Zerit

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Stavudine 15mg

제공처:

Bristol-Myers Squibb (NZ) Limited

INN (국제 이름):

Stavudine 15 mg

복용량:

15 mg

약제 형태:

Capsule

구성:

Active: Stavudine 15mg Excipient: Gelatin Lactose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

패키지 단위:

Blister pack, (not marketed), 56 capsules

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company

치료 징후:

ZERIT (stavudine) is indicated for the treatment of HIV infection in adults and paediatric patients, in combination with other anti-retrovirals.

제품 요약:

Package - Contents - Shelf Life: Blister pack, - 56 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 60 capsules - 24 months from date of manufacture stored at or below 30°C

승인 날짜:

1996-05-20

제품 특성 요약

Zerit version number 5.0
1
DATA SHEET
1
PRODUCT NAME
Zerit

stavudine capsules 40mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zerit 40 mg hard capsules
Each hard capsule contains 40 mg of stavudine.
Excipients with known effect
Each hard capsule contains 159.06 mg of lactose anhydrous.
Each hard capsule contains 79.53 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
PRODUCT STRENGTH AND PACK
CAPSULE SHELL COLOUR
MARKINGS ON CAPSULE
(IN BLACK INK)
40mg
60’s (bottle)
56’s (carton)
Dark orange
BMS
1967
40
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zerit (stavudine) is indicated for the treatment of HIV infection in
adults (12 years of age or older)
and paediatric patients greater than 30kg in weight, in combination
with other anti-retrovirals
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS (12 YEARS OF AGE OR OLDER)
The recommended starting dosage based on body weight is as follows:
40mg every 12 hours for patients

60kg
30mg every 12 hours for patients <60kg
PAEDIATRIC PATIENTS
1mg/kg every 12 hours for patients <30kg *
30mg every 12 hours for patients

30 to <60kg
Zerit version number 5.0
2
* Zerit capsules should not be used in patients < 30kg because an
appropriate dose cannot be given
with the currently available capsule strengths.
When Zerit is taken with food, peak plasma levels are altered, but
overall exposure is unchanged (see
5.2 Pharmacokinetic properties). The clinical significance of this is
unknown.
DOSAGE ADJUSTMENT IN PATIENTS WITH PERIPHERAL NEUROPATHY
Patients should be monitored for the development of peripheral
neuropathy, which is usually
characterised by numbness, tingling, or pain in the feet or hands. If
these symptoms develop, Zerit
therapy should be interrupted. Symptoms may resolve if therapy is
withdrawn promptly. Some
patients may experience a temporary worsening of symptoms following
discontinuation of therapy. If
symptoms resolve satisfactorily, resumption of treatment with Zerit
may be considered using half the
rec