TARGIN 10

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

NALOXONE HYDROCHLORIDE (AS DIHYDRATE); OXYCODONE HYDROCHLORIDE

제공처:

RAFA LABORATORIES LTD

ATC 코드:

V03AB15

약제 형태:

TABLETS PROLONGED RELEASE

구성:

OXYCODONE HYDROCHLORIDE 10 MG; NALOXONE HYDROCHLORIDE (AS DIHYDRATE) 5 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

치료 그룹:

NALOXONE

치료 영역:

NALOXONE

치료 징후:

Targin is indicated for the relief of moderate to severe pain.The oxycodone component is indicated for the relief of moderate to severe pain in adults who require continuous around-the-clock opioid analgesia for several days or more. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.

승인 날짜:

2023-12-31

환자 정보 전단

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
TARGIN 5, TARGIN 10, TARGIN 20, TARGIN 30, TARGIN 40
PROLONGED RELEASE TABLETS
ACTIVE INGREDIENTS:
PRODUCT
Oxycodone hydrochloride
(Oxycodone HCl)
Naloxone hydrochloride
(Naloxone HCl)
TARGIN 5
5 mg
2.5 mg
TARGIN 10
10 mg
5 mg
TARGIN 20
20 mg
10 mg
TARGIN 30
30 mg
15 mg
TARGIN 40
40 mg
20 mg
For the list of additional ingredients, see section 6. See also
‘Important information about some of
the medicine’s ingredients’ in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions,
please refer to your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
it seems to you that their medical condition is similar to yours.
Medicines of the opioids group may cause addiction, especially with
prolonged use and they
have a potential for misuse and overdose. A reaction to an overdose
may be manifested by slow
breathing and may even cause death.
Make sure you know the name of the medicine, the dosage that you take,
how often you take it,
the duration of treatment, potential side effects and risks.
Additional information regarding the risk of dependence and addiction
can be found at the link:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf
Taking this medicine along with medicines from the benzodiazepines
group, other medicines which
depress the central nervous system (including drugs) or alcohol may
cause a feeling of profound
drowsiness, breathing difficulties (respiratory depression), coma and
death.
1. WHAT IS THE MEDICINE INTENDED FOR?
Targin is intended for the relief of moderate to severe pain. Targin
has two active ingredients,
oxycodone and naloxone. The oxycodone is intended for the relief of
moderate to severe pain in
adults who need opioid pain relief throughout the en

제품 특성 요약

1
DL-Targin -SPC-21-September- 2023- 08
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
_Targin 5_, _Targin 10, Targin 20, Targin 30_, _Targin 40 _
_ _
Prolonged-release tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Targin 5 _
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride
equivalent to 4.5 mg oxycodone, and
2.73 mg of naloxone hydrochloride dihydrate equivalent to 2.5 mg
naloxone hydrochloride and 2.25 mg naloxone.
_Targin 10 _
Each prolonged-release tablet contains 10 mg of oxycodone
hydrochloride equivalent to 9 mg oxycodone, and
5.45 mg of naloxone hydrochloride dihydrate equivalent to 5 mg
naloxone hydrochloride and 4.5 mg naloxone.
_Targin 20 _
Each prolonged-release tablet contains 20 mg of oxycodone
hydrochloride equivalent to 18 mg oxycodone, and
10.9 mg of naloxone hydrochloride dihydrate equivalent to 10 mg
naloxone hydrochloride and 9 mg naloxone.
_Targin 30 _
Each prolonged-release tablet contains 30 mg of oxycodone
hydrochloride equivalent to 27 mg oxycodone, and
16.48 mg of naloxone hydrochloride dihydrate equivalent to 15 mg
naloxone hydrochloride and 13.5 mg naloxone.
_ _
_Targin 40 _
Each prolonged-release tablet contains 40 mg of oxycodone
hydrochloride equivalent to 36 mg oxycodone, and
21.8 mg of naloxone hydrochloride dihydrate equivalent to 20 mg
naloxone hydrochloride and 18 mg naloxone.
Excipient with known effect:
Each tablet of _Targin 5_ contains 71.75 mg lactose monohydrate.
Each tablet of _Targin 10_ contains 64.25 mg lactose monohydrate.
Each tablet of _Targin 20_ contains 54.5 mg lactose monohydrate.
Each tablet of _Targin 30_ contains 38.42 mg lactose monohydrate.
Each tablet of _Targin 40_ contains 109 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged-release tablets.
_ _
_Targin 5_ are oblong, blue film-coated tablets, unscored and marked
“OXN” on one side and “5” on the other side.
_Targin 10_ are oblong, white film-coated tablets, unscored and marked
“OXN” on