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Инструкция по применению ATROPINA SOLFATO AKKORD
Содержание инструкции
Atropina Solfato Accord 0.1 mg/ml, injectable solution in pre-filled syringe
atropina solfato
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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Atropina Solfato Accord is and what it is used for
- 2. What you need to know before you use Atropina Solfato Accord
- 3. How to use Atropina Solfato Accord
- 4. Possible side effects
- 5. How to store Atropina Solfato Accord
- 6. Contents of the pack and other information
1. What is Atropina Solfato Accord and what is it used for
Atropine belongs to a group of medicines called anticholinergics. An anticholinergic is a
substance that blocks the neurotransmitter acetylcholine in the central and peripheral nervous system. It is
used in emergency situations when the heart beats too slowly, as an antidote, for example,
to organophosphate-based insecticides or in nerve gas poisoning and mushroom poisoning.
It can be used as part of premedication before general anesthesia. It can also be
used to prevent the undesirable effects of other drugs used to reverse the effects of
muscle relaxants after surgical procedures.
Atropina Solfato Accord 0.1 mg/ml injectable solution in pre-filled syringe is used to treat
adults and children from birth with a body weight greater than 3 kg.
2. What you need to know before using Atropina Solfato Accord
Do not use Atropina Solfato Accord if:
- you are allergic (hypersensitive) to atropine or to any of the other ingredients of this medicine (listed in section 6), - you have difficulty urinating,
- you have high intraocular pressure (glaucoma), -
- you have esophageal disease (achalasia of the esophagus), an intestinal blockage (paralytic ileus) or an acute form of colon distension (toxic megacolon). -
These contraindications do not apply in emergency situations that are life-threatening.
Warnings and precautions
Talk to your doctor before using Atropina Solfato Accord if you suffer from:
- hyperthyroidism, -
- prostate disease, -
- heart failure, -
- liver or kidney disease, -
- certain heart conditions, -
- stomach disease, such as pyloric stenosis, -
- chronic bronchitis, -
- fever, -
- if you are a child or an elderly person, -
- myasthenia gravis (severe muscle weakness), -
- heartburn (reflux). -
Other medicines and Atropina Solfato Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine:
- tricyclic antidepressants, -
- certain antihistamines, -
- medicines for Parkinson's disease, -
- phenothiazine, clozapine or neuroleptic drugs (for mental illnesses), -
- quinidine or disopyramide (for heart diseases), - antispasmodic drugs (for irritable bowel syndrome).
Pregnancy and breastfeeding
Pregnancy
Limited data relating to the use of atropine in pregnant women indicate the absence of adverse
effects on pregnancy or on the health of the fetus. Atropine crosses the placenta. Intravenous
administration of atropine during pregnancy or at term may cause a faster heart rate in the fetus and
mother. This medicine should be administered during pregnancy only after a careful assessment of the
benefits and risks of treatment.
Breastfeeding
Small amounts of atropine may pass into breast milk and may have effects on the baby.
Atropine can inhibit the production of breast milk. The doctor will assess the benefit of breastfeeding
compared to the benefit of treatment. Breastfeeding should be discontinued if you decide to use the
treatment. However, if you decide to continue breastfeeding during treatment, your doctor will
perform additional tests on the baby.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before you are given this
medicine.
Driving and using machines
Injection of atropine can cause confusion or blurred vision. After receiving an injection
you should not drive or use machines.
Atropina Solfato Accord contains sodium
This medicine contains 17.7 mg of sodium (the main component of table salt) in each
pre-filled syringe of 5 ml. This is equivalent to 0.885% of the maximum recommended daily
intake of sodium for an adult. The 10 ml syringe contains 35.4 mg of sodium, equivalent to
1.77% of the maximum recommended daily intake for an adult.
3. How to use Atropina Solfato Accord
The doctor will decide the correct dose for you and how and when the injection will be administered.
The usual doses are:
As premedication before anesthesia
Intravenous (i.v.) administration immediately before surgery; if necessary,
intramuscular administration 30-60 minutes before surgery is possible.
Adults: 0.3-0.6 mg i.v.
Children: 0.01-0.02 mg/kg, dose adjusted based on the patient's response and tolerance (maximum
0.6 mg per dose).
To counteract the effects of muscle relaxants:
Adults: 0.6-1.2 mg i.v. with neostigmine.
Children: 0.02 mg/kg i.v.
In case of slow heartbeat, heart block or cardiac arrest:
Adults:
- Sinus bradycardia (slow heartbeat): 0.5 mg i.v., every 2-5 minutes until the desired heart rate is achieved.
- Atrioventricular block (blockage of the transmission of contraction between atrium and ventricle): 0.5 mg i.v., every 3-5 minutes (maximum 3 mg).
Children: 0.02 mg/kg i.v. in a single dose (maximum dose 0.6 mg).
As an antidote to organophosphate poisoning (insecticides or nerve gas), to anticholinesterases
and in muscarinic mushroom poisoning:
Adults: 0.5-2 mg i.v., repeatable after 5 minutes and subsequently every 10-15 minutes as needed
Children: 0.02 mg/kg possibly repeated several times until the signs and symptoms disappear.
Other forms of the medicine may be more suitable if a dose greater than 1
mg is required.
Use in children
Atropine is used to treat children from birth with a body weight greater than 3 kg.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
The injection will be administered by a doctor or nurse, so it is unlikely that you will receive
an excessive dose of atropine. If you believe you have received too much atropine, you feel your heart is
beating very fast, you are breathing rapidly, you have a high fever, you feel restless, confused, suffer from
hallucinations or have lost coordination, you should inform the person administering the injection.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects depend on the dose administered and usually disappear when the
treatment is stopped.
Rarely, an allergic reaction may develop, which can cause skin rashes, severe
itching, skin peeling, swelling of the face (especially around the lips and eyes),
a lump in the throat and difficulty breathing or swallowing, fever, dehydration, shock and
fainting.
These are all very serious side effects. Tell your doctor immediately if you experience any
of these side effects. You may need urgent medical attention.
Very common side effects (may affect more than 1 in 10 people)
- visual disturbances (pupil dilation, difficulty focusing, blurred vision, inability to tolerate light),
- reduced bronchial secretion,
- dry mouth (difficulty swallowing and speaking, feeling thirsty),
- constipation and heartburn (reflux),
- reduced gastric acid secretion,
- loss of taste,
- nausea,
- vomiting,
- feeling of bloating,
- lack of sweating,
- dry skin,
- urticaria,
- skin rash.
Common side effects (may affect up to 1 in 10 people)
- excitation (especially at higher doses),
- loss of coordination (especially at higher doses),
- confusion (especially at higher doses),
- hallucinations (especially at higher doses),
- overheating of the body,
- certain heart conditions (rapid heartbeat, irregular heartbeat, temporary further slowing of the heartbeat),
- hot flashes,
- difficulty urinating.
Uncommon side effects (may affect up to 1 in 100 people)
- psychotic reactions.
Rare side effects (may affect up to 1 in 1,000 people)
- allergic reactions,
- convulsions (seizures),
- drowsiness.
Very rare side effects (may affect up to 1 in 10,000 people)
- severe hypersensitivity reaction,
- irregular heartbeat, including ventricular fibrillation,
- chest pain,
- sudden increase in blood pressure.
Not known (frequency cannot be estimated based on available data)
- headache,
- restlessness,
- unsteady walking and balance problems,
- insomnia.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at 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 Atropina Solfato Accord
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 package, on the syringe and on the
blister.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
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 Atropina Solfato Accord contains
The active ingredient is atropine sulfate: Each ml of injectable solution contains 0.1 mg of atropine
sulfate monohydrate, equivalent to 0.083 mg of atropine.
Each 5 ml syringe contains 0.5 mg of atropine sulfate monohydrate, equivalent to 0.415 mg of
atropine.
Each 10 ml syringe contains 1 mg of atropine sulfate monohydrate, equivalent to 0.83 mg of
atropine.
The other ingredients are: Sodium chloride, sulfuric acid (for pH adjustment) and sodium
hydroxide (for pH adjustment), water for injections.
Description of the appearance of Atropina Solfato Accord and contents of the pack
Atropina Solfato Accord is a clear, colorless solution, free from visible particles, contained in a
pre-filled glass syringe.
Prefilled 5 ml syringe in clear glass (Type I clear glass) with a tip cap, plunger stopper (bromobutyl rubber) and plunger rod (polypropylene). Graduations of 0.5 ml, from 0 ml to 5 ml, are present on the
syringe barrel.
Prefilled 10 ml syringe in clear glass (Type I clear glass) with a tip cap, plunger stopper (bromobutyl rubber) and plunger rod (polypropylene). Graduations of 1 ml, from 0 ml to 10 ml, are present on the
syringe barrel.
The pre-filled syringe is supplied without a needle, packaged in an outer carton.
Atropina Solfato Accord is available in a pack containing 1 pre-filled syringe.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50,
95-200 Pabianice
Poland
Or
Pharmadox Healthcare Ltd.
KW20A
Kordin Industrial Park,
Paola, PLA3000, Malta
Or
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040,
Spain
Or
Accord Healthcare B.V.
Winthontlaan 200, 3526KV Utrecht
Netherlands
--------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
The pre-filled syringe is for single-patient use only. Discard the syringe after use.
Do not reuse.
The product should be visually inspected for the presence of particles and color changes before administration. Use only clear and colorless solution free from
particles or precipitates.
Needles from 23 to 20 gauge are suitable for intravenous administration and from 23 to
21 gauge for intramuscular administration with the syringe.
Unused medicine and waste materials derived from such medicine should be disposed of in
accordance with local regulations.
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- Страна регистрации
- Форма выпускаInjectable solution in pre-filled syringe, 0.1 MG/ML
- Код АТХA03BA01
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги ATROPINA SOLFATO AKKORDФорма выпуска: Injectable solution, 0.1 MG/MLДействующее вещество: atropineПроизводитель: LABORATOIRE AGUETTANTОтпускается по рецептуФорма выпуска: Injectable solution, 1 MG/MLДействующее вещество: atropineПроизводитель: BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A.Отпускается по рецептуФорма выпуска: Injectable solution, 0.5MG/MLДействующее вещество: atropineПроизводитель: INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.Отпускается по рецепту
Аналоги ATROPINA SOLFATO AKKORD в других странах
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Аналог ATROPINA SOLFATO AKKORD в Испания
Аналог ATROPINA SOLFATO AKKORD в Польша
Аналог ATROPINA SOLFATO AKKORD в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
ATROPINA SOLFATO AKKORD требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ATROPINA SOLFATO AKKORD — atropine. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ATROPINA SOLFATO AKKORD производится компанией ACCORD HEALTHCARE, S.L.U.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения ATROPINA SOLFATO AKKORD с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить ATROPINA SOLFATO AKKORD в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (atropine) включают ATROPINA SOLFATO AGUETTANT, ATROPINA SOLFATO BIOINDUSTRIA L.I.M., ATROPINA SOLFATO GALENIKA SENESE. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
