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AKIS Solution for injection (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

AKIS 75 mg/ml solution for injection.

Qualitative and quantitative composition

The active ingredient is diclofenac sodium. <u>Each 1 ml ampoule contains:</u> 75 mg of diclofenac sodium. For a full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. Clear to slightly amber coloured transparent solution.

Therapeutic indications

<u>By intramuscular and subcutaneous injection:</u> AKIS Solution for Injection is effective in acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, acute back ...

Posology and method of administration

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). Posology Adults ...

Contraindications

Known hypersensitivity to the active substance or to any of the excipients. Active gastric or intestinal ulcer, bleeding or perforation. History of gastrointestinal bleeding or perforation related to previous ...

Special warnings and precautions for use

General Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and GI and cardiovascular risks below). The concomitant ...

Interaction with other medicinal products and other forms of interaction

The following interactions include those observed with Diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac. <u>Lithium:</u> NSAIDs have been reported to increase blood lithium ...

Fertility, pregnancy and lactation

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...

Effects on ability to drive and use machines

Patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking Diclofenac, should refrain from driving or using machines.

Undesirable effects

Clinical trials The most common undesirable effects observed during clinical trials with AKIS are gastrointestinal in nature or injection site reactions which are generally mild and transitory. Clinical ...

Overdose

Symptoms There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. ...

Pharmacodynamic properties

Pharmacotherapeutic category: non-steroidal antinflammatory drugs (NSAIDs) ATC Code: M01AB05 It is therapeutic subgroup classification: musculo-skeletal system/anti-inflammatory and antirheumatic products/ ...

Pharmacokinetic properties

Absorption Intramuscular injection After administration of AKIS 75 mg/ml Solution for Injection by the i.m. route, absorption is rapid and the mean peak plasma concentration of 2.603 ± 0.959 µg/ml (2.5 ...

Preclinical safety data

No new preclinical safety studies have been performed on sodium diclofenac. The safety profile of the medicinal product is well-established. The local tolerance study demonstrated that the formulation ...

List of excipients

Hydroxypropylbetadex Polysorbate 20 Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

2 years. The medicinal product must be used immediately after opening any remaining solution must be discarded.

Special precautions for storage

Store below 25°C. Do not refrigerate or freeze. Store in the original packaging in order to protect from light.

Nature and contents of container

Transparent type I glass ampoule. Package of 1, 3 and 5 ampoules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

An additional overfill is included in each ampoule to ensure that 1.0 mL of solution can be extracted. Ampoules: No special requirements. The product should not be used if crystals or precipitates are ...

Marketing authorization holder

IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900, Lodi (Italy)

Marketing authorization number(s)

PL 21039/0042

Date of first authorization / renewal of the authorization

13/10/2017

Date of revision of the text

20/12/2020

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