Paracetamol Kabi 1000mg Fresenius Kabi is medium pain and fever (48 bottles x 100ml)

Dosage form 48 bottles x 100ml bottle
Specifications Paracetamol

Ingredient

Thành phần cho 100ml

Composition information	Content
Paracetamol	1000mg

Uses

Indications

Paracetamol Kabi 1000 drugs are indicated in the following cases:

Short -term treatment medium pain, especially after surgery.

Short -term treatment of fever. N-acetyl-P-P-Aminophenol) is a substance that is active in phenacetin, an effective analgesic-antipyretic drug that can replace aspirin, but unlike aspirin, paracetamol has no inflammatory treatment. With equal dose in grams, paracetamol has analgesic and antipyretic effects similar to Aspirin.

paracetamol reduces the body temperature in fever, but rarely reduces the body temperature in normal people. The drug acts on the hypothalamus causing cooling, increasing heat due to vasodilation and increasing peripheral blood flow.

With treatment dose, paracetamol has little impact on the cardiovascular and respiratory system, does not change the balance of acid-base, does not cause irritation, ulcers or stomach bleeding as when using salicylate. The effect of paracetamol on cyclooxygenase activity is not fully known. With a dose of 1g/day Paracetamol is a weak cyclooxygenase inhibitor.

Inhibition effects of paracetamol on cyclooxygenase - 1 weak. Paracetamol is often chosen as an analgesic and antipyretic, especially in the elderly and in people with contraindicated use of salicylate or other NSAIDs, such as people with asthma, a history of peptic ulcer and children.

Paracetamol does not work on platelets or bleeding time.

With the dose of treatment, paracetamol metabolizes mainly through the Sulfate and Glucuronid complex reaction. A small amount usually turns into a toxic metabolite, N-acetyl-P-Benzoquinonimin (NAPQI). Napqi is detoxified by glutathion and eliminated into urine or bile.

When the metabolic is not connected to Glutathion, it will be toxic to liver cells and cause cell necrosis. Paracetamol is often safe when used for treatment, because the amount of Napqi is formed relatively low and glutathion formed in liver cells that are sufficiently associated with NAPQI. However, when overdose or sometimes with the common dose used in some sensitive people (such as malnutrition, or drug interaction, alcoholism, genetics), Napoi concentration can accumulate toxic to the liver.

Paracetamol Kabi 1000 gives an analgesic effect starting for 5-10 minutes after use. The maximum pain relief effect is reached for about 1 hour and often retains analgesic effect from 4 to 6 hours.

Paracetamol Kabi 1000 reduces fever within 30 minutes after use. The antipyretic effect is kept for at least 6 hours.

pharmacokinetic

Adults

absorption

Paracetamol pharmacokinetics after taking 1 single dose and repeat within 24 hours is linear until 2g.

Paracetamol's bioavailability after transmitting 500mg and 1g is the same as when transmitting 1g and 2g propacetamol (corresponding to 500mg and 1g Paracetamol).

Agriculture in plasma (cmax) achieved at the end of the 15 -minute transmission when transmitting 500mg and 1g paracetamol respectively about 15µg/ml and 30µg/ml.

Distribution

Paracetamol's distribution volume is about 1L/kg. Paracetamol is not much attached to plasma proteins (about 10%) 20 minutes after 1g paracetamol transmission, significant concentration of paracetamol (about 1.5µg/ml) detected in cerebrospinal fluid.

Metabolism

Paracetamol is mainly metabolized in the liver in two main lines: associated with glucuronic acid and sulfuric acid. At higher dose than treatment, the second path is quickly saturated. A small amount (less than 4%) is converted by Cytocrom P450 into an intermediate substance (N --acetyl Benzoquinon Imin). This intermediate substance, at normal doses, will quickly be detoxified with glutathion and excreted in the urinary tract after connecting with cysteine and mercapturic acid. However, in the case of overdose, this toxic metabolic substance increases.

Elimination

Paracetamol metabolites are mainly eliminated in the urine. 90%of doses are excreted within 24 hours, mainly in the form of glucuronid complex (60 - 80%) and sulfate (20 - 30%). Under 5% is eliminated in constant form. The selling time in plasma is 2.7 hours and the body clearance coefficient is 18l/hour.

babies, children and children

Paracetamol pharmacokinetics parameters in children and children are the same as in adults, except for a slightly shorter plasma semi -discharged time (1.5 to 2 hours) compared to adults. In newborns, the time for selling plasma is longer in children, which is about 3.5 hours. Babies, young children and children under 10 years old excreting Glucuronid combinations less and more sulfate than in adults.

Table: Pharmacokinetic values related to age (standard clearance, *cl/f disease (I/hour/70kg).

In the term) 3,3 5.9 (Age after birth) 10

11.1 (Age after birth) 25 16.3

kidney failure

In case of severe renal failure (creatinine clearance 10 - 30ml/min), paracetamol elimination is slightly reduced, the sale time is about 2 to 5.3 hours. With glucuronid and sulfate agents, the excretion rate in people with renal failure weighs 3 times lower than in healthy people. Therefore, when using paracetamol for people with severe renal failure (creatinine clearance

Elderly

Paracetamol's metabolic and pharmacokinetic parameters do not change in the elderly. No need to adjust the dose with these patients.

Before taking Paracetamol Kabi 1000mg Fresenius Kabi is medium pain and fever (48 bottles x 100ml)

How to use

Be careful when prescribing and using Paracetamol Kabi ad 10mg/ml to avoid the wrong dose due to confusion between Miligam (Mg) and Mililt (ml). This mistake can lead to an overdose and death. Caution should be careful to ensure communication and distribution at the right dose. When prescribed, record the total dose both by Mg and volume. Be cautious to ensure the dose is measured and used correctly.

Use only 1 time. Excess solution must be removed.

Before use, the product needs to be checked for strange and eye -catching urine.

Paracetamol solution is intravenous within 15 minutes.

Patient weight ≤ 10 kg

Do not hang paracetamol kabi ad 10mg/ml as an infusion device because it only needs a small volume of the drug in this group patient.

The volume of fluids to be transmitted should be drawn from the vial and dilute 10 times with 0.9% Naci solution or 5% glucose (1 volume of Paracetamol Kabi ad 10mg/ml phase with 9 transmission volumes for dilution) and transmitted within 15 minutes.

Use 1 syringe 5 or 10ml to measure the dosage corresponding to the child's weight. However, each dose must not exceed 7.5ml.

Use drugs to comply with the instructions for the dose of the product.

To dilute Paracetamol Kabi ad 10mg/ml to see the compatibility of drug interaction.

Dosage

Intravenous injection dose.

100ml vials for adults, adolescents or children weighs> 33kg.

50ml vials for babies, children, children to practice and children weigh up to 33kg.

Dosage based on patient weight function (see the dose table below).

Weight

Dosage

Maximum daily dose of the day ≤33kg 15mg/kg 1.5ml/kg 49.5ml 60mg/kg, no more than 2g 3G

50kg, have more risk factors for liver poisoning 1G 100ml 100ml 3g Gan 1G 100ml 100ml

** Maximum dose of the day: The maximum dose of the day given in the table above is for patients to use other paracetamol products and need to be adjusted by the amount of use of these products.

*** Lighter weight patients need a smaller volume.

The minimum distance between use at least 4 hours.

The minimum distance between use in patients with severe renal impairment (creatinine clearance

The maximum dose of the day should not be over 3g for adults with liver cells, chronic alcoholism, poor nutrition for a long time (Low liver glutathione reserves), dehydration. Do not use more than 4 doses within 24 hours.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? In these cases, overdose can lead to death.

Symptoms of overdose

The common symptom appears within the first 24 hours including: nausea, vomiting, anorexia, pale and abdominal pain.

Overdose when used 1 time 7.5g paracetamol or more for adults or 1 time 140mg/kg for children leading to liver cell damage, can lead to non -recovery cirrhosis and resulting in liver cell failure, metabolic acidosis and brain disease. Thus, in this direction can lead to coma, sometimes leading to death. At the same time, the increase in the amount of liver transaminase (AST, ALT), lactat dehydrogenase and bilirubin comes with a decrease in prothrombin at 12 - 48 hours after taking the drug.

Clinical symptoms of liver lesions usually appear after 2 days, and reach a maximum after 4-6 days.

Overdose treatment

Transfer immediately to the hospital.

Before starting treatment, as soon as possible after an overdose, need to take blood to determine the amount of paracetamol in the blood.

Therapy includes detoxification, n-acetylcysteine (NAC) both by venous or orally, in the first 10 hours if possible. N-acetylcystein can also protect to a certain extent even after 10 hours, but in this case will need prolonged treatment.

Symptomatic treatment

Testing for liver function at the beginning of treatment and repeat after every 24 hours. Typically, the liver transaminase returns to normal for 1 to 2 weeks and the liver function recovers normally. However, the case is very heavy may need liver transplant.

Dialycemia can reduce paracetamol levels in plasma, but the effect is very limited.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Paracetamol Kabi ad, you may experience unwanted effects (ADR).

Rare, ADR

Transport disorders: Hypertension.

Systemic disorders and at the injection position: fatigue.

Testing: Increase transaminase.

Very rare, ADR

Disorders of blood and lymphatic systems: thrombocytopenia, neutropenia, grain leukocytes.

The immune system disorder: Hypersensitivity (from skin rash or itching to anaphylaxis should stop the drug immediately and treat), bronchospasm.

Unknown

Heart disorders: tachycardia.

Skin and subcutaneous tissue disorders: Red rash, blushing, itching.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Paracetamol Kabi ad drug is contraindicated in the following cases:

Hypersensitivity to paracetamol, propacetamol hydrochlorid (paracetamol's precursor) or any ingredient of the drug.

Heavy liver cell failure (Child-Pugh> 9).

Precautions when using

The risk of confusion

Be careful to avoid the wrong dose due to confusion between Miligam (Mg) and Mililit (ML). This confusion can lead to an overdose and death.

If you can take oral route, you should take an oral painkiller.

To avoid the risk of overdose, it is necessary to check to ensure that the patient has not used any other drug containing paracetamol or propacetamol hydrochlorid.

The dose is higher than the recommended dose that contains the risk of very serious liver damage. Clinical signs and symptoms of liver damage (including hepatitis outbreak, liver failure, cholestatic hepatitis, cirrhosis) are often not recognized for up to 2 days and up to 4-6 days after taking the drug. Need for antidote as soon as possible.

Pay special attention when using paracetamol under the following conditions:

Cell disorders and abnormal liver function (Child-Pugh

Liver disorders.

MaulreTht Gilbert syndrome (Hematopoppediale is family -soluble).

Severe renal failure (creatinine clearance

Chronic alcoholism.

Low -lasting malnutrition (Low liver glutathion reserves).

Completely nurtured through the injection (TPN).

Use enzyme induction.

Use toxic to the liver.

In patients with gene G6PD (Favism), after using paracetamol may appear hemolysis due to a decrease in glutathion distribution.

Dehydration.

Doctors should warn the patient about signs of serious skin reactions such as Steven-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (Ten) or Lyell, Systemic Syndrome: Acute Generalized Exanthematous Pustulosis (AGEP).

Powering and operating machinery

Paracetamol Kabi Ad does not affect the ability to drive and operate machinery.

Pregnancy

does not have much clinical experience in using paracetamol intravenously. However, the epidemiological data on the use of oral paracetamol shows that there is no unexpected effect on pregnant women or on the fetus/infant.

Predicted data on pregnant women shows that an overdose does not increase the risk of fetal deformities.

No animal reproduction studies have not been conducted in paracetamol. However, studies with oral drugs do not show any monsters or toxic effects for the fetus.

Despite this, only Paracetamol Kabi Ad is used for pregnant women after having carefully considered the benefits and risks. In this case, the dosage and duration of use should be closely monitored.

Breastfeeding period

After drinking, a small amount of paracetamol is excreted in milk. There has not been any desired effect on babies. Therefore, Paracetamol Kabi Ad can be used for women who are breastfeeding.

Drug interaction

Compatibility

Paracetamol Kabi ad 10mg/ml can be diluted in 9mg sodium chloride solution/ml (0.9%) or glucose solution 50mg/ml (5%) to 10 times (1 volume of Paracetamol Kabi AD 10mg/ml into 9 volumes of phase transmission).

The dilute solution must be tested by the eye and must be removed immediately if it is opaque or with a strange or precipitate.

Interactive

Probenecid causes about twice the clearing of paracetamol due to paracetamol bonding inhibitors with glucuronic acid. Paracetamol dose should be reduced if used simultaneously with probenecid.

salicylamid can extend the sale time of paracetamol.

Paracetamol metabolism is impaired in patients taking enzyme induction drugs such as rifampicin, barbiturates, 3 -round antidepressants, and some anti -epileptic drugs (carbamazepin, phenytoin, phenobarbital, primidone).

There have been single reports that describe the common toxicity on the liver in patients with alcohol or are taking enzyme induction drugs.

Simultaneously using paracetamol and chloramphenicol can extend the effect time of chloramphenicol.

Simultaneous use of paracetamol and azt (zidovudin) increases the trend of leukemia.

Concentrated Paracetamol with oral contraceptives can reduce the sale time of paracetamol.

Simultaneous use of paracetamol (4g/day for at least 4 days) with oral anticoagulants can lead to slight changes in Inr value. In this case, it is necessary to enhance the control of Inr value during simultaneous use of 2 drugs as well as 1 week after stopping treatment with paracetamol.

Storage

Store at temperatures not exceeding 30 ° C. No storage in refrigerators or freezing.

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