bhpardo/ema_en · Datasets at Hugging Face

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In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
Postmarketing Experience
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Tumour growth potential
2 BG-София 1407 Тел.: +359 2 806 3030
Usual warning symptoms may disappear in patients with longstanding diabetes.
Blood and the lymphatic system disorders U
1.
leukopenia, neutropenia, thrombocytopenia
Adults and adolescents (12 years of age and over): one 5 mg Azomyr orodispersible tablet placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
EU/ 1/ 95/ 003/ 010
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable.
PHARMACEUTICAL FORM
AVANDAMET 2 mg/ 500 mg film-coated tablets
In patients scheduled for major elective orthopaedic surgery, with a baseline haemoglobin of 10 to 13 g/ dl, the incidence of thrombotic/ vascular events (most of which were DVTs), in the overall patient population of the clinical trials, appeared to be similar across the different epoetin alfa dosing groups and placebo group, although the clinical experience is limited.
following treatment with any erythropoietin
LABEL/ SYRINGE
The active substance in Avandia, rosiglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Ask your pharmacist how to dispose of medicines no longer required.
Medicines should not be disposed of via wastewater or household waste.
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).
These can include:
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin alfa.
180
15.
After reconstitution, promptly dilute vials and do not store for subsequent use.
4.4 Special warnings and precautions for use
0.4 ml (100 µg/ ml)
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Norge Roche Norge AS Tlf: +47 - 22 78 90 00
Rare:
No effects on ability to drive and use machines have been observed.
1.
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
1 pre-filled syringe
Česká republika Eli Lilly ČR, s.r.o.
d ise 1.
9.8
Oral use.
In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.
Astellas Pharma Europe B. V.
MPS I is a heterogeneous and multisystemic disorder characterised by the deficiency of α -L-iduronidase, a lysosomal hydrolase which catalyses the hydrolysis of terminal α -L-iduronic residues of dermatan sulfate and heparan sulfate.
--------------------------------------------------------------------------------------------------------------------------- -- The following information is intended for medical or healthcare professionals only:
Clinically relevant hypocalcaemia should be corrected by intravenous administration of calcium gluconate.
HOW TO STORE APROVEL
OTHER SPECIAL WARNING(S), IF NECESSARY
The following adverse reactions have been identified during postmarketing use of Aranesp:
Progression-free survival and objective response rate were inferior in the Avastin monotherapy arm compared to the FOLFOX-4 arm.
15 January 2006
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Abseamed is given by injection under the skin (subcutaneously).
6.6 Special precautions for disposal and other handling
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
3 years.
EU/ 1/ 07/ 412/ 013 EU/ 1/ 07/ 412/ 014
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
5% (2%)
Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischaemic attack have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
(IU/ dl/ IU/ kg) Cmax (IU/ dl) Clearance (dl/ kg· h) MRT (h) VSS (dl/ kg) * Geometric Mean
Pharmacotherapeutic group; protease inhibitor; ATC Code:
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex).
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
500 IU and 1000 IU:
Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.
POSSIBLE SIDE EFFECTS
If you have other circulatory diseases, your doctor might also not prescribe BEROMUN
1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate)
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
11.
- if you are taking ergot alkaloids (such as dihydroergotamine, ergotamine, or methylergometrine) for
Slovenská republika BRISTOL-MYERS SQUIBB SPOL.
CONDITIONS OF THE MARKETING AUTHORISATION
Rebound hypertension has not been observed.
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium
POSSIBLE SIDE EFFECTS
If the haemoglobin exceeds 13 g/ dl (8.1 mmol/ l), discontinue therapy until it falls below 12 g/ dl (7.5 mmol/ l) and than reinstitute epoetin alfa therapy at a dose 25% below the previous dose.
Packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
In studies performed after the repeated administration of Caelyx to rats and dogs, serious dermal inflammations and ulcer formations were observed at clinically relevant dosages.
United Kingdom Roche Products Ltd.
Baraclude should not be used during pregnancy unless clearly necessary.
The final solution should be inspected visually for particulate matter before administration.
Solution for injection in a pre-filled syringe (injection)
MARKETING AUTHORISATION NUMBER(S)
Fondaparinux should not be prescribed to pregnant women unless clearly necessary.
See package leaflet.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Very rare:
Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.
Rare side effects These may affect up to 1 in 1,000 people: • fluid in the lungs (pulmonary oedema) causing breathlessness • heart failure • swelling of the retina at the back of the eye (macular oedema) • liver doesn’t function as well as it should (increase in liver enzymes).
It is used when the patient is considered to be at high risk of developing MS.
3.
6.6 Special precautions for disposal
Metabolism: low blood sugar
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON FOR BOTTLE) PARTICULARS TO APPEAR ON THE BOTTLE LABEL
Gastrointestinal disorders:
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies.
Italia Takeda Italia Farmaceutici SpA Tel: + 39 06 5026 01

In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).

Postmarketing Experience

The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.

Tumour growth potential

2 BG-София 1407 Тел.: +359 2 806 3030

Usual warning symptoms may disappear in patients with longstanding diabetes.

Blood and the lymphatic system disorders U

1.

leukopenia, neutropenia, thrombocytopenia

Adults and adolescents (12 years of age and over): one 5 mg Azomyr orodispersible tablet placed in the mouth once a day for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).

EU/ 1/ 95/ 003/ 010

In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable.

PHARMACEUTICAL FORM

AVANDAMET 2 mg/ 500 mg film-coated tablets

In patients scheduled for major elective orthopaedic surgery, with a baseline haemoglobin of 10 to 13 g/ dl, the incidence of thrombotic/ vascular events (most of which were DVTs), in the overall patient population of the clinical trials, appeared to be similar across the different epoetin alfa dosing groups and placebo group, although the clinical experience is limited.

following treatment with any erythropoietin

LABEL/ SYRINGE

The active substance in Avandia, rosiglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.

Ask your pharmacist how to dispose of medicines no longer required.

Medicines should not be disposed of via wastewater or household waste.

Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).

These can include:

There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin alfa.

180

15.

After reconstitution, promptly dilute vials and do not store for subsequent use.

4.4 Special warnings and precautions for use

0.4 ml (100 µg/ ml)

According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.

Norge Roche Norge AS Tlf: +47 - 22 78 90 00

Rare:

No effects on ability to drive and use machines have been observed.

1.

In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).

1 pre-filled syringe

Česká republika Eli Lilly ČR, s.r.o.

d ise 1.

9.8

Oral use.

In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.

Astellas Pharma Europe B. V.

MPS I is a heterogeneous and multisystemic disorder characterised by the deficiency of α -L-iduronidase, a lysosomal hydrolase which catalyses the hydrolysis of terminal α -L-iduronic residues of dermatan sulfate and heparan sulfate.

--------------------------------------------------------------------------------------------------------------------------- -- The following information is intended for medical or healthcare professionals only:

Clinically relevant hypocalcaemia should be corrected by intravenous administration of calcium gluconate.

HOW TO STORE APROVEL

OTHER SPECIAL WARNING(S), IF NECESSARY

The following adverse reactions have been identified during postmarketing use of Aranesp:

Progression-free survival and objective response rate were inferior in the Avastin monotherapy arm compared to the FOLFOX-4 arm.

15 January 2006

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Abseamed is given by injection under the skin (subcutaneously).

6.6 Special precautions for disposal and other handling

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

3 years.

EU/ 1/ 07/ 412/ 013 EU/ 1/ 07/ 412/ 014

MedDRA system organ class Skin and Subcutaneous Tissue Disorders

5% (2%)

Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischaemic attack have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.

(IU/ dl/ IU/ kg) Cmax (IU/ dl) Clearance (dl/ kg· h) MRT (h) VSS (dl/ kg) * Geometric Mean

Pharmacotherapeutic group; protease inhibitor; ATC Code:

The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex).

General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.

500 IU and 1000 IU:

Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.

POSSIBLE SIDE EFFECTS

If you have other circulatory diseases, your doctor might also not prescribe BEROMUN

1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate)

Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.

It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.

11.

- if you are taking ergot alkaloids (such as dihydroergotamine, ergotamine, or methylergometrine) for

Slovenská republika BRISTOL-MYERS SQUIBB SPOL.

CONDITIONS OF THE MARKETING AUTHORISATION

Rebound hypertension has not been observed.

SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium

POSSIBLE SIDE EFFECTS

If the haemoglobin exceeds 13 g/ dl (8.1 mmol/ l), discontinue therapy until it falls below 12 g/ dl (7.5 mmol/ l) and than reinstitute epoetin alfa therapy at a dose 25% below the previous dose.

Packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.

In studies performed after the repeated administration of Caelyx to rats and dogs, serious dermal inflammations and ulcer formations were observed at clinically relevant dosages.

United Kingdom Roche Products Ltd.

Baraclude should not be used during pregnancy unless clearly necessary.

The final solution should be inspected visually for particulate matter before administration.

Solution for injection in a pre-filled syringe (injection)

MARKETING AUTHORISATION NUMBER(S)

Fondaparinux should not be prescribed to pregnant women unless clearly necessary.

See package leaflet.

It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Very rare:

Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.

Rare side effects These may affect up to 1 in 1,000 people: • fluid in the lungs (pulmonary oedema) causing breathlessness • heart failure • swelling of the retina at the back of the eye (macular oedema) • liver doesn’t function as well as it should (increase in liver enzymes).

It is used when the patient is considered to be at high risk of developing MS.

3.

6.6 Special precautions for disposal

Metabolism: low blood sugar

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON FOR BOTTLE) PARTICULARS TO APPEAR ON THE BOTTLE LABEL

Gastrointestinal disorders:

Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).

A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies.

Italia Takeda Italia Farmaceutici SpA Tel: + 39 06 5026 01