NEXIUM Hp7 esomeprazole tablet, amoxicillin capsule and clarithromycin tablet composite pack blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

esomeprazole magnesium trihydrate, Quantity: 22.3 mg (Equivalent: esomeprazole, Qty 20 mg)

제공처:

AstraZeneca Pty Ltd

INN (국제 이름):

amoxicillin trihydrate,Clarithromycin,esomeprazole magnesium trihydrate

약제 형태:

Tablet, enteric coated

구성:

Excipient Ingredients: microcrystalline cellulose; crospovidone; purified talc; iron oxide yellow; sodium stearylfumarate; synthetic paraffin; methacrylic acid copolymer; hypromellose; hyprolose; triethyl citrate; iron oxide red; magnesium stearate; polysorbate 80; glyceryl monostearate; titanium dioxide; macrogol 6000; maize starch; sucrose

관리 경로:

Oral

패키지 단위:

14 esomeprazole 20mg tablets, 14 clarithromycin 500mg tablets, 28 amoxycillin 500mg tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Healing of duodenal ulcer associated with Helicobacter pylori and eradication of Helicobacter pylori in patients with active or healed peptic ulcer.

제품 요약:

Visual Identification: A light pink, oblong, biconvex, film-coated tablet with '20mg' on one side and 'A/EH' on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 34 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2016-12-07

환자 정보 전단

NEXIUM
® HP7
®
_esomeprazole, amoxicillin and clarithromycin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
NEXIUM Hp7. It does not contain
all the available information about
NEXIUM Hp7.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
NEXIUM Hp7 against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THESE MEDICINES, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINES.
You may need to read it again.
WHAT NEXIUM HP7 IS
USED FOR
NEXIUM Hp7 is a combination
pack, which contains three different
medicines. When taken together in
the right doses, they will kill the
bacteria in your stomach called
Helicobacter pylori and let your
peptic ulcer heal.
Depending on the position of the
ulcer it is called a gastric or duodenal
ulcer. A gastric ulcer occurs in the
stomach. A duodenal ulcer occurs in
the duodenum which is the tube
leading out from the stomach.
Most people who have a peptic ulcer
also have a bacterium called
Helicobacter pylori in their stomach.
If the bacteria are killed it is unlikely
that your ulcer will come back.
NEXIUM is the brand name of
esomeprazole (E), and it is given
with amoxicillin (A), brand name
Amoxil and clarithromycin (C),
brand name Klacid. Amoxil and
Klacid are both types of antibiotic.
_HOW NEXIUM HP7 WORKS_
NEXIUM is a type of medicine
called a proton-pump inhibitor.
NEXIUM works by decreasing the
amount of acid made by the stomach,
to give relief of symptoms and allow
healing to take place. This does not
stop food being digested in the
normal way.
Amoxicillin and clarithromycin are
both antibiotics that help kill
Helicobacter pylori. NEXIUM also
helps kill the bacteria. When all three
are taken together they are more
effective than taken one or two at a
time. It is possible that the antibiotics
may not always kill Helicobacter
pylori.
ASK YOUR DOCTO

제품 특성 요약

Nexium
®
Hp7
®
Product Information
Doc ID-002256762 v 26.0
1(36)
This document refers to the use of esomeprazole, amoxicillin and
clarithromycin in
combination for the healing of patients with duodenal ulcer associated
with
_Helicobacter pylori_ and for the eradication of _Helicobacter pylori_
in patients with
active or healed peptic ulcer. The components of this therapy are
frequently used to
treat other conditions. For information about the treatment of other
conditions, refer
to full Product Information for the appropriate component.
AUSTRALIAN PRODUCT INFORMATION
NEXIUM
® HP7
®
(ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, AMOXICILLIN
TRIHYDRATE, CLARITHROMYCIN)
1.
NAME OF THE MEDICINE
NEXIUM Hp7 is a combination pack containing:
•
esomeprazole magnesium trihydrate
•
amoxicillin trihydrate
•
clarithromycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NEXIUM
The active ingredient in NEXIUM is esomeprazole magnesium trihydrate,
a
substituted benzimidazole. NEXIUM 20 mg tablets contain esomeprazole
magnesium trihydrate 22.3 mg as the active ingredient.
AMOXIL
The active ingredient in AMOXIL is amoxicillin trihydrate. AMOXIL 500
mg capsule
contains amoxicillin trihydrate equivalent to amoxicillin 500 mg.
KLACID
The active ingredient in KLACID is clarithromycin. KLACID tablets
contain
clarithromycin 500 mg.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
NEXIUM Hp7 consists of:
•
NEXIUM 20 mg tablets which are light pink, oblong, biconvex,
film-coated
tablets
Nexium
®
Hp7
®
Product Information
Doc ID-002256762 v 26.0
2(36)
•
AMOXIL 500 mg capsules which are red/yellow, hard, gelatin capsules
•
KLACID 500 mg tablets which are pale yellow, smooth, film-coated
ovaloid
tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Healing of duodenal ulcer associated with _Helicobacter pylori_ and
eradication of
_Helicobacter pylori_ in patients with active or healed peptic ulcer.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage regimen of NEXIUM Hp7 is NEXIU