10 mg / ml solution for infusion
Paracetamol
What Paracetamol Panpharma 10 mg/ml solution for infusion is and what it is used for
This is an analgesic (pain-relieving) and an antipyretic (antipyretic) medicine.
The 10 ml glass vial should only be used in full-term neonates and infants weighing less than 10 kg.
The bag or glass vial containing 50 ml should only be used for infants and children weighing more than 10 kg and less than 33 kg.
The bag or glass vial containing 100 ml should only be used for adults, adolescents, and children weighing more than 33 kg (from about 11 years of age).
It is used for short-term treatment of moderate pain, especially after surgery, and for short-term treatment of fever.
Paracetamol contained in Paracetamol Panpharma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Paracetamol Panpharma 10 mg/ml solution for infusion
Do not use Paracetamol Panpharma 10 mg / ml solution for infusion
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic (hypersensitive) to propacetamol (another painkiller, given as an infusion and converted to paracetamol )
- if you have severe liver disease
Warnings and cautions
Talk to your doctor or pharmacist before using Paracetamol Panpharma 10 mg/ml solution for infusion.
- use a suitable oral (oral) painkiller as soon as possible
- if you have liver or kidney disease or alcohol abuse
- if you are taking other medicines containing paracetamol
- in case of problems with malnutrition or dehydration
- in glucose -6-phosphate dehydrogenase deficiency (which may lead to hemolytic anemia ), a blood disorder.
Tell your doctor before treatment if any of the above apply to you.
Other medicines and Paracetamol Panpharma 10 mg/ml solution for infusion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine contains paracetamol, which must be taken into account if you are taking other medicines that contain paracetamol or propacetamol so that the maximum recommended daily dose is not exceeded (see next section). Tell your doctor if you are taking other medicines that contain paracetamol or propacetamol.
Dose reduction should be considered during concomitant treatment with probenecid.
Tell your doctor or pharmacist if you are taking oral blood thinners ( anticoagulants ). More controls may be needed to investigate the effect of the blood thinner.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If necessary, Paracetamol Panpharma can be used during pregnancy. However, you should be given the lowest possible dose that relieves your pain and/or fever and receives the medicine for the shortest possible time.
Contact a doctor or midwife if the pain and/or fever do not decrease or if you need to take the medicine more often.
Breast-feeding
Paracetamol Panpharma can be used during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Paracetamol Panpharma 10 mg/ml solution for infusion contains sodium and glucose
This medicine contains 7.9 mg sodium (the main ingredient in table salt/table salt) per 10 ml vial. This corresponds to 0.4% of the highest recommended daily intake of sodium for adults. When diluted with 0.9% sodium chloride solution to one-tenth, this medicinal product contains up to 613.4 mg sodium (the main component of table salt/table salt) per dose administered. This corresponds to 31.05% of the recommended maximum daily intake of sodium for an adult.
This medicine contains 39.1 mg of sodium (the main ingredient in table salt/table salt) per 50 ml sachet or vial. This corresponds to 2% of the maximum recommended daily sodium intake for adults.
When diluted with 0.9% sodium chloride solution to one-tenth, this medicine contains up to 4049 mg of sodium (the main component of table salt/table salt) per dose administered. This corresponds to 205% of the recommended maximum daily intake of sodium for an adult.
This medicine contains 79 mg sodium (the main ingredient in table salt/table salt) per 100 ml bag or vial. This corresponds to 4% of the highest recommended daily intake of sodium for adults.
This medicine contains 1.65 g of glucose per 50 ml bag or vial. This should be considered by patients with diabetes mellitus.
This medicine contains 3.3 g of glucose monohydrate per 100 ml bag or vial. This should be considered by patients with diabetes mellitus.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Paracetamol Panpharma 10 mg / ml solution for infusion
The paracetamol solution is given by healthcare professionals.
Dosage
Dosage based on patient weight (see dosing table below)
| Patient’s weight | Dosage per administration | Volume per administration | Maximum volume of Paracetamol Panpharma 10 mg/ml per administration based on upper group weight limits (ml) *** | Maximum daily dose ** |
|---|---|---|---|---|
| ≤10 kg * | 7.5 mg / kg | 0.75 ml / kg | 7.5 ml | 30 mg / kg |
| > 10 kg to ≤33 kg | 15 mg / kg | 1.5 ml / kg | 49.5 ml | 60 mg / kg, not exceeding 2 g |
| > 33 kg to ≤50 kg | 15 mg / kg | 1.5 ml / kg | 75 ml | 60 mg/kg, not exceeding 3 g |
| > 50 kg with additional risk factors for liver toxicity | 1 g | 100 ml | 100 ml | 3 g |
| > 50 kg and without additional risk factors for liver toxicity | 1 g | 100 ml | 100 ml | 4 g |
| * Premature neonates: No data on safety and efficacy are available for premature infants (see section 5.2).** Maximum daily dose: The maximum daily dose shown in the table above applies to patients who are not receiving other medicines containing paracetamol and should be adjusted for such medicines.*** Patients who weigh less need smaller volumes. |
The interval between each administration must be at least 4 hours.
The interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
More than 4 doses in 24 hours should not be given.
Method of use
| RISK OF ERROR MEDICATIONBe careful to avoid dosing errors due to confusion between milligrams (mg) and milliliters (ml), which may result in accidental overdose and death. |
Intravenous use.
The paracetamol solution is given by infusion into one of your veins.
The paracetamol solution is given as an intravenous infusion over 15 minutes.
For 10 ml, 50 ml, and 100 ml vials a 0.8 mm needle (21 gauge needle) must be used and the stopper must be perforated vertically at the specially marked place.
50 ml bag or vial:
It can also be diluted with 0.9% sodium chloride solution or 5% glucose solution up to one-tenth (one volume of Paracetamol Panpharma in nine volumes of diluent ).
The diluted solution should be inspected visually and should not be used if it is unclear, or contains visible particles or precipitates.
If you have the impression that the effect of Paracetamol Panpharma 10 mg/ml is too strong or too weak, talk to your doctor.
| If you take more Paracetamol Panpharma than you should if you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. In the event of an overdose, seek medical attention immediately, as there is a risk of permanent liver damage. In case of overdose, the symptoms generally appear within the first 24 hours and consist of nausea, vomiting, loss of appetite, pallor, and abdominal pain. There is a risk of liver damage. Tell your doctor if you notice any of these symptoms. If you have any further questions on the use of this product, ask your doctor or pharmacist. |
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- In rare cases (which affect more than 1 in 10,000 users, but less than 1 in 1,000 users) the following may occur: malaise, lowering of blood pressure, or changes in laboratory values: abnormally high levels of liver enzymes have been detected in blood samples. If this happens, consult your doctor as blood tests may be needed later.
- Very rare cases of severe skin reactions have been reported.
- In very rare cases (affects less than 1 in 10,000 people, including occasional reports), severe skin rash or an allergic reaction may occur. In such cases, treatment should be stopped immediately and your doctor should be informed. In isolated cases, other changes in laboratory values have been observed, which have required regular blood tests: abnormally low levels of certain blood cells ( platelets and white blood cells ) may occur, which may cause bleeding from the nose or gums. If this happens, tell your doctor.
- Pain or a burning sensation at the injection site has been reported, which may be due to the rate at which an infusion is given and which does not necessarily disappear with a reduced infusion rate.
- Redness of the skin, hot flashes, itching, and abnormal increase in heart rate have been reported in some cases.
How to store Paracetamol Panpharma 10 mg / ml solution for infusion
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 carton after EXP. The expiration date is the last day of the specified month.
Special precautions for storage of PVC bags:
Do not store above 25 ° C.
Special precautions for storage of glass vials:
Do not store above 25 ° C.
Store the bag or vial in the outer carton.
Store the inner packaging in the outer packaging.
Before use, the product must be inspected visually. Do not use Paracetamol Panpharma if you see particles.
For single use only. The drug should be used immediately after opening. Any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is paracetamol 10 mg/ml.
Other ingredients are:
Glucose monohydrate, concentrated acetic acid, sodium acetate trihydrate, sodium citrate dihydrate, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injections.
What the medicine looks like and the contents of the pack
10 ml colorless type II glass vial. Pack sizes of 10 or 50 vials. 50 or 100 ml colorless type II glass vial. Pack sizes of 10 or 12 vials.
50 ml or 100 ml bag (PVC). Pack sizes of 10, 12, or 50 bags.
10, 50, or 100 ml glass vial is closed with a halogenated butyl stopper.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
PANPHARMA
ZI DU CLAIRE
35133 LUITRÉ
FRANCE
Manufacturer
PANPHARMA
ZI DU CLAIRE
35133 LUITRÉ
FRANCE
Or:
ALTAN PHARMACEUTICALS SAPOLIGONO
INDUSTRIAL DE BERNEDO S / N 01118
BERNEDO (ALAVA)
SPAIN
Or:
PANPHARMA GmbH
MEDICINES
BUNSENSTRASSE 4
22946 TRITTAU
GERMANY
Or:
INFORMED FLUIDS SRL
50 THEODOR PALLADY STREET
3RD DISTRICT
BUCHAREST
COD 032266
ROMANIA
This medicinal product is authorized under the European Economic Area under the names:
| Bulgaria: | Paracetamol Panfarma 10 mg / ml infusion solution |
| Denmark: | Paracetamol Panpharma 10 mg / ml solution for infusion |
| Finland: | Paracetamol Panpharma 10 mg / ml, infusion test, liuos |
| Germany: | Paracetamol Rotexmedica 10 mg / ml Infusion solution |
| Hungary: | Paracetamol Panpharma 10 mg / ml oldatos infusion |
| Lithuania: | Paracetamol Panpharma 10 mg / ml infusinis tirpalas |
| Latvia: | Paracetamol Panpharma 10 mg / ml şķīdums infūzijām |
| Norway: | Paracetamol Panpharma 10 mg / ml, solution for infusion |
| Poland: | Paracetamol Panpharma, 10 mg / ml, roztwór do infusion |
| Romania: | Paracetamol Infomed 10 mg / ml, perfuzaliba solution |
| Sweden: | Paracetamol Panpharma 10 mg / ml, solution for infusion |