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EFFERALGAN PEDIATRIC SOL 30MG/ML 90ML

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
EFFERALGAN-KIDS-drug/medicine aproximate price on "EFFERALGAN PEDIATRIC SOL 30MG/ML 90ML" in Riga city, Latvia is:
  • 3.96€  4.28$  3.4£  457Rub  45.6SEK  17PLN  15.67₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine  EFFERALGAN PEDIATRIC SOL 30MG/ML 90ML     Recheck

Reģ. Nr.: 97-0236

ATC codeN02BE01 

Active substances: Paracetamolum

 


Vendor, principal: Bristol-Myers Squibb
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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EFFERALGAN 30 mg/ml šķīdums, 90 ml

 .

EFFERALGAN 30MG/1ML 90ML

PACKAGE LEAFLET: INFORMATION FOR THE USER

Efferalgan, 30 mg/mL oral solution for children

paracetamol

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

This medicine is available without prescription. Nevertheless you still need to use Efferalgan exactly as described in this leaflet to get the best results from it.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse after three days.

What is in this leaflet

1.   What Efferalgan is and what it is used for
2.   What you need to know before you use Efferalgan
3.   How to use Efferalgan
4.   Possible side effects
5.   How to store Efferalgan
6.   Contents of the pack and other information

1.   What Efferalgan is and what it is    used    for

Efferalgan oral solution is a medicine intended for the treatment of pain and/or fever.
It is meant for alleviating fever and/or pain for example in case of headache, colds, toothache or muscle pain.

2. What you need to know before you use Efferalgan Do not use Efferalgan

-   if the child is allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
-   if the child has a severe liver disease.
You should check with your doctor or pharmacist if you are not sure.

Warnings and precautions

Consult with a doctor before using paracetamol or giving it to a child:
■   if you have a severe kidney disease;
■   if you have Gilbert's syndrome (familial hyperbilirubinaemia);
■   chronic or compensated active liver disease (mild to moderate hepatic impairment);
■   if you have glucose-6-phosphate dehydrogenase deficiency (risk of hemolytic anemia);
■   if you have anorexia, bulimia, cachexia or chronic malnutrition;
■   if you have significant weight loss (dehydration, hypovolemia);
■   if the doctor has ordered tests to determine uric acid or sugar content in blood, inform him/her that you are using this medicine.
Paracetamol might cause severe skin reactions. The treatment should be stopped if extensive skin rash develops or if signs of hypersensitivity appear.
Exceeding recommended doses of paracetamol might cause severe liver impairment. Clinical symptoms of liver impairment usually develop 1-2 days after overdosage. The most marked symptoms are usually observed on the 3rd-4th day (see section 3 “If you take more Efferalgan than you should”).

Important information about some of the ingredients of Efferalgan:

In patients on diet with restricted sugar content or having diabetes it should be considered when calculating daily sugar ration that this medicine contains 0.67 g of saccharose per 4 kg interval shown on the dosator.
This medicine should not be used in case of fructose intolerance, glucose and galactose malabsorption syndrome and saccharase-isomaltase deficiency (rare metabolic diseases).

Other medicines and Efferalgan

Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Concurrent use with drugs that induce hepatic enzymes like certain hypnotics and anticonvulsive agents (including phenobarbital, phenytoin, carbamazepine) and antibiotics (isoniazid, rifampicin) or alcohol may cause liver damage with otherwise harmless paracetamol doses.
In case of concurrent administration of paracetamol and chloramphenicol the excretion of chloramphenicol may decrease significantly and its toxicity may increase.
Concurrent use of paracetamol and zidovudine (AZT) increases the risk of serious blood change (neutropenia). Therefore paracetamol should be used concurrently with zidovudine only by doctor’s recommendation.
Continuous and concomitant use of paracetamol with oral anticoagulants, including warfarin, may cause changes in INR values and increase the risk of haemorrhaging. During treatment with paracetamol and up to one week after its discontinuation it is recommended to monitor INR values.
Cholestyramine decreases, and metoclopramide and domperodone increase paracetamol absorption.
Do not use Efferalgan with other paracetamol-containing medicines to avoid exceeding the recommended daily dose. Simultaneous use of paracetamol with other painkillers is not recommended.

3. How to use Efferalgan

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Posology

Paracetamol dose depends on the child’s weight. Age is given only as general guidance. Recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is administered as 4 individual doses, i.e. about 15 mg/kg every 6 hours. If you do not know the child’s weight, you should weigh the child to administer most adequate dose. Paracetamol is supplied in different strengths, therefore the dose may be adjusted for the weight of every child.
Current composition is suitable for children with body weight of 4-32 kg (i.e. from about 1 month to 12 years of age).
Important: use only dosator provided in the package. It is specially designed for administering this medicine. Do not use any other dosator.
The dosator is graduated on the basis of kilograms, showing 4, 8, 12 and 16 kg. Other markings show intermediate values of 6, 10 and 14 kg.
Fill the dosator according to the child’s body weight and adjust the liquid level to required marking:
■   4-16 kg: fill the dosator to the marking corresponding to the child’s weight or what is closest to it. For example for body weight 4-5 kg: fill the dosator to 4 kg mark;
■   16-32 kg: at first fill the dosator and to get the required volume fill the dosator again until you get the dose corresponding to the child’s weight. For example in case of body weight of 18-19 kg: at first fill the dosator to the 10 kg mark and then fill the second time to 8 kg mark.

Method of administration

For oral administration. The solution may be taken in original form or dilute in a small volume of liquid (e.g. water, milk or fruit juice).
To open the bottle press and turn the childproof cap. Close the bottle after every use.

Administration time and frequency

Regular administration helps to avoid recurrence of pain and temperature fluctuations. There should be regular, recommended 6-hour intervals between administrations during night and day.

Renal impairment

In case of severe renal disease (severe renal failure) there should be an at least 8-hour interval between administrations.
Do not exceed the maximum daily dose of 60 mg/kg.

Liver impairment

Paracetamol should not be used in patients with severe liver impairment. Doses should be decreased or the dosage interval should be prolonged in the case of liver impairment. It is important that maximum daily dose does not exceed 60 mg/kg/day or 2 g/day, if:
■   you weigh less than 50 kg;
■   you have chronic or compensated active liver disease, especially with mild to moderate hepatic impairment;
■   you have Gilbert's syndrome (familial hyperbilirubinaemia);
■   you suffer from chronic alcoholism;
■   you have chronic malnutrition;
■   you are dehydrated.
If you feel that the effect of Efferalgan is too strong or too weak, talk to your doctor or pharmacist.

If you take more Efferalgan than you should

In case of overdose or unintended administration of too large dose consult a doctor immediately.
In case of overdose in the beginning (during the 1st day) nausea, vomiting, sweating, sleepiness and general malaise may occur. Despite the improvement of general status on the 2nd day progressive liver damage, even liver coma may develop on the 3rd day.

If you forget to take Efferalgan

Do not take a double dose to make up for a forgotten dose.

Other important information

When the child’s temperature rises above 38.5 °C, the following measures will promote the effect of the medicine:
•   remove the child’s clothing;
•   give a lot to drink to the child;
•   do not leave the child in too warm place;
•   bathe the child in water with a temperature 2°C below the child’s body temperature, if required.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following side effects have been reported in post-marketing experience:
Might occur rarely (1 patient in 1,000 to 10,000) after using paracetamol
■   diarrhoea and abdominal pain;
■   increase or decrease in blood coagulation parameters (INR values);
■   increase in activity of liver enzymes (transaminases).
Usually these changes are mild, reversible and no not require discontinuation of treatment.
Have been described very rarely (less than 1 patient in 10,000) after using paracetamol:
■   Renal impairment has been observed very rarely.
■   Skin rashes (hives, erythema, pruritus) and allergic reactions, including angioedema or anaphylactic shock (anaphylaxia with severe hypotension) and severe skin damage, for example acute generalised exanthematous pustulosis, toxic epidermal necrolysis, StevensJohnson syndrome, have been described after using paracetamol.
■   Liver impairment, hepatic necrosis, hepatitis.
■   Abnormally low levels of certain blood cells (thrombocytopenia, leukopenia, neutropenia) have reported in association with paracetamol use. This might cause bleeding from nose or gums or recurrence of fever or infection symptoms.
If this occurs, stop treatment immediately and inform your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5.   How to store Efferalgan

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use Efferalgan after the expiry date which is stated after “EXP”. The expiry date refers to the last day of that month.
The shelf-life of the solution is 3 months after the first opening of the bottle.
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 Efferalgan contains

-   The active substance is paracetamol. 1 mL of oral solution contains 30 mg of paracetamol.
-   The other excipients are macrogol 6000, saccharose, soluble saccharin, potassium sorbate (E200), citric acid, caramel-vanilla flavour additive, purified water.

What Efferalgan looks like and contents of the pack

Brown, slightly viscous solution with caramel and vanilla aroma. 90 mL of oral solution in a bottle.

Marketing Authorisation Holder

Bristol-Myers Squibb Gyogyszerkereskedelmi Kft. Lövöhaz u. 39 1024, Budapest Hungary

Manufacturer

UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen
France
or
UPSA SAS
979 Avenue des Pyrenees 47520 Le Passage France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Amicus Pharma OÜ Phone: 640 1030 E-mail:
[email protected]
u

This leaflet was last revised in December 2016.

5





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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