natgillin/translations-raw huggingface dataset:
Der er rapporteret reversibel øgning af serum- lithiumkoncentrationer og toksicitet ved samtidig administration af lithium og angiotensin- konverterende enzymhæmmere.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Såfremt samtidig administration skønnes nødvendig, anbefales det at kontrollere serum - lithiumværdier omhyggeligt.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Når angiotensin II- antagonister administreres samtidig med nonsteroide antiinflammatoriske lægemidler (fx selektive COX- 2 hæmmere, acetylsalicylsyre (> 3 g/ dag) og nonselektive NSAID) kan den antihypertensive virkning svækkes.
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i. e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Det gælder især hos patienter som i forvejen har dårlig nyrefunktion.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
34 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Imidlertid kan en lille øget risiko ikke udelukkes.
34 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Det vides ikke om irbesartan udskilles i human modermælk.
Aprovel is contraindicated (see section 4.3) during breast-feeding. It is not known whether irbesartan is excreted in human milk.
35 Undersøgelser:
35 Common:
Voldsom træthed Brystsmerter
fatigue chest pain
Ualmindelig:
Uncommon: sexual dysfunction
36 Hud og subkutane væv:
Skin and subcutaneous tissue disorders:
Metabolisme og ernæring:
36 Metabolism and nutrition disorders:
I et randomiseret forsøg med 318 hypertensive børn og unge i aldersgruppen 6 til 16 år sås følgende relaterede bivirkninger i den 3- ugers dobbeltblinde fase: hovedpine (7, 9%), hypotension (2, 2%), svimmelhed (1, 9%), hoste (0, 9%).
Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Erfaringerne med behandling af voksne, med doser op til 900 mg/ dag i 8 uger, viste ingen toksicitet.
Experience in adults exposed to doses of up to 900 mg/ day for 8 weeks revealed no toxicity.
Der kan også opstå bradykardi på grund af overdosering.
The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Farmakoterapeutisk klassifikation: angiotensinII- antagonister, almindelige.
Angiotensin-II antagonists, plain.
Irbesartan er en potent, oral aktiv, selektiv angiotensin- II receptor (type AT1) antagonist.
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
24 timer efter dosering) som i gennemsnit er 8- 13/ 5- 8 mm Hg (systolisk/ diastolisk) større end ved placebo- behandling.
24 hours after dosing) by an average of 8-13/ 5-8 mm Hg (systolic/ diastolic) greater than those associated with placebo.
150 mg, 1 gang dagligt, gav minimums - og gennemsnitlig 24 timers respons svarende til samme døgndosis givet 2 gange dagligt..
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Der er ikke observert rebound - hypertension.
Rebound hypertension has not been observed.
Den blodtrykssænkende effekt af irbesartan og diuretika af thiazidtypen er additiv.
37 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Reduktion af blodtryk med 0, 5 mg/ kg (lav), 1, 5 mg/ kg (middel) og 4, 5 mg/ kg (høj) mål- titrerede doser af irbesartan evalueredes, over en periode på 3 uger, hos 318 børn og unge med hypertension eller med risiko for at udvikle hypertension (diabetes, familiær disposition for hypertension) i aldersgruppen 6 til 16 år.
Reduction of blood pressure with 0.5 mg/ kg (low), 1.5 mg/ kg (medium) and 4.5 mg/ kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Hos 1. 715 hypertensive patienter med type2- diabetes, proteinuri ≥ 900 mg/ dag og serum - kreatininværdier i intervallet 1, 0- 3, 0 mg/ dl, evalueredes langtidseffekterne (median 2, 6 år) ved Aprovel med henblik på progression af nyresygdom og totalmortalitet.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of Aprovel on the progression of renal disease and all-cause mortality were examined.
I samtlige af behandlingsgrupperne fik patienterne typisk mellem 2 og 4 antihypertensive lægemidler (f. eks. diuretikum, betablokkere, alfablokkere) for at opnå en foruddefineret blodtryksværdi på ≤ 135/ 85 mmHg eller en 10 mmHg reduktion i systolisk tryk, hvis baseline var > 160 mmHg.
Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e. g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/ 85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Irbesartan reducerede signifikant den relative risiko i det kombinerede primære endepunkt med fordobling af serum- kreatinin, slutstadium af nyresygdom (ESRD) eller totalmortalitet.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all- cause mortality.
33% af patienterne i irbesartan gruppen nåede det primære kombinerede nyreendepunkt sammenlignet med henholdsvis 39% og 41% i placebo - og amlodipin- gruppen (20% relativ risikoreduktion versus placebo (p= 0, 024) og 23% relativ risiko reduktion sammenlignet med amlodipin (p= 0, 006).
Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
38 kvinder og sorte patienter, henholdsvis 32% og 26% af den samlede forsøgspopulation, sås der ingen evidens for nyrefordel, selvom sikkerhedsintervallerne ikke udelukker det.
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it.
Der sås forøget hyppighed af ikke- fatalt MI hos kvinder og en reduceret hyppighed af ikke- faltalt MI hos mænd i irbesartan - gruppen versus det placebo- baserede regime. Alligevel var der ingen foskel blandt de tre grupper i den overordnede population, hvad angår det sekundære endepunkt af fatal og ikke- fatal kardiovaskulær hændelse.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
Der sås øget hyppighed af ikke fatalt MI og slagtilfælde hos kvinder i det irbesartan - baserede regime versus det amlodipin- baserede regime, mens frekvensen af hospitalindlæggelse på grund af hjertefejl blev reduceret i den samlede population.
An increased incidence of non-fatal MI and stroke was seen in females in the irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart failure was reduced in the overall population.
IRMA 2- studiet (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus) viste, at irbesartan 300 mg forsinker progression til klinisk proteinuri hos patienter med mikroalbuminuri.
38 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
IRMA 2 var et placebo- kontrolleret dobbeltblindt morbiditetsstudie med 590 patienter med type 2- diabetes, mikroalbuminuri (30- 300 mg/ dag) og normal nyrefunktion (serum- kreatinin ≤ 1, 5 mg/ dl hos mænd og < 1, 1 mg/ dl hos kvinder).
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/ day) and normal renal function (serum creatinine ≤ 1.5 mg/ dl in males and < 1.1 mg/ dl in females).
Yderligere antihypertensive præparater (eksklusiv ACE- hæmmere, angiotensin II- receptor antagonister og dihydropyridin - calciumblokkere) blev tilføjet efter behov for at nå blodtryksmålet.
Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Der var dog færre patienter i irbesartan- gruppen der fik 300 mg (5, 2%) som nåede endepunktet, klinisk proteinuri, sammenlignet med placebo- gruppen (14, 9%) og irbesartan- gruppen der fik 150 mg (9, 7%), hvilket viste en relativ risikoreduktion på 70% versus placebo (p= 0, 0004) ved den højere dosis.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Forhaling af progression til klinisk proteinuri var tydelig allerede efter 3 måneder og den varede ved gennem hele 2- års perioden.
The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Fordelingsvolumenet er 53- 93 liter.
The volume of distribution is 53 - 93 litres.
Efter oral eller intravenøs administration af 14C irbesartan, kan 80- 85% af den cirkulerende radioaktivitet i plasma tilskrives uomdannet irbesartan.
Following oral or intravenous administration 14 of C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
In vitro- undersøgelser viser, at irbesartan primært oxideres af cytokrom P450 enzymet CYP2C9. Isoenzym CYP3A4 har kun ubetydelig effekt.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Der blev observeret en mindre end proportional øgning af oral absorption ved doser over 600 mg (2 gange den maksimale anbefalede dosis). Årsagen til dette er ukendt.
A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Spidskoncentrationen i plasma opnås 1, 5- 2 timer efter oral administration.
Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Total body - og nyre- clearance er henholdsvis 157- 176 og 3- 3, 5 ml/ min.
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/ min, respectively.
Den terminale halveringstid for irbesartan er 11- 15 timer.
The terminal elimination half-life of irbesartan is 11 - 15 hours.
Steady- state plasmakoncentrationen nås i løbet af 3 dage efter påbegyndelse af behandling 1 gang dagligt.
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Irbesartan AUC - og Cmax - værdier var også noget større hos ældre patienter (≥ 65 år) end hos yngre patienter (18- 40 år).
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40 years).
39 Farmakokinetik af irbesartan evalueredes hos 23 hypertensive børn efter administration af enkeltdosis irbesartan og gentagne doser irbesartan (2 mg/ kg) i doser på op til maksimalt 150 mg dagligt i 4 uger.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
39 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med mild/ moderat cirrhose.
Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Hypromellose Silikondioxid Magnesiumstearat.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
Lactosemonohydrat Hypromellose Titandioxid (E171) Macrogol 3000 Carnaubavoks.
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000 Carnauba wax.
40 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 4 Særlige opbevaringsforhold
40 6.4 Special precautions for storage
Æsker med 14 filmovertrukne tabletter:
Cartons of 14 film-coated tablets:
1 blisterkort med 14 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
1 blister card of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 28 filmovertrukne tabletter:
Cartons of 28 film-coated tablets:
2 blisterkort med 14 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
2 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 30 filmovertrukne tabletter:
Cartons of 30 film-coated tablets:
2 blisterkort med 15 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
2 blister cards of 15 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 56 filmovertrukne tabletter:
Cartons of 56 film-coated tablets:
4 blisterkort med 14 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
4 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 84 filmovertrukne tabletter:
Cartons of 84 film-coated tablets:
6 blisterkort med 14 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
6 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 90 filmovertrukne tabletter:
Cartons of 90 film-coated tablets:
6 blisterkort med 15 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
6 blister cards of 15 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 98 filmovertrukne tabletter:
Cartons of 98 film-coated tablets:
7 blisterkort med 14 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
7 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Æsker med 56 x 1 filmovertrukne tabletter; 7 blisterkort med 8 x 1 filmovertrukken tablet i hvert perforeret PVC/ PVDC/ aluminiumblister med éngangsdoser.
Cartons of 56 x 1 film-coated tablet; 7 blister cards of 8 x 1 film-coated tablet each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
27. august 1997
27 August 1997 Date of latest renewal:
51, 00 mg lactosemonohydrat per tablet.
51.00 mg of lactose monohydrate per film-coated tablet.
4. 3 Kontraindikationer
42 4.3 Contraindications
44 Graviditet:
Pregnancy:
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA skønnes nødvendig.
43 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
45 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Imidlertid kan en lille øget risiko ikke udelukkes.
44 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
46 Undersøgelser:
Investigations:
Almindelig:
45 Common:
47 Hud og subkutane væv:
Skin and subcutaneous tissue disorders:
Metabolisme og ernæring:
46 Metabolism and nutrition disorders:
Den blodtrykssænkende effekt af irbesartan og diuretika af thiazidtypen er additiv.
47 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
49 kvinder og sorte patienter, henholdsvis 32% og 26% af den samlede forsøgspopulation, sås der ingen evidens for nyrefordel, selvom sikkerhedsintervallerne ikke udelukker det.
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it.
IRMA 2- studiet (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus) viste, at irbesartan 300 mg forsinker progression til klinisk proteinuri hos patienter med mikroalbuminuri.
48 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
50 Farmakokinetik af irbesartan evalueredes hos 23 hypertensive børn efter administration af enkeltdosis irbesartan og gentagne doser irbesartan (2 mg/ kg) i doser på op til maksimalt 150 mg dagligt i 4 uger.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
49 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
51 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 4 Særlige opbevaringsforhold
50 6.4 Special precautions for storage
102, 00 mg lactosemonohydrat per tablet.
102.00 mg of lactose monohydrate per film-coated tablet.
4. 3 Kontraindikationer
52 4.3 Contraindications
55 Graviditet:
Pregnancy:
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA skønnes nødvendig.
53 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
56 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Imidlertid kan en lille øget risiko ikke udelukkes.
54 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
57 Undersøgelser:
Investigations:
Almindelig:
55 Common:
58 Hud og subkutane væv:
Skin and subcutaneous tissue disorders:
Metabolisme og ernæring:
56 Metabolism and nutrition disorders:
Den blodtrykssænkende effekt af irbesartan og diuretika af thiazidtypen er additiv.
57 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
60 kvinder og sorte patienter, henholdsvis 32% og 26% af den samlede forsøgspopulation, sås der ingen evidens for nyrefordel, selvom sikkerhedsintervallerne ikke udelukker det.
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it.
IRMA 2- studiet (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus) viste, at irbesartan 300 mg forsinker progression til klinisk proteinuri hos patienter med mikroalbuminuri.
58 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
61 Farmakokinetik af irbesartan evalueredes hos 23 hypertensive børn efter administration af enkeltdosis irbesartan og gentagne doser irbesartan (2 mg/ kg) i doser på op til maksimalt 150 mg dagligt i 4 uger.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
59 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
62 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 4 Særlige opbevaringsforhold
60 6.4 Special precautions for storage
3 blisterkort med 10 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
3 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
9 blisterkort med 10 filmovertrukne tabletter i PVC/ PVDC/ aluminiumblistere.
9 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
64 BILAG II
61 ANNEX II
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F- 33565 Carbon Blanc Cedex Frankrig
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Sanofi- Synthelabo Limited Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT Storbritannien
Sanofi-Synthelabo Limited Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT United Kingdom
Sanofi Winthrop Industrie 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 Frankrig
Sanofi Winthrop Industrie 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 France
Pharmacovigilancesystem Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilancesystemet, som beskrevet i version 3. 0 i Modul 1. 8. 1 i ansøgningen om markedsføringstilladelse, er på plads og fungerer før og så længe produktet er markedsført.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
66 BILAG III
63 ANNEX III
68 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
EU/ 1/ 97/ 046/ 010 14 tabletter EU/ 1/ 97/ 046/ 001 28 tabletter EU/ 1/ 97/ 046/ 002 56 tabletter EU/ 1/ 97/ 046/ 013 56 x 1 tabletter EU/ 1/ 97/ 046/ 003 98 tabletter
EU/ 1/ 97/ 046/ 010 14 tablets EU/ 1/ 97/ 046/ 001 28 tablets EU/ 1/ 97/ 046/ 002 56 tablets EU/ 1/ 97/ 046/ 013 56 x 1 tablets EU/ 1/ 97/ 046/ 003 98 tablets
70 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
67 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
71 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
EU/ 1/ 97/ 046/ 011 14 tabletter EU/ 1/ 97/ 046/ 004 28 tabletter EU/ 1/ 97/ 046/ 005 56 tabletter EU/ 1/ 97/ 046/ 014 56 x 1 tabletter EU/ 1/ 97/ 046/ 006 98 tabletter
EU/ 1/ 97/ 046/ 011 14 tablets EU/ 1/ 97/ 046/ 004 28 tablets EU/ 1/ 97/ 046/ 005 56 tablets EU/ 1/ 97/ 046/ 014 56 x 1 tablets EU/ 1/ 97/ 046/ 006 98 tablets
73 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
74 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING