DIFTETALL 0,5 ML Injectable suspension in pre-filled syringe
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Інструкція із застосування DIFTETALL
Зміст інструкції
DIFTETALL injectable suspension
Diphtheria and tetanus vaccine, adsorbed (with reduced antigen content)
Read this leaflet carefully before using this medicine 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.
- This medicine can only be prescribed and administered by a doctor and has been prescribed only for you or your child. Do not give it to other people, even if they have the same symptoms as you, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.
Contents of this leaflet:
- 1. What DIFTETALL is and what it is used for
- 2. What you need to know before you use DIFTETALL
- 3. How to use DIFTETALL
- 4. Possible side effects
- 5. How to store DIFTETALL
- 6. Contents of the pack and other information
1. What is DIFTETALL and what is it used for
DIFTETALL is a vaccine used in people from 7 years of age to prevent diphtheria
and tetanus.
Diphtheria is a contagious disease that mainly affects the respiratory system
causing inflammation of the nose, throat and airways and which can eventually
cause suffocation. The bacterium that causes diphtheria also releases a toxin that can
enter the bloodstream and affect the heart and kidneys. Without treatment, diphtheria can lead
to death.
Tetanus is a disease caused by a bacterium that enters the body through a wound
on the skin, such as a cut or burn. The bacterium that causes tetanus releases a toxin
that affects the nervous system causing stiffness and muscle spasm of the jaw, of the
back, chest and abdominal muscles. Without treatment, tetanus can lead to death.
DIFTETALL works by stimulating the immune system (the body's natural defense
system) to produce its protection (antibodies) against the disease. None of the
components of this vaccine can cause tetanus or diphtheria.
2. What you need to know before using DIFTETALL
To make sure that DIFTETALL is suitable for you or your child, it is important to inform your
doctor or pharmacist if any of the following apply to you or your child. If there is
anything you do not understand, ask your doctor or pharmacist for clarification.
Do not use DIFTETALL if you or your child:
- are allergic (hypersensitive) to diphtheria and tetanus anatoxins, to any of the ingredients of DIFTETALL or to formaldehyde (see section 6 “Further information”).
- have a disease with high fever or an acute infection. In this case, vaccination should be postponed until you or your child have recovered.
- have had an allergic (hypersensitive) reaction or a neurological reaction (brain or nervous system) to a previous vaccination.
Warnings and precautions
- As with all vaccines, DIFTETALL may not fully protect all people who have been vaccinated.
- Tell your doctor if you or your child are undergoing medical treatment that weakens the immune system; this type of medical treatment may lower your immune response. Your doctor may decide to postpone vaccination until treatment is completed.
- Fainting, feeling faint, or other reactions related to this type of stress (especially in adolescents) may occur following, or even before any injection with a needle. Therefore, inform your doctor or nurse if you or your child have previously fainted during an injection.
- Latex-sensitive individuals:
- Prefilled syringe with fixed needle: the needle cap contains latex. It may cause serious allergic reactions. If you are allergic to latex, talk to your doctor before receiving DIFTETALL.
- Prefilled syringe without fixed needle: although natural rubber latex has not been detected in the syringe tip stopper, the safety of using DIFTETALL in individuals sensitive to latex has not been established. Tell your doctor if you have ever had an allergic reaction to latex.
Other medicines or vaccines and DIFTETALL
Tell your doctor or pharmacist if you or your child are taking or have recently
taken any other vaccines or medicines, including those purchased without a prescription.
If you or your child have a weakened immune system or are undergoing medical
treatment that weakens the immune system (such as corticosteroids, cytotoxic drugs or
radiotherapy) you may not have an adequate immune response.
Pregnancy, breastfeeding and fertility
Tell your doctor if you are pregnant and if your child is breastfeeding.
Your doctor will decide whether vaccination with DIFTETALL can be carried out during pregnancy or
breastfeeding.
Driving and using machines
No studies have been conducted on the ability to drive vehicles and operate machinery, therefore
be careful if you need to drive vehicles and operate machinery after vaccination.
DIFTETALL contains
1 dose of DIFTETALL (0.5 ml) contains less than 4.25 mg of sodium chloride. This means that
DIFTETALL is essentially sodium-free.
Formaldehyde is used in the manufacturing process and may be present in the vaccine in
very small quantities (see section 6 “Further information”).
3. How to use DIFTETALL
Vaccination schedule
The vaccination schedule consists of 3 distinct administrations carried out at different times
and of further booster doses.
Your doctor will assess the most appropriate schedule for you and your child, based on the
previous medical history, current health conditions and vaccinations previously
performed.
It is important to follow the doctor's or nurse's instructions regarding the administration of
DIFTETALL.
Method and route(s) of administration
Dosage
DIFTETALL is administered in single doses of 0.5 ml
Method of administration
Your doctor will administer DIFTETALL by injection into the muscle of the upper arm (deltoid muscle)
The vaccine must never be administered into a blood vessel.
If you need any clarification on the use of this product, please contact your doctor or
pharmacist.
4. Possible side effects
Like all medicines, DIFTETALL can cause side effects, although not everybody gets them.
Side effects detected in clinical studies
The following side effects have been observed in clinical studies:
Very common (may affect more than 1 in 10 people):
- Redness at the injection site (erythema), pain at the injection site, swelling at the injection site, hardening of the skin at the injection site (induration).
- General malaise
- Fever
- Muscle pain (myalgia)
- Joint pain (arthralgia)
- Headache
Common (may affect up to 1 in 10 people):
- Itching and inflammation at the injection site
- Swelling of the lymph nodes in the neck, armpits or groin (lymphadenopathy)
- Nausea
- Flu-like symptoms
Uncommon (may affect up to 1 in 100 people):
- Bruising at the injection site (hematoma)
- Skin rash (urticaria)
- Inflammation of the stomach and intestines (gastroenteritis)
- Ear pain (otitis media)
- Sore throat (pharyngitis)
Other side effects
In addition, the side effects listed below have been reported after DIFTETALL was placed on the market. Due to the nature of reporting, it is not possible to estimate the frequency of these side effects.
- Reduced number of cells for blood clotting (thrombocytopenia)
- Diarrhea, vomiting
- Swollen glands near the injection site (lymphadenopathy at the injection site)
- Formation of a boil under the skin at the injection site (abscess at the vaccination site)
- Allergic reaction
- Decreased appetite
- Inflammation of the nerves that can lead to weakness and numbness in the arms (neuralgic amyotrophy)
- Inflammation of the nerves that can lead to muscle weakness or temporary loss of movement (Guillain Barré syndrome)
- Drowsiness
- Irritability
- Hypersensitivity reactions, anaphylactic reactionsThe administration of any type of vaccine can cause hypersensitivity reactionsincluding anaphylactic reaction (occurring in less than 1 in 10,000 people) Characteristic symptoms of anaphylactic reaction are:severe and sudden drop in blood pressure, acceleration or slowing of the heartbeat, unusual tiredness or weakness, anxiety, agitation, loss of consciousness, difficulty breathing or swallowing, itching (especially on the soles of the feet or palms of the hands), urticaria with or without angioedema (swollen and itchy skin areas located more frequently on the extremities, external genitalia and face, especially in the eye and lip area), redness of the skin (especially around the ears), nausea, vomiting, cramp-like abdominal pain, diarrhea.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
You can also report side effects directly through the national reporting system:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store DIFTETALL
Keep DIFTETALL out of the reach and sight of children.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Do not use DIFTETALL after the expiry date which is stated on the pack after the abbreviation
“EXP”. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
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. Contents of the pack and other information
What DIFTETALL contains:
The active ingredients are:
Tetanus toxoid not less than 20 IU
Diphtheria toxoid not less than 2 IU
Aluminum hydroxide (adsorbent) 1.5 milligrams
IU are international units for measuring the activity of the vaccine
added to accelerate, improve and/or prolong the protective effect of the vaccine.
The other ingredients are:
Sodium chloride
Water for injections.
Residuals from the manufacturing process are:
Formaldehyde (not more than 0.001 mg)
Description of the appearance of DIFTETALL and contents of the pack
The vaccine is presented as an opalescent injectable suspension, contained in:
- Prefilled syringe of 0.5 ml with or without needle, in a pack of 1 syringe
Marketing Authorisation Holder
Astro-Pharma GmbH
Allerheiligenplatz 4
1200 Vienna, Austria
Manufacturers
GSK Vaccines S.r.l.
Bellaria-Rosia, 53018 Sovicille (SI), Italy
Released by
GSK Vaccines S.r.l.
Bellaria-Rosia, 53018 Sovicille, Italy
The following information is intended exclusively for doctors or healthcare professionals:
As with all injectable vaccines, appropriate medical treatment and control must always be
readily available in the event of an anaphylactic reaction following
vaccine administration.
The vaccine must not be administered intravascularly under any circumstances.
Shake before use. Visually inspect for the presence of particles or changes in color of the
product. If present, do not use the vaccine.
The vaccine is presented as an opalescent suspension.
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- Країна реєстрації
- Лікарська формаInjectable suspension in pre-filled syringe, 0,5 ML
- Код АТХJ07AM51
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до DIFTETALLЛікарська форма: Injectable suspension, 0.5 MLДіюча речовина: Столбнячный анатоксинВиробник: SANOFI WINTHROP INDUSTRIEРецепт не потрібенЛікарська форма: Powder and solvent for injectable solution, 0,5 MLДіюча речовина: haemophilus influenzae B, combinations with toxoidsВиробник: SANOFI WINTHROP INDUSTRIEПотрібен рецептЛікарська форма: Injectable suspension in pre-filled syringe, 0.5MLДіюча речовина: meningococcus B, multicomponent vaccineВиробник: GLAXOSMITHKLINE VACCINES S.R.L.Рецепт не потрібен
Аналоги DIFTETALL в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог DIFTETALL у Польща
Аналог DIFTETALL у Україна
Аналог DIFTETALL у Іспанія
Лікарі онлайн щодо DIFTETALL
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
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Заповніть форму за 2 хвилини
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Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
DIFTETALL не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у DIFTETALL — tetanus toxoid, combinations with diphtheria toxoid. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
DIFTETALL виробляється компанією ASTRO-PHARMA VERTRIEB UND HANDEL VON PHARMAZEUTISCHEN PRODUKTEN GMBH. 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 DIFTETALL 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 DIFTETALL 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 (tetanus toxoid, combinations with diphtheria toxoid) включають IMOVAX TETANO, AKTIB, BEXSERO. 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.
