PARACONICA Solution for infusion (2012)

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Περιεχόμενα

1. Name of the medicinal product

Paraconica 1 g I.V.

2. Qualitative and quantitative composition

Active substance: paracetamol 10 mg/mL.

3. Pharmaceutical form

Solution for infusion: 1 vial contains 1 g paracetamol in 100 mL.

4.1. Therapeutic indications

For short-term treatment of mild to moderately severe pain when oral administration is not possible (e.g. immediately post-operatively, when non-steroidal anti-inflammatory agents are often contraindicated). ...

4.2. Posology and method of administration

Use of the product Paraconica 1 g I.V. is restricted to patients weighing more than 33 kg. Administration Paraconica is a ready-to-use solution. It is administered as a 15-minute I.V. infusion. Efficacy ...

4.3. Contraindications

Hypersensitivity reactions to paracetamol, propacetamol (prodrug of paracetamol) or any of the excipients in the composition (see the section Composition). Glucose-6-phosphate dehydrogenase deficiency ...

4.4. Special warnings and precautions for use

Paracetamol should be used with caution in cases of: hepatocellular insufficiency, severe renal insufficiency (creatinine clearance ≤30 mL/min; see Pharmacokinetics), chronic alcoholism, concomitant administration ...

4.5. Interaction with other medicinal products and other forms of interaction

The concomitant use of Paraconica with other medicines can increase the likelihood of undesirable effects. Co-medication with phenytoin can lead to decreased efficacy of paracetamol and, due to the increase ...

4.6. Pregnancy and lactation

Pregnancy Animal reproductive toxicity studies have not been conducted with the intravenous form of paracetamol. However, studies on oral administration revealed no malformations or foetotoxic effects. ...

4.7. Effects on ability to drive and use machines

No such studies have been performed.

4.8. Undesirable effects

Blood and lymphatic system disorders Rare: allergy-related thrombocytopenia, haemolysis, leukopenia, pancytopenia, neutropenia, agranulocytosis Immune system disorders Very rare: allergic ...

4.9. Overdose

There is a risk of intoxication especially in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in chronically malnourished patients and in patients receiving ...

5.1. Pharmacodynamic properties

ATC code: N02BE01 Mechanism of action Paraconica, with the active substance paracetamol, is an analgesic and antipyretic which contains no salicylic acid or opioids. Regarding the analgesic action ...

5.2. Pharmacokinetic properties

Absorption The pharmacokinetics of paracetamol in adults is linear up to a dose of 2 g, administered as a single dose and after repeated administration over 24 hours. The peak plasma concentration (C ...

5.3. Preclinical safety data

Preclinical data indicate no special hazards for humans beyond the information in other sections of this prescribing information. Local tolerability studies of paracetamol I.V. in rats and rabbits showed ...

6.1. List of excipients

Mannitol, disodium phosphate dihydrate, antioxidant: cysteine hydrochloride monohydrate 25 mg, water for injections q.s.p. 100 mL.

6.2. Incompatibilities

It is recommended not to mix Paraconica with other medicinal products without first checking compatibility.

6.3. Shelf life

Note the expiry date. The solution for infusion contains no preservatives and should, for microbiological reasons, be used immediately after opening. Any remaining solution must be discarded. Stability ...

6.4. Special precautions for storage

Store at room temperature (15-25°C). Must not be stored in the refrigerator. Do not freeze. Protect from light.

6.5. Nature and contents of container

Paraconica 1 g I.V. solution for infusion: 10 100 mL vials (hospital pack).

6.6. Special precautions for disposal and other handling

Notes on handling Prior to use, Paraconica should be checked for particles and discolouration. The solution should be clear and colourless. Impact of diagnostic methods Paracetamol can cause false results ...

7. Marketing authorization holder

Acino Pharma AG, Liesberg

8. Marketing authorization number(s)

62711 (Swissmedic)

10. Date of revision of the text

December 2012

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