.


Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.


Do not store above 25C. Do not refrigerate or freeze.


Keep the container in the outer carton in order to protect from light. When exposed to air or light, adrenaline deteriorates rapidly and will become pink or brown. Please remember to check the contents of the glass cartridge in the Nepipe Junior Auto-Injector from time to time to make sure the liquid is still clear and colourless. Replace the Auto-Injector by the expiry date or earlier if the solution is discoloured or contains a precipitate (solid matter).


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Nepipe Junior contains


The active substance is adrenaline. Each dose contains 150 micrograms adrenaline.


The other ingredients are:

Sodium Chloride

Sodium Metabisulfite (E223)

Hydrochloric Acid

Water for Injections.


What Nepipe Junior looks like and contents of the pack


Clear and colourless solution in a pre-filled pen (Auto-Injector).

The Auto-Injector contains 2 ml solution for injection. Each Auto-Injector delivers one single dose (0.3 ml) of 0.15 mg adrenaline.

Exposed and protected needle length approx. 13 mm


Pack sizes:

1 Auto-Injector.

2 x 1 Auto-Injector.


Not all pack sizes may be marketed.


Marketing Authorisation Holder

[To be completed nationally]


Manufacturer

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

D-61352 Bad Homburg

Germany


This medicinal product is authorised in the Member States of the EEA under the following names:


Name of Member State

Name of medicinal product

Bulgaria,

Епипен 150 микрограма инжекционен разтвор в предварително напълнена писалка

Greece

EpiPen Jr.

Estonia,

Epipen

Italy

Fastjekt

France

EPIPEN 0,15 mg/ 0,3 ml, solution injectable en stylo pré-rempli

Romania

EpiPen 150 micrograme solutje injectabila in stilou preumplut

Ireland

EpiPen Junior 150 micrograms, Solution for injection in pre-filled pen

Lithuania

Epipen 150 mikrogramų injekcinis tirpalas užpildytame švirkštiklyje

Latvia

Epipen 150 mikrogrami šķīdums injekcijām pildspalvveida pilnšļircē

Portugal

Epipen 150 microgramas, solução injetável em seringa pré-cheia

Slovenia

Epipen za otroke 150 mikrogramov/ 0,3 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku

Sweden

Nepipe Junior 150 mikrogram injektionsvätska, lösning i förfylld injektionspenna

This leaflet was last revised in 2016-09-07.

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