PARACETAMOLO 10 mg /Ml Инфузионный Раствор

Содержание инструкции

1. Paracetamolo Baxter 10 mg/ml solution for infusion
   1. What is Paracetamolo Baxter and what is it used for
   2. What you need to know before using Paracetamolo Baxter
   3. How to use Paracetamolo Baxter
   4. Possible side effects
   5. How to store Paracetamolo Baxter
   6. Package Contents and Other Information

Paracetamolo Baxter 10 mg/ml solution for infusion

Generic medicine
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.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Paracetamolo Baxter and what is it used for

This medicine contains the active ingredient paracetamol and is an analgesic (relieves pain) and an
antipyretic (reduces fever).

Full-term newborns, infants, young children and children (with a weight of 33 kg or less)
Use the 50 ml vial.

Adults, adolescents and children (weighing more than 33 kg)
Use the 100 ml vial.
It is indicated for the short-term treatment of moderate pain, especially following
surgery and for the short-term treatment of fever.

2. What you need to know before using Paracetamolo Baxter

Do not use Paracetamolo Baxter:

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to propacetamol hydrochloride. This is another pain reliever that is converted by the body into paracetamol;
• if you have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before using Paracetamolo Baxter, if any of the
following conditions apply to you:

• if you could take pain relievers orally as an alternative, as this is the recommended route of administration;
• if you suffer from liver or kidney disease or if you drink too much alcohol;
• if you are taking other medicines containing paracetamol;
• in case of malnutrition or dehydration;
• if you have glucose-6-phosphate dehydrogenase deficiency. This is a blood disorder.

Other medicines and Paracetamolo Baxter
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Paracetamolo Baxter can affect other medicines and be affected by
them:

• other medicines containing paracetamol or propacetamol, in order not to exceed the recommended daily dose (see section 3 "How to use Paracetamolo Baxter");
• probenecid: a reduction in the dose of paracetamol may be necessary;
• salicylamide, a non-steroidal anti-inflammatory medicine;
• oral anticoagulants. It may be necessary to monitor the effect of the anticoagulant;
• medicines that activate liver enzymes: close monitoring of the dose of paracetamol is necessary to avoid liver damage.

Paracetamolo Baxter with alcohol
Limit your alcohol intake during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask
your doctor for advice before taking this medicine.

Pregnancy
If necessary, Paracetamolo Baxter can be administered during pregnancy. You will be given the
lowest possible dose to reduce pain or fever. Contact your doctor if pain or fever does not
decrease.

Breastfeeding
Paracetamolo Baxter can be used during breastfeeding.

Driving and using machines
Paracetamolo Baxter does not affect the ability to drive vehicles or operate machinery

Paracetamolo Baxter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
'sodium-free'.

3. How to use Paracetamolo Baxter

For intravenous use.
Paracetamolo Baxter will be administered to you by a healthcare professional by infusion into one of your veins.
The dose will be adjusted individually by the doctor, based on your body weight and your
general condition. The dosage is based on the patient's weight and their overall health
condition.

Term newborns, infants, young children and children (with a weight less than or equal to 33 kg)
Use the 50 ml vial. Refer to the table below for the volume per
body weight.

Adults, adolescents and children (weighing more than 33 kg)
Use the 100 ml vial. Refer to the table below for the volume per
body weight.

Posology
For the recommended dose, refer to the table below.

• The minimum interval between each administration must be at least 4 hours.
• The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
• No more than 4 doses must be administered within 24 hours.
• The medicine is administered as an intravenous infusion in 15 minutes.
• Before administration, the medicine must be visually checked by healthcare professionals. Paracetamolo Baxter must not be used if particles or a change in color are observed, which are signs of deterioration.

* Premature infants:no safety and efficacy data are available for premature infants.

**Patients weighing less will require smaller volumes.
*** Maximum daily dose:the maximum daily dose of paracetamol reported in the table
above relates to patients who are not taking other products containing paracetamol, and must be
modified accordingly taking into account such products.
Renal impairment:
In patients with renal impairment, the interval between each administration will be adjusted.
Hepatic insufficiency
In patients with chronic or compensated active liver disease, hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's syndrome, weight less than 50 kg: the maximum daily dose should not exceed 3 g.

Paracetamol solution is administered as an intravenous infusion in 15 minutes.
If you feel that the effect of this medicine is too strong or too weak, consult your
doctor.

If you take more Paracetamolo Baxter than you should
Overdosage is unlikely, as this medicine will be administered to you by a healthcare
professional. The doctor will ensure that you are not given doses higher than the recommended dose for
your case.

An overdose of Paracetamolo Baxter is potentially fatal due to liver damage

irreversible.The risk of serious liver damage exists even if you are in good health.

To avoid liver damage, it is essential to receive medical treatmentas soon as possible. The

shorter the interval between the infusion and the start of treatment with the antidote (as few hours

as possible), the greater the likelihood of avoiding liver injury.
In case of overdose, symptoms generally appear within the first 24 hours and include:
nausea, vomiting, anorexia, pallor and abdominal pain and risk of liver injury. Seek
medical attention immediately if you or your child are given an excessive dose of this
medicine, even if you or your child appear to be in good health. This is because an
excessive dose of paracetamol can cause delayed and serious liver damage.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect less than 1 in 1,000 people)
The following may be observed:

• malaise;
• low blood pressure;
• changes in laboratory values: abnormal increase in liver enzyme levels found in blood tests. In this case, inform your doctor, as regular blood tests may be necessary afterwards.

Very rare (may affect less than 1 in 10,000 people)
The following may be observed:

• severe skin rash or allergic reaction. In these cases, stop treatment immediately and inform your doctor;
• other changes in laboratory values have been observed that required regular blood tests: abnormal decrease in the levels of certain types of blood cells (platelets, white blood cells), with possible consequent bleeding from the nose or gums;
• very rare cases of severe skin reactions have been reported.

Not known (frequency cannot be estimated from available data)

• Cases of skin redness, flushing, itching and abnormally accelerated heartbeat have been reported.
• Cases of pain and burning sensation at the site of administration have been reported.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. 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 Paracetamolo Baxter

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 box and on the label of the
vial after Exp. The expiry date refers to the last day of the month.
Do not refrigerate or freeze.
Medicines not used and waste derived from such medicine must be disposed of in accordance with
current local regulations.

6. Package Contents and Other Information

What Paracetamolo Baxter Contains
The active ingredient is paracetamol.
1 ml contains 10 mg of paracetamol.
Each 50 ml vial contains 500 mg of paracetamol.
Each 100 ml vial contains 1,000 mg of paracetamol.
The other components are mannitol (E421), cysteine hydrochloride monohydrate (E920), disodium phosphate
dihydrate (E339), sodium hydroxide (for pH adjustment) (E524), hydrochloric acid (for
pH adjustment) (E507), water for injections.

Description of the Appearance of Paracetamolo Baxter and Contents of the Pack
Paracetamolo Baxter is a clear, colourless to slightly yellowish solution, free from visible
particles.
This medicine is available in glass vials of 50 ml or 100 ml, with red or blue aluminium
stoppers and flip-off caps, respectively.
Paracetamolo Baxter is supplied in a pack of 25 vials.

Marketing Authorisation Holder and Manufacturer
Baxter Holding B.V.
Kobaltweg 49,
3542CE Utrecht,
Netherlands

Bieffe Medital S.P.A
Via Nuova Provinciale
23034-Grosotto (SO),
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
------------------------------------------- TEAR-OFF SECTION
BELOW----------------------------------The following information is intended exclusively for
doctors and healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

A summary of information relating to dosage, dilution, administration and

storage of Paracetamolo Baxter 10 mg/ml, solution for infusion. See the Summary of

Product Characteristics for complete prescribing information.

For intravenous use.
Term neonates, infants, young children and children (weighing 33 kg or less)
Use the 50 ml vial.

Adults, adolescents and children (weighing more than 33 kg)
Use the 100 ml vial.
As with all solutions for infusion contained in glass vials, close monitoring is required, especially at the end of the infusion, regardless of the route of
administration. Such monitoring at the end of the infusion must be adopted especially in
the case of infusions through central veins, in order to avoid gas embolism.

Dosage
Information prior to dose preparation

• The minimum interval between each administration must be at least 4 hours.
• The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
• No more than 4 doses should be administered within 24 hours.
• Paracetamol solution is administered as an intravenous infusion over 15 minutes (for further information, see paragraph "Method of administration" under the dosage table).
• The diluted solution must be visually inspected and should not be used if opalescence, visible particles or precipitates are present.

RISK OF THERAPEUTIC ERRORS
Take care to avoid dosage errors due to confusion between milligrams (mg) and
millilitres (ml), which can lead to accidental overdose and death (see Summary of
Product Characteristics, paragraph 4.2).
The dosage is established based on the patient's weight (refer to the dosage table below)

* Pre-term neonates:no safety and efficacy data are available for pre-term neonates.

**Patients weighing less will require smaller volumes.
*** Maximum daily dose:the maximum daily dose reported in the table above refers to
patients who are not taking other products containing paracetamol, and must be adjusted
accordingly taking into account such products.
Renal impairment
In patients with renal impairment, the minimum interval between each administration must be
modified according to the following schedule:

Hepatic insufficiency
In patients with active chronic or compensated liver disease, hepatocellular insufficiency, chronic alcoholism,
chronic malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's syndrome, weight less than 50 kg: the maximum daily dose should not exceed 3 g.

Method of administration
Patients weighing ≤10 kg:

• The glass vial of paracetamol should not be hung as in the case of an infusion due to the small volume of product to be administered in this population.
• The volume to be administered must be drawn up from the vial and can be administered undiluted or diluted in 0.9% sodium chloride solution or 5% glucose solution up to a one-to-ten ratio (one volume of paracetamol in nine volumes of diluent) and administered over 15 minutes.
• A 5 or 10 ml syringe should be used to measure the appropriate dose for the child's weight and the desired volume. The volume administered in this weight group should never exceed 7.5 ml per dose.
• The user should be referred to the dosage recommendations in the summary of product characteristics.

To remove the solution, use a 0.8 mm (21 gauge) needle and puncture the stopper
vertically at the precise point indicated. For single use only. Unused solution must be
discarded.
The unused medicinal product and waste materials derived from such medicinal product must be disposed of in accordance with
current local regulations.

Shelf life after dilution
Chemical and physical stability during use in solutions has been demonstrated for 48 hours at 20-25 °C.
From a microbiological point of view, the medicine must be used immediately. If not used immediately, the storage times during use and the conditions of storage before use
are the responsibility of the user and normally do not exceed 24 hours at 2-8 °C, unless the
dilution has taken place under controlled and validated aseptic conditions.