CELLDEMIC 0.5 mL Injectable suspension
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Інструкція із застосування KELLDEMIK
Зміст інструкції
Celldemic injectable suspension in pre-filled syringe
Zoonotic 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 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, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Celldemic is and what it is used for
- 2. What you need to know before you receive Celldemic
- 3. How Celldemic is administered
- 4. Possible side effects
- 5. How to store Celldemic
- 6. Contents of the pack and other information
1. What is Celldemic and what is it used for
Celldemic is a vaccine to be used in adults and children aged 6 months and over,
intended to be administered in anticipation of or during outbreaks of zoonotic influenza viruses
(i.e., those that can be transmitted from animals to humans) with pandemic potential,
to prevent influenza caused by H5N1 viruses (“avian influenza”).
Zoonotic influenza viruses occasionally infect humans and can cause illness
ranging from mild upper respiratory tract infections (infection of the nose and throat) to influenza-like
illness with rapid progression to severe lung infection, acute respiratory distress
syndrome, shock and even death. Human infections are mainly caused by
contact with infected animals, but are not easily transmitted between people.
Celldemic is administered before or during an H5N1 outbreak with pandemic potential. It contains
certain parts of the H5N1 virus, which has previously been inactivated so as not to cause
disease. When a person receives the vaccine, the immune system recognizes the
parts of the virus present in the vaccine as “foreign” and produces antibodies against them. If the person comes into contact with the virus, these antibodies, together with other components of the immune system, are able to
kill the virus, thus helping to protect against the disease. None of the vaccine components can
cause influenza.
2. What you need to know before you receive Celldemic
You must not receive Celldemic
- 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 previously 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 treatment and medical supervision are readily available in the event of a rare anaphylactic reaction (a very severe allergic reaction, with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) after the administration of Celldemic.
- 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 compromised or if you are receiving treatment that affects your immune system, such as with cancer medicines (chemotherapy) or corticosteroids (see section “Other medicines and Celldemic”).
- 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 Celldemic 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 Celldemic
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines, including those available without a prescription, 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 Celldemic in women during breastfeeding. It is not expected that
Celldemic 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 use machines. Wait until these effects
have passed before driving and using machines.
Celldemiccontains 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 Celldemic is administered
The doctor or nurse will administer the vaccine in accordance with official recommendations.
Adults and children aged 6 months and over:
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, Celldemic can cause side effects, although not everybody gets them.
manifest.
Very serious side effects
Allergic reactions, which can be severe, may occur after vaccination. Inform your
doctor immediately 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 Celldemic include those listed below.
Adults aged 18 years and over
The following side effects have occurred with Celldemic 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
- Itchy skin
- 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
- Pain 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 Celldemic.
- 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 drop in blood pressure which, if left untreated, can lead to shock. Doctors are aware of this possibility and have emergency treatments available to use in such cases
- Neurological disorders such as severe, intense shooting or 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 reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Celldemic
Keep this vaccine out of the sight and reach of children.
Do not use Celldemic after the expiry date stated on the pack and label after Expiry. 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 Celldemic contains
- Active substance: The active ingredients of the vaccine are purified viral proteins (called hemagglutinin and neuraminidase).
One dose (0.5 mL) of the vaccine contains 7.5 micrograms of hemagglutinin from the strain of the influenza A/turkey/Turkey/1/2005 (H5N1) virus 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 paragraph 2 Celldemic contains sodium and potassium.
Description of the appearance of Celldemic and package contents
Celldemic 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
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.
-----------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
Appropriate medical treatment and supervision must always be readily available in the event of
a rare anaphylactic event after vaccine administration.
Shake gently before use. After shaking, Celldemic normally appears
as a milky white suspension.
Before administration, the vaccine must 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 KELLDEMIKЛікарська 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 потрібенЛікарська форма: Injectable suspension in pre-filled syringe, 0.5 MLДіюча речовина: influenza, inactivated, split virus or surface antigenВиробник: SEQIRUS NETHERLANDS B.V.Рецепт не потрібен
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Часті запитання
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Діюча речовина у KELLDEMIK — influenza, inactivated, split virus or surface antigen. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
KELLDEMIK 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 KELLDEMIK з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
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Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (influenza, inactivated, split virus or surface antigen) включають EFLUELDA TETRA, EFLUELDA, FLUAD TETRA. 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.
