TARGINACT Prolonged release tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
TarginAct 5 mg/2,5 mg. TarginAct 10 mg/5 mg. TarginAct 20 mg/10 mg. TarginAct 40 mg/20 mg. <u>Strength:</u> 5 mg/2,5 mg. 10 mg/5 mg. 20 mg/10 mg. 40 mg/20 mg. <u>Pharmaceutical form:</u> Prolonged Release ...
2. Qualitative and quantitative composition
Qualitative declaration Oxycodone hydrochloride and naloxone hydrochloride. Quantitative declaration Each TarginAct 5 mg/2,5 mg contains 5 mg oxycodone hydrochloride and 2,5 mg naloxone hydrochloride. ...
3. Pharmaceutical form
Prolonged Release Tablets. TarginAct 5 mg/2,5 mg is a blue capsule shaped tablet, marked OXN on one side and 5 on the other side. TarginAct 10 mg/5 mg is a white capsule shaped tablet, marked OXN on one ...
4.1. Therapeutic indications
TarginAct is indicated for the treatment of moderate to severe pain, which requires the use of an opioid analgesic. TarginAct is indicated as second line symptomatic treatment of patients with severe to ...
4.2. Posology and method of administration
Posology TarginAct is for oral administration and must be swallowed whole and not broken or chewed. It may be taken with or without food with sufficient liquid. Pain The dosage should be adjusted to the ...
4.3. Contraindications
TarginAct is contraindicated in patients with known hypersensitivity to the active substances or to any of the excipients. Any situation where opioids are contraindicated. Severe respiratory depression ...
4.4. Special warnings and precautions for use
The major risk of all opioid excess is respiratory depression. Caution must be exercised when administering TarginAct to elderly or infirm patients, patients with opioid-induced paralytic ileus, patients ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed in adults. The concomitant use of opioids with sedative medicines such as benzodiazepines or related medicine increases the risk of sedation, respiratory depression, ...
4.6. Fertility, pregnancy and lactation
Pregnancy TarginAct is not recommended for use in pregnancy or during labour. Both oxycodone and naloxone pass into the placenta. Long-term administration of oxycodone during pregnancy may lead to withdrawal ...
4.7. Effects on ability to drive and use machines
TarginAct may impair the ability to drive and use machines. This is particularly likely at the beginning of treatment with TarginAct, after dose increase or product rotation and if TarginAct is combined ...
4.8. Undesirable effects
The reactions are listed as MeDRA preferred term by system organ class and absolute frequency. Body<br />System Frequency of Occurrence Very<br />Common <br /> ≥10% Common<br /> ≥1% and<br /> <10% ...
4.9. Overdose
Symptoms of intoxication Depending on the history of the patient, an overdose of TarginAct may be manifested by symptoms that are either triggered by oxycodone (opioid receptor agonist) or by naloxone ...
5.1. Pharmacodynamic properties
A 2.9 Other Analgesics <b>ATC code:</b> N02AA55 Oxycodone and naloxone have an affinity for kappa, mu and delta opiate receptors in the brain, spinal cord and peripheral organs (e.g. intestine). Oxycodone ...
5.2. Pharmacokinetic properties
Oxycodone Absorption Oxycodone has an absolute bioavailability of up to 87% following oral administration. Distribution Following absorption, oxycodone is distributed throughout the entire body. Approximately ...
5.3. Preclinical safety data
There are no preclinical data pertaining to the genotoxicity/ carcinogenicity/ reproductive toxicity of the combination of oxycodone and naloxone at the 2:1 ratio. The data presented here are for studies ...
6.1. List of excipients
<u>Tablet core:</u> ethylcellulose, lactose monohydrate, magnesium stearate, stearyl alcohol, talc. TarginAct 5 mg/2,5 mg contains hydroxypropylcellulose. TarginAct 10 mg/5 mg; 20 mg/10 mg and 40 mg/20 ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store at or below 25°C. Do not remove from the outer carton until required for use.
6.5. Nature and contents of container
TarginAct is supplied in clear PVC and silver aluminium foil blister packs of 28, which are enclosed in a cardboard carton.
7. Marketing authorization holder
Mundipharma (Pty) Ltd, Block D, Grosvenor Square, Park Lane, Century City, 7441, Cape Town, South Africa
8. Marketing authorization number(s)
<u>South Africa:</u> S6 TarginAct 5 mg/2,5 mg: 46/2.9/0645 TarginAct 10 mg/5 mg: 46/2.9/0646 TarginAct 20 mg/10 mg: 46/2.9/0647 TarginAct 40 mg/20 mg: 46/2.9/0648 <u>Namibia:</u> NS4 TarginAct 5 mg/2,5 ...
9. Date of first authorization / renewal of the authorization
06 August 2015
10. Date of revision of the text
10 March 2022
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