INCELLIPAN 0.5 mL Injectable suspension
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Інструкція із застосування INKELLIPAN
Зміст інструкції
Incellipan injectable suspension in pre-filled syringe
Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in
cell cultures)
This medicinal product is subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.
Read this leaflet carefully before receiving this vaccine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Incellipan is and what it is used for
- 2. What you need to know before you receive Incellipan
- 3. How Incellipan is administered
- 4. Possible side effects
- 5. How to store Incellipan
- 6. Contents of the pack and other information
1. What is Incellipan and what is it used for
Incellipan is a vaccine intended to be administered to prevent influenza in an officially declared pandemic.
A pandemic influenza is a type of influenza that occurs at intervals ranging from less than 10 years
to many decades. It spreads rapidly throughout the world. The signs of pandemic influenza are similar to
those of common influenza, but may be more severe.
It is used to prevent influenza caused by the H5N1 type of the virus.
When a person receives the vaccine, the body's natural defense system (immune system)
produces its own protection (antibodies) against the disease. None of the components of the
vaccine can cause influenza.
2. What you need to know before you receive Incellipan
You must not receive Incellipan
- if you are allergic
- to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
- to beta-propiolactone, polysorbate 80 or cetyltrimethylammonium bromide (CTAB), which are trace residues from the manufacturing process;
- if you have had a severe allergic reaction (e.g. anaphylaxis) to a previous influenza vaccination
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive this vaccine.
BEFORE you receive this vaccine
- The doctor or nurse will ensure that appropriate medical treatment and supervision are readily available in the event of a rare anaphylactic reaction (a very serious allergic reaction, with symptoms such as difficulty breathing, dizziness, weak and rapid pulse and skin rash) after the administration of Incellipan.
- Tell your doctor or nurse if you feel nervous about the vaccination procedure or if you have fainted in the past after an injection.
- Tell your doctor or nurse if you have an acute illness including fever among the symptoms. Your doctor may decide to postpone vaccination until the fever has gone. However, you can receive the vaccination in the presence of mild fever or an upper respiratory tract infection such as a cold.
- Tell your doctor or nurse if you have bleeding problems, if you bruise easily or if you are taking a medicine to prevent blood clots.
- You must inform your doctor or nurse if your immune system is impaired or if you are receiving treatment that affects your immune system, for example with cancer medicines (chemotherapy) or corticosteroids (see section “Other medicines and Incellipan”).
- The doctor must inform you about the possibility of seizures, especially if you have had episodes of epilepsy in the past.
As with all vaccines, it is possible that Incellipan may not fully protect all vaccinated people
vaccinated.
Children under 6 months of age
The vaccine is not currently recommended in children under 6 months of age, as safety and
efficacy have not been established in this age group.
Other medicines and Incellipan
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines, or if you have recently
received any other vaccine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding
ask your doctor or nurse for advice before receiving this vaccine. The doctor must
assess the benefits and potential risks of administering the vaccine in your case.
There is no experience with the use of Incellipan in breastfeeding women. It is not expected that
Incellipan will pass into breast milk and therefore no effects on infants are anticipated.
Driving and using machines
Some of the effects of vaccination reported in section 4 (Possible side effects) may
temporarily affect your ability to drive and operate machinery. Wait until these effects
have passed before driving and operating machinery.
Incellipan contains sodium and potassium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium
free’.
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium
free’.
3. How Incellipan is administered
The doctor or nurse will administer the vaccine in accordance with official recommendations.
Adults and children 6 months of age and older:
A dose (0.5 mL) of the vaccine will be injected into the upper arm (deltoid muscle) or
into the upper thigh, depending on age and muscle mass.
A second dose of vaccine must be administered after an interval of at least 3 weeks.
4. Possible side effects
Like all medicines, Incellipan can cause side effects, although not everybody gets them.
manifest.
Very serious side effects
Allergic reactions, which can be severe, may occur after vaccination. Immediately inform your
doctor or go to the nearest hospital emergency room if you experience any of the following signs or
symptoms of an allergic reaction:
- difficulty breathing
- dizziness
- weak and rapid pulse
- skin rash
If these symptoms occur, urgent medical attention or hospitalisation may be necessary.
Other side effects
Other side effects that may occur with Incellipan include those listed below.
Adults aged 18 years and over
The following side effects have occurred with Incellipan in clinical studies in adults, including the
elderly:
Very common (may affect more than 1 in 10 people):
- Pain at the injection site
- Muscle pain (myalgia)
- Joint pain (arthralgia)
- Headache
- Fatigue
- General feeling of being unwell (malaise)
Common (may affect up to 1 in 10 people):
- Feeling sick (nausea)
- Loss of appetite
- Chills
- Bruising at the injection site
- Hardening of the skin at the injection site (induration)
- Fever Uncommon (may affect up to 1 in 100 people):
- Swollen lymph nodes (lymphadenopathy)
- Dizziness
- Diarrhoea
- Vomiting
- Skin rash
- Itching
- Redness at the injection site (erythema)
- Bleeding at the injection site (haemorrhage)
Elderly subjects aged 65 years and over have generally reported a lower number of
reactions compared to younger adults.
Children from 6 months to less than 18 years of age
The following side effects have been reported in a clinical study with children from 6 months to less
than 18 years of age.
From 6 months to less than 6 years of age
Very common
- Decreased appetite
- Painfulness at the injection site
- Sleepiness
- Irritability
- Fever
Common
- Redness at the injection site (erythema)
- Hardening of the skin at the injection site (induration)
- Vomiting
- Diarrhoea
From 6 to less than 18 years of age
Very common
- Headache
- Nausea
- Decreased appetite
- Muscle pain (myalgia)
- Joint pain (arthralgia)
- Pain at the injection site
- Fatigue
- General feeling of being unwell (malaise)
Common
- Redness at the injection site (erythema)
- Hardening of the skin at the injection site (induration)
- Fever
- Vomiting
- Diarrhoea
The following additional side effects have been reported with the use of seasonal influenza vaccines
in general and with a pandemic vaccine similar to Incellipan.
- Temporary low number of platelets which may lead to bleeding or bruising (transient thrombocytopenia)
- Allergic reactions possibly with wheezing, whistling breath, swelling of the throat or causing a dangerous decrease in blood pressure which, without
treatment, can lead to shock. Doctors are aware of this possibility and have
emergency treatments available to use in such cases
- Neurological disorders such as intense, throbbing pain along one or more nerves (neuralgia), tingling (paresthesia), inflammation of the nerves (neuritis), seizures (convulsions), inflammation of the central nervous system (encephalomyelitis), a type of paralysis (Guillain-Barré syndrome), fainting (syncope) or feeling faint (presyncope), drowsiness
- Irregular or strong heartbeat (palpitations), faster than normal heartbeat (tachycardia)
- Inflammation of blood vessels that can cause skin rashes, joint pain and kidney problems (vasculitis)
- Widespread skin reactions, including hives, unspecified rash, abnormal swelling of the skin, usually affecting the area around the eyes, lips, tongue, hands or feet, due to an allergic reaction (angioedema)
- Extensive swelling of the vaccinated limb
- Cough
- Pain in the limbs, muscle weakness
- Abdominal pain
- General weakness (asthenia)
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system detailed in
Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Incellipan
Keep this vaccine out of the sight and reach of children.
Do not use Incellipan after the expiry date stated on the pack and label after Exp. The
expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Discard the vaccine if it has been frozen.
Keep the pre-filled syringe in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Incellipan Contains
- Active ingredient: The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase) prepared from the influenza virus strain in accordance with the recommendations of the World Health Organization and the EU decision in an officially declared pandemic situation.
One dose (0.5 mL) of the vaccine contains 7.5 micrograms of haemagglutinin from the influenza A/turkey/Turkey/1/2005 (H5N1) strain propagated in Madin Darby canine kidney cells (MDCK) (this is the special cell culture in which the influenza virus is grown).
Adjuvant: MF59C.1 is contained in this vaccine as an adjuvant. Adjuvants are substances
contained in some vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.
MF59C.1 is an adjuvant that contains squalene, polysorbate 80, sorbitan trioleate, sodium citrate and citric
acid.
- Other components: The other components are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, dipotassium hydrogen phosphate and water for injections, see section 2 Incellipan contains sodium and potassium.
Description of the Appearance of Incellipan and Contents of the Pack
Incellipan is a milky white suspension
It is supplied in a ready-to-use syringe containing a single dose (0.5 mL) for injection, in a
pack of 10 pre-filled syringes equipped with a Luer-Lock system. Needles are not included.
Marketing Authorisation Holder and Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105BJ Amsterdam
Netherlands
A marketing authorisation has been granted to Incellipan “subject to conditions”. This means that additional data on this medicinal product must
be provided.
The European Medicines Agency will review the new information on this annually at least.
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.
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The following information is intended exclusively for healthcare professionals:
Appropriate treatment and medical supervision must always be readily available in the event of
a rare anaphylactic event following vaccine administration.
Shake gently before use. After shaking, Incellipan normally appears
as a milky white suspension.
Before administration, the vaccine should be visually inspected for the presence of
particulate matter and colour change. If foreign particles and/or a change in
physical appearance are observed, do not administer the vaccine.
To use the pre-filled syringe without a needle equipped with a Luer-Lock system, remove the
tip cap by unscrewing it counterclockwise. Once the tip cap is removed, attach the needle
to the syringe by screwing it clockwise until it locks. Use a sterile needle of appropriate size
for intramuscular injection. Once the needle is locked in place, remove the
needle protection and administer the vaccine.
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- Країна реєстрації
- Лікарська формаInjectable suspension, 0.5 mL
- Код АТХJ07BB02
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до INKELLIPANЛікарська форма: Injectable suspension, 0.5 mLДіюча речовина: influenza, inactivated, split virus or surface antigenВиробник: SEQIRUS NETHERLANDS B.V.Рецепт не потрібенЛікарська форма: Injectable suspension in pre-filled syringe, 60 Microgrammi/HaДіюча речовина: influenza, inactivated, split virus or surface antigenВиробник: SANOFI WINTHROP INDUSTRIEРецепт не потрібенЛікарська форма: Injectable suspension in pre-filled syringe, 60 MICROGRAMSДіюча речовина: influenza, inactivated, split virus or surface antigenВиробник: SANOFI WINTHROP INDUSTRIEРецепт не потрібен
Аналоги INKELLIPAN в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог INKELLIPAN у Іспанія
Аналог INKELLIPAN у Польща
Аналог INKELLIPAN у Україна
Лікарі онлайн щодо INKELLIPAN
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
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Заповніть форму за 2 хвилини
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Лікар розглядає ваш випадок
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Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
INKELLIPAN не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у INKELLIPAN — influenza, inactivated, split virus or surface antigen. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
INKELLIPAN виробляється компанією SEQIRUS NETHERLANDS B.V.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування INKELLIPAN з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати INKELLIPAN у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (influenza, inactivated, split virus or surface antigen) включають KELLDEMIK, EFLUELDA TETRA, EFLUELDA. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
